August 24, 2022
RFA-DK-20-032 - Pilot and Feasibility Studies to Facilitate the Use of Diabetes Self-Management Education and Support to Improve Diabetes Care (R34 Clinical Trial Required)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The purpose of the Notice is to clarify the types of studies that are appropriate for RFA-DK-20-032: Pilot and Feasibility Studies to Facilitate the Use of Diabetes Self-Management Education and Support to Improve Diabetes Care (R34 Clinical Trial Required).
Part 1. Overview Information
The Funding Opportunity Purpose previously stated:
The purpose of this funding opportunity announcement (FOA) is to test an innovative and pragmatic approach to address barriers to and facilitate greater use of diabetes self-management education and support (DSMES) by people living with diabetes mellitus. Research applications should engage key stakeholders in cultivating a practical and sustainable strategy with the potential for dissemination. The pilot trial of the proposed strategy should be designed to generate preliminary data in support of a future, full-scale trial to study broader dissemination and implementation to expand the use of DSMES.
The Funding Opportunity Purpose now reads:
The purpose of this funding opportunity announcement (FOA) is to test an innovative and pragmatic approach to address barriers to and facilitate greater participation in currently accredited or recognized diabetes self-management education and support (DSMES) programs by people living with diabetes mellitus. Research applications should engage key stakeholders in cultivating a practical and sustainable strategy with the potential for dissemination. The pilot trial of the proposed strategy should be designed to generate preliminary data in support of a future, full-scale trial to study broader dissemination and implementation to expand the use of DSMES.
Part 2. Full Text of Announcement
Goals of this RFA previously stated:
This FOA aims to support pilot and feasibility studies to foster innovative strategies to address barriers for use of DSMES and to generate key preliminary data on the intervention in a pilot study that will facilitate planning for a future dissemination and implementation trial. The goal is to ultimately broaden and increase utilization of DSMES for all patients with diabetes; therefore, the proposed approach should be feasible, practical, and acceptable to diverse patient populations and relevant stakeholders and have the potential to be sustained. Leveraging input from key stakeholders in developing the strategy prior to submission of the application is encouraged and plans for active and meaningful stakeholder engagement in relevant aspects of the proposed project is required. Refinement of the strategy and pilot trial design based on stakeholder input post-award should not exceed the first grant year. Strategies that address one or more barriers on multiple levels (health care system, provider, patient and environment) are encouraged with relevant methodology for studying the multilevel intervention. The development of strategies that consider the following is highly encouraged:
- Target social, racial and systemic inequities that prevent populations disproportionately burdened with diabetes from receiving DSMES
- Foster collaborative community and clinic strategies to address social determinants of health that hinder engagement in regular DSMES for populations most at risk for poor outcomes
- Use of novel delivery and care paradigms/systems that may involve integration of systems to more efficiently broaden referral and uptake of DSMES across clinical, community and home contexts where individuals seek care and services
- Utilize incentives to improve provider communication, referral and follow-up on DSMES and to encourage patient uptake and engagement in DSMES
- Use of technology, monitoring devices and data from connected devices to facilitate and enhance patient-centered approaches to DSMES accounting for social determinants of health, improve engagement in DSMES, and foster sustained behavioral changes
- Leverage and engage key family members and peer support in the DSMES process, especially for patients (eg. older adults with physical and/or cognitive impairments, youths, or socioeconomically disadvantaged patients) who require assistance with diabetes-self management
Proposed projects should seek to increase and facilitate use of an accredited or recognized DSMES service that meets evidence-based standards (https://www.cdc.gov/diabetes/dsmes-toolkit/standards/index.html). While applications addressing diverse populations at high risk for poor diabetes-related outcomes are encouraged, proposed approaches focused solely on singular or very minor adaptations of an existing program (such as a basic DSMES element substitution or changing DSMES materials into another language or education level) is not consistent with the focus of this FOA.
Key outcomes for the pilot trial must include some metrics of acceptability and feasibility (which may include both qualitative measures and process measures) relevant for patients, providers or other key stakeholders. Improvements in knowledge, adoption of skills, and changes in behavior are indicators of successful DSMES engagement and including one or more of these outcomes is required. While the pilot trial does not need to be adequately powered to detect a difference in meaningful clinical outcomes (eg. HgA1C, cost, health care utilization), one or more clinical outcomes must be assessed to aid in developing plans for a future, definitive dissemination and implementation trial.
This FOA aims to support pilot and feasibility studies to foster innovative strategies to address barriers for use of currently accredited or recognizedDSMES programs and to generate key preliminary data on the intervention in a pilot study that will facilitate planning for a future dissemination and implementation trial.
Goals of this RFA now reads:
Goals of this FOA
This FOA aims to support pilot and feasibility studies to foster innovative strategies to address barriers for use of currently accredited or recognized DSMES programs and to generate key preliminary data on the intervention in a pilot study that will facilitate planning for a future dissemination and implementation trial. The goal is to ultimately broaden and increase utilization of DSMES for all patients with diabetes; therefore, the proposed approach should be feasible, practical, and acceptable to diverse patient populations and relevant stakeholders and have the potential to be sustained. Leveraging input from key stakeholders in developing the strategy prior to submission of the application is encouraged and plans for active and meaningful stakeholder engagement in relevant aspects of the proposed project is required. Refinement of the strategy and pilot trial design based on stakeholder input post-award should not exceed the first grant year. Strategies that address one or more barriers on multiple levels (health care system, provider, patient and environment) are encouraged with relevant methodology for studying the multilevel intervention. The development of strategies that consider the following is highly encouraged:
- Target social, racial and systemic inequities that prevent populations disproportionately burdened with diabetes from receiving DSMES
- Foster collaborative community and clinic strategies to address social determinants of health that hinder engagement in regular DSMES for populations most at risk for poor outcomes
- Use of novel delivery and care paradigms/systems that may involve integration of systems to more efficiently broaden referral and uptake of DSMES across clinical, community and home contexts where individuals seek care and services
- Utilize incentives to improve provider communication, referral and follow-up on DSMES and to encourage patient uptake and engagement in DSMES
- Use of technology, monitoring devices and data from connected devices to facilitate and enhance patient-centered approaches to DSMES accounting for social determinants of health, improve engagement in DSMES, and foster sustained behavioral changes
- Leverage and engage key family members and peer support in the DSMES process, especially for patients (eg. older adults with physical and/or cognitive impairments, youths, or socioeconomically disadvantaged patients) who require assistance with diabetes-self management
Proposed projects should seek to increase and facilitate use of an accredited or recognized DSMES service that meets evidence-based standards (https://www.cdc.gov/diabetes/dsmes-toolkit/standards/index.html). While applications addressing diverse populations at high risk for poor diabetes-related outcomes are encouraged, proposed approaches focused solely on singular or very minor adaptations of an existing program (such as a basic DSMES element substitution or changing DSMES materials into another language or education level) is not consistent with the focus of this FOA. Applications testing new DSMES-related content, rather than addressing barriers to a currently accredited DSMES program, are not appropriate for this FOA and will not be reviewed. Investigators are strongly encouraged to speak with program staff about their proposal prior to submitting.
Key outcomes for the pilot trial must include some metrics of acceptability and feasibility (which may include both qualitative measures and process measures) relevant for patients, providers or other key stakeholders. Improvements in knowledge, adoption of skills, and changes in behavior are indicators of successful DSMES engagement and including one or more of these outcomes is required. While the pilot trial does not need to be adequately powered to detect a difference in meaningful clinical outcomes (eg. HgA1C, cost, health care utilization), one or more clinical outcomes must be assessed to aid in developing plans for a future, definitive dissemination and implementation trial.
This FOA aims to support pilot and feasibility studies to foster innovative strategies to address barriers for use of currently accredited or recognized DSMES programs and to generate key preliminary data on the intervention in a pilot study that will facilitate planning for a future dissemination and implementation trial.
Shavon Artis Dickerson, DrPH, MPH (for health disparities and health equity in type 2 diabetes research in adults)
National Institute of Diabetes and Digestive and KidneyDiseases (NIDDK)
Telephone: 301-435-3055
Email: shavon.artisdickerson@nih.gov
Miranda Broadney, M.D., M.P.H. (for type 1 diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-6841
Email: miranda.broadney@nih.gov
Henry B. Burch, M.D. (for digital health technology to prevent or treat type 2 diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-0827
Email: henry.burch@nih.gov
Maureen Monaghan Center, PhD (for behavioral diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-3269
Email: maureen.center@nih.gov
Barbara Linder, M.D., Ph.D. (for pediatric type 2 diabetesresearch)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-0021
Email: bl99n@nih.gov
and Human Services (HHS)
