Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions

StatusTerminated
PhasePhase 1/2
Started

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Record History

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  1. Stopped Trial terminated Sponsor's reason: Grant Terminated by Sponsor Show 7 more changesShow less
    • Phase changed: not applicable → Phase 1/2
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Final enrollment: 937 participants (planned 1300)
    • Primary completion date changed from estimate of Sep 15, 2026 to May 15, 2026
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 2 of 2 sites
    • Collaborators: 1 to 2
  2. 2 versions Re-verified since Dec 1, 2023, no change to tracked fieldsv2-v3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination.
Trial Details
NCT Number NCT05282654
Lead Sponsor Brigham and Women's Hospital
Collaborators: RAND, Agency for Healthcare Research and Quality (AHRQ)
Conditions
(from sponsor)
Multiple Chronic Conditions, Adverse Event
Related terms Multiple Chronic Conditions
Enrollment 937 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov