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.


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.

UG3 Projects

Title Principal Investigator Sponsoring Institution Phase
Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training (ACP PEACE)  Tulsky, James; Volandes, Angelo Dana-Farber Cancer Institute UG3
Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) Wolf, Myles Duke University UG3
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 UG3
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 UG3
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) Ho, Michael; Bull, Sheana University of Colorado UG3
Primary Palliative Care for Emergency Medicine (PRIM-ER) Grudzen, Corita New York University School of Medicine UG3

UH3 Projects

Title Principal Investigator Sponsoring Institution Phase
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
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
Improving Chronic Disease Management with Pieces (ICD-Pieces) Vazquez, Miguel UT Southwestern Medical Center 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
Suicide Prevention Outreach Trial (SPOT) Simon, Gregory Kaiser Permanente Washington Health Research Institute UH3
Time to Reduce Mortality in End-Stage Renal Disease (TiME) Dember, Laura University of Pennsylvania UH3

In 2017, the NIH Collaboratory Coordinating Center conducted a series of interviews with the Principal Investigators of these Demonstration Projects to share challenges and lessons learned that may help in the conduct of future pragmatic trials.

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. Hover over a pin for more information.

*Please note that pins may represent more than one site per state, and the pin location is not an exact representation.

Demonstration Studies Placeholder
Demonstration Studies

NH Health Care Systems Research Collaboratory Implementation Team

 

David Shurtleff, PhD, Co-Chair (NCCIH)

Catherine M. Meyers, Assistant to the Chair (NCCIH)

Barbara Wells, Assistant to the Chair (NHLBI)

Kevin C. Abbott (NIDDK) Jeri Miller (NINR)
Robin Boineau (NCCIH) Andrew Narva (NIDDK)
Erica Breslau (NCI) Jane Pearson (NIMH)
Leslie Derr (OD/OSC) Linda L. Porter (NINDS)
Gregory Deye (NIAID) Matthew Rudorfer (NIMH)
Sarah Duffy (NIDA) Marcel Salive (NIA)
Brett Hagman (NIAAA) Jerry Suls (NCI)
Clayton Huntley (NIAID) Chuck Washabaugh (NIAMS)
Paul Kimmel (NIDDK) Wendy Weber (NCCIH)

Executive Secretary: Christina Brackna (NCCIH)

Advisors: Elaine Collier (NCATS) and Debra Egan (NCCIH)

 

UH3 Demonstration Projects: Principal Investigators
Back left to right: Doug Zatzick, Greg Simon, Miguel Vazquez, Vince Mor, Jerry Jarvik
Front left to right: Bev Green, Lynn DeBar, Susan Huang, Laura Dember, Gloria Coronado

 

Citation:

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: https://rethinkingclinicaltrials.org/demonstration-projects/. Updated January 7, 2019.