NIH expands program that conducts large-scale clinical trials in real-world settings

The National Institutes of Health’s Health Care Systems (HCS) Research Collaboratory, which involves health care systems in conducting large-scale clinical studies, has announced five new research awards—totaling $4.15 million for a one-year planning phase, with an estimated $30.85 million expected for four subsequent years of study implementation. The HCS Research Collaboratory was developed by the NIH Common Fund in 2012 and is administered by the National Center for Complementary and Integrative Health (NCCIH) and the National Institute on Aging (NIA). The HCS Research Collaboratory is currently supporting nine large-scale clinical trials with health care systems across the United States, and a collaboratory coordinating center at Duke University, Durham, North Carolina. The ongoing trials focus on many different diseases, including colon cancer, chronic pain, kidney failure, hospital-acquired infections, suicide prevention, and multiple chronic medical conditions.

Health care systems, which include health maintenance organizations and other large integrated care settings, see large populations of patients. Through these collaborative research projects, NIH is also able to conduct large-scale and cost-effective clinical research on a variety of diseases within the settings where patients are already receiving their care.

“The collaboratory program pioneered efforts at NIH to conduct large-scale clinical trials within health care systems, and we are excited about expanding this initiative,” said Dr. Shurtleff, NCCIH acting director. “Conducting clinical trials in real-world settings is a critical aspect of the collaboratory program.”

“This kind of trans-NIH collaboration is important as we test interventions on a large scale and in real world clinical care settings,” said Richard J. Hodes, M.D., director of NIA, who oversees the collaboratory with Shurtleff.

The five new projects for the NIH HCS Research Collaboratory are supported by six NIH institutes, centers, and offices, including NCCIH, NIA, the National Institute on Drug Abuse (NIDA), the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Disease Prevention (ODP), and the National Heart, Lung, and Blood Institute (NHLBI). The new projects include:

• Primary Palliative Care for Emergency Medicine; New York University, New York City; Dr. Corita Grudzen. This 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. (NCCIH and NIA, Grant 1-UG3-AT-009844-01)
• EMBED: Pragmatic Trial of User-centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder; Yale University, New Haven, Connecticut; Drs. Edward Melnick and Gail D’Onofrio. This 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. (NIDA, Grant 1-UG3-DA-047003-01)
• Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems; University of Washington, Seattle; Drs. Richard Catalano, Margaret Kuklinski, and Stacy Sterling. This trial will embed a parental guidance and education program within pediatric primary care for adolescents that is aimed at making good choices, and assess prevention of substance use, depression, anxiety, and anti-social behavior. (NCCIH, NIDA, OBSSR, and ODP, Grant 1-UG3-AT-009838-01)
• Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications; University of Colorado, Denver; Drs. Michael Ho and Sheana Bull. This trial will test the ability of nudges via text messaging and artificially intelligent interactive chat bot to improve medication adherence and clinical outcomes in patients with chronic cardiovascular conditions. (NHLBI, Grant 1-UG3-HL-144163-01)
• Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training; Dana Farber Cancer Institute, Boston; Drs. James Tulsky and Angelo Volandes. This 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. (NIA, Grant 1-UG3-AG-060626-01)

The overall goal of the HCS Research Collaboratory is to strengthen the national capacity to implement cost-effective, large-scale research studies that involve health care delivery organizations. The aim of the program is to provide a framework of implementation methods and best practices that will enable the participation of many health care systems in clinical research. Research conducted with health care systems is essential to strengthen the relevance of research results to health practice.