NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)

5U24AT009676-09 Since 2012, the NIH Pragmatic Trials Collaboratory Coordinating Center (CC) has worked with the NIH to nurture >35 large-scale embedded pragmatic clinical trials (ePCTs) by providing leadership, resources, tools, training, and coordination of diverse elements. In 2019, the CC began working with a group of ePCTs supported by the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM), a program of NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). The PRISM trials are determining the effectiveness of non-opioid interventions for treating pain and assessing the impact of implementing interventions or guidelines to improve pain management and reduce reliance on opioids. The CC also supports additional HEAL pain trials to address pain management in rural populations and coordinated pain care in the primary care setting. The CC maintains expert Core Working Groups and committees; supports dissemination and implementation efforts; and established the online Living Textbook of Pragmatic Clinical Trials to translate learnings for the research community. The CC has created and disseminated guidance so that investigators can work with health systems to embed their research in the delivery of health care and use routinely collected health care information as a core data source for the full spectrum of clinical research, including randomized trials. The CC is also providing essential guidance to funders, reviewers, institutional review boards (IRBs), and data safety monitoring boards regarding the ethical and regulatory aspects of ePCTs. In this next phase of work, we will build on lessons learned and new experiences gleaned from the next set of Demonstration Projects to continue to refine the pragmatic trials model (Aims 1-3).