Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the Distributed Research Network, and study designs and results from the NIH Collaboratory Trials.
This year, the NIH Collaboratory contributed nearly 30 articles to the peer-reviewed literature, including the study design papers for the GRACE and BackInAction trials.
The total number of published articles from the NIH Collaboratory surpassed 300 this year. Learn more about the program's publications.
Coordinating Center
- Intervention delivery for embedded pragmatic clinical trials: development of a tool to measure complexity
- Moving from idealism to realism with data sharing
Cross-Core Collaboration
- From the the Electronic Health Records Core, the Health Care Systems Interactions Core, the Health Equity Core, and the Patient-Centered Outcomes Core — Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory
Distributed Research Network
Biostatistics and Study Design Core
- Improving sandwich variance estimation for marginal Cox analysis of cluster randomized trials
- Designing three-level cluster randomized trials to assess treatment effect heterogeneity
Ethics and Regulatory Core
- Stakeholder perspectives on data sharing from pragmatic clinical trials: unanticipated challenges for meeting emerging requirements
- Think pragmatically: investigators' obligations to patient-subjects when research is embedded in care
- Do clinicians have a duty to participate in pragmatic clinical trials?
ACP PEACE
- Reaching ambulatory older adults with educational tools: comparative efficacy and cost of varied outreach modalities in primary care
- Structural barriers to well-grounded advance care planning for the seriously ill: a qualitative study of clinicians' and administrators' experiences during a pragmatic trial
- Forms or free-text? Measuring advance care planning activity using electronic health records
- Video intervention and goals-of-care documentation in hospitalized older adults: the VIDEO-PCE randomized clinical trial
BackInAction
EMBED
- Racial and ethnic disparities in emergency department-initiated buprenorphine across five health care systems
- Implementation strategies to address the determinants of adoption, implementation, and maintenance of a clinical decision support tool for emergency department buprenorphine initiation: a qualitative study
- Fentanyl-associated overdose deaths outside the hospital
- Clinical decision support: moving beyond interruptive "pop-up" alerts
GRACE
- Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol
- Developing an implementation blueprint for the NIH HEAL Initiative GRACE trial: perspectives on acupuncture and guided relaxation for chronic sickle cell disease pain
- Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for chronic sickle cell disease pain
LIRE
Nudge
- Patient engagement with prescription refill text reminders across time and major societal events
- Secondary analysis of electronic opt-out consent in pragmatic research: A study design method to diversify clinical trials?
- Description of patient questions received by clinical pharmacists in the Nudge Study
OPTIMUM
PRIM-ER
- Emergency providers' knowledge and attitudes toward hospice and palliative care: a cross-sectional analysis across 35 emergency departments in the United States
- Emergency nurses' perceived barriers and solutions to engaging patients with life-limiting illnesses in serious illness conversations: a US multicenter mixed-method analysis