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

NCT05282654 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2026-04-20

No results posted yet for this study

Summary

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.

Conditions

  • Multiple Chronic Conditions
  • Adverse Event

Interventions

BEHAVIORAL

ePRO Application

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.

Sponsors & Collaborators

  • RAND

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Anuj Dalal, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-09-15
Completion
2026-10-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282654 on ClinicalTrials.gov