NCCIH Research Blog

Health Care Systems Research: New Funding for Large-Scale Pragmatic and Implementation Trials

October 28, 2021

Wendy J. Weber, N.D., Ph.D., M.P.H.

Wendy J. Weber, N.D., Ph.D., M.P.H.

Branch Chief

Clinical Research in Complementary and Integrative Health Branch

National Center for Complementary and Integrative Health

View biographical sketch

Robin Elizabeth Boineau, M.D., M.A.

Robin Elizabeth Boineau, M.D., M.A.

Director

Office of Clinical and Regulatory Affairs

Medical Officer

Office of Clinical and Regulatory Affairs

National Center for Complementary and Integrative Health

View biographical sketch

The National Institutes of Health (NIH) Health Care Systems Research Collaboratory (HCS Collaboratory) just published a new funding opportunity announcement (FOA) to solicit phased cooperative research applications to conduct efficient large-scale pragmatic or implementation trials embedded within health care systems:

As mentioned in two previous blog posts (The NIH Health Care Systems Research Collaboratory–New Funding Opportunities for Health Systems Researchers and NIH Collaboratory Expands Its Portfolio of Pragmatic Clinical Trials), the National Center for Complementary and Integrative Health (NCCIH) and the National Institute on Aging (NIA) have been leading the HCS Collaboratory (initiated as an NIH Common Fund program). The HCS Collaboratory has pioneered approaches for conducting large-scale, cost-effective randomized pragmatic trials in the health care settings where patients normally receive their care.

Studies focused on improving health outcomes in Americans across the lifespan and addressing health disparities in populations who experience higher rates of certain diseases and higher mortality compared with the general population are a high priority for the new FOA. Results from the trials supported by the FOA should inform policymakers, payers, health care providers, and patients across diverse patient care settings.

Health Care Systems Research Funding Opportunity

Key features of this new funding opportunity include the following: 

  • The FOA uses the UG3 and UH3 cooperative agreement funding mechanisms. Awards will initially support a 1-year planning phase (UG3), with possible transition to a performance phase (UH3) for awards that have met scientific milestone and feasibility requirements. The UG3/UH3 application must be submitted as a single application.
  • Trials should be conducted across three or more health care systems that provide care to generalizable patient populations, and investigators are encouraged to include populations experiencing health disparities. 
  • Trials to evaluate the effectiveness of or study strategies to effectively, equitably, and efficiently implement evidence-based interventions and/or guidelines are among the areas of research encouraged in this initiative.
  • All trials will become part of and work with the NIH Health Care Systems Research Collaboratory program and have access to the expertise of the Health Care Systems Collaboratory Coordinating Center (https://rethinkingclinicaltrials.org).
  • The receipt dates for applications are December 15, 2021, and June 17, 2022.

NCCIH’s Interests

NCCIH’s interests within this FOA are in pragmatic or implementation trials that evaluate the effectiveness of complementary interventions delivered via health care systems or how to implement these interventions into health care delivery. The complementary interventions proposed should have strong evidence of efficacy to warrant their inclusion in health care delivery. Applications will be considered of high programmatic priority if they propose projects that study a mind and body or integrated approach for one of the following high-priority topic areas:

  • Management of chronic pain syndromes
  • Promotion of whole person health, health restoration, emotional well-being, or resilience
  • Prevention or treatment of symptoms including sleep disorders or disturbances, depression, anxiety, post-traumatic stress (disorder), and obesity
  • Improving minority health and eliminating disparities in priority health conditions
  • The role of social and structural determinants of health
  • Enhancement of adherence to medications or prescribed behavioral approaches (e.g., physical activity and healthy eating)
  • Reduction of inappropriate use of medications or substances (e.g., substance use disorder or medications that are contraindicated in specific patient populations)

Applications that propose trials of regulated products (dietary supplements, devices, or biologics) for indications that have not been approved or cleared by the U.S. Food and Drug Administration will not be considered responsive to this FOA.

If your research interests don’t align with NCCIH’s, please review the interests of the other participating Institutes and Centers, as described in the FOA. They include NIA; the National Heart, Lung, and Blood Institute; the National Institute of Arthritis and Musculoskeletal and Skin Diseases; the National Institute of Nursing Research; and the National Institute on Minority Health and Health Disparities. The Office of Disease Prevention and Office of Behavioral and Social Sciences Research may co-fund applications. The scientific program staff at the participating Institutes and Centers highly encourage you to contact them to share your research aims and determine whether you have a good match before developing your application.

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