Demonstration Projects

Demonstration Projects

The NIH Collaboratory is designed in part to support the design and rapid execution of several pragmatic clinical trial Demonstration Projects. These projects address questions of major public health importance and engage healthcare delivery systems in research partnerships. The data, tools, and resources produced by the Demonstration Projects will be made available to the greater research community to facilitate a broadened base of partnerships with healthcare systems. A UH2/UG3 is a cooperative agreement that supports the development of exploratory or innovative research activities (considered a pilot phase for feasibility assessment), and a UH3 award provides support for the second phase of research activities initiated with the UH2/UG3.

The lessons learned from the first 4 years of the Collaboratory and experiences with the Demonstration Projects are highlighted in the article Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory. The authors highlight some of the challenges encountered and solutions developed and discuss remaining barriers and opportunities for large-scale evidence generation using pragmatic clinical trials.

For a list of NIH staff supporting the Demonstration Projects, please see the NIH Implementation Team.

Drs. Lesley Curtis, Adrian Hernandez, and Catherine Meyers share their enthusiasm for the 6 new UG3 Demonstration Projects, which include new areas of expertise, such as pediatrics, new digital technologies, and the Collaboratory’s first A vs B trial.

PRISM UG3 Projects

Title Principal Investigator Sponsoring Institution Phase
Fibromyalgia TENS in Physical Therapy Study (FM TIPS) Crofford, Leslie; Sluka, Kathleen University of Iowa UG3
Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting (OPTIMUM) Morone, Natalia Boston Medical Center UG3
Non-pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) Cheville, Andrea; Tilburt, Jon Mayo Clinic Rochester UG3
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (AcuOA) DeBar, Lynn; Sherman, Karen J Kaiser Foundation Research Institute UG3

UH3 Projects

Title Principal Investigator Sponsoring Institution Phase
Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) Wolf, Myles Duke University UH3
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) Ho, Michael; Bull, Sheana University of Colorado UH3
Primary Palliative Care for Emergency Medicine (PRIM-ER) Grudzen, Corita New York University School of Medicine UH3
Improving Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE)  Tulsky, James; Volandes, Angelo Dana-Farber Cancer Institute UH3
Guiding Good Choices for Health (GGC4H): Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems Kuklinski, Margaret; Sterling, Stacy University of Washington UH3
Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (EMBED) Melnick, Edward; D'Onofrio, Gail Yale University UH3
A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS]) Zatzick, Douglas University of Washington UH3

Improving Chronic Disease Management with Pieces (ICD-Pieces) Vazquez, Miguel UT Southwestern Medical Center UH3
Pragmatic Trial of Video Education in Nursing Homes (PROVEN) Mor, Vincent; Volandes, Angelo; Mitchell, Susan Brown University School of Medicine UH3
Suicide Prevention Outreach Trial (SPOT) Simon, Gregory Kaiser Permanente Washington Health Research Institute UH3

 Completed Projects

Title Principal Investigator Sponsoring Institution Phase
Active Bathing to Eliminate (ABATE) Infection Huang, Susan University of California, Irvine UH3
Collaborative Care for Chronic Pain in Primary Care (PPACT) DeBar, Lynn Kaiser Foundation UH3
Lumbar Imaging with Reporting of Epidemiology (LIRE) Jarvik, Jeffrey University of Washington UH3
Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) Coronado, Gloria Kaiser Foundation Research Institute UH3

Time to Reduce Mortality in End-Stage Renal Disease (TiME) Dember, Laura University of Pennsylvania UH3

Inactive Projects

Title Principal Investigator Sponsoring Institution Phase
A Blood Pressure Medication Timing Study (BPMedTime) Rosenthal, Gary University of Iowa UH2

NIH Collaboratory Demonstration Project Site Distribution

NIH Collaboratory Demonstration Projects are active in health systems across the United States, as shown in the map below.



Demonstration Projects: Demonstration Projects. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated March 12, 2020.