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

NCT05282654 | Recruiting

• 1 other identifier: 2021P002593
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Digital Health; Patient Reported Outcomes; Symptom Monitoring; Predictive Model; Care Transitions; Post Acute Care

Outcome Measures

Primary Outcomes (2)

• Actual adverse events (AEs)

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

  Up to 30-days after discharge from index hospitalization

• Actual preventable adverse events (AEs)

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

  Up to 30-days after discharge from index hospitalization

Secondary Outcomes (3)

• Potential adverse events (AEs)

  Up to 30-days after discharge from index hospitalization

• Post-discharge healthcare utilization events (hospital readmissions)

  Up to 30-days after discharge from index hospitalization

• Post-discharge healthcare utilization (ambulatory events)

  Up to 30-days after discharge from index hospitalization

Other Outcomes (2)

• Time to actual AE

  Up to 30-days after discharge from index hospitalization

• Time to potential AE

  Up to 30-days after discharge from index hospitalization

Study Arms (3)

Usual Care (Arm 1)

NO INTERVENTION

During the 18-month Baseline Period (Arm 1, n=450) patients will be enrolled and receive usual care to develop the initial predictive model.

Usual Care (Arm 2)

NO INTERVENTION

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.

Intervention (Arm 3)

EXPERIMENTAL

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.

Behavioral: ePRO Application

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.

Intervention (Arm 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
• Two or more chronic conditions: Anxiety, Asthma\*, Arthritis (Osteoarthritis, Rheumatoid), Atrial Fibrillation, Cancer\*, Cerebral vascular accident, Chronic kidney disease\*, Chronic obstructive pulmonary disease (COPD)\*, Cirrhosis, Coronary artery disease/Ischemic heart disease, Dementia, Depression, Diabetes mellitus\*, End-stage renal disease\*, Heart failure\*, Hepatitis B, C\*, HIV/AIDs, Hyperlipidemia, Hypertension, Inflammatory bowel disease, Osteoporosis, Sickle cell disease, Substance abuse (Alcohol/Opioid)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• RAND: collaborator

Study Sites (2)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anuj Dalal, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anuj Dalal, MD

CONTACT

(617) 525-8891; adalal1@bwh.harvard.edu

Savanna Plombon, MPH

CONTACT

857-307-2668; splombon@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During main trial (post-implementation period), study investigators, outcomes assessor will be masked to randomization status of all participants
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Model Details: Baseline, pre-implementation period (usual care arm 1) and main trial (RCT) period (usual care arm 2 and intervention/experimental arm 3)

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 16, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-03

Locations

US (2)