Table 1 Summary of trials in the Pragmatic Trials Collaborative Project
Trial name | PI/affiliation/sponsor | Trial title | Significance | Setting/target population | Recruitment strategy | Intervention | Primary and (secondary) outcomes | Design/analysis (sample size) |
|---|---|---|---|---|---|---|---|---|
ENGAGES | M. AVIDAN, MD (Washington University)/NIA | Electroencephalograph Guidance of Anesthesia to Alleviate Geriatric Syndromes | Reduce postoperative delirium associated w/cognitive impairment and falls | Hospital/elective surgery patients age 60 + years | Drawn from patients enrolled in SATISFY-SOS study (consent obtained by RA in pre-op clinic) | EEG-guided anesthesia vs. usual care | Postoperative delirium (patient-reported health-related quality of life; postoperative falls) | Block randomization (patients) Intent-to-treat (N = 1232) |
HUSH | D. BUYSSE, MD (University of Pittsburgh)/NHLBI | Pragmatic Trial of Behavioral Interventions for Insomnia in Hypertensive Patients | Reduce insomnia disorder using non-drug treatment in primary care | Primary care/adult patients w/HTN, hypnotic medication, or insomnia diagnosis | PCP referral via Research Recruitment Alert (RRA); telephone screen; electronic consent | Two CBT interventions (one online) vs. usual care | Self-reported sleep; health indicators (symptoms, health, and patient/provider satisfaction; sleep, depression, anxiety, fatigue) | Stratified block randomization (age and sex) Intent-to-treat (N = 625) |
PART | H. WANG, MD (University of Alabama at Birmingham)/NHLBI | Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest | Identification of best approach for out-of-hospital cardio-pulmonary arrest | Community-emergency/non-trauma cardiac arrest – adult patients | N/A | Endotracheal intubation and supraglottic airways approaches | 72-hour hospital survival (return of spontaneous circulation, airway management performance, clinical adverse events) | Cluster-crossover (randomization at EMS level – no consent) Intent-to-treat (N = 2612) |
PROOF Check | M. GONG, MD; O. GAJIC, MD (Albert Einstein College of Medicine of Yeshiva University)/NHLBI | Prevention of Severe Acute Respiratory Failure in Patients w/PROOFCheck | Prevent acute respiratory failure leading to organ failure | Hospital/all at-risk patients | High-risk patients identified by APPROVE (EMR-based) | Clinician notification of high-risk and PROOFCheck (bundle of care practices) vs. usual care | Hospital mortality (organ failure, ventilator-free days, 6- and 12-month mortality, ICU and hospital length of stay, ability to return home on discharge) | Stepped-wedge, cluster randomized (hospital level – no consent) Intent-to-treat (N = 7778 minimum) |
REDAPS | S. HALPERN, MD (University of Pennsylvania)/NIA | Default Palliative Care Consultation for Seriously Ill Hospitalized Patients | Determine effectiveness and cost of inpatient palliative care consult services | Hospital (w/integrated EHR) Patients ≥ 65 years w/end stage renal disease, advanced COPD, or advanced dementia | Intake assessment (nurse); EHR algorithm generates default palliative care order | Opt-out default for palliative care services vs. usual care (opt-in) | Composite measure hospital mortality and length of stay (hospital and ICU mortality; pain, transfer to ICU and CPR after randomization; days of mechanical ventilation; discharge disposition; 30-day hospital readmission; total hospital costs) | Stepped-wedge, cluster randomized (waiver of informed consent) Intent-to-treat (N ≥ 23,000) |