About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (18 years or older)
Hospitalized on the general medicine services at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital for at least 24 hours
Have a discharge status of home, home with services, or facility
English-speaking patients or their English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
Disqualifiers
Less than 18 years of age
Less than two chronic conditions
Hospitalized less than 24 hours
No identifiable healthcare proxy or next of kin (i.e., a family caregiver)
Trial design
Parallel
Treatments tested in this trial
ePRO Application
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Actual adverse events (AEs)
The number of actual AEs during the 30-day post-discharge period
Actual preventable adverse events (AEs)
The number of actual AEs during the 30-day post-discharge period
Secondary outcomes
Potential adverse events (AEs)
The number of new or worsening symptoms reported by the patient
Post-discharge healthcare utilization events (hospital readmissions)
Hospital readmissions
Post-discharge healthcare utilization (ambulatory events)
Composite of unanticipated ambulatory, urgent care, ED visits
Other outcomes
Time to actual AE
The number of days until first AE detected
Time to potential AE
The number of days until first potential AE detected
Sponsors and contacts
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Brigham and Women's Hospital
Lead sponsor
RAND
Collaborator