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

Not Applicable

Recruiting

• Conditions: Multiple Chronic Conditions; Adverse Event
• Interventions: Behavioral: ePRO Application

• Registration Number: NCT05282654
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Adverse events (AE) during care transitions range from 19-28% and may lead to readmissions, representing an ongoing threat to patient safety. Early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians is critical, especially for patients with multiple chronic conditions (MCC). Clinically integrated digital health apps have the potential to more accurately predict post-discharge AEs and improve communication for patients, their caregivers, and the care team. Such tools can provide individualized risk assessments of AEs by systematically collecting relevant patient-reported outcomes (PROs) and leveraging standardized application programming interfaces (API) to combine them with electronic health record (EHR) data. While patient-reported outcomes (PROs) are increasingly used in ambulatory settings, their use for real-time symptom monitoring and escalation during transitions from the hospital is novel and potentially transformative-by both empowering patients to better understand their individualized risks of post-discharge AEs, and improving monitoring while transitioning out of the hospital. Our proposed intervention is grounded in evidence-based frameworks for care transitions, and scaling and spread of digital health tools. To inform our intervention, we propose developing and validating a predictive model of post-discharge AEs for 450 MCC patients using relevant PRO questionnaires and electronic health record (EHR) derived variables during our baseline pre-implementation period. Simultaneously, we will combine, adapt, extend, and refine our previously developed EHR-integrated hospital and ambulatory-focused digital health infrastructure to support MCC patients in real-time symptom monitoring using PROs when transitioning out of the hospital. Our intervention uses interoperable, data exchange standards and APIs to seamlessly integrate with existing vendor patient portal offerings, thereby addressing critical gaps and supporting the complete continuum of care. Our multidisciplinary team uses principles of user-centered design and agile software development to rapidly identify, design, develop, refine, and implement requirements from patients and clinicians. Our team will rigorously evaluate this intervention in a large-scale randomized controlled trial of 850 in which we compare our real-time symptom monitoring intervention (425) to usual care (425) for patients with MCCs transitioning out of the hospital. Finally, we will conduct a robust mixed methods evaluation to generate new knowledge and best practices for disseminating, implementing, and using this interoperable intervention at similar institutions with different EHR vendors

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-07
• Primary Completion: 2026-09-15
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (Arm 3)	ePRO Application	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.

Primary Outcome Measures

Name	Time	Method
Actual adverse events (AEs)	Up to 30-days after discharge from index hospitalization	The number of actual AEs during the 30-day post-discharge period
Actual preventable adverse events (AEs)	Up to 30-days after discharge from index hospitalization	The number of actual AEs during the 30-day post-discharge period

Secondary Outcome Measures

Name	Time	Method
Potential adverse events (AEs)	Up to 30-days after discharge from index hospitalization	The number of new or worsening symptoms reported by the patient
Post-discharge healthcare utilization (ambulatory events)	Up to 30-days after discharge from index hospitalization	Composite of unanticipated ambulatory, urgent care, ED visits
Post-discharge healthcare utilization events (hospital readmissions)	Up to 30-days after discharge from index hospitalization	Hospital readmissions

Trial Locations

Locations (2)

Brigham and Women's Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States