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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05282654
Status
Recruiting
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Conditions

  • Adverse Event
  • Multiple Chronic Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ePRO Application — BEHAVIORAL
    The intervention consists of a patient portal, EHR-integrated web-app to communicate risk of post-discharge adverse events using patient-reported outcome questionnaires, discharge preparation checklist during hospitalization. After discharge, the intervention will provide real-time symptom monitoring using ePROs and facilitate communication with clinicians based on prediction model-informed ePRO score trends exceeding escalation thresholds.

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
Mar 2026
Primary completion
Sep 15, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
1,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Usual Care (Arm 1)
    During the 18-month Baseline Period (Arm 1, n=450) patients will be enrolled and receive usual care to develop the initial predictive model.
  • No Intervention: Usual Care (Arm 2)
    During the 30-month Main Trial (RCT) Period, patients will be randomized to usual care (Arm 2, n=425). Data collection for post-discharge AE determination will occur during both periods.
  • Experimental: Intervention (Arm 3)
    During the 30-month Main Trial (RCT) Period, patients will be randomized to the intervention (Arm 3, n=425). Data collection for post-discharge AE determination will occur during both periods.

Primary Outcome Measure

Actual adverse events (AEs) [ Time Frame: Up to 30-days after discharge from index hospitalization ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's Faulkner HospitalBostonMassachusetts02115
Anuj K Dalal, MD
Brigham and Women's HospitalBostonMassachusetts02115
Anuj K Dalal, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Faulkner Hospital· Boston, MABrigham and Women's Hospital· Boston, MA

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