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.

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	Catalano, Richard; 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
Lumbar Imaging with Reporting of Epidemiology (LIRE)	Jarvik, Jeffrey	University of Washington	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
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.

Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

Demonstration Projects