Actively Recruiting
Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions
Led by Brigham and Women's Hospital · Updated on 2026-04-20
1300
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
R
RAND
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of real-time symptom monitoring through electronic patient-reported outcomes (ePROs) to predict and reduce adverse events (AEs) after hospital discharge in patients with multiple chronic conditions (MCC). The study aims to develop and validate a predictive model for post-discharge AEs, improve digital health tools integrated with electronic health records (EHR), and assess the impact of this intervention compared to usual care. This large-scale randomized controlled trial is supported by Brigham and Women's Hospital and focuses on improving safety during care transitions for MCC patients. The study includes three main periods: an 18-month baseline period where 450 patients receive usual care to help develop the predictive model, followed by a 30-month randomized controlled trial (RCT) where 850 patients are assigned either to usual care or to the intervention group using an ePRO application. This app is integrated with patient portals and EHR systems to communicate risk and monitor symptoms in real time based on patient-reported questionnaires. It also facilitates communication with clinicians when symptom trends suggest potential risks. Participants will be hospitalized adults with multiple chronic conditions discharged to home or care facilities. They will be monitored for up to 30 days after hospital discharge for actual and preventable adverse events, as well as healthcare utilization such as readmissions and ambulatory visits. The study collects patient-reported outcomes, EHR data, and uses digital tools for symptom tracking and communication. Researchers will also evaluate barriers and facilitators to the intervention's use with the goal of sustainable implementation and wider dissemination.
CONDITIONS
Brief Title
Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Hospital stay of at least 24 hours
Participants receive discharge preparation using the ePRO application during hospitalization, including risk communication of post-discharge adverse events.
1 visit (in-person) during hospitalization
Duration - Up to 30 days after discharge
After discharge, participants use the ePRO application for real-time symptom monitoring and communication with clinicians based on symptom reports.
Regular symptom reporting through the app with clinician communication as needed
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Anuj Dalal, MD
S
Savanna Plombon, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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