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Table 1 Summary of trials in the Pragmatic Trials Collaborative Project

From: Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains

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)
  1. COPD chronic obstructive pulmonary disease, CPR cardiopulmonary resuscitation, EEG electroencephalogram, EHR electronic health record, EMR electronic medical record, HTN hypertension, ICU intensive care unit, NIA National Institute on Aging, N/A not applicable, w/with
  2. Trials: ENGAGES Electroencephalograph Guidance of Anesthesia to Alleviate Geriatric Syndromes Trial, HUSH Pragmatic Trial of Behavioral Interventions for Insomnia in Hypertensive Patients, PART Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest, PROOFCheck Prevention of Severe Acute Respiratory Failure in Patients w/PROOFCheck (Electronic Checklist to Prevent Organ Failure), REDAPS Default Palliative Care Consultation for Seriously Ill Hospitalized Patients