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 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 |
|---|---|---|---|
| Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) | Doorenbos, Ardith; Schlaeger, Judith; Molokie, Robert; Ezenwa, Miriam; Shah, Nirmish | University of Illinois at Chicago | UG3 |
| Nonpharmacologic Pain Management in Federally Qualified Health Centers Primary Care Clinics (BeatPain Utah) | Fritz, Julie | University of Utah | UG3 |
PRISM UH3 Projects
| Title | Principal Investigator | Sponsoring Institution | Phase |
|---|---|---|---|
| Fibromyalgia TENS in Physical Therapy Study (FM-TIPS) | Crofford, Leslie; Sluka, Kathleen | University of Iowa | UH3 |
| Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting (OPTIMUM) | Morone, Natalia | Boston Medical Center | UH3 |
| Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) | Cheville, Andrea; Tilburt, Jon | Mayo Clinic Rochester | UH3 |
| Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction) | DeBar, Lynn; Sherman, Karen J | Kaiser Foundation Research Institute | UH3 |
UH3 Projects
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 |
| Pragmatic Trial of Video Education in Nursing Homes (PROVEN) | Mor, Vincent; Volandes, Angelo; Mitchell, Susan | Brown University School of Medicine | 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 |
| 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 |
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. Our trials have over >1,100 clinical sites across 90% of the United States.
