RFA-DP-25-041_20241114.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION

Connecting Organizations and People to Empower Diabetes Prevention and Treatment

(Connections)

RFA-DP-25-041

01/06/2025

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Overview

Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Connecting Organizations and People to Empower Diabetes Prevention and Treatment (Connections) Activity Code U18 - Research Demonstration Cooperative Agreements

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-25-041

Assistance Listings Number(s) 93.945 Category of Funding Activity HL - Health NOFO Purpose The purpose of this NOFO is to support evaluation of the effectiveness of existing Community- Clinical Linkage or Social Connectedness programs to reduce disparities in diabetes risk factors, incidence, or complications. Additionally, research supported by this NOFO will assess how various mechanisms (e.g., improving specific social or environmental conditions, mental health, or self-efficacy) will impact diabetes outcomes. Specifically, the results of this funded research NOFO will: (a) guide future scaling regarding programs using Community-Clinical Linkage and Social Connectedness; (b) demonstrate mitigation of observed disparities in diabetes risk factors, incidence, and complications through Community-Clinical Linkage and Social Connectedness programs; and (c) inform the understanding of the mechanisms by which Community-Clinical Linkage and Social Connectedness programs achieve successful health outcomes and the features that characterize effective programs.

Key Dates Publication Date:

To receive notification of any changes to RFA-DP-25-041, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

12/02/2024

Application Due Date:

01/06/2025

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

03/11/2025 This date is an estimate.

Secondary Review:

04/28/2025 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

This date is an estimate.

Estimated Start Date:

09/30/2025 Expiration Date:

01/07/2025 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. 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. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

• Purpose: The purpose of this NOFO is to support evaluation of the effectiveness of existing Community-Clinical Linkage or Social Connectedness programs to reduce disparities in diabetes risk factors, incidence, or complications. Additionally, research supported by this NOFO will assess how various mechanisms (e.g., improving specific social or environmental conditions, mental health, or self-efficacy) will impact diabetes outcomes. Specifically, the results of this funded research NOFO will: (a) guide future scaling regarding programs using Community-Clinical Linkage and Social Connectedness; (b) demonstrate mitigation of observed disparities in diabetes risk factors, incidence, and complications through Community-Clinical Linkage and Social Connectedness programs; and (c) inform the understanding of the mechanisms by which Community-Clinical Linkage and Social Connectedness programs achieve successful health outcomes and the features that characterize effective programs.

• Mechanism of Support: U18

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire three (3)-year period of performance is $3,150,000.00. The number of awards will be three (3). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards will depend upon the number, quality, duration and cost of the applications received.

https://grants.nih.gov/grants/how-to-apply-application-guide.html

• Budget and Period of Performance: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $1,050,000 with individual awards of approximately $350,000 each for three awards. The estimated total funding (direct and indirect) for the entire Period of Performance will be $3,150,000.00. The period of performance is anticipated to run from 09/30/2025 to 09/29/2028.

• Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

• Eligible Institutions/Organizations: Institutions/organizations listed in Section III of this announcement are eligible to apply.

• Eligible Project Directors/Principals Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities are always encouraged to apply.

• Number of PDs/PIs: There will only be one PD/PI for each application.

• Number of Applications: Only one application per institution (normally identified by having a unique UEI number) is allowed.

• Application Type: New

• Application Materials: See Section IV.1 for application materials. Please note that

SF424 (R&R) Form H is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description

Statutory Authority This program is authorized under Section 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2) and Section 301(a) of the PHS Act, 42 U.S.C. 241(a).

1. Background and Purpose Health Equity, Health Disparities and the Social Determinates of Health

Health equity is the state in which everyone has a fair and just opportunity to attain their highest level of health. Health Disparities are preventable differences in the burden of disease or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged.

Eliminating health disparities and advancing health equity are foundational to Health and Human Service’s Healthy People 2030. Many health disparities stem from the unequal distribution of social and environmental factors, such as safe and stable housing, access to nutritious food, reliable transportation, employment and financial security, discrimination, education, and other stressors (1). These and other nonmedical factors which constitute the conditions in which people are born, grow, work, live, and age are referred to as the Social Determinants of Health (SDOH).

The confluence of SDOH factors impacts health behaviors and physical and mental health (2), accounting for 50-60% of poor health outcomes (1). Breaking down barriers to health equity by https://grants.nih.gov/grants/how-to-apply-application-guide.html https://www.cdc.gov/health-equity/what-is/index.html https://www.cdc.gov/health-equity/what-is/index.html https://health.gov/healthypeople/objectives-and-data/social-determinants-health https://www.cdc.gov/health-equity-chronic-disease/social-determinants-of-health-and-chronic-disease/index.html https://www.cdc.gov/health-equity-chronic-disease/social-determinants-of-health-and-chronic-disease/index.html addressing SDOH is a top priority for CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP).

Health Disparities in Diabetes

Diabetes is the eighth leading cause of death in the United States (3) and is responsible for approximately 12% of deaths annually (4). People with diabetes also have significant clinical, physical, and psychological comorbidities including macro- and microvascular disease, foot and leg amputations, depression, and diabetes distress (5). Significant health disparities in diabetes incidence and rates of diabetes complications exist according to race and ethnicity and socioeconomic status (6). Achieving health equity in diabetes prevention and treatment requires overcoming economic, social, and other obstacles to health and health care to eliminate preventable health disparities. CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) supports this effort by addressing the SDOH that drive inequity in health outcomes. Two key approaches of NCCDPHP’s effort to reduce health disparities by addressing SDOH are Community-Clinical Linkages and Social Connectedness. Evaluating how Community-Clinical Linkages and Social Connectedness programs may reduce disparities in diabetes risk factors, incidence, and complications is the primary focus of this NOFO.

Community-Clinical Linkages as a Strategy to Address Diabetes Disparities

Community-Clinical Linkages are connections made among health care systems and services, public health agencies, and community-based organizations to improve population health.

Effective Community-Clinical Linkages improve chronic disease outcomes by increasing access to and utilization of preventive and chronic care services in local communities (7). They represent a promising approach to addressing the social and environmental factors that may be driving disparities in diabetes related risk factors, incidence and complications. Broadly, Community-Clinical Linkage Programs may involve connecting people to community or clinical services through dedicated Community Health Workers or Health Navigators, connecting people to community or clinical services through referral systems, physically co-locating clinical or community resources together, or through a combination of these approaches:

• Integrating Community Health Workers (CHW), Health Navigators, Community Health Representatives, or Promotoras into clinical teams.

o This approach entails utilizing these dedicated staff members, who are often trusted members of the local community, to help to coordinate patient care and connect patients with non-medical social resources to improve disease management/health outcomes, increase access to community resources, and address health-related social needs. Research suggests that CHW programs can be effective at improving cardiovascular disease risk factors (8), access to care among rural populations (9), glycemic control among adults with diabetes (10- 12), and reducing chronic disease related emergency department visits and hospitalizations (13).

• Establishing coordinated care/referral systems or patterns between clinical services and community resources, community partners, or the community sector.

o This approach entails establishing relationships and referral systems between healthcare service providers and community organizations that assist in meeting patients’ social needs such as housing, nutrition, transportation, and education.

https://www.cdc.gov/health-equity-chronic-disease/social-determinants-of-health-and-chronic-disease/index.html https://www.cdc.gov/health-equity-chronic-disease/social-determinants-of-health-and-chronic-disease/index.html https://www.cdc.gov/social-connectedness/about/ https://www.cdc.gov/chronic-disease/php/community-health-worker-resources/index.html https://mhpsalud.org/our-programs/promotoras-de-salud/

These programs may include bi-directional systems where providers submit referrals to community organizations and the organization sends information to the provider. For example, health systems may connect patients with diabetes to community-based organizations providing diabetes self-management and education services (14) or they may refer patients at risk of diabetes with food insecurity to community food pantries or assist patients in applying for federal food security benefits (15).

• Physically co-locating and integrating community and clinical services (e.g., primary care services and social services) to create a continuum of care and reduce barriers to care and social need resources.

o Some examples of this approach include integrating diabetes management resources within community pharmacies, locating social service assistance offices or food pantries in healthcare facilities, or using mobile health clinics to deliver services to populations with inadequate healthcare access. Community-Clinical Linkage pharmacy intervention studies have demonstrated improvements in body mass index (16, 17), hemoglobin A1c, total cholesterol, and blood pressure (18), and medication refill adherence (19). Mobile health clinics have demonstrated improvements in hypertension, blood lipid, and glycemic control (20).

Despite evidence suggesting Community-Clinical Linkage programs can be effective at improving diabetes and chronic disease outcomes, research gaps exist (21). For example, there is a need for information regarding the pathways, processes, and characteristics that make Community-Clinical Linkage interventions effective. More evidence is also needed on how Community-Clinical Linkage programs impact long term health outcomes, and how programs can be scaled cost-effectively for large scale implementation. There is also a need for further evidence on implementation with specific populations experiencing disparities in diabetes risk and complications, such as rural populations. Finally, there is a need to investigate how innovative technologies can be applied in Community-Clinical Linkage programs and to determine the effectiveness of providing services in innovative community settings such as barber shops and beauty salons.

Social Connectedness as a Strategy to Address Diabetes Disparities

Disparities in diabetes risk factors, incidence, and complications may also be driven, in part, by lack of opportunities for social connectedness(22). Social connectedness reflects the degree to which individuals and groups have the objective and subjective number, quality, and diversity of relationships to meet their functional social needs and includes a sense of belonging and being cared for, valued, and supported (23). Social relationships shape interpersonal interactions and intrapersonal experiences that can alter physiology across the life course. Hence, Social Connectedness, or lack thereof, is a significant determinant of mental, emotional, and physical health. Social isolation and loneliness are some of the indicators for lack of Social Connectedness. Social isolation is the objective state of having few social relationships or infrequent social contact with others, while loneliness is a subjective feeling of being isolated.

Recent data from the Behavioral Risk Factor Surveillance System found that approximately 32% of adults report feeling lonely and approximately 25% of adults lack social and emotional support (24). Loneliness and lack of social and emotional support are more prevalent among https://www.cdc.gov/social-connectedness/about/ https://www.cdc.gov/social-connectedness/risk-factors/index.html https://www.cdc.gov/social-connectedness/risk-factors/index.html adults with lower incomes and less education, African American, Hispanic, and multiracial persons, and those who identify as gay, lesbian, bisexual, or transgender (25).

There are a variety of promising approaches to address Social Connectedness that may help reduce social isolation and loneliness. Previous studies have suggested that social isolation and loneliness are risk factors for diabetes incidence (26, 27) and complications among adults with diabetes (28) and that increased social support is associated with improved glycemic control and quality of life among adults with diabetes (1). Programs that enhance Social Connectedness can help reduce loneliness and social isolation and may improve self-efficacy and risk factors for diabetes incidence or complications (29, 30). Social Connectedness has also been shown to improve disease management and self-rated health of people with diabetes (31).

However, the overall evidence around Social Connectedness interventions shows mixed results and there remain important gaps in literature regarding Social Connectedness interventions (21, 32, 33) For example, more information is needed on the effectiveness of digital Social Connectedness interventions on various populations experiencing health disparities and the specific digital intervention activities and components that work best for each population.

Evidence is also needed to compare the effectiveness of various intervention strategies and the delivery modes that are more effective for each. Also, more information is needed on the specific Social Connectedness intervention needs of people who live in settings or with conditions that put them at increased/higher risk of social isolation and loneliness such as those in rural communities, persons living with chronic diseases, and other populations disproportionately affected by social isolation and loneliness. Finally, research is needed on the effectiveness of culturally tailored interventions for specific populations. Thus, there remains the need to identify effective, culturally competent approaches and equitably adapt existing interventions to improve social connectedness among priority populations and assess how such interventions impact health seeking behaviors among these populations. For more information, see the World Health Organization evidence and gap map for in-person and digital interventions for reducing social isolation and loneliness in older adults.

Research Objectives of this NOFO

Community-Clinical Linkage or Social Connectedness programs show promising potential to improve diabetes risk factors and to reduce diabetes incidence and complications. However, further research is needed to address important gaps in the evidence base and determine how these programs can be used to address disparities in diabetes outcomes.

Therefore, the purpose of this NOFO is to support evaluation of the effectiveness of existing Community-Clinical Linkage or Social Connectedness programs to reduce disparities in diabetes risk factors, incidence, or complications. Additionally, research supported by this NOFO will assess how various mechanisms (e.g., improving specific social or environmental conditions, mental health, or self-efficacy) will impact diabetes outcomes. Specifically, the results of this funded research NOFO will: (a) guide future scaling regarding programs using Community- Clinical Linkage and Social Connectedness; (b) demonstrate mitigation of observed disparities in diabetes risk factors, incidence, and complications through Community-Clinical Linkage and Social Connectedness programs; and (c) inform the understanding of the mechanisms by which Community-Clinical Linkage and Social Connectedness programs achieve successful health outcomes and the features that characterize effective programs.

https://www.cdc.gov/social-connectedness/data-research/promising-approaches/index.html https://www.decadeofhealthyageing.org/find-knowledge/support/toolkits/who-evidence-and-gap-map-on-in-person-interventions-for-reducing-social-isolation-and-loneliness-(all-ages)#:~:text=gap%20map%20examines%20the%20evidence%20on%20in-person,loneliness%20across%20all%20ages%2C%20including%20older%20people.

https://www.who.int/initiatives/decade-of-healthy-ageing/evidence-gap-map/sil-digital

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Healthy People 2030 and other National Strategic Priorities Reduce the number of diabetes cases diagnosed yearly. D01

Reduce the rate of death from any cause in adults with diabetes. D-09

Reduce the rate of foot and leg amputations in adults with diabetes. D-08

Increase the proportion of adults with diabetes using insulin who monitor their blood sugar daily

— D-07

Increase the proportion of adults with diabetes who get a yearly urinary albumin test — D-05

Increase the proportion of adults with diabetes who have a yearly eye exam — D-04

Increase the proportion of eligible people completing CDC-recognized type 2 diabetes prevention programs — D-D01

Increase the proportion of people with diabetes who get formal diabetes education — D-06

Reduce the proportion of adults with diabetes who have an A1c value above 9 percent — D-03

Reduce the rate of hospital admissions for diabetes among older adults — OA-5

Reduce the proportion of adults who don't know they have prediabetes — D-02

May also address:

Reduce the proportion of people who can't get medical care when they need it — AHS-04

Increase the proportion of adults who get recommended evidence-based preventive health care

— AHS-08

Increase the proportion of adults with depression who get treatment — MHMD-05

Increase the proportion of adults with serious mental illness who get treatment — MHMD-04

Public Health Impact Research supported by this NOFO will identify effective Community-Clinical Linkage and Social Connectedness programs that generate evidence that can guide public health decisions on how to advance health equity in diabetes and other chronic disease outcomes. Rigorous evaluation research will advance our understanding of what works, for whom, and why. This research will fill important gaps in knowledge about 1) the effectiveness of Community-Clinical Linkage and Social Connectedness programs at reducing disparities in diabetes-related outcomes in economically or socially disadvantaged populations (i.e., people with lower incomes, lower educational attainment, those living in rural or hard-to-reach communities, racial and ethnic minority groups, and persons with disabilities), 2) the resources (e.g. training, personnel, financial) required for implementation and scaling of programs and 3) the mechanisms (e.g.

https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/reduce-number-diabetes-cases-diagnosed-yearly-d-01 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/reduce-rate-death-any-cause-adults-diabetes-d-09 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/reduce-rate-foot-and-leg-amputations-adults-diabetes-d-08 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/increase-proportion-adults-diabetes-using-insulin-who-monitor-their-blood-sugar-daily-d-07 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/increase-proportion-adults-diabetes-using-insulin-who-monitor-their-blood-sugar-daily-d-07 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/increase-proportion-adults-diabetes-who-get-yearly-urinary-albumin-test-d-05 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/increase-proportion-adults-diabetes-who-have-yearly-eye-exam-d-04 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/increase-proportion-eligible-people-completing-cdc-recognized-type-2-diabetes-prevention-programs-d-d01 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/increase-proportion-eligible-people-completing-cdc-recognized-type-2-diabetes-prevention-programs-d-d01 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/increase-proportion-people-diabetes-who-get-formal-diabetes-education-d-06 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/reduce-proportion-adults-diabetes-who-have-a1c-value-above-9-percent-d-03 https://health.gov/healthypeople/objectives-and-data/browse-objectives/older-adults/reduce-rate-hospital-admissions-diabetes-among-older-adults-oa-05 https://health.gov/healthypeople/objectives-and-data/browse-objectives/diabetes/reduce-proportion-adults-who-dont-know-they-have-prediabetes-d-02 https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care-access-and-quality/reduce-proportion-people-who-cant-get-medical-care-when-they-need-it-ahs-04 https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care-access-and-quality/increase-proportion-adults-who-get-recommended-evidence-based-preventive-health-care-ahs-08 https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care-access-and-quality/increase-proportion-adults-who-get-recommended-evidence-based-preventive-health-care-ahs-08 https://health.gov/healthypeople/objectives-and-data/browse-objectives/mental-health-and-mental-disorders/increase-proportion-adults-depression-who-get-treatment-mhmd-05 https://health.gov/healthypeople/objectives-and-data/browse-objectives/mental-health-and-mental-disorders/increase-proportion-adults-serious-mental-illness-who-get-treatment-mhmd-04 improving specific social or environmental conditions, mental health, or self-efficacy) by which Community-Clinical Linkage and Social Connectedness programs achieve successful health outcomes and 4) the features that characterize effective programs and specific program elements and strategies that contribute to intervention effectiveness and potential impact on health disparities. The results of funded research under this NOFO will help guide future scaling regarding programs, policies, and practices using Community-Clinical Linkage and Social Connectedness to mitigate observed disparities in diabetes risk factors, incidence, and complications.

Relevant Work

• Scaling the National Diabetes Prevention Program in Underserved Areas: Funding for

DP17-1705 | State, Local, and National Partner Diabetes Programs | CDC

• Community Health Workers for COVID Response and Resilient Communities (CCR) https://www.cdc.gov/COVID-community-health-workers/index.html;

• Simulation Model of Interventions Linking Evidence to Social Determinants of Health

(SMILES)

• Health Promotion and Disease Prevention Research Centers (RFA-DP-24-004)

• Addressing Conditions to Improve Population Health (ACTion; RFA-DP-23-0058:

https://www.cdc.gov/addressing-sdoh-chronic-disease/about/action-funding-awardees.html

2. Approach General Approach

The purpose of this NOFO is to support evaluation of the effectiveness of existing Community- Clinical Linkage or Social Connectedness programs to reduce disparities in diabetes risk factors, incidence, or complications. Additionally, research supported by this NOFO will assess how various mechanisms and intermediate program outcomes (e.g., improving specific social or environmental conditions, mental health, or self-efficacy) will impact diabetes outcomes. This NOFO is not intended to fund the initiation of new programs or interventions, cross-sectional studies, or studies assessing a program without an appropriate comparison group.

Investigators will evaluate one or more existing Community-Clinical Linkage or Social Connectedness program(s) as identified in their application. For either Community-Clinical Linkage or Social Connectedness programs to be evaluated, applicants are expected to demonstrate active cooperation with the organization implementing the program to be evaluated as demonstrated by a signed letter of support specifying that program has not been evaluated previously regarding the study outcomes being assessed in the proposed research.

Applicants are expected to also identify one or more priority populations among program participants with high prevalence of diabetes, diabetes complications, or their risk factors such as historically socially disadvantaged subgroups (i.e. people with lower incomes, lower educational attainment, those living in rural or hard-to-reach communities, racial and ethnic minority groups, and people with disabilities). Through a letter of support, applicants are expected to also demonstrate cooperation with organizations that are representative of the identified priority populations, or other organizations that have a demonstrated record of, or a historical commitment to, serving each identified priority population that is the focus of proposed study.

https://www.cdc.gov/diabetes-state-local/php/funding/funding-for-dp17-1705.html https://www.cdc.gov/diabetes-state-local/php/funding/funding-for-dp17-1705.html https://www.cdc.gov/COVID-community-health-workers/index.html https://www.cdc.gov/addressing-sdoh-chronic-disease/about/action-funding-awardees.html https://www.cdc.gov/addressing-sdoh-chronic-disease/about/action-funding-awardees.html

The existing Community-Clinical Linkage or Social Connectedness program(s) to be evaluated are expected to be identified in the application and are expected to reasonably be expected to affect behaviors relevant to diabetes risk or risk factors for diabetes complications. The programs are expected to be fully enacted and in place for a minimum of 1 year to ensure the intervention is sustainable. A minimum of one year of follow-up time for outcome data after program exposure are expected to be available at the start of the period of performance for the proposed study population. Evaluation of innovative programs that have been culturally adapted or tailored to fit the cultural identifies of their populations and/or settings and interventions that have potential generalizability and feasibility to be adopted in other places or populations is encouraged.

Community-Clinical Linkage Program Characteristics and Research Priorities

Community-Clinical Linkage programs to be evaluated are expected to address both medical needs and social factors such as safe and stable housing, access to nutritious food, reliable transportation, employment and financial security, discrimination, and education. They may be administered by health systems, public health agencies, local governments, community organizations or other entities and may focus on populations at risk for diabetes, those living with diabetes, or both. Programs may use referral networks, community health workers (CHWs), patient navigators, mobile health clinics, community pharmacies or novel health promotion locations, referral programs, or other means to connect populations with medical and community services.

Community-Clinical Linkage research priorities for funding include:

1. Research that assesses the impact of expanding services and support provided by health professionals, such as CHWs, to population groups and in settings (e.g., rural settings, faith-based settings, etc.) with disparities in access to and quality of care.

2. Research on how to optimize interventions integrating health-related social needs into clinical practice and the pathways and characteristics that make the intervention effective.

3. Research assessing the effectiveness and feasibility of service delivery interventions, such as mobile health clinics and interventions at community pharmacies or novel community locations on short- and long-term diabetes outcomes.

Social Connectedness Program Characteristics and Research Priorities

Social Connectedness programs to be evaluated are expected to include interventions targeted for chronic disease management, prevention, or health promotion that address social isolation or loneliness among people at risk for diabetes or living with diabetes. These may include individual and group level interventions (i.e., support groups or group memberships) that encourage social connection as one of the strategies used to promote health, belonging, and wellbeing (e.g., book clubs, walking groups, volunteerism, workout classes). Programs may include activities such as team building exercises or small group discussions, rather than didactic education, or provide guidance to help people build social networks and support. Programs may be administered by health systems, managed care organizations, workplaces, community organizations, local governments, or other entities and are expected to be reasonably expected to improve social connection and decrease feelings of loneliness or social isolation related to health outcomes.

Social Connectedness research priorities for funding include:

1. Assessing the effectiveness of digital interventions and strategies on Social Connectedness and their impact on diabetes outcomes.

2. Comparative effectiveness research to understand which intervention strategies are most effective for promoting social engagement (e.g., psychological, group exercise, skills training, health education, peer support) and to identify the most-effective modes of delivery for interventions that promote social engagement component (e.g., individual, group, community-based, technology-based, animal-assisted) and impact diabetes outcomes.

3. Research that helps to improve understanding of the processes, effectiveness, and impacts of Social Connectedness program interventions on diabetes outcomes for a diverse range of populations that are disproportionately at risk for isolation and limited Social Connectedness, including individuals living with physical and mental disabilities, individuals living with other chronic conditions, rural-residing individuals, individuals with low income, individuals that identify as LGBTQIA+, and population groups based on constructs of race and ethnicity that disproportionately experience risk factors for diabetes.

4. Research that expands the knowledge base on Social Connectedness interventions that focus on prevention of mental and physical illness (e.g., diabetes) in youth and adolescents.

Analytic Approach and Data Considerations

Studies are expected to use rigorous longitudinal research designs such as natural experiments or quasi-experimental designs with concurrent control conditions or interrupted time series designs.

Investigators are particularly encouraged to identify opportunistic, natural experiments wherein accessible comparable control data can be assembled and confounders and biases can be limited through study design, sample selection, and statistical analysis. Control populations identified are expected to reasonably match the exposed study population regarding demographic (age, sex, race, and ethnicity), socioeconomic status, and health parameters (e.g., similar prevalence of comorbidities or risk of diabetes outcomes being assessed). If interrupted time series or similar study designs are utilized without a separate control population, applicants are expected to describe how an appropriate control condition will be used to allow valid inferences regarding the effect of the program.

Applicants are expected to demonstrate access to relevant data on program attributes, process measures, and diabetes-related health outcomes for the study population exposed to the program being evaluated along with comparable control populations as evidenced by signed data-use or data-sharing agreements. Applicants are expected to demonstrate that available data provides sufficient statistical power to reasonably detect selected study outcomes. Data sources may include survey data, medical information systems such as electronic medical records, nontraditional sources, and cohort data. Data elements are expected to also include measures of exposure to Community-Clinical Linkage or Social Connectedness program being evaluated, demographic information to identify the population of interest, and other socioeconomic or potentially confounding factors. If programmatic exposure, sociodemographic, and/or diabetes outcome data are derived from separate datasets, access to each dataset required are expected to be demonstrated with data-use or sharing agreements and feasible methods for linking the datasets are expected to be provided. Applicants are expected to demonstrate access to or ability to collect data on intermediate outcome factors (changes in social needs, mental health, diabetes distress, etc.) and program characteristics that help to explain the mechanisms by which Community-Clinical Linkage or Social Connectedness programs impact diabetes outcomes.

Other Approach Considerations

For all research proposals, applicants are expected to:

• Establish goals and objectives that are realistic, measurable, and time-oriented for all phases of the project.

• Develop a research protocol involving human subjects for Institutional Review Board (IRB) review and approval by all cooperating institutions participating in the research project.

• Identify one or more research gap or priority that the project aims to address.

• Engage community-level partners (including individuals with lived experience and patients, where applicable) in their research process (planning and execution) and ensure that partners support the selected study outcomes. Include a letter of support from community-based organizations or other organizations that are representative of the identified priority populations, or other organizations that have a demonstrated record of, or a historical commitment to, serving each identified priority population(s) that is the focus of proposed study.

• Utilize existing data on exposure and outcomes at the outset of the funding period.

• Develop, design, and pilot research protocols and instruments and conduct appropriate data management procedures when applicable.

• Describe plans to analyze data and disseminate findings in peer-reviewed journals and presentations at scientific conferences and other meetings.

Objectives/Outcomes Applicants are expected…