RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-01
Study Completion:2026-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05282654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult (18 years or older)
  2. * Hospitalized on the general medicine services at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital for at least 24 hours
  3. * Have a discharge status of home, home with services, or facility
  4. * English-speaking patients or their English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  5. * Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  6. * 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)
  1. * Less than 18 years of age
  2. * Less than two chronic conditions
  3. * Hospitalized less than 24 hours
  4. * No identifiable healthcare proxy or next of kin (i.e., a family caregiver)

Contacts and Locations

Study Contact

Anuj Dalal, MD
CONTACT
(617) 525-8891
adalal1@bwh.harvard.edu
Savanna Plombon, MPH
CONTACT
857-307-2668
splombon@bwh.harvard.edu

Principal Investigator

Anuj Dalal, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02115
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Anuj Dalal, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2026-10-15

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2026-10-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Multiple Chronic Conditions
  • Adverse Event