Since 2012, the National Institutes of Health (NIH) Health Care Systems Research Collaboratory has supported the design, conduct, and implementation of innovative embedded pragmatic clinical trial (ePCT) Demonstration Projects. To date, the Collaboratory Coordinating Center (CC) has worked with the NIH to nurture 15 Demonstration Projects by providing leadership, resources, tools, training, and coordination of diverse elements. The CC maintains expert Core Working Groups, supports dissemination and implementation, and established the online Living Textbook of Pragmatic Clinical Trials to translate learnings for the research community. In an effort to speed scientific solutions for addressing the national opioid public health crisis, the NIH in 2018 announced two new funding opportunities for up to 9 more ePCTs that will address pain management and the opioid crisis. These projects are part of the NIH?s Helping to End Addiction Long-term (HEAL) Initiative and will be supported by the proposed NIH HEAL Collaboratory Resource Coordinating Center. The HEAL Initiative will invite phased UG3/UH3 cooperative research studies in the following areas: (1) Pragmatic Randomized Controlled Trials of Acupuncture for Management of Chronic Low Back Pain in Older Adults: 1 to 2 large-scale ePCTs that evaluate acupuncture treatment of older adults (65 years and older) with chronic low back pain (RFA-AT-19-005), and (2) Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM): 6 to 7 large-scale ePCTs or implementation studies designed to improve pain management and reduce unnecessary opioid prescriptions (RFA-AT-19-004). The Demonstration Projects in the HEAL Initiative will build on lessons learned and experiences gleaned from the first set of Demonstration Projects to continue to refine the ePCT model with these Specific Aims:
Specific Aim 1 : Work collaboratively with each HEAL Initiative Demonstration Project team supported through the HEAL Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed Demonstration Projects while providing technical, design, and coordination support.
Specific Aim 2 : Develop and refine technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems.
Specific Aim 3 : Disseminate the best strategies for conducting successful embedded pragmatic clinical trials, including engaging health care systems as research partners to improve health and care delivery.
The National Institutes of Health (NIH) HEAL Collaboratory Resource Coordinating Center works to strengthen the nation?s ability to implement cost-effective, large-scale research studies that engage health care delivery organizations as research partners. The Collaboratory will develop and share knowledge about pragmatic clinical trials including those targeted to the HEAL Initiative, including an estimate of their value, in order to promote the use and acceptance of these research methods by various decision-makers.