Concept: Health Care Systems Research Collaboratory

Project Concept Review

Council Date: January 15, 2021

Program Director: Wendy Weber, N.D., Ph.D., M.P.H.

Background 

The overall goal of the NIH Health Care Systems (HCS) Research Collaboratory program has been strengthening the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations and patients as research partners. The NIH HCS Research Collaboratory Program established a Collaboratory Coordinating Center (CCC) in 2012 (https://rethinkingclinicaltrials.org/about-nih-collaboratory/) that is providing national leadership and technical expertise. Since 2012, the CCC has facilitated the successful planning and implementation of 19 full-scale pragmatic clinical trials launched in the NIH HCS Research Collaboratory Program. The program was initially supported by the NIH Common Fund in 2012. In 2017, the program transitioned to Common Fund support for the Coordinating Center and support for the pragmatic trials coming from participating institutes and centers. 

The aim of the HCS Research Collaboratory program is to provide a framework of implementation methods and best practices that will enable the participation of many health care systems in pragmatic research, not to support a defined health care research network. Health care systems have interest in participating in studies that may potentially impact the care they deliver, including pragmatic clinical research addressing the introduction of effective interventions or technologies into care or assessing the methods for dissemination and implementation of known effective treatments or guidelines. Research conducted in partnership with health care systems is essential to strengthen the relevance of research results to “real world” health practice. Successful approaches and best practices established through this initiative for research partnerships with health care systems should have a major impact on clinical research in the United States. The Collaboratory is also well-suited for testing how readily practice guidelines can be implemented in HCS, and for assessing outcomes of implementation across a broad range of patient subgroups. The Collaboratory could also leverage existing efforts, such as those of the U.S. Preventive Services Task Force, for generating evidence regarding screenings, counseling services, and preventive medications to improve the health of Americans. 

Purpose of Proposed Initiative

This initiative will support the continuation of the Health Care Systems Research Collaboratory for an additional 6 years of support by participating institutes and centers across NIH. The program would support 1) the continued support of the coordinating center through a limited competition funding opportunity announcement; and 2) a set of pragmatic trials or implementation science research studies conducted in partnership with at least three health care delivery systems. Trials must meet NIH requirements for diversity and inclusion for phase 3 trials. Projects and the Coordinating Center will ultimately make available data, tools, resources, and lessons learned from Collaboratory research projects to facilitate a broadened base of research partnerships with HCS.

Although 20th century scientific and technological advances have improved the health and well-being of the U.S. population overall, some populations in the United States do not benefit to the same extent. Racial and ethnic groups; socioeconomically disadvantaged, underserved populations; rural populations; and sexual and gender minority populations continue to experience a disproportionate share of many acute or chronic diseases and adverse health outcomes. Several characteristics make addressing health disparities an especially challenging problem. The challenges lie in the interactions of influences at various levels (e.g., individual, interpersonal, family, community, societal), the diversity of the relevant mediators (e.g., exposures, resilience factors), and the multiple interacting mechanisms involved (e.g., biological, behavioral, environmental, sociocultural, and health care system). Pragmatic trials and implementation studies are needed to address many disease settings that have predominantly impacted underserved patient populations, leading to increases in disease burden and unfavorable disease outcomes. Policies, clinical practice guidelines, and tools and interventions require careful assessment within HCS to address existing health inequities that continue to have negative health outcomes in these populations. Research is needed to study strategies to most effectively, equitably, and efficiently implement evidence-based interventions, and guidelines if applicable, to further assess their effectiveness in “real world” settings for underserved populations.

Each participating institute and center will co-fund the Coordinating Center and then support individual pragmatic trials or implementation science studies in high priority areas for that institute or center. The participating institutes and centers have indicated a strong interest in supporting research in health care systems that deliver care to underserved populations.

Objectives

The objectives to be met by this concept include but are not limited to the following:

• Coordinating Center 
  • Further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of pragmatic clinical effectiveness and implementation trials in partnership with health care systems
  • Work collaboratively with each pragmatic study team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed study while providing technical, design, and coordination support
  • Learn and disseminate the best strategies for engaging health care systems as research partners to improve health and care delivery.
     
• Pragmatic and Implementation Trials 
  • Support embedded pragmatic or implementation trials to evaluate the impact of health care system changes to improve health 
  • Support pragmatic or implementation trials that will reduce or eliminate health inequities in health care systems
  • Support trials that will evaluate the impact of integrating evidence-based interventions into health care delivery
  • Conduct pragmatic clinical trials that will inform health care policy makers, such as Federal, state, and private health care systems.