Monitoring symptoms in patients with multiple chronic conditions to prevent adverse events after hospital discharge
Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions
This study is testing a digital health app that helps keep track of symptoms in patients with multiple chronic conditions after they leave the hospital to see if it can prevent problems and improve communication with their healthcare providers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05282654 on ClinicalTrials.gov |
What this trial studies
This study aims to reduce post-discharge adverse events (AEs) for patients with multiple chronic conditions by utilizing a digital health application that monitors patient-reported symptoms in real-time. The approach involves developing a predictive model to identify risks of AEs and integrating this model with electronic health records to enhance communication between patients and healthcare providers. The study will validate this model with 450 patients and evaluate the effectiveness of the monitoring application through a randomized controlled trial. Additionally, mixed methods will be used to assess the implementation and sustainability of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with two or more chronic conditions who are hospitalized for at least 24 hours and are being discharged to home or a care facility.
Not a fit: Patients who do not have multiple chronic conditions or those who are not English-speaking without an English-speaking proxy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of adverse events and hospital readmissions for patients transitioning from hospital to home care.
How similar studies have performed: While the use of patient-reported outcomes in ambulatory settings is becoming more common, the real-time monitoring and escalation of symptoms during hospital transitions is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Faulkner Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Anuj Dalal, MD — Brigham and Women's Hospital
- Study coordinator: Anuj Dalal, MD
- Email: adalal1@bwh.harvard.edu
- Phone: (617) 525-8891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.