Investigators from the NIH Pragmatic Trials Collaboratory in 2022 shared study results, generated new knowledge, and developed innovative research methods in 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 has produced nearly 50 articles in the peer-reviewed literature, including the primary results of the EMBED, PPACT, and SPOT trials, the study designs of the BeatPain Utah, FM-TIPS, GGC4H, and NOHARM studies, and more.
Coordinating Center
- The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory
- Concordance between patient-reported health data and electronic health data in the ADAPTABLE trial
Distributed Research Network
Biostatistics and Study Design Core
- Two weights make a wrong: cluster randomized trials with variable cluster sizes and heterogeneous treatment effects
- Designing three-level cluster randomized trials to assess treatment effect heterogeneity
Ethics and Regulatory Core
- Responding to signals of mental and behavioral health risk in pragmatic clinical trials: ethical obligations in a healthcare ecosystem
- Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials
- Think pragmatically: investigators’ obligations to patient-subjects when research is embedded in care
- Patients’ reactions to letters communicating collateral findings of pragmatic clinical trials: a national web-based survey
- Promoting ethical deployment of artificial intelligence and machine learning in healthcare
- Toward meeting the obligation of respect for persons in pragmatic clinical trials
- Do clinicians have a duty to participate in pragmatic clinical trials?
- Ethics challenges in sharing data from pragmatic clinical trials
Health Care Systems Interactions Core
ACP PEACE NIH Collaboratory Trial
- Association of an advance care planning video and communication intervention with documentation of advance care planning among older adults: a nonrandomized controlled trial
- Natural language processing to identify advance care planning documentation in a multisite pragmatic clinical trial
- Patient factors and hospital outcomes associated with atypical presentation in hospitalized older adults with COVID-19 during the first surge of the pandemic
BeatPain Utah NIH Collaboratory Trial
EMBED NIH Collaboratory Trial
- Moving upstream: a social emergency medicine approach to opioid use disorder
- Emergency department visits for nonfatal opioid overdose during the COVID-19 pandemic across 6 US healthcare systems
- Trends and disparities in access to buprenorphine treatment following an opioid-related emergency department visit among an insured cohort, 2014-2020
- Main Outcome Paper: User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial
EMBED/PRIM-ER NIH Collaboratory Trials
FM-TIPS NIH Collaboratory Trial
- Study Design Paper: The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study (FM-TIPS) Protocol: a multisite embedded pragmatic trial
- Features and methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a Delphi expert consensus study
GGC4H NIH Collaboratory Trial
- Study Design Paper: Parent-focused prevention of adolescent health risk behavior: study protocol for a multisite cluster-randomized trial implemented in pediatric primary care
GRACE NIH Collaboratory Trial
LIRE NIH Collaboratory Trial
- A comparison of natural language processing methods for the classification of lumbar spine imaging findings related to lower back pain
- Osteoporosis identification among previously undiagnosed individuals with vertebral fractures
NOHARM NIH Collaboratory Trial
- Study Design Paper: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): protocol for a stepped-wedge cluster-randomized pragmatic clinical trial
PPACT NIH Collaboratory Trial
- Main Outcome Paper: A primary care-based cognitive behavioral therapy intervention for long-term opioid users with chronic pain: a randomized pragmatic trial
- Economic evaluation: a randomized pragmatic trial of a primary care-based cognitive behavioral intervention for adults receiving long-term opioids for chronic pain
PRIM-ER NIH Collaboratory Trial
- Arranging hospice care from the emergency department: a single center retrospective study
- Leveraging emergency department information systems to address palliative care needs of ED patients during the COVID pandemic
- Locating advance care planning documents in the electronic health record during emergency care
- Knowledge and attitudes toward hospice and palliative care: instrument validation among emergency providers
- Emergency provider perspectives on facilitators and barriers to home and community services for older adults with serious life limiting illness: a qualitative study
- Palliative care models for patients living with advanced cancer: a narrative review for the emergency department clinician
- Household income and older adult population predict number of integrative medicine providers around US hospitals: an environmental scan study
- Emergency and post-emergency care of older adults with Alzheimer’s disease/Alzheimer’s disease related dementias
PROVEN NIH Collaboratory Trial
- Effect of a video-assisted advance care planning intervention on end-of-life health care transitions among long-stay nursing home residents
- Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness
SPOT NIH Collaboratory Trial
- Connecting research and practice: implementation of suicide prevention strategies in learning health care systems
- Main Outcome Paper: Effect of offering care management or online dialectical behavior therapy skills training vs usual care on self-harm among adult outpatients with suicidal ideation: a randomized clinical trial
TSOS NIH Collaboratory Trial
- Nationwide survey of trauma center screening and intervention practices for posttraumatic stress disorder, firearm violence, mental health, and substance use disorders
- Rapid ethnographic assessment of the impact of the COVID-19 pandemic on mental health services delivery in an acute care medical emergency department and trauma center
- A pragmatic clinical trial approach to assessing and monitoring suicidal ideation: results from a national US trauma care system study
- The Emergency Department Longitudinal Integrated Care (ED-LINC) intervention targeting opioid use disorder: a pilot randomized clinical trial
- Post-traumatic stress disorder (PTSD) symptoms and alcohol and drug use comorbidity at 25 US level I trauma centers