NIH Collaboratory to Coordinate Pragmatic Clinical Trials on Pain Management
The NIH Health Care Systems Research Collaboratory program has received funding to serve as the Resource Coordinating Center for a new group of large-scale embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing.
As part of the NIH Collaboratory, the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center will provide technical support and pragmatic trial expertise for the research that this program funds. PRISM trials will determine the effectiveness of multiple non-opioid interventions for treating pain and assess the impact of implementing interventions or guidelines to improve pain management and reduce reliance on opioids.
The PRISM Resource Coordinating Center funding and new research awards, described below, are part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). This federal research initiative, launched in early 2018 by NIH Director Francis S. Collins, aims to apply scientific solutions to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery for opioid addiction.
The PRISM awards total approximately $35.7 million and are supported by eight participating NIH institutes, centers and offices. With these awards, the NIH Collaboratory will add four new large-scale ePCTs to its portfolio of innovative Demonstration Projects. The trials will be conducted at Boston Medical Center, Kaiser Foundation Research Institute, Mayo Clinic and University of Iowa. They include:
• Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial
• Fibromyalgia TENS in Physical Therapy Study (TIPS): An embedded pragmatic clinical trial
• Group-based mindfulness for patients with chronic low back pain in the primary care setting
• Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
The NIH Collaboratory aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. The Collaboratory has five Core Working Groups of experts that help research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.
“The NIH Collaboratory Coordinating Center is excited to be supporting these novel pragmatic trials that address an urgent health crisis,” said Adrian Hernandez, M.D., M.H.S., vice dean for clinical research at Duke University School of Medicine, in a statement. “We hope the patients, clinicians, researchers, and health systems will benefit from knowledge we’ve gained supporting complex trials embedded in health care systems over the past seven years, which will help deliver improvements in pain management to the American public faster.”
