This post was updated on August 3, 2018.
The NIH Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects. The new research awards, which are supported by 6 NIH institutes, centers, and offices, total $4.15 million for an initial 1-year planning phase and an estimated $30.85 million for 4 years of study implementation.
NIH Collaboratory Demonstration Projects are multicenter, pragmatic trials that engage healthcare delivery systems in research partnerships to gather real-world evidence and answer clinical questions of major public health importance. Five Core Working Groups of experts, each focused on a specific topic related to the implementation of pragmatic clinical trials, support all of the Demonstration Projects. The Core Working Groups help the research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process.
In its first 5 years, the NIH Collaboratory successfully guided 10 complex Demonstration Projects through the planning phase, 9 of which proceeded to full study implementation.
The 5 new Demonstration Projects are supported by the National Center for Complementary and Integrative Health (NCCIH), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute on Drug Abuse (NIDA), the Office of Behavioral and Social Sciences Research (OBSSR), and the Office of Disease Prevention (ODP). They include:
- PRIM-ER: Primary Palliative Care for Emergency Medicine: The PRIM-ER trial will assess the impact of a primary palliative care for emergency medicine intervention on emergency department visits for older adults with serious life-limiting conditions. (New York University. Principal investigator: Dr. Corita Grudzen. Supported by NCCIH and NIA.)
- EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder: The EMBED project will develop and test an electronic health record tool to help busy emergency department physicians initiate patients with opioid use disorder on buprenorphine/naloxone and refer them to ongoing treatment. (Yale University. Principal investigators: Dr. Edward Melnick and Dr. Gail D’Onofrio. Supported by NIDA.)
- GGC4H (Guiding Good Choices for Health): Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems: This trial will embed a parental guidance and education program within pediatric primary care for adolescents, and assess prevention of substance use, depression, anxiety, and antisocial behavior. (University of Washington. Principal investigators: Dr. Richard Catalano, Dr. Margaret Kuklinski, and Dr. Stacy Sterling. Supported by NCCIH, NIDA, OBSSR, and ODP.)
- Nudge: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: The Nudge project will test the ability of nudges via text messaging and an artificially intelligent interactive chat bot to improve medication adherence and clinical outcomes in patients with chronic cardiovascular conditions. (University of Colorado. Principal investigators: Dr. Michael Ho and Dr. Sheana Bull. Supported by NHLBI.)
- ACP PEACE: Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training: The ACP PEACE trial will assess the impact of a comprehensive advance care planning program, which incorporates both clinician training and patient video decision aids, for older patients with advanced cancer. (Dana Farber Cancer Institute. Principal investigators: Dr. James Tulsky and Dr. Angelo Volandes. Supported by NIA.)
Over the next 5 years, the new Demonstration Projects will extend the NIH Collaboratory’s mission to improve how clinical trials are conducted by creating a new infrastructure for implementing cost-effective, large-scale research studies that involve healthcare delivery organizations.
Update: A sixth new Demonstration Project, HiLo, was subsequently announced.