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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,300 Participants
are divided into 3 treatment groups
Group A: Usual Care (Arm 1)No intervention 0 interventions
Group B: Usual Care (Arm 2)No intervention 0 interventions
Group C: Intervention (Arm 3)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Actual adverse events (AEs)

The number of actual AEs during the 30-day post-discharge period

Time frame
Up to 30-days after discharge from index hospitalization
2

Actual preventable adverse events (AEs)

The number of actual AEs during the 30-day post-discharge period

Time frame
Up to 30-days after discharge from index hospitalization

Secondary outcomes

1

Potential adverse events (AEs)

The number of new or worsening symptoms reported by the patient

Time frame
Up to 30-days after discharge from index hospitalization
2

Post-discharge healthcare utilization events (hospital readmissions)

Hospital readmissions

Time frame
Up to 30-days after discharge from index hospitalization
3

Post-discharge healthcare utilization (ambulatory events)

Composite of unanticipated ambulatory, urgent care, ED visits

Time frame
Up to 30-days after discharge from index hospitalization

Other outcomes

1

Time to actual AE

The number of days until first AE detected

Time frame
Up to 30-days after discharge from index hospitalization
2

Time to potential AE

The number of days until first potential AE detected

Time frame
Up to 30-days after discharge from index hospitalization

Sponsors and contacts

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