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• PMID: 38924457
• Bookshelf ID: NBK604493
• DOI: 10.17226/27820

Racial and ethnic inequities in health and health care impact individual well-being, contribute to millions of premature deaths, and cost the United States hundreds of billions of dollars annually. Addressing these inequities is vital to improving the health of the nation’s most disadvantaged communities—and will also help to achieve optimal health for all. In 2003, the Institute of Medicine examined these inequities in Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care.

Because disparities persist, the National Academies convened an expert committee with support from the Agency for Healthcare Research and Quality and the National Institutes of Health. The committee’s report reviews the major drivers of health care disparities, provides insight into successful and unsuccessful interventions, identifies gaps in the evidence base, and makes recommendations to advance health equity.

Copyright © 2024, National Academy of Sciences.

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Homelessness and Kidney Disease—Time for Action

• 1 Division of Nephrology, Dell Seton Medical School, University of Texas at Austin, Austin
• Original Investigation Homelessness and Risk of End-Stage Kidney Disease and Death Among Veterans Alain K. Koyama, ScD; Robert Nee, MD; Wei Yu, MA, MS; Devasmita Choudhury, MD; Fei Heng, PhD; Alfred K. Cheung, MD; Monique E. Cho, MD; Keith C. Norris, MD, PhD; Guofen Yan, PhD JAMA Network Open

Kidney health disparities have been documented since the 1970s. Black and African American and Hispanic and Latine individuals are consistently more likely to develop kidney failure, yet are less likely to receive a kidney transplant, than White individuals. 1 Black men in the US are the demographic group with the highest lifetime risk of kidney failure and are disproportionately represented among people with kidney failure compared with the general population. 1 A study 2 examining the association of neighborhood socioeconomic status and racial differences with mortality among US adults receiving dialysis found that low socioeconomic status was associated with higher mortality, and the risk was higher for Black compared with White individuals living within the same zip code. These disparities persist despite advances in therapeutics for diabetes, hypertension, obesity, and other causes of kidney disease, suggesting that factors outside the clinic and access to health care are contributing.

Koyama et al 3 quantify the risk of kidney failure and death associated with homelessness among US veterans. Veterans are more likely than the general population to experience homelessness, and in 2010 US President Barack Obama and the Department of Veterans affairs announced a priority to eliminate homelessness for veterans. 4 This resulted in comprehensive veteran housing efforts, including investment in veteran-specific housing programs using a housing first approach, and funding programs that prevent veterans from becoming homeless. Screening for homelessness at outpatient Veterans Health Affairs clinics began in 2012, and positive screens triggered automatic referrals and enrollment in veteran-specific housing programs. 4 As a result of these exemplary efforts, the number of homeless veterans decreased from over 74 000 in 2010 to approximately 33 000 in 2024. 4

Koyama et al 3 conducted a retrospective cohort study of US veterans with incident chronic kidney disease (CKD) stages 3 to 5 between 2005 and 2017 and examined whether documentation of homelessness within the 2 years proceeding CKD diagnosis was associated with risk of kidney failure and death. 3 They found that homelessness was associated with higher risk of both kidney failure and death. The association with kidney failure was no longer significant after accounting for comorbidities, suggesting that comorbidity burden among those with homelessness was underlying this association. 3 They also found the association of homelessness with kidney failure attenuated in later study years, and was no longer significant after the first 6 years of follow-up. 3 The association between homelessness and mortality remained significant in fully adjusted models. 3

The findings of Koyama et al 3 support a growing body of evidence linking housing status with kidney health disparities. Housing has been associated with incident albuminuria, poor CKD risk factor control, delayed health care engagement among people with CKD, higher risk of kidney failure, and increased mortality among people undergoing dialysis. 5 Koyama et al 3 add to the literature by highlighting the impact of housing on kidney health even in the setting of having health care access, and the potential role for housing interventions.

Kidney health disparities are postulated to be partly associated with inconsistent health care access for historically vulnerable populations. For example, among patients receiving incident dialysis, living in a Medicaid expansion state was associated with significantly better 1-year survival compared with those living in non-Medicaid expansion states. 6 The study sample in Koyama et al 3 included veterans who were considered regular users of outpatient Veterans Health Affairs clinics, defined as a combination of at least 1 outpatient visit during the 2 years before incident CKD, and documentation in annual utilization files. All had health insurance and theoretically attended medical appointments. Yet, documented homelessness was still associated with worse outcomes, demonstrating that homelessness fragments care despite health care access.

Koyama et al 3 appropriately concluded that more aggressive outreach and disease control efforts are needed for patients with CKD experiencing homelessness. However, without intervening on homelessness itself, outreach efforts are less likely to be successful. Another novel contribution of this study was the secondary analysis demonstrating associations between homelessness and kidney failure attenuated with time. Considering the comprehensive screening, referral, and funding efforts that rolled out throughout the follow-up period, this may speak to the potential potency of housing interventions, particularly with respect to narrowing kidney health disparities.

Also notable was the high prevalence of homelessness in this study. 3 Approximately 6% of the sample had a documented history of homelessness, which was likely a conservative estimate considering the limitations in using electronic medical records to identify housing status. 5 An estimated 1% to 2% of the US population may experience homelessness in a given year, and 3.7% of US veterans have experienced homelessness at some point in their lives. 4 Although there are limitations to estimating the prevalence of unstable housing and making comparisons with national estimates, this may suggest housing issues are more common among people with kidney disease. Kidney failure is thought to be associated with homelessness due to the disease and treatment-related limitations on employment, financial resource strain, and increasing costs of housing throughout the country. 5 Given the morbidity and mortality associated with kidney failure, which are even higher when homeless, and that inflation-adjusted Medicare expenditures for patients with kidney failure totaled more than $50 billion in 2020, 1 research is needed to understand the potential benefit of replicating the veteran housing initiative for all people with kidney failure.

Achieving kidney health equity requires attention to those at highest risk. Koyama et al 3 add to the evidence supporting that people experiencing homelessness are among the most vulnerable. Prioritizing interventions on housing and other social determinants of health is needed to improve outcomes and advance care for this population.

Published: September 10, 2024. doi:10.1001/jamanetworkopen.2024.31906

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Novick TK. JAMA Network Open .

Corresponding Author: Tessa K. Novick, MD, MSW, MHS, Division of Nephrology, Dell Seton Medical School, University of Texas at Austin, 1601 Trinity St, Bldg B, Austin, TX 78712 ( [email protected] ).

Conflict of Interest Disclosures: None reported.

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Novick TK. Homelessness and Kidney Disease—Time for Action. JAMA Netw Open. 2024;7(9):e2431906. doi:10.1001/jamanetworkopen.2024.31906

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$3.5M grant funds major study on health disparities linked to childhood factors

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In the United States, wealthy people live on average 10 years longer than poor people, and Black people can expect to live an average of 5 years less than White people. Now, thanks to a $3.5 million grant, researchers will examine why these disparities persist – and how to address them. Led by University of Maryland SPH Professor Dahai Yue, a research team will gather large-scale historical data to understand and quantify how education and infectious disease in childhood play a role in these stark mortality disparities.

Yue, assistant professor in UMD's Department of Health Policy and Management and associate director at the Center on Aging, earned the grant from the National Institute on Aging (NIA), together with professors Adriana Lleras-Muney at the University of California, Los Angeles, and Joseph Price at Brigham Young University in Provo, Utah. 

The team will embark on an extensive study to gather, link and analyze data on the life and death of approximately 20 million people including a large and representative sample of Black people and White people to examine how certain childhood experiences impact longevity. Data will be collected from publicly available censuses from 1890 up to 1940 and from the National Death Index and linked to family tree information in the database of Family Search, a nonprofit genealogy company.

This is the first study to follow a huge sample of people from birth all the way to death, looking at the causal relationship between childhood origins of health and health disparities. To our knowledge, this will be the largest individual-level data-gathering on mortality in the U.S." Dahai Yue, University of Maryland SPH Professor 

Researchers will measure two key factors – quality of education and the infectious disease environment in childhood – against the age and cause of death of each person. Evidence shows that education and child health both play a significant role in determining someone's longevity, and that there are also substantial variations in these two factors between racial groups and geographical areas. 

"Our hope is that this research will contribute to policies that can improve health equity. And these are two very practical areas where policy-makers can use the results to make equitable decisions," said Yue. 

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Jie Chen, Ph.D., chair of the UMD Health Policy and Management Department and director of UMD's Center on Aging, also an investigator on the project, notes that the data-gathering element of the grant will in itself be a huge contribution to aging research. 

"This innovative research and the new datasets it will reveal on health, education, life expectancy and race will be invaluable resources for scientists, policy-makers and practitioners," Chen said. "It's a great example of what the Center on Aging is doing." 

This research is funded under NIH grant: R01AG088639.

University of Maryland

Posted in: Child Health News | Medical Research News | Healthcare News

Tags: Aging , Child Health , Education , Health Disparities , Life Expectancy , Mortality , pH , Research

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UC Irvine electronic patient-reported outcome tool reduces cancer care disparities

Alexandre Chan, chair and professor of clinical pharmacy practice at UC Irvine

Photo: Alexandre Chan

Management of cancer patients' symptoms always has been a challenge for providers, especially among racial/ethnic minoritized (REM) populations that often face health disparities that might negatively impact their health outcomes.

THE PROBLEM

Hence, over the years many researchers have evaluated whether electronic tools can help facilitate early recognition of symptoms.

These studies, however, were:

• Mostly implemented in populations that are mostly non-Hispanic white.
• Seldom involved allied health professionals (such as pharmacists) as a resource for symptom management with electronic patient-reported outcomes (ePRO) results.
• Rarely integrated multilingual tools particularly important among REM.

"Early recognition of health issues by pharmacists often is impeded by patients' limited health literacy or poor communication due to language barriers, issues that are highly prevalent among REM," said Alexandre Chan, chair and professor of clinical pharmacy practice at UC Irvine.

UC Irvine decided on an intervention building on the scientific framework backed by the National Institute on Minority Health and Health Disparities (NIMHD), which advocates for a multi-domain and multilevel approach to address health disparity.

"Improving early recognition of health issues among REM also may facilitate timely interventions," Chan explained. "Our results show the use of a multi-language ePRO for symptom management, spearheaded by oncology pharmacists, has the potential to address various health disparity issues faced by REM patients.

"And with REM patients being more likely to report certain symptoms – such as pain, nausea and vomiting – our results highlight the use of an ePRO can recognize these symptoms early, reducing health disparities in symptom severity."

MEETING THE CHALLENGE

Adult patients ages 18 years or older newly diagnosed with cancer and receiving intravenous anticancer treatment at the UCI Health Chao Family Comprehensive Cancer Center in Orange were evaluable for inclusion in the study.

Eligible patients were screened through the pharmacy schedule by oncology pharmacists within the electronic health record . The multilevel intervention incorporates ePRO measures to assist oncology pharmacists with symptom management in patients undergoing anticancer treatment. There were three components for the intervention.

"First, screening of symptoms using ePRO," Chan said. "Standardized ePRO assessments were administered through REDCap using computer adaptive tests (CAT). Patients were provided a dedicated iPad prior to or during their infusion and completed their assessments at their infusion chair. The ePRO comprised the Patient-Reported Outcomes Measurement Information System (PROMIS) measures developed by the National Institutes of Health.

"Our ePRO measured seven health domains: nausea and vomiting, physical impairment, anxiety, depression, fatigue, cognitive impairment, and pain interference," he continued. "All domains were administered as CAT, except nausea and vomiting. Measures were chosen to holistically assess toxicities of treatment and physical, mental and social health.

Patients' sociodemographic characteristics, responses to individual PROMIS items, and metrics of PROMIS utilization were also captured.

"Both English and Spanish versions were available," Chan noted. "When a specific language – for example, Vietnamese or Korean – was unavailable, we engaged medical interpreters through video remote technology. After a patient completed the ePRO, raw scores were transformed to degrees of severity (normal, mild, moderate and severe) based on normative thresholds in real time."

The second component is symptom management provided by trained oncology pharmacists.

"An oncology pharmacist immediately reviewed the results from symptom screening and delivered personalized symptom management and treatment counseling to the patient, with content that aligns with current requirements provided by the ASCO QOPI certification program standards," he said.

"Participating pharmacists attended an in-person training session to understand the workflow and to review existing care pathways," he added. "In addition, pharmacists could communicate and document treatment decisions, including ordering prescriptions, with other members of the oncology care team via the EHR ."

And the third component is study wrap-up and patients' follow-up. After each visit, patients were asked regarding their satisfaction and acceptability toward the program. Satisfaction was assessed using a single item: "How satisfied are you with the counseling provided by your pharmacist?" on a 5-point Likert scale (very dissatisfied to very satisfied) as adapted from similar studies.

"Acceptability to the length of the ePRO and education session were similarly assessed," Chan explained. "Finally, based on the pharmacist's assessment of patients' symptomatology, participants would either be discharged from the study based on mutual agreement or followed-up at a subsequent visit. This allowed the pharmacist to provide reassessment of patients' symptoms, additional interventions, and/or counseling as necessary.

"By facilitating symptom reporting and intervention, reducing language barriers, and improving communication, our intervention shows potential in addressing health disparity issues at various levels, for example, individual and interpersonal," he continued. "Importantly, our racial/ethnic distribution paralleled the demographic characteristics of the county where the study took place, and patients across racial/ethnic groups expressed willingness to continue with the intervention through multiple visits at a comparable rate."

By implementing an intervention that involves an electronic-patient reported outcome tool coupled with digital analytics, racial/ethnic minorities (Hispanic/Latinx and Asian patients) receiving chemotherapy treatment at Chao Family Comprehensive Cancer Center (a majority minority cancer center) unveiled two times higher likelihood in reporting pain as well as two times higher likelihood in reporting nausea and vomiting compared with non-Hispanic whites.

These findings are likely to be observed in other settings where REM patients diagnosed with cancer are being treated, Chan said.

"Additionally, we also have observed that Hispanic/Latinx patients are two times more likely to use urgent care compared with non-Hispanic white patients," he observed. "This also holds true among other ethnic patients – they are at four times more likely to use urgent care compared with non-Hispanic white patients.

"Using the intervention, the oncology pharmacists also were able to personalize the care of our patients," he continued. "With 90% of the patients expressing satisfaction, our ePRO-driven intervention, led by oncology pharmacists, facilitated symptom assessment and management."

ADVICE FOR OTHERS

Healthcare provider organizations should consider how their tool (if they are developing one) can personalize care if they are dealing with a similar problem, Chan advised.

"Besides integrating into electronic health records, they also need to think about whether they are able to engage pharmacists and providers on the ground to provide timely and immediate personalized symptom management," he concluded. "Additionally, it is important to engage with providers to ensure the organization understands the need of providers."

Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him:  [email protected] Healthcare IT News is a HIMSS Media publication.

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Emerging and Understudied Topics at the Intersection of Health Services Research and Climate Change

Research in health services is essential for informing policy decisions to address and forestall the detrimental health consequences of climate change. Part 2 of this blog series identifies priority health services research areas for continued health system reform to address the climate crisis.

Health Systems Resiliency and Opportunities for Health Services Research

Part 1 of this blog series discussed how health services research can inform climate change responses within health systems with attention to quality, cost, and health outcomes, as well as help policymakers identify what health care services are essential before, during, and after climate emergencies. The following topics include research areas receiving a lot of attention and understudied topics that should be prioritized to fill persisting gaps.

ESTABLISHED AND EMERGING RESEARCH AREAS 

Climate-impacts on health and well-being

The widespread  impact of climate change on population health has been well established. An  overview of systematic reviews on the health impacts of climate change identifies adverse climate-related effects on respiratory, cardiovascular, reproductive, neurological, nutritional, psychological, and occupational health.  A recent study in Nature  found that not only are large-scale weather disasters costly on municipal and federal budgets, but they are also associated with excess ED visits and mortality in Medicare beneficiaries. The Environmental Protection Agency (EPA) has documented the harmful health impacts of extreme heat events and identifies extreme heat as one of the leading causes of weather-related deaths. Marginalized racial and ethnic communities in urban areas experience  disproportionate vulnerability to extreme heat due to systemic racism and residential segregation which shapes “ thermal inequity .”

New care delivery models and emerging technologies

Another area that received increased research attention since the COVID-19 pandemic is digital-based care delivery models like telehealth.  Telehealth could be an important tool for lowering health care-related greenhouse gas emissions by  reducing the carbon footprint associated with facility usage, travel, and equipment costs. 

Health informatics and biomedical  research is also focusing on the use of digital health technologies and wearable devices in assessing individual-level climate risks and exposures. A  scoping review identified 142 studies examining how digital health technologies have been used to help manage climate change-triggered environmental health risks and infectious diseases and reduce the health care system’s contribution to greenhouse gases. For example,  wearable devices (e.g., Fitbits) can monitor the effect of heat stress and poor air quality on heart rate, sleep, and physical activity.  Smart phones and other mobile devices can be used to record data on how climate events impact dietary behavior and physical activity. 

UNDERSTUDIED TOPICS AND AREAS FOR FURTHER HSR CONTRIBUTIONS

Improving data collection and reporting of the health system’s impact on climate change

In April of this year, the Centers for Medicare and Medicaid Services (CMS) proposed a new rule which would, among many other things, support more streamlined collection and sharing of greenhouse gas emissions data between health systems and CMS. Should this new rule be implemented, participating states could voluntarily report metrics related to greenhouse gas emissions and receive technical assistance from CMS to help address threats to patient health due to climate change. Future health services research could evaluate the effectiveness of such climate-response mechanisms and whether there is sufficient uptake or whether increased organizational carbon footprint awareness results in downstream population health improvements. Another health services research topic of growing interest is how savings from health system decarbonization initiatives can be reinvested into expanding equitable access to health care resources.  

Collecting and analyzing climate-driven population health outcomes

How climate-related morbidities are recorded in electronic health records (EHR) and health insurance claims data is also  understudied . With  advancements in health data collection and reporting, health services researchers can pool longitudinal health insurance claims data together following climate events in specific geographic locations to understand risk factors, health care utilization patterns, and health care spending trends. EHR data can be used to link patient outcomes with region-specific climate events, environmental vulnerabilities, access to health care resources services, and community protective factors. The  National Center for Health Statistics (NCHS) is integral to shaping priorities for national health data collection, analysis and dissemination of statistical reports. During the  pandemic , NCHS quickly mobilized to develop a robust surveillance system of real-time COVID-19 mortality data. NCHS can adapt lessons learned during the pandemic to monitor and evaluate the collection of climate-related morbidities to guide health policy and public health practice.

Comparing region-specific climate exposures, disparities, and inequities

Health services researchers can employ analytic methods to compare the impact of climate-related risk exposures across an array of contrasting settings including comparisons between Medicaid-expansion versus non-expansion states, rural versus urban settings, and land-locked versus coastal regions. For example, health services researchers may explore whether Medicaid expansion and implementation of demonstration projects have resulted in meaningful improvements in health outcomes in climate-stricken areas. In addition, health services researchers can add to the  literature documenting how residential segregation and historic redlining practices have systematically placed toxic environmental exposures (e.g., landfills, waste treatment facilities, industrial agriculture farms) while simultaneously underinvesting in health-promoting infrastructure and health care resources in Black, Latino, and Indigenous neighborhoods. 

While several research areas related to health and climate change have received increased attention in the last decade, the evidence base surrounding health services and delivery reforms needed in response to adverse climate effects is still very nascent. Concerted efforts are needed across the health sector to build a resilient health system. Health services research can help bring these efforts together by generating evidence on the finance mechanisms, care delivery models, public health interventions, organizational structures, and workforce competencies needed to ensure our health system can withstand the pressures of climate change.

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The concepts of health inequality, disparities and equity in the era of population health

a Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, MA, USA

b College of Nursing, Daeyang University, Lilongwe, Malawi

Deogwoon Kim

Jacqueline fawcett, 1. introduction.

Unequal distribution of health and health care among groups of the U.S. population has been a national health problem at least since the founding of the country. The problem of differences in health status within the United States (U.S.). Population by factors such as race/ethnicity, gender, education, and geography ( National Academies of Sciences, Engineering, and Medicine, 2017 ) direct our attention and perspectives away from individual risk factors and toward factors that influence population health.

The term, “population health” has evolved over last three decades in response to the questions, “What makes some people healthy and others unhealthy?” ( Kindig, 2007 ; Robert Wood Johnson, 2017 ; Young, 2004 ) and “Why treat people's illness without changing what makes them sick in the first place?” ( WHO, 2008 ) These questions imply that there is an unequal distribution of health outcomes across populations as well as an unequal distribution of societal factors influencing health. Consequently, the concepts of disparity, inequity, inequality and their antecedents require our attention and should be incorporated as a guide for health policies and interventions targeted to populations. The purpose of this paper is to define health inequality, health disparity, and health inequity from a population health perspective and to illustrate the meaning of each term by presenting authentic real-world examples. This paper will extend our understanding of these concepts from an individual perspective to a population perspective ( Fawcett, 2019 ).

2. Definitions of health inequality, health disparities, and health inequity in population health

2.1. health inequality.

Dictionaries define inequality as the “quality of being unequal or uneven” ( Merriam-Webster, n.d. ). The term, health inequality, used in most countries other than the U.S., is based on the seminal work of Margaret Whitehead in the United Kingdom ( Whitehead, 2007 ), and refers not only to the quality of being unequal or uneven in health outcomes between groups but also to differences in social hierarchy. For the purposes of this paper, health inequality is defined as differences in the distribution of health status and achievement of health outcomes that exist among specific groups due to genetic or other factors that cannot be prevented or modified ( Kawachi et al., 2002 ).

Example 1 illustrates an unequal distribution of health conditions. These conditions are the result of gender associated biological differences rather than to avoidable social conditions ( Keyes & Galea, 2016 ). Women have a much higher incidence and morality of breast cancer than do men. Prostate cancer may be a better example of inequality of health conditions as only men can have prostate cancer, inasmuch as women obviously do not have a prostate gland.

An example of health inequalities: Differences in types of cancers by gender.

Gender inequalities by type of cancer: incidence and mortality of cancers worldwide ( GLOBOCAN, 2018 online analysis, http://globocan.iarc.fr ).

There is a higher incidence and mortality related to breast cancer among women than men.

2.2. Health disparities

Braveman et al. (2011) defined health disparities as systematic, plausibly avoidable health differences adversely affecting socially disadvantaged groups. In this definition, health disparities refer to both the different distribution of health outcomes as well as the different distribution of social determinants that are antecedents responsible for either promoting or decreasing the health of a population. Similarly, the U.S. Centers for Disease Control and Prevention ( CDC, 2018 ) defined health disparity as the preventable differences in the burden of disease, injury, violence, or the opportunities to achieve optimal health that are experienced by socially disadvantaged populations. These definitions refer to poor health outcomes among socially disadvantaged people without further specification. Healthy People 2010 had defined health disparities in very general terms as the differences in health among different population groups. It is interesting to note that one of the two overarching goals of Health People 2010 was “eliminating health disparities” which was a more aggressive change from “reducing health disparities” of Healthy People 2000. Recognizing the need for clarity, Healthy People 2020 defined health disparities as a particular type of health difference that is closely linked with economic, social, or environmental disadvantage ( National Academics of Sciences, Engineering, and Medicine, 2019 ). Thus, health disparity refers to the systematic difference in any measurable aspect of health outcomes across populations due to the different distribution of social conditions across these populations.

Example 2 illustrates the meaning of health disparities.

COVID-19 incident rates.

COVID-19 incidence rates by race.

The graph based on the CDC weekly COVID-19 data by race, from January 22, 2020 to May 30, 2020 depicts disproportionally high infection rates among minority ethnicity. Among the 1,761,503 aggregate cases reported to CDC, individual case reports for 1,406,098 were submitted to CDC case surveillance. Among 599,636 cases with known race and ethnicity, 34% were Hispanic or Latino of any race (Hispanic), 21% were non-Hispanic black (black). These findings pointed out to the fact that these groups account for 18% and 13% of the U.S. population, respectively, are disproportionally affected by the COVID-19 pandemic.

Example 2 focuses on COVID-19 infection incidence rates to illustrate differences in health outcomes due to the different distribution of social conditions of race, living conditions, occupations, and health care access which cause the deteriorating health outcomes of COVID-19 mortality ( Stokes et al., 2020 ). Disaggregating data by race reveals that there are higher rates of COVID-19 infection among Blacks and Hispanics in all age groups. Thirty-three percent of those infected were Hispanic, and 22% were Black, whereas these groups account for only 18% and 13% of the U.S. population ( U.S. Census Bureau, 2020 ), respectively. Physical risk factors such as CVD, diabetes, and chronic lung disease cannot fully explain why Blacks and Hispanics, especially, Hispanics are disproportionately infected with COVID-19 ( Stokes et al., 2020 ). Social determinants can help to explain this health disparity. The members of these ethnic minority groups are more likely to work in service industries that require interaction with the general public or close contract with co-workers, are not amendable to teleworking, and use public transportation ( U.S. Bureau of Labor Statistic, 2019 ; Substance Abuse and Mental Health Services Administration [SAMHSA], 2020 ) that place them at risk for exposure to COVID-19. They are more likely to be uninsured or/and do not have a usual source of health care, which are barriers to accessing COVID-19 testing and treatment ( Hayes et al., 2017 ; SAMHSA, 2020 ). Moreover, they are more likely to live in public, multigenerational, or multi-family housing where social distancing and self-isolation are impossible ( Cohn & Passel, 2018 ; SAMHSA, 2020 ). Thus, the definition and measurement of disparities in COVID-19 infection requires greater emphasis on understanding the places where they live and where they work.

2.3. Health inequity

Healthy People 2020 defines equity to mean social justice or fairness; it is an ethical concept, grounded in principles of distributive justice. The Secretary's Advisory Committee for Healthy People 2030 (2018) recommended that achieving health equity require eliminating avoidable, unjust, and unfair health inequities and health disparities through short- and long-term actions. However, Lowe (2015) has pointed out that equity in health is considered a value judgment on the equal or unequal health status of individuals, families, communities, or whole populations.

The term of inequity has evolved over time starting from differences between groups of people, with a focus on the quality of being fair, impartial, and inequality ( Oxford English Dictionary, n.d. ) to the World Health Organization ( WHO, 2020 ) definition of “the absence of avoidable or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically”. We posit that health inequity is the difference in health outcomes of populations due to avoidable antecedent factors, which is an unfair and social injustice.

Example 3 illustrates the health inequity of funding for sickle cell anemia (SCD) research. Approximately 70,000 to 100,000 Americans have sickle cell disease, the most common form of an inherited blood disorder. It is more common among people of African descent, about 1 in 13 carriers of the sickle cell gene are African American ( CDC, 2019 ). The difference in sickle cell anemia incidence across populations can be considered an inequality because sickle cell anemia is a genetic disease, which is caused by a mutation in the hemoglobin-Beta gene found on chromosome 11 ( Ashley-Koch et al., 2000 ; Steinberg & Sebastiani, 2012 ). This description sounds like health inequality because the difference is due to unavoidable biological factors. However, if this case is further unpacked we find that there are a number of avoidable factors including that life expectancy is 30 years shorter than people without sickle cell anemia, that the majority of the sickle cell anemia population are Medicaid beneficiaries, that these people experience longer waiting times to see a physician or get pain medication, and that the number of physicians trained and willing to treat sickle cell anemia patients is limited. Moreover, although this disease was discovered move than 100 years ago, there are only two medications that have been approved for treatment of the disease (see Example 3 ). This seems to indicate that this disease, which is most frequently found among Blacks, has received little attention including the research and funding necessary for better treatment. The differences in health outcomes in this case are a result of systemic and unjust distribution of treatment and research opportunities.

An example of health inequities in research funding: Sickle cell anemia disease and cystic fibrosis

NIH research funding and private, nonprofit association support of SCD and cystic fibrosis.

Sickle cell anemia disease (SCD) is the world's most common genetic disease, occurring in 1 of every 16,300 Hispanic-Americans and Whites, 1 of 365 Blacks (including 1 in 13 Black infants) ( CDC, 2019 ). However, National Institutes of Health research funding for cystic fibrosis, which occurs in only a third of the number affected by SCD, is 3.5 times than for SCD research, and private foundation funding is approximately 400 times higher for cystic fibrosis than for SCD.

3. Discussion

The terms inequality, disparity, and inequity are often used interchangeably in population health without clarification of their meanings, underlying values, and antecedents. For example, Healthy People's overarching goals increasingly recognize the differences in health outcomes of groups of the U.S. population and the importance of the societal impact on health. Healthy People 2000 was the first to introduce the term focused on reducing disparities, and it was strengthened in 2010 with a call to eliminate disparities. Health People 2020 included achieving equity and recognized the need for improving social and physical environments that promote health for all. However, it is important to define terms before developing metrics about them and deciding what we would like to accomplish. Therefore, we propose the definitions of equality, disparity, and equity in health we have given in this paper (see the Table 1 ). Clarifying these concepts and having accurate and meaningful metrics to measure the socioeconomic and demographic factors of health, as well as measures that address disparities in health and health care, can have a major impact on population health. It seems that the definitions of health equity are more than ones simply reflecting differences in health outcomes or that are empirically measurable. Measuring health inequities requires consideration of how to define unfair inequalities, inasmuch as social justice and fairness can be interpreted differently from different ethical, legal, and technical perspectives, these values may generate different definitions of health inequity. However, the distinctions are important because they inform health strategies and health policies that guide priorities and resource distribution to improve population health more broadly or to reduce health inequities with a focus on fairness and justice.

Definitions of concepts.

Noteworthy is that health inequity is linked with health disparity, inasmuch as health inequity is measured by health disparities metrics. In particular, whereas health disparity is the metric for assessing health equity, health inequity includes the additional dimension of the human right to have good health and social justice. Furthermore, inequities in health care are a result of unfair, avoidable differences in access to the resources needed to improve and maintain health or health outcomes and offer policy relevant information, whereas health inequality simply refers to the uneven distribution of health conditions or health outcomes.

4. Clinical implications

The WHO Constitution declared in 1948 that, “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition” ( Meier, 2017 ). This statement constitutes a very powerful mandate of moving toward health equity as a human right. Health equity is a subset of health differences between countries and within countries. It is relevant to social justice because these differences are deeply rooted in social conditions related to systematic associations with avoidable health differences. Clear definitions will assist us to develop effective health policies and strategies and determine priorities for use of limited resources and to accurately measure the health of populations and determinants of health as well as assess progress in these areas. However, the notion of “avoidability” can be highly subjective. Clarifying the meaning of health inequality, disparity, and inequity, with an understanding of the philosophical value-laden subjectivity of health equity will enable nurse practitioners, educators, researchers, and health policy makers to be more effective in advocating for what conditions make health disparities unfair and unjust and in development strategies to move toward health equity. This, in turn, may lead to further clarification and consistency in our communication about population health and fairness in the distribution of health outcomes and health resources.

CRediT authorship contribution statement

Haeok Lee: Conceptualization, Methodology, Writing - original draft. Deogwoon Kim: Resources, Visualization, Validation. SangA Lee: Resources, Visualization, Validation. Jacqueline Fawcett: Validation, Writing - review & editing.

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Part 1. Overview Information

Agency for Healthcare Research and Quality ( AHRQ )  

NOTE: The policies, guidelines, terms, and conditions stated in this Notice of Funding Opportunity (NOFO) may differ from those used by the NIH. Where this NOFO provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO. Also note that AHRQ has different page limits than NIH for the application Research Strategy, which can be found within each individual NOFO.

U19 Research Program – Cooperative Agreements

• August 22, 2024 - AHRQ Grantees - Upcoming Mandatory Submission of Final Reports in eRA’s Grant Closeout (GC) Module for AHRQ Awards that end after October 1, 2024. See NOT-HS-24-020.
• June 6, 2024 - Notice of Information to Publish Notice of Funding Opportunity Announcements for AHRQ’s Healthcare Extension Service to Accelerate Implementation of Patient-Centered Outcome Research Evidence into Practice. See NOT-HS-24-016 .
• May 13, 2024 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Improve Care Delivery, Access, Quality, Equity, and Health Outcomes for Older Adults. See Notice NOT-HS-24-013
• February 12, 2024 - Salary Limitation on AHRQ FY2024 Grants, Cooperative Agreements, and Contracts. See NOT-HS-24-007 .
• December 21, 2023  - Reminder of eRA Commons ID Requirement for All Personnel on the R&R Senior/Key Person Profile Form. See Notice NOT-OD-24-O42 .
• November 16, 2023  - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Improve Healthcare for Persons Living with Disabilities. See Notice  NOT-HS-24-004
• November 1, 2023 - Notice of Intent to Publish a Funding Opportunity Announcement to Create State-based Healthcare Extension Cooperatives to Accelerate Implementation of Actionable Evidence into Practice. See NOT-HS-24-003 .
• May 11, 2022 - Competitive Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Enhance Workforce Diversity in Health Services Research. See PA-22-175
• January 10, 2020  - AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b). See Notice  NOT-HS-20-005 .
• January 11, 2019 - AHRQ Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, effective FY2019. See NOT-HS-19-007 .

See Section III. 3. Additional Information on Eligibility .

The Agency for Healthcare Research and Quality (AHRQ) is developing a Healthcare Extension Service to accelerate the dissemination and implementation of patient-centered outcomes research (PCOR) evidence into healthcare delivery through improvements in healthcare policy, payment, and practice, and to reduce healthcare disparities especially among people who receive Medicaid, are uninsured, and other people who are medically underserved.  

This NOFO invites applications to establish and support State-based Healthcare Extension Cooperatives (referred to as Cooperatives) to conduct an initiative that is based on PCOR evidence to improve care for medically underserved people; the initiative's focus must be on behavioral healthcare. To support this initiative, the Cooperative will (1) engage key stakeholders including Medicaid agencies, managed care organizations, and other organizations that address the health needs of people who are medically underserved in identifying and addressing barriers and facilitators to implementing patient-centered healthcare delivery improvements that are based on PCOR evidence, (2) work with healthcare policy, payment, community, care delivery, and research organizations that serve people who are medically underserved to build their capacity to implement patient-centered healthcare delivery improvements based on PCOR evidence, and to support ongoing learning, (3) conduct evaluations of the Cooperative's activities and (4) provide the support structure to ensure these activities are integrated and aligned.

The Cooperative recipients will work closely with AHRQ and recipients of two related NOFOs: National Evaluation Center (NEC) for AHRQ's Healthcare Extension Service: State-based Solutions to Healthcare Improvement (U19) and National Coordinating Center (NCC) for AHRQ's Healthcare Extension Service: State-based Solutions to Healthcare Improvement (U54).  

30 days prior to the application due date

The application due date for this NOFO is December 12, 2024.

No late applications will be accepted for this NOFO.

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Not Applicable

Generally, four months after the receipt date

Generally, four months after the peer review date

It is critical that applicants follow the Multi-Project (M) Instructions in the  SF424 (R&R) Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the  NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at  http://www.ahrq.gov/funding/policies/nofoguidance/index.html .

When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section i. notice of funding opportunity description.

Purpose & Objective

The purpose of this Notice of Funding Opportunity (NOFO) is to accelerate the dissemination and implementation of patient-centered outcomes research (PCOR) evidence into healthcare delivery through improvements in healthcare policy, payment, and practice, and to reduce healthcare disparities especially among people who receive Medicaid, are uninsured, and other people who are medically underserved.  This NOFO will fund recipients to create State-based Healthcare Extension Cooperatives (Cooperatives) to conduct an initiative based on PCOR evidence to improve care for medically underserved people; the initiative's focus must be on behavioral healthcare. To support this initiative, the Cooperative will  (1) engage key stakeholders, including Medicaid agencies, managed care organizations, and other organizations that address the health needs of medically underserved people, in identifying and addressing barriers and facilitators to implementing patient-centered healthcare delivery improvements based on PCOR evidence, (2) work with healthcare policy, payment, community, care delivery, and research organizations that serve medically underserved populations to build their capacity to implement patient-centered healthcare delivery improvements based on PCOR evidence and to support ongoing learning, (3) conduct evaluations of the impacts and refinements of the processes of the Cooperative's activities, and (4) provide the support structure to ensure these activities are integrated and aligned.    

AHRQ’s Healthcare Extension Service will consist of the Cooperatives awarded under this NOFO, a National Coordinating Center (NCC) that will provide technical assistance to the Cooperatives, and a National Evaluation Center (NEC) that will report on the outcomes and impacts of AHRQ's Healthcare Extension Service. Cooperatives will collaborate with the NCC, NEC, AHRQ program staff, and other recipients of this NOFO to share approaches, methods, and data.

As this is one of three related NOFOs, applicants are strongly encouraged to review the other two to prepare applications for this one.

Background on Healthcare Extension

It can take a long time for new findings from PCOR to be implemented in healthcare delivery. There can be tremendous variation within and across healthcare delivery organizations and states in the quality and consistency of the delivery of evidence-based care. As seen in  AHRQ’s National Healthcare Quality and Disparities Reports, the United States often struggles to deliver high-quality, evidence-based care, particularly for lower-income people and people from certain racial and ethnic groups and geographic areas who receive their care from safety net healthcare delivery organizations.

Barriers to the dissemination and implementation of PCOR evidence into healthcare delivery include (1) policies and payment structures that do not align with implementing evidence-based care; (2) health information technology that does not produce real-time information that can be used for quality improvement and does not facilitate data sharing across healthcare settings; (3) workforce issues such as shortages, inefficiencies, and lack of training; (4) limited coordination and technical support for practice transformation; and (5) limited connections between healthcare delivery organizations and other sectors, such as public health and community organizations. These challenges occur across the healthcare delivery system and significantly affect more resource-challenged safety net healthcare delivery organizations.

A promising path to accelerate the dissemination and implementation of patient-centered healthcare delivery improvements is to build relationships and implementation capacity within and across organizations. At the state level, there needs to be coordination and alignment of improvement efforts through a systematic process inclusive of affected stakeholders, including but not limited to Medicaid agencies, managed care organizations, safety net healthcare delivery organizations, clinicians and staff, patients, and community-based organizations. On a more local level, improvements may also include delivering targeted support to local healthcare delivery organizations, improving healthcare delivery processes, and providing training, education, and other types of assistance to organizations, clinicians, and staff.

AHRQ's Healthcare Extension Service, modeled after the  U.S. Department of Agriculture Cooperative Extension System and incorporating principles from  learning health systems , proposes to help healthcare policy, payment, and delivery organizations overcome implementation barriers and improve the quality of healthcare services for medically underserved people through state- or system- and local-level, evidence-based improvements. Building from the strengths of these models, each recipient will support: 1. An Engagement, Training, Education, and Assistance Core; 2. A Monitoring, Feedback, and Evaluation Core; and 3. An Administrative Core. The Administrative Core will also establish and facilitate a Multistakeholder Council to provide expert advice and guidance to the Cooperative.  Each recipient will use this structure to complete an initiative focused on behavioral health during the award period that will accelerate the dissemination and implementation of patient-centered healthcare delivery improvements based on PCOR evidence and reduce health disparities within the State.

More specific details on the Extension Services are described below in Cooperative Components . Each applicant should partner with appropriate organizations within the state and build upon existing infrastructure to deliver all services and support the necessary administration and staffing for the Cooperative. Extension services may be provided by the recipient, organizations represented in the Multistakeholder Council, or other existing organizations that have arrangements with the recipient.

AHRQ's Healthcare Extension Service is aligned with AHRQ's mission to produce evidence that improves healthcare by making it safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. The Cooperative's structure and function detailed below are intended to address  AHRQ’s Patient Centered Outcomes Research Trust Fund Strategic Framework’s mission, goals, vision, and priorities. This includes early, ongoing, meaningful stakeholder engagement, addressing and measuring impacts on health equity, and supporting a wide range of healthcare delivery organizations.

Key Terms for this NOFO:

For purposes of this NOFO, the following definitions apply:

Behavioral Health: An umbrella term that includes mental health and substance use conditions, life stressors and crises, stress-related physical symptoms, and health behaviors.

Clinicians and staff:  An umbrella term that includes licensed, registered or certified health care providers who interact directly with patients, including but not limited to physicians, nurses, pharmacists, allied health professionals, technicians and technologists, health aides, and clinic staff.

Cooperatives:  See State-based Healthcare Extension Cooperatives below.

Evidence-based, patient-centered, healthcare delivery improvement ("Evidence-based improvement"): Consistent with Brownson and colleagues (1), evidence-based, patient-centered, healthcare delivery improvements are defined as healthcare delivery interventions, programs, education, training, practices, processes, guidelines, and policies with some evidence of effectiveness in improving health outcomes that are meaningful for patients and their caregivers. This includes clinical evidence, evidence on how best to deliver healthcare that is potentially generalizable beyond specific health conditions or healthcare delivery circumstances (e.g., management strategies, models of care), or evidence-based policies. (1) Brownson RC, Shelton RC, Geng EH, Glasgow RE. Revisiting concepts of evidence in implementation science. Implement Sci. 2022 Apr 12;17(1):26. doi: 10.1186/s13012-022-01201-y. PMID: 35413917; PMCID: PMC9004065.

Healthcare delivery organization: An organization of people, institutions, and resources that is responsible for the delivery of healthcare services to meet the healthcare needs of a target population. For the purposes of this NOFO, healthcare delivery organizations include but are not limited to health systems, hospitals, ambulatory care practices (including primary care practices and specialty practices), managed care organizations, pre-hospital services, community-based organizations that provide healthcare services, and skilled nursing facilities.

Healthcare Extension Agent(s): Individual(s) who provides external support to improve the healthcare delivery system to improve population health. Healthcare extension agents work to achieve the goals of the Cooperative. Examples of healthcare extension agents include education and training professionals; health IT advisors; human factors, systems engineering or task analysis experts; implementation experts; practice facilitators and coaches.

Multistakeholder Council: A group of stakeholders that come together to provide expert advice and guidance in support of the Cooperative. The Multistakeholder Council is responsible for identifying and providing advice on policy and system change(s) across the state that support the implementation of the Cooperative's initiative. Policy and system changes may include State and local policies as well as policies and practices within the healthcare delivery organizations that influence the implementation of evidence-based improvements.

Safety Net Healthcare Delivery Organizations: Healthcare delivery organizations that provide a significant level of healthcare and health-related services to medically underserved people, including people who are uninsured, receive Medicaid, people made vulnerable by poverty, and others. Examples of safety net organizations include Community Health Centers, Federally Qualified Health Centers (and look-alikes), CMS Rural Health Clinics, Safety Net Hospitals, Indian Health Service providers, pre-hospital service organizations, and primary care practices that serve these populations.

State-based Healthcare Extension Cooperatives (“Cooperatives”): State-level entities that serve as a coordinating entity for supporting the identification and delivery of patient-centered improvements within the State based on PCOR evidence.

Cooperative Components Requirements

Each Cooperative must include the following Cores: (1) Engagement, Training, Education, and Assistance Core, (2) Monitoring, Feedback, and Evaluation Core, and (3) Administrative Core. The Administrative Core will include a Multistakeholder Council (see below). The Cooperative will plan, execute, and evaluate an initiative focused on behavioral health within the award period. The leadership of the Cooperative is provided by the Program Director(s)/Principal Investigator(s).

Engagement, Training, Education, and Assistance Core

Engagement, Training, Education, and Assistance Core is responsible for establishing and maintaining relationships with safety net healthcare delivery organizations and community partners and providing training, education, and assistance to support the improvement goals of the initiative. Applicants are expected to build on existing relationships and that this core will be staffed with individuals with ties to the regions and communities they serve. Cooperatives may start by delivering extension services in sub-state regions.

• Healthcare extension agents will be key to implementing the Cooperative's initiative. Healthcare extension agents will be responsible for assisting with implementing the selected healthcare delivery improvements and implementation strategies based on PCOR evidence and informed by local and regional safety net healthcare delivery organizations, healthcare professionals, and patients and families. Healthcare extension agents will assist safety net healthcare delivery organizations develop an implementation plan. This plan must include the ability to tailor the implementation strategies to improve the fit with their organizations and make adaptations to address the needs of different populations the organization serves. Healthcare extension agents will learn from these partners about the regional and local successes and challenges in implementing evidence-based, patient-centered healthcare improvements in safety net healthcare delivery organizations. This will give the Cooperative a real-time understanding of implementation progress, guide potential adaptations to the intervention(s) or implementation strategies, and problem-solve issues with the Multistakeholder Council.   
• Healthcare extension agents may develop activities such as (1) convening a statewide or sub-state regional learning community, (2) providing tailored support to specific healthcare delivery organizations, (3) engaging managed care organizations in improving the quality of the services they deliver, (4) working with community-based organizations to encourage involvement in improvement activities, (5) presenting information to policymakers and payers to inform their decisions, (6) assisting organizations in leveraging their health information technology to build capacity to monitor improvement efforts, (7) analyzing and improving work processes and workforce composition, and (8) addressing healthcare workforce needs through training and education. They may also collect information about healthcare delivery organizations and community priorities and share their observations with other state initiatives.
• Given the breadth of activities that healthcare extension agents may perform, Cooperatives may deploy more than one type of agent to address these needs. If the applicant organization cannot employ healthcare extension agents directly, they must partner or subcontract with organizations with that capacity. Healthcare extension agents must focus on safety net healthcare delivery organizations but may work with other organizations to achieve the initiative's goals.
• Sharing local barriers and corresponding solutions to implementing healthcare delivery improvements as part of the initiative.
• Sharing local facilitators to implement healthcare delivery improvements as part of the initiative.
• Sharing methods for meaningful engagement and partnership with communities.
• Sharing resources from other state and federal initiatives to improve the initiative's implementation.
• Sharing interim results developed by the Monitoring, Feedback, and Evaluation Core from their monitoring efforts and giving feedback to improve implementation efforts as part of the initiative.

Monitoring, Feedback, and Evaluation Core

The Monitoring, Feedback, and Evaluation Core will be responsible for monitoring the formation and functioning of the Cooperative, applying feedback on improvements that may be needed, and evaluating the implementation, processes, and impact of the Cooperative. This core will assess the implementation, processes, and overall impact of the Cooperative’s initiative. This core will also be required to collaborate with the NEC, as specified below. The Monitoring, Feedback, and Evaluation activities must be performed by an organization within the state that can conduct a rigorous and independent evaluation, such as an academic medical center, public or private institutions of higher education, or other research organization. If the applicant organization cannot independently perform this, they must partner with an organization that can perform these tasks.

Collect and analyze qualitative and quantitative data to inform, monitor, and evaluate the Cooperative’s improvement initiative. The Cooperative must acquire and analyze state-level healthcare data and information to monitor the functioning and impacts of the Cooperative’s initiative. Examples of state-level data and information may include but are not limited to, quantitative data such as Medicaid claims data, state workforce statistics, and other data collected as part of federal or state programs, as well as qualitative data such as reports and information on state reimbursement policies and practices. These data should be shared on a regular and timely basis within the Cooperative, Multistakeholder Council and other relevant audiences.

Collect and summarize PCOR evidence on improvements and strategies for the Cooperative’s initiative.

Monitor the Cooperative’s activities and performance. The monitoring activities must focus on obtaining regular, frequent information on the Cooperative and initiative using measures and data reporting methods identified in collaboration with the NEC. Each Cooperative must:

• Monitor the Cooperative’s governance, operations, functioning, and initiative. Each Cooperative will collect data on its governance, operations, functioning, and initiative and share these data with the NEC.
• Report to NEC on measures of practice context, practice-level capacity, implementation, and process measures regarding the initiative's development, uptake of improvements, and implementation strategies as part of the initiative.
• Propose monitoring metrics and other measures, recognizing that Cooperatives will ultimately develop and use standard reporting measures identified in collaboration with the NEC after award. Each Cooperative may collect additional data beyond these standard reporting measures.

Feedback and Improvement. Each Cooperative must propose an approach for using self-monitoring and local evaluation data to support ongoing improvement of the initiative. Each Cooperative must:

• Detail a process for sharing monitoring and local evaluation data within the Cooperative to inform subsequent improvements.
• Share monitoring results and information regularly with partners in the state or sub-state region and the NCC to spread effective practices within the Cooperative and across other Cooperatives.
• Translate evaluation findings into information useful to the Cooperative, the Multistakeholder Council, healthcare delivery organizations, and decision-makers across the State.

Evaluate the Cooperative’s implementation and impact . Each Cooperative must evaluate the implementation and impact of their activities and the initiative. Each Cooperative must evaluate:

• Implementation of the overall Cooperative.
• Improvement in organizational outcomes, including organizational capacity, for healthcare delivery organizations participating in the initiative.
• The role of health information technology and health information exchange in the implementation and sustainment efforts of the initiative.
• Adoption, implementation, and sustainment of PCOR evidence-based, patient-centered healthcare delivery improvements throughout the initiative.
• The impact of the Cooperative and its initiative. The specific measures will be determined based on the initiative and will be proposed by the applicants, but they must include information such as the number of individuals who received evidence-based, patient-centered care as a direct result of the Cooperative and its initiative and any improvement in their health status.
• Impacts on health equity . This may include examining whether the Cooperative has sufficiently served safety net healthcare delivery organizations, delivered evidence-based, patient-centered improvement(s) equitably throughout the state, or addressed disparities in healthcare or health outcomes.

Administrative Core

The Administrative Core manages, coordinates, and supports the activities of the Cooperative and the initiative. 

• Promptly forms and administers the Cooperative, including its organizational and leadership structure, governance, and responsibilities of members and member organizations.
• Is responsible for the overall management of the Cooperative, including subcontracts, compliance with grant requirements, and meeting the proposed timelines.
• Hires and supervises staff.
• Establishes, manages, and facilitates the Multistakeholder Council (see Multistakeholder Council below).
• Identifies and coordinates with other similar initiatives in the state to develop collaboration opportunities and reduce duplication.
• Cooperates and collaborates with the NCC. The Cooperative will participate in the Learning Networks created by the NCC. The NCC will serve as the point of contact to provide or coordinate technical assistance involving the NEC as needed. The Cooperative will collaborate with the NCC to communicate and disseminate resources, tools, and learnings.
• Cooperates and collaborates with the NEC. The NEC will coordinate the monitoring of the progress of the Cooperatives across AHRQ's Healthcare Extension Service. The NEC will assist with sharing best practices for monitoring across the Cooperatives (see Monitoring, Feedback, and Evaluation Core above). The NEC will conduct the formative and summative evaluation of the entire initiative across all Cooperatives as well as conducting the process evaluation on the formation and function of each Cooperative. Each Cooperative must partner with the NEC to (1) harmonize measures, instruments, and data collection across the Cooperatives, (2) share instruments and data with AHRQ and the NEC, (3) participate in evaluation activities with the NEC, (4) review evaluation reports from the NEC and identify key actions based on the report findings.
• Disseminates resources, tools, and learnings in coordination with the NCC.
• Grant recipients, with input from the Multistakeholder Council, will discuss a long-term financial and operational sustainability plan for the Cooperative and its activities by the end of the third year of the grant. 

The Administrative Core will establish the Multistakeholder Council and is responsible for providing expert advice and guidance to the Cooperative. The Multistakeholder Council must, at a minimum:

• Guide Cooperative’s initiative focused on behavioral health  using a data-informed and collaborative process with a facilitator.
• Support the implementation of the Cooperative's initiative. Members of the Council will provide input during the initiative's implementation, including potential adaptations to implementation strategies to enhance its success. Proposed adaptations to the implementation strategies approved for the grant recipient must be within the original scope of the approved grant award.
• Provide guidance and support on state- and local-level barriers and facilitators to improvements that are part of the initiative. These activities may include providing recommendations to align payment policies and performance metrics, identifying workforce issues, enhancing timely and consistent data sharing, or developing healthcare delivery workflows and processes for healthcare delivery organizations.
• Support coordination with state-level efforts to improve healthcare policy, payment, and practice for safety net healthcare delivery organizations. This can include activities such as assisting with the identification of and coordination with other public and private improvement efforts occurring within the state or leveraging resources at the State and local levels to augment the Cooperative’s initiative.
• Evaluating the Cooperative's potential for long-term sustainability, including identifying opportunities for ongoing support for specific activities of the Cooperative.

Membership of the Multistakeholder Council. The Program Director(s)/Principal Investigator(s) and other key personnel from the project team will be critical participants in the Multistakeholder Council. Additional members should be determined based on the state context and the functions listed above, as well as the ability to develop the Cooperative's initiative. Each member of the Multistakeholder Council should have a clear role and purpose for participation that maps to the initiative's goals. Membership should be representative of the state’s demographic and geographic diversity. The Multistakeholder Council may establish working committees within the Council to work on specific topics, such as payment alignment or health information technology. To the extent possible, stakeholders representing organizations should have the authority to make commitments on behalf of their organizations. The members described below are required as they are instrumental in guiding and driving change in safety net healthcare delivery. It is expected that the Multistakeholder Council will include these members and additional members who can contribute to the success of the Cooperative. It is expected that the Multistakeholder Council will consist of at least 15 members. The exact size of the council will depend on the state context.

Required members for the Multistakeholder Council.  Applicants must include at least one member from each category listed below for the Multistakeholder Council.

• A representative from the State Medicaid agency or agency that manages Medicaid is required to be a full and active participant in the Multistakeholder Council. Where possible, they should work to align payment and performance metrics with the initiative's improvement goals and facilitate Medicaid data sharing and analysis with the Cooperative.
• A representative from Medicaid managed care organizations (MCOs) (if applicable): If the applicant’s State Medicaid-funded services are primarily delivered through MCOs, a representative from the largest MCOs must be included.
• An executive from safety net healthcare delivery organizations will be responsible for sharing needs and priorities from their respective organizations, aligning their organization’s improvement activities with the initiative, and sharing the barriers and facilitators they encounter with the Multistakeholder Council.
• Clinicians and staff from safety net healthcare delivery organizations. These individuals will explain how evidence-based improvements and implementation strategies would function in local healthcare delivery organizations.
• Patients, families, and caregivers who receive care from safety net healthcare delivery organizations or are members of underserved populations must participate to bring unique perspectives to the Multistakeholder Council, including but not limited to their personal experience in receiving healthcare in safety net organizations, in identifying health outcomes that are important to them, and in developing patient-centered improvements and strategies.
• Other members of the Multistakeholder Council. Additional members should include stakeholders relevant to the initiative of the Cooperative and the state’s healthcare landscape and may include representatives from (1) other state and local agencies and officials (e.g., public health departments, state behavioral health agencies), agencies that purchase state employee health benefits, governor’s health office, State insurance regulators, State legislators, foundations, Tribal or county officials), (2) other major payers in the State (e.g., private health insurance plans, self-insured employers, HHS/CMS regional representatives, foundations), (3) healthcare quality improvement and practice transformation organizations, (4) organizations that support health information technology, such as health information exchanges, (5) state associations and advocacy organizations (e.g., primary care associations, healthcare professional associations, patient advocacy groups), (6) community service organizations (e.g., social service agencies, food and hunger groups, homeless and housing organizations), (7) healthcare professional educators, such as Area Health Education Centers (AHECs), (8) Cooperative Extension Office, (9) academic medical centers, public or private institutions of higher education, or other research organizations based in the state that engage in healthcare research or improvement/extension-type activities.
• The AHRQ Program Official and other AHRQ staff may participate in the Multistakeholder Council as needed to provide support to the recipient.

Initiative: Behavioral Health

Each Cooperative must conduct an initiative focused on behavioral health to accelerate the dissemination and implementation of patient-centered healthcare delivery improvements based on PCOR evidence and reduce disparities in safety net healthcare delivery organizations.

The initiative should incorporate evidence-based improvements and corresponding implementation strategies based on PCOR findings that work at multiple levels to achieve a specific outcome. These activities should incorporate attention to future sustainability.

The initiative must address the current behavioral health crisis with the selected topic based on state data and stakeholder priorities. Applicants must specify the behavioral health focus of this initiative, including the evidence-based, patient-centered improvement(s) to be implemented in safety net healthcare delivery organizations. Applicants must describe a process by which the implementation of the evidence-based improvement(s) will be refined throughout the initiative based on input from the Multistakeholder Council, the Healthcare Extension Agents, and data from the Monitoring, Feedback, and Evaluation core.  The focus may be on a specific behavioral health condition or a strong behavioral health component or how behavioral healthcare is delivered or integrated into the medical safety net. When choosing their focus, applicants must use state data, PCOR evidence, data on health and healthcare disparities, and consultation with current or anticipated members of their Multistakeholder Council to determine their priorities. Applicants should describe their stakeholder engagement process to support their selection of initiative focus. An initiative may focus on a single area or combination that will accelerate the implementation of PCOR evidence in practice, including aligning payment, developing workforce, enhancing technology, or improving work performance and processes. Cooperatives should align and coordinate with other state and federal initiatives working on the same behavioral health issue.

Examples of Initiatives Responsive to this NOFO

Below are some examples of initiatives that would be responsive to this NOFO. Applicants should consider interventions that could be transformational in nature, providing whole-person, person-centered care, potential for addressing health-related social needs often contributing to mental health and behavioral healthcare treatment, and tailoring interventions across the life course.This list is not exhaustive of all possible initiatives that are responsive to this NOFO. 

Example Initiative: Unhealthy Alcohol Use Screening and Intervention. State data show that unhealthy alcohol use is a leading cause of death and disability. After conferring with the primary care association, medical professional associations, and the Medicaid agency, the applicant has learned that many safety net clinicians are unaware of effective screening and treatment options and of resources in their community. To reduce the rate of unhealthy alcohol use among adults in the state, the recipient will:

• Adapt existing resources for screening and brief intervention for unhealthy alcohol use for safety net healthcare delivery organizations.
• Send healthcare extension agents to train health system and practice champions in implementing these resources and help them develop linkages to recovery support organizations in the community for referrals.
• Provide additional training to develop the peer support workforce to integrate within healthcare delivery organizations.
• Engage the Multistakeholder Council to work on expanding the number of inpatient treatment centers in the State that accept Medicaid.
• Provide training and technical assistance to increase the number of clinicians that provide evidence-based whole-person care to individuals with unhealthy alcohol use. Training will focus on taking into consideration the impact of other health behaviors, physical health, and social determinants on unhealthy alcohol use, and the provision of evidence-based medications for alcohol use disorder.

Example Initiative: Integrated Screening and Treatment for Depression and Anxiety.  Reports from the four largest health systems in the State indicate that only a small portion of the adult population are being screened for depression, anxiety, and suicide risk per recommendations of the U.S. Preventive Services Task Force. Screening rates are lowest in Medical Shortage Areas where residents have lower incomes and are more likely to be uninsured or publicly insured. After convening stakeholders, including the Medicaid agency, major health systems, self-insured employers, small primary care practices, mental health advocacy groups, patients with depression and family members, community mental health centers, and leaders from immigrant communities, the applicant has concluded that this topic is a priority for their State to address and that stigma and lack of trust are barriers to screening and treatment. To decrease the rates of depression and anxiety among adults in the state, the recipient will:

• Use healthcare extension agents to help healthcare delivery organizations implement integrated screening and provide evidence-based resources for treating depression and anxiety.
• Work with community leaders to develop a culturally and linguistically appropriate awareness campaign to encourage participation in screening and treatment.
• Train community health workers employed by health systems to conduct screenings and follow up on referrals for treatment.
• Members of the Multistakeholder Council will identify and address workforce shortages in behavioral health to support the increased need for treatment generated by the systematic screening effort.

Example Initiative: Implementing the Collaborative Care Model. Studies in the State have demonstrated that immigrants, Hispanic persons, and African American persons seek mental health services at lower rates, and they have fewer completed referrals than White persons. There is also a documented shortage of mental health clinicians who serve Medicaid beneficiaries and the uninsured. The State’s Community Mental Health Association, the State’s Refugee Coordinator, several networks of rural and community health centers, and two Medicaid managed care plans have agreed to implement the Collaborative Care Model, which is effective and efficient and to reduce mental health disparities. The recipient will:

• Engage the Multistakeholder Council in increasing the behavioral health workforce and its diversity.
• Engage the Multistakeholder Council to set standards and reimbursement levels for the Collaborative Care Model and align payment policies across several payers within the State.
• Implement mental health shared care plans so that all primary care and behavioral health clinicians on the Collaborative Care Model Team can access the care plan electronically.
• Develop and have healthcare extension agents deliver training and coaching to provide the skills and tools to implement culturally appropriate collaborative care across a range of underserved populations.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, AHRQ scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

The  OER Glossary  and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s).

AHRQ intends to fund up to 15 awards. The number of awards is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Future year funding is contingent upon the availability of funds for each year of support.

The total costs (direct and indirect) for a project awarded under this NOFO will not exceed $6.25 million in any given year and $25 million for the entire project period.  Applicants may propose different total annual budgets based on their proposed approach.

An application with a budget that exceeds $6.25 million total costs in any given year or that proposes a project period less than five years will not be reviewed. 

Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS  Grants Policy Statement . 

The project period must be 5 years.  

These projects are being funded pursuant to 42 USC 299b-37 which authorizes AHRQ to make these awards to support the agency's dissemination of comparative clinical effectiveness research findings

All applications submitted and AHRQ grants made in response to this NOFO are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards;  https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , the HHS Grants Policy Statement (see  https://www.ahrq.gov/funding/policies/hhspolicy/index.html ), and the terms and conditions set forth in the Notice of Award.

Section III. Eligibility Information

1. eligible applicants eligible organizations higher education institutions public/state controlled institutions of higher education private institutions of higher education the following types of higher education institutions are always encouraged to apply for ahrq support as public or private institutions of higher education: hispanic-serving institutions historically black colleges and universities (hbcus) tribally controlled colleges and universities (tccus) alaska native and native hawaiian serving institutions asian american native american pacific islander serving institutions (aanapisis) nonprofits other than institutions of higher education nonprofits with 501(c)(3) irs status (other than institutions of higher education) nonprofits without 501(c)(3) irs status (other than institutions of higher education) for-profit organizations small businesses for-profit organizations (other than small businesses) local governments state governments county governments city or township governments special district governments indian/native american tribal governments (federally recognized) indian/native american tribal governments (other than federally recognized) federal governments eligible agencies of the federal government u.s. territory or possession other independent school districts public housing authorities/indian housing authorities native american tribal organizations (other than federally recognized tribal governments) faith-based or community-based organizations regional organizations hhs grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. if consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the recipient and what substantive role the applicant organization will play. justification can be provided in the specific aims or research strategy section of the phs398 research plan component sections of the sf424 (r&r) application.  there is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.  foreign organizations foreign components, as defined in the hhs grants policy statement via https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf may participate in projects as member of consortia or as subcontractors only. non-domestic (non-u.s.) entities (foreign organization) are not eligible to apply. non-domestic (non-u.s.) components of u.s. organizations are not eligible to apply. required registrations applicant organizations applicant organizations must complete and maintain the following registrations as described in the how to apply- application guide to be eligible to apply for or receive an award. all registrations must be completed prior to the application being submitted. registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.  system for award management (sam) – applicants must complete and maintain an active registration, which requires renewal at least annually . the renewal process may require as much time as the initial registration. sam registration includes the assignment of a commercial and government entity (cage) code for domestic organizations which have not already been assigned a cage code. nato commercial and government entity (ncage) code – foreign organizations must obtain an ncage code (in lieu of a cage code) in order to register in sam. unique entity identifier (uei) - a uei is issued as part of the sam.gov registration process. the same uei must be used for all registrations, as well as on the grant application. era commons - once the unique organization identifier is established, organizations can register with era commons in tandem with completing their grants.gov registration; all registrations must be in place by time of submission. era commons requires organizations to identify at least one signing official (so) and at least one program director/principal investigator (pd/pi) account in order to submit an application. grants.gov – applicants must have an active sam registration in order to complete the grants.gov registration. program directors/principal investigators (pd(s)/pi(s)) all pd(s)/pi(s) must have an era commons account.  pd(s)/pi(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in era commons. if the pd/pi is also the organizational signing official, they must have two distinct era commons accounts, one for each role. obtaining an era commons account can take up to 2 weeks. eligible individuals (program director/principal investigator) any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director(s)/principal investigator(s) (pd(s)/pi(s)) is invited to work with his/her organization to develop an application for support.  individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for ahrq support. for institutions/organizations proposing multiple pds/pis, visit the multiple program director/principal investigator policy and submission details in the senior/key person profile (expanded) component of the sf424 (r&r) application guide. the ahrq multiple pds/pis policy can be found at https://grants.nih.gov/grants/guide/notice-files/not-hs-16-018.html . pd/pi(s) level of effort: for the overall cooperative, a single pd/pi must devote at least 20% minimum fte (i.e., at least 8 hours per week) in each given year of the project. if multiple pd(s)/pi(s) are proposed, each pd/pi must devote at least 10% minimum fte (i.e., at least 4 hours per week). if any effort is in-kind, this should be explained in the budget justification, and a letter of support from an authorized institutional official is required.  2. cost sharing.

This NOFO does not require cost sharing.

While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. Additional Information on Eligibility

Applicant organizations may NOT submit more than one application.

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. 

Applications that describe proposed improvements in healthcare policy, payment, and practice work to be conducted in more than one state will be deemed non-responsive and will not be reviewed. 

Section IV. Application and Submission Information

1. requesting an application package.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most AHRQ opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review. 

In addition, by sending a letter of intent, an applicant is giving AHRQ permission to share the information in the letter of intent with other submitters from your State. AHRQ strongly urges potential applicants in a State to collaborate on a single application. 

By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Matthew Simpson, MD, MPH  Division of Practice Improvement Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Email: [email protected]   

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application. The application should consist of the following components: Overall: required Engagement Core: required, maximum of 1 Monitoring Core: required, maximum of 1 Administrative Core: required, maximum of 1 Initiative: required, maximum of 1 Pre-application Technical Assistance Conference Calls

AHRQ encourages applicants to check the following webpage for resources for this NOFO:    AHRQ’s Healthcare Extension Service Initiative | Agency for Healthcare Research and Quality . AHRQ encourages applicants to take advantage of any TA webinars that may be held by AHRQ program staff. Participation is optional and is not required to apply. Information about a TA webinar will be published through the NIH Guide and posted on the AHRQ website. 

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Follow standard instructions.

Research & Related Other Project Information (Overall)

Project/performance site locations (overall).

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

Budget Component: Special Instructions for AHRQ applications.

AHRQ is not using the Modular Grant Application and Award Process. Recipients applying for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

Budget Allocation:

• PI(s) Level of Effort: For the overall Cooperative, a single PD/PI must devote at least 20% minimum FTE (i.e., at least 8 hours per week) in each year of the project. If multiple PD(s)/PI(s) are proposed, each PD/PI must devote at least 10% minimum FTE (i.e., at least 4 hours per week). If any effort is in-kind, this should be explained in the budget justification, and a letter of support from an authorized institutional official is required.
• There are no requirements for the level of effort for each core.
• Travel: Applicants must budget for up to four key personnel to travel to the Washington, DC area once each year to meet with individuals from the NCC, NEC, AHRQ staff, other recipients, and any invited guests for a two-day meeting.
• Evaluation liaison: Applicants must designate an Evaluation Liaison to collaborate with AHRQ and the NEC on all evaluation matters. The Evaluation Liaison must be designated as key personnel and have at least 25% FTE dedicated to Evaluation Liaison activities. If the PD(s)/PI(s) or other key personnel will serve in this role, FTE requirements are cumulative.
• Multistakeholder Council: Applicants should budget for reasonable and allowable costs for participation in Multistakeholder Council meetings, where applicable. (see https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf. )

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Clearly indicate the state you will be working in to meet the objectives of the NOFO, and describe the overall focus of the Cooperative and proposed initiative. Summarize the expected outcome(s) of the Cooperative as a whole, including the impact that the results of the proposed initiative will have in the state, particularly as it relates to reducing disparities for safety net populations. Briefly describe how the Cooperative is structured and how the cores and initiative alone and together fit into the overall goals. 

Research Strategy: This section should summarize the structure and the overall strategy for the design and approach of the Cooperative. This section should also describe the coordination with other federally funded initiatives, state initiatives, as well as with the NCC and the NEC. The Research Strategy must consist of the following sections:

State-based Healthcare Extension Cooperative Overview.

• How the cores contribute individually and collectively to achieve the goals of this NOFO.
• Experience and capacity of investigators to engage in the proposed work, including relationships with key stakeholders.

Responsiveness to State Healthcare Environment. In this section, applicants must describe characteristics of healthcare in their state to demonstrate that the proposed work will address known challenges and to build sustainable learning and improvement systems at the state level to accelerate implementation of evidence-based improvements in healthcare policy, payment, and practice and reduce healthcare disparities especially among Medicaid, uninsured, and medically underserved people. Applicants must also describe current healthcare disparities in their state and how their proposed work may address those disparities. Relevant information may include:

• The state’s population, demographics, healthcare insurance coverage, quality, and health outcomes. For states with an American Indian or Native Alaskan population, applicants should describe the healthcare environment for these communities.
• The state of healthcare quality in the safety net, including metrics that demonstrate a gap between current and evidence-based practice.
• Disparities in healthcare access, delivery, and outcomes in uninsured individuals, Medicaid recipients, and racial and ethnic minorities including tribal members.
• The state’s Medicaid environment, including managed care arrangements.
• The current state of healthcare for the behavioral health focus that the applicant has selected, including current payment policies and incentives, workforce policies and characteristics, health information technology, and gaps between evidence-based practice and actual care delivery.
• Existing quality improvement support to safety net healthcare delivery organizations in the state.
• Existing initiatives within the state, including federally funded state initiatives and a plan to ensure coordination, rather than duplication, with these initiatives. 

Letters of Support: Letters of support from partner organizations and entities should specify the nature of collaboration and their role in the Cooperative. Applications must include letter(s) of support from an institutional official that endorses the proposed Cooperative and describe the available institutional resources that will support the activities of the Cooperative. Letters from individuals who will serve as consultants or collaborators on the project, but with no specified levels of efforts, should also be included. Do not include letters from individuals who will be supported by the grant who are named in the application.  Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included. (i.e., general letters of support for the project) .

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:  Data Management Plan should NOT be submitted under Other Plans attachment, it is to be submitted under Resource Sharing  plan as per AHRQ DMP policy.

Submission of a data management plan is required. AHRQ applicants are reminded to refer to NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy ( https:/grants.nih.gov/grants/guide/notice-/NOT-HS-20-011.html  for additional information on how to incorporate their data management plan into the resource sharing plan.

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide ; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note:  Delayed onset  does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

When preparing your application, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Research & related other project information (administrative core).

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Travel Funds: The budget should include funds to support travel for members of the Multistakeholder Council to attend meetings.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims:  Clearly state how the Administrative Core will provide leadership for the Cooperative and coordinate the proposed activities and maintain internal information flow. This includes managing and coordinating interaction among the PD/PI(s), the cores, personnel at the applicant institution as well as outside institutions, the Multistakeholder Council, stakeholder organizations, appropriate institutional administrative personnel, and the staff of the awarding agency.

Research Strategy:   In this section, applicants must describe the structure, governance, and operations of the proposed Cooperative. This includes descriptions of the following:

• Clearly indicate the state that the applicant will be working in to meet the goals of the NOFO.
• Structure, leadership, and governance of the Cooperative. AHRQ anticipates that multiple organizations may need to form a partnership for this cooperative agreement, which may include multiple subawards, a multiple PI arrangement, and funding to additional organizations and individuals. Applicants must describe the roles and responsibilities of each organization and key personnel and any history of working together. Applicants must include an organizational chart and describe the governance and management of the Cooperative.
• Staffing. Describe specific expertise of the Overall PDs/PIs, Leaders for each Core, and other Key Personnel that makes them appropriate for their proposed roles, without duplicating information in biosketches. For the Overall PD(s)/PI(s), describe prior experience leading multi-institutional endeavors. Describe how this team has previously collaborated. Include a description of proposed partnerships between organizations and include evidence of prior collaborative projects, if applicable, and how their expertise is complementary and will strengthen the Cooperative. Include plans for hiring any staff needed for the cores and initiatives.
• capacity to organize and manage the Multistakeholder Council, and to work collaboratively across key state agency, payer, clinical, and community-based partners to provide expert advice and recommendations for system change across the State.
• ability to serve as a facilitator or identify a facilitator that will be able to recruit and work with all types of stakeholders.
• ability to develop a governance policy for the Multistakeholder Council that specifies data and evidence that will be used by the Multistakeholder Council to inform decisions and the process by which decisions are made. 
• The applicant must describe the activities the Multistakeholder Council will undertake, in keeping with those stated in the Requirements section for this NOFO.
• Demonstrate that their Multistakeholder Council will be demographically and geographically diverse and include the full range of those individuals and organizations that drive healthcare improvement in the State, including those who represent community perspectives and those with lived experiences. Applicants must demonstrate that the State Medicaid agency plays a central role in the Council and that other key players in healthcare improvement in the State are involved.
• The Cooperative’s relationship with other organizations and initiatives, including how the Cooperative will coordinate implementation support throughout the state and complement – not duplicate – other state and federal initiatives. Applicants that are building upon existing entities or initiatives in the state must describe what specific enhancements will be funded through this cooperative agreement, how they were identified, and how they are expected to contribute to the objectives of this NOFO. Grants may not be used to supplant funds already being spent in the state to increase the delivery of evidence-based interventions.
• The applicant must describe how they will coordinate with state-level convenings of State Medicaid Agencies, payer partners and other stakeholders in Innovation Models from the Centers for Medicare & Medicaid Services Innovation Center (e.g., Making Care Primary Model, States Advancing All-Payer Health Equity Approaches and Development Model).
• The Cooperative’s finances, including in-kind support (which is highly encouraged) and how the Cooperative will ensure equitable distribution of funds among partners and organizations. AHRQ expects the initiative to be inclusive of organizations that are not traditionally AHRQ recipients, such as community-based organizations, and patient organizations. Applicants must describe how funding will flow to such partners in a way that ensures their full participation.
• Operational or Work Teams that will carry out the work of the Cooperative, including staffing, contracting, and hiring plans.
• Project Timeline, including a detailed timeline and a Gantt Chart (or other similar graphic timeline) documenting when all major aspects of the proposed work will be conducted and completed.
• Mitigation strategies, including the potential challenges, barriers, and facilitators to establishing a Cooperative and proposed strategies to address them.
• Collaboration with the National Coordinating Center, including a commitment to participate in Learning Networks and technical assistance activities.
• Collaboration with the National Evaluation Center, including a commitment to harmonize measures across the initiative, share instruments and data with the NEC and AHRQ, and participate in evaluation activities by the NEC.
• Collaboration with AHRQ: Describe plans to engage with AHRQ on key activities and decisions.
• Description of how the Multistakeholder Council members will prepare for operations after the end of this award (e.g., diversifying funding sources). Applicants may find  Finding Sustainable Funding for Primary Care Extension Programs a useful resource.

Letters of Support: Provide letters of support from the Institution(s) and partners that are included in the Cooperative.

The application must include letters of support from collaborating organizations and individuals which document specific contributions, including but not limited to a description of the precise nature of past and proposed collaborations, products, services, and other activities that will be provided by and to the applicant through the proposed collaboration.

Applicants must submit a letter of support from the State Medicaid Agency. Letters of support from the State’s Medicaid Agency must:

• Describe the commitment to participate in the Multistakeholder Council.
• Identify specific individuals within the State Medicaid Agency who will participate in the Cooperative.
• Detail the role that these individuals and the State Medicaid Agency will have within the Cooperative.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide,

PHS Human Subjects and Clinical Trials Information (Administrative)

When involving human subjects research, clinical research, and clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information  form or a Delayed Onset Study record.

All instructions in the SF424 (R&R) Application Guide must be followed

Note:  Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, use Component Type ‘Core.’

SF424 (R&R) Cover (Engagement, Training, Education, and Assistance Core)

Phs 398 cover page supplement (engagement, training, education, and assistance core), research & related other project information (engagement, training, education, and assistance core), project /performance site location(s) (engagement, training, education, and assistance core), research & related senior/key person profile (engagement, training, education, and assistance core).

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

Budget (Engagement, Training, Education, and Assistance Core)

Phs 398 research plan (engagement, training, education, and assistance core).

Specific Aims:      

Research Strategy: In this section applicants must describe their approach to the following activities:

Engage safety net healthcare delivery organizations and clinicians to establish and maintain relationships or build upon previous relationships. Applicants must describe:

• How the Cooperative’s engagement strategies will attract safety net healthcare delivery organizations and clinicians with varying degrees of organizational readiness.
• How the Cooperative will draw on existing learning and improvement networks such as quality collaboratives.
• How the Cooperative will coordinate within states where there are other state-level learning communities. Examples of state-level learning communities include, but are not limited to, learning communities that are formed as part of Innovation Models from the Centers for Medicare & Medicaid Services Innovation Center (e.g., Making Care Primary Model, States Advancing All-Payer Health Equity Approaches and Development Model).
• The potential challenges, barriers, and facilitators to engage safety net organizations and proposed strategies to address them.

Design and deliver implementation support , including:

• Describe how healthcare extension agents will aid with the implementation of the selected healthcare delivery improvements and implementation strategies as part of the initiative.
• Describe how healthcare extension agents will assist safety net healthcare delivery organizations with the development of an implementation plan, including the ability to tailor the implementation plan to the organization, clinicians, staff, and patient populations served by the organization.
• Describe how healthcare extension agents will work with healthcare delivery organizations, including the number and type of safety net organizations and clinicians that may be engaged, with what levels of intensity, at what points in time, and for how long.
• Describe the range of implementation support the Cooperative will provide for the initiative. Support may include education & training, practice facilitation, health IT support, local learning opportunities, expert consultation, quality measurement standardization and support, financial management guidance, community resource identification, tele-mentoring, task analysis, and workforce development.

Facilitate learning across the state or sub-state region:  Applications must describe the approach to facilitating learning across the state or sub-state region, including:

• How the Cooperative will learn from the healthcare extension agents, healthcare delivery organizations, clinicians, and staff about local or regional successes and challenges with implementation of the initiative.
• How the Cooperative will share this information with healthcare extension agents, healthcare delivery organizations, clinicians, and staff to iteratively improve the initiative.
• How the Cooperative will share this information with the NCC.
• How the Cooperative will share PCOR evidence, evidence-based resources and learnings from other state and national initiatives with healthcare extension agents, healthcare delivery organizations, clinicians, and staff in their state or sub-state region.

Letters of support from partner organizations and entities should specify the nature of collaboration and their role in the Engagement, Training, Education, and Assistance Core. Applications must include letter(s) of support from an institutional official that endorse the proposed approach for the Engagement, Training, Education, and Assistance Core and describe the available institutional resources that will support the activities of the Engagement, Training, Education, and Assistance Core. Letters from individuals who will serve as consultants or collaborators on the project, but with no specified levels of efforts, should also be included. Do not include letters from individuals who will be supported by the cooperative agreement and are named in the application.

PHS Human Subjects and Clinical Trials Information (Engagement, Training, Education, and Assistance Core)

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed

SF424 (R&R) Cover (Monitoring, Feedback, and Evaluation Core)

Phs 398 cover page supplement (monitoring, feedback, and evaluation core), research & related other project information (monitoring, feedback, and evaluation core).

Application guide states that Project Narrative is required.  However, it is only required for the Overall component.  If you would like the applicant to provide a project narrative for this component, update the above instructions accordingly. Specific names provided for Other Attachments must be no more than 50 characters including spaces.

Project /Performance Site Location(s) (Monitoring, Feedback, and Evaluation Core)

Research & related senior/key person profile (monitoring, feedback, and evaluation core), budget (monitoring, feedback, and evaluation core), phs 398 research plan (monitoring, feedback, and evaluation core).

Specific Aims:  Succinctly describe the specific objectives and goals of the Monitoring, Feedback, and Evaluation Core. In addition, list in priority order, the broad activities, and services of the Monitoring, Feedback, and Evaluation Core. In addition, state the Core's relationship to the other Cores in the Cooperative, the initiative in the application, and the National Evaluation Center.

Research Strategy: In this section applicants must describe their monitoring, feedback, and evaluation plans, including:

• Data sources including state-level data
• The approach to identifying PCOR evidence and corresponding implementation strategies and sharing this information with the Multistakeholder Council for the initiative.
• The approach to analyzing and sharing state data with the Multistakeholder Council.
• The approach to monitoring and sharing Cooperative activities and performance.
• The approach to evaluating the process of Cooperative formation and growth, the engagement of stakeholders, the processes and outcomes of the Multistakeholder Council, the processes and outcomes of the Engagement, Training, Education, and Assistance Core. Describe process, implementation, and outcome measures; data sources and collection; and analysis plan.
• Describe how health equity and disparities will be incorporated throughout monitoring and evaluation activities.
• Describe how feedback will be delivered to improve the processes and operations of the Cooperative and its initiative.
• A commitment to work with AHRQ’s NEC on the evaluation, including sharing monitoring and evaluation data and cooperating with qualitative data collection activities. 

Letters of support from partner organizations and entities should specify the nature of collaboration and their role in the Monitoring, Feedback, and Evaluation Core. Applications must include letter(s) of support from an institutional official that endorse the proposed approach for the Monitoring, Feedback, and Evaluation Core and describe the available institutional resources that will support the activities of the Monitoring, Feedback, and Evaluation Core. Letters from individuals who will serve as consultants or collaborators on the project, but with no specified levels of efforts, should also be included. Do not include letters from individuals who will be supported by the award and are named in the application.  

The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. NOFOs that do not allow clinical trials use this form for human subjects. See https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/PHSHumanSubjectsandClinicalTrialsInformationForm-Internal_Use_Only.pptx for more information.

PHS Human Subjects and Clinical Trials Information (Monitoring, Feedback, and Evaluation Core)

When preparing your application, use Component Type ‘Project.’

SF424 (R&R) Cover (Initiative: Behavioral Health)

• Descriptive Title of Applicant’s Initiative
• Proposed Initiative Start/Ending Dates

PHS 398 Cover Page Supplement (Initiative: Behavioral Health)

Research & related other project information (initiative: behavioral health).

Application guide states that Project Narrative is required.  However, it is only required for the Overall component.

Project /Performance Site Location(s) (Initiative: Behavioral Health)

Research & related senior/key person profile (initiative: behavioral health), budget (initiative: behavioral health).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply .

PHS 398 Research Plan (Initiative: Behavioral Health)

Specific Aims:  List the Aims of the proposed project. State the individual project's relationship to the Cooperative's overall goals and milestones and how it relates to other projects or cores.    

Research Strategy: This section should provide a detailed discussion of all aspects of the required behavioral health initiative. Recipients should consult with the Multistakeholder Council after award and may change specifics of the Initiative based on stakeholders’ input. Applicants must address the following:

• Explain the behavioral health focus of the initiative and how healthcare delivery will be changed if the proposed aims are achieved, with specific goals and improvement targets.
• Explain why and how the behavioral focus was selected, including use of State data and PCOR findings and engagement of current or future members of the Multistakeholder Council.
• Describe the scientific premise for the proposed initiative, including consideration of the strengths and weaknesses of published PCOR or preliminary data crucial to the support of the initiative.
• Discuss how the proposed initiative will address disparities.
• Describe in detail the proposed evidence-based approach to implementing the initiative, including specific goals and strategies. Applicants may draw upon many sources of PCOR evidence, such as AHRQ's Evidence Reports resources.
• Include a timeline for implementing the initiative with major milestones.
• Discuss plans for collaborations with community partners.
• If applicable, describe proposed strategies for recruiting healthcare delivery organizations.
• If applicable, describe the focus of training and workforce development
• If applicable, describe how implementation support resources will be developed, tested, and shared. AHRQ encourages stakeholder engagement and human-centered design in the development and testing of resources.  

PHS Human Subjects and Clinical Trials Information (Initiative: Behavioral Health)

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. 

Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review .

6. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at  http://www.ahrq.gov/funding/grants/policies/hhspolicy.html .

Grant funds may NOT be used for the purchase of food of any kind (refreshments, meals, etc.). AHRQ will not award funds to support the cost of food.

These awards will not be made under expanded authorities; therefore, pre-award costs are not allowable.

NOTE: No-Cost Extensions will not be allowed.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted. 

Applicants must complete all required registrations before the application due date.   Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the  Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field   of the Senior/Key Person Profile form .  Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See  more tips for avoiding common errors.

The applicant should pay particular attention to the SF424 (R&R) application guide instructions  https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf ) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, and for responsiveness by AHRQ. Applications that are incomplete or non-compliant will not be reviewed.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see  https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html ). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Please be sure that you observe the total cost, project period, and page number limitations specified above for this NOFO. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in  the policy . Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ is committed to the inclusion of priority populations in health services research. The overall portfolio of health services research that AHRQ conducts and supports shall include the populations specifically named in AHRQ’s authorizing legislation: inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care. 42 U.S.C. 299(c)(1). AHRQ also includes in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

AHRQ will broadly implement this inclusion policy across the research that AHRQ supports and conducts so that the portfolio of research is inclusive of all populations. AHRQ intends that these populations be included in studies such that the research design explicitly allows conduct of valid analyses. The policy applies to all grant applications. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at  https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-015.html . Applicants under this NOFO must consider and discuss including priority populations in research design as specified in this Notice.

Public Access to AHRQ-Funded Scientific Publications

Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications , which is available at ( http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html ). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher’s date of publication.

AHRQ Data Management Plan Policy

Investigators should review the document titled AHRQ Data Management Plan (DMP) Policy, which is available at ( https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html ). This policy requires applicants for AHRQ new/competing grants and research contracts to include a DMP for managing, storing and disseminating the primary data, samples, physical collections, and other supporting materials created or gathered in the course of research funded by AHRQ, or state why data management is not possible, as a component of their grant application or research contract application.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data should describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected (see  NOT-HS-18-012 : Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine-readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by recipient under this NOFO will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The recipient should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ recipients may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use, or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on recipients to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that recipients notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to  [email protected]  at least four to six weeks in advance of the journal’s expected publication date.

Regulations applicable to AHRQ recipients concerning intangible rights and copyright can be found at 45 CFR 75.322.

Section V. Application Review Information

1. criteria.

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.

AHRQ's priority areas of focus are detailed here:  https://www.ahrq.gov/funding/policies/nofoguidance/index.html .

As part of this mission, applications are submitted to AHRQ to support health services research which are evaluated for scientific and technical merit through the AHRQ peer review system.

Applications that are complete and responsive to the NOFO will be evaluated for scientific and technical merit by an appropriate objective group convened in accordance with standard AHRQ peer-review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this NOFO will not be reviewed. Only the review criteria described below will be considered in the review process.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How will successful completion of the proposed work result in new, sustainable capacity to increase the delivery of PCOR evidence-based improvements in the state?

How will successful completion of the proposed work reduce disparities within the State in the delivery of PCOR evidence-based interventions to safety net populations?

How does the proposed work support a significant increase, as opposed to a modest incremental improvement, in the state’s capacity to disseminate and implement PCOR evidence-based improvements for safety net organizations?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the PD(s)/PI(s) have experience working in the state and with key stakeholders in the state including payors and healthcare delivery organizations that address the health needs of people who are underserved?

Is the single PD/PI devoting at least 20% minimum FTE (i.e., at least 8 hours per week) in each given year of the project? Are the multiple PD(s)/PI(s) each devoting at least 10% minimum FTE (i.e., at least 4 hours per week)? 

Is the Liaison to the NEC devoting at least 25% FTE to evaluation liaison activities? 

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies for human subjects?

If the project involves human subjects and/or  clinical research, are the plans to address:

1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

 To what extent has the applicant demonstrated a clear understanding of the context of healthcare delivery in the state, including safety net healthcare delivery organizations and geographic diversity, and the need for this program and the planned activities. 

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

To what extent do letters of support from collaborating organizations and individuals indicate substantial engagement and document specific contributions of the partner during the proposed collaboration? 

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Review Criteria - Engagement, Training, Education, and Assistance Core

How effectively will the applicant’s proposed approach facilitate learning across the state or sub-state region?

How effectively does the applicant’s proposed approach utilize healthcare extension agents to provide support for dissemination and implementation of PCOR evidence-based improvements?

Review Criteria Monitoring, Feedback, and Evaluation Core

How likely is it that the monitoring and feedback activities will enable the Cooperative to refine and improve its Cores and the initiative?

How likely is it that the evaluation will provide valid and useful information for state and national stakeholders?

Are the evaluation questions clear, meaningful, and consistent with the objectives of this NOFO?

Review Criteria - Administrative Core

How well does the applicant’s proposed approach fulfill the requirements of the Administrative Core?

How effectively will the applicant’s proposed approach create a Multistakeholder Council that can provide guidance and support for the Cooperative's initiative?

How effectively does the applicant’s approach create a Multistakeholder Council that includes participation from safety net healthcare delivery organizations and patients, families, and caregivers that represent the state’s diversity?

Review Criteria - Initiative

How likely is it that the approach of the Initiative will accelerate PCOR evidence-based improvement?    

How effectively will the proposed Initiative address the needs and priorities of the state?

Data Management Plan

The reviewers will comment on whether the Data Management Plan is reasonable

Inclusion of Priority Populations

Peer reviewers will assess the adequacy of plans to address the needs of AHRQ priority populations.

Peer reviewers must include their assessment of the proposed inclusion plan for priority populations in evaluating the overall scientific and technical merit of the application and assigning the impact score.

In evaluating the overall impact of the application, the review groups will:

• Evaluate the application for the presence or absence of the inclusion plan based on the proposed research objectives.
• Evaluate the adequacy of the proposed plan for the inclusion of priority populations.
• Evaluate the proposed justification for the exclusion of priority populations when a requirement for inclusion is described as inappropriate with respect to the purpose of the research.
• Evaluate the plans for outreach and recruitment of study participants, including priority populations, where appropriate.
• Evaluate the proposed plan for study design, execution, and outcome assessments so that study results will be relevant to one or more priority populations, where appropriate.
• Assess the plan as being acceptable or unacceptable with regard to the appropriateness of the inclusion or exclusion of priority populations in the proposed research.

Degree of Responsiveness

Reviewers will assess how well the application addresses the purpose and objectives of this NOFO. How responsive is the application to the special eligibility criteria, including the project requirements, noted in the NOFO?

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable, and whether the requested period of support is appropriate in relation to the proposed research.

Resubmissions

Additional review considerations - overall, applications from foreign organizations, 2. review and selection process applications that are complete and responsive to the nofo will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with standard ahrq peer review procedures that are described in 42 cfr part 67, subpart a. incomplete and/or non-responsive applications or applications not following instructions given in this nofo will not be reviewed. as part of the scientific peer review, all applications: may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. will receive a written critique. the following will be considered in making funding decisions: scientific and technical merit of the proposed project as determined by scientific peer review. availability of funds. responsiveness to goals and objectives of the nofo. relevance and fit within ahrq research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities 3. anticipated announcement and award dates.

After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the  eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (see  https://www.ahrq.gov/funding/policies/hhspolicy/index.html ).

Section VI. Award Administration Information

1. award notices.

If the application is under consideration for funding, AHRQ Division of Grants Management staff will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" ( https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html ). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b)” https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html ".

IIf all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the e-mail address designated by the recipient organization during the eRA Commons registration process.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions .

Any application awarded in response to this NOFO will be subject to the UEI, SAM Registration, and Transparency Act requirements.

Individual awards are based on the application submitted to, and as approved by, the AHRQ and are subject to the AHRQ-specific terms and conditions identified in the NoA.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to HHS’s “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards,” ( http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 , and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html ), and the terms and conditions set forth in the Notice of Award.

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award and requires that recipients inform their employees in writing of employee whistleblower rights and protections under 41 U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If you receive an award, HHS may terminate it if any of the conditions in 2 CFR 200.340(a)(1)-(4) are met. No other termination conditions apply.

There is a prohibition on certain telecommunications and video surveillance services or equipment that became effective on or after August 13, 2020.

If you receive an award, you must follow all applicable nondiscrimination laws. You agree to this when you register in SAM.gov. You must also submit an Assurance of Compliance ( HHS-690 ). To learn more, see the HHS Office for Civil Rights website .

Below are available HHS resources on Health Literacy:

• HHS Health.gov: Health Literate Care Model
• AHRQ: Health Literacy Universal Precautions Toolkit

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Recipient Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all AHRQ grants and cooperative agreements except fellowships.

The following Terms and Conditions will be incorporated into the award notice and will be provided to the recipient at the time of award.

Terms and Conditions of Cooperative Agreement Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 75, and other DHHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering this cooperative agreement.

The administrative and funding instrument used for this program is the cooperative agreement. A cooperative agreement is an "assistance" mechanism (rather than an "acquisition” mechanism), in which substantial AHRQ programmatic involvement with the recipient is anticipated during the performance of the activities. Under a cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the grant recipient and the PD(s)/PI(s) for the project as a whole, although specific tasks and activities may be shared between the recipient and AHRQ as described in the NOFO. Cooperative activities are intended to strengthen the individual recipient activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by AHRQ.

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, with certain exceptions, are currently required to be cleared by OMB under the Paperwork Reduction Act (PRA). (44 USC 3501-3521). PRA review and approval is required in cooperative agreements if AHRQ has significant input or control over the data collection activity. Submissions for clearance under the PRA are through AHRQ and HHS. Therefore, impacted recipients should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least 6 months from date of initial submission to AHRQ and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until recipients receive written notification via e-mail from AHRQ that clearance has been obtained.

obtained. Detailed information on the PRA can be found at Paperwork Reduction Act (PRA) of 1995 | Guidance Portal (hhs.gov)

Program Director/Principal Investigator (PD/PI) Responsibilities

The PD(s)/PI(s) will have the primary responsibility for operating the Cooperative in accordance with the terms and conditions of the Notice of Award, and cooperating with other key parties, including the AHRQ Program Official, other recipients, the NCC, and the NEC.

The PD(s)/PI(s) will be responsible for sharing issues with AHRQ and the NCC as it relates to the formation and operation of the Cooperative.

The PD(s)/PI(s) will be responsible for collaborating with AHRQ staff, the NEC, and the NCC in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources.   

The PD(s)/PI(s) will participate in monthly teleconferences with the Program Official and representatives from the NEC, NCC, or other AHRQ personnel as appropriate. The PD(s)/PI(s) will attend an annual meeting with AHRQ and other recipients, which is held in the Washington, D.C. area.

Learning Networks of State-based Healthcare Extension Cooperatives will be created to bring together recipients, NCC staff, NEC staff, and AHRQ staff to discuss progress on the Healthcare Extension Service, identify common challenges and engage in problem solving. Each PD/PI and any key personnel for the Cooperative's cores are expected to participate in the learning networks.

In addition to the annual progress report, the recipient is required to submit quarterly progress reports to AHRQ. The recipient is required to submit a logic model within the first six months of award.  Instructions on reporting requirements will be provided at the time of award.

AHRQ Responsibilities

AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across the projects. Specific cooperative aims and activities in carrying out individual projects may be shared among the recipients and with the NCC, the NEC, and the AHRQ program officials.

AHRQ staff will provide advice and support to the recipient and will assist in the cooperative work of the project beyond the usual program stewardship for grants.

The Program Official will maintain regular contact with the PD(s)/PI(s) to consult on key project decisions, help to troubleshoot implementation barriers and challenges, and confirm that projects are proceeding according to project timelines and plans. The Program Official will coordinate with the recipient, the NEC, and the NCC to disseminate project findings to research and policy audiences. Progress will be reviewed quarterly.

• Review the development of project timelines and project plans and assess progress.
• Work closely with recipients and the NEC to ensure harmonization of cross-recipient metrics for evaluation.
• Coordinate and facilitate collaboration and engagement with stakeholders.
• Facilitate the development of common frameworks, tool kits, and other products for implementation and evaluation activities.
• Participate in conference calls with recipients and annual in-person meetings.
• Work closely with recipients and other federal partners to ensure dissemination of products.
• Review and provide input on written documents, including information and materials for the activities conducted, prior to submission for publication or public dissemination.

Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Collaborative Responsibilities

Awardees will be required to work collaboratively with each other and with AHRQ to share information and develop common resources as noted above. Awardees and AHRQ will also participate in periodic meetings including monthly teleconferences and annual in-person meetings.

For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html . If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the start date of the next budget period of the award.

Recipients are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement ( https://www.ahrq.gov/funding/policies/hhspolicy/index.html ). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in

which the budget period ends. For example, if the budget period ends 4/30/2023, the annual FFR is due 9/30/2023 (90 days after the end of the calendar quarter of 6/30/2023).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 120 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/funding/grant-mgmt/index.html#Closeout .

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the 2 CFR Part 170 ( https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-170 ) for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Program planning and performance reporting requirements:

Recipient performance will be measured based on success in the following Program goals:

Reach: Who was reached by the project?

• Performance measures:
• Number and type of stakeholders participating in the Multistakeholder Council
• Number, type, and size of safety net healthcare delivery organizations served by grant-supported healthcare extension services
• Timeline: Annual

Structure and Process: What strategies were implemented and how?

• Number of Multistakeholder Council meetings conducted and number of participants attending
• Timeline: Report Annually
• Number and type of healthcare extension agents hired or employed
• Number and type of policy, payment, or practice improvement activities planned and implemented
• Number and type of monitoring activities conducted and impact on program activities
• Costs and resources (personnel and non-personnel) associated with implementing healthcare extension service
• Timeline: Report annually (if possible) and cumulative at 5 years

Impact: What was the impact of implemented improvements?

• Improvement in outcome and equity measures relevant to projects selected by Cooperatives
• Timeline: Report annually
• Experience/satisfaction of organizations and individuals reached by extension services.
• Decision-making informed by patient-centered outcomes research
• Patient-centered outcomes research implemented in clinical practice
• Use of behavioral health services  targeted by state-based Healthcare Extension Service (percentage of Medicaid recipients in the state receiving evidence-based service (e.g., percent of adult Medicaid recipients screened for depression and anxiety)
• Timeline: Data collected through year 5, reach targets

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online:  https://www.era.nih.gov/need-help  (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email:  [email protected]  (preferred method of contact) Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email:  [email protected]

Matthew Simpson, MD, MPH  Division of Practice Improvement Center for Evidence and Practice Improvement Agency for Healthcare Research and  Quality Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Xavier Bogle, PhD Scientific Review Officer Division of Scientific Review  Office of Extramural Research, Education, and Priority Populations  Agency for Healthcare Research and Quality  Email: [email protected]   

Name:  Janene Dyson Office of Management Services Division of Grants Management Agency for Healthcare Research and Quality Telephone: 301-427-1491 Email:  [email protected]  

Section VIII. Other Information

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices ( https://www.ahrq.gov/funding/policies/hhspolicy/index.html) .

This program is described in the Assistance Listings (formerly called the Catalog of Federal Domestic Assistance) at https://sam.gov/content/home and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

Awards are made under the authority of 42 USC 299 et seq., and in accordance with 45 CFR Part 75 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/funding/policies/hhspolicy/index.html