Care Transitions App for Patients With Multiple Chronic Conditions

NCT06051058 | Recruiting DMC

• 1 other identifier: 2023P001447
• Study Type: interventional
• Target: 798
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to widely implement and evaluate the Care Transitions App in a randomized controlled trial. The app the investigators designed for patients with multiple chronic conditions has four envisioned modules: 1) falls-reduction content, 2) a digital post-discharge transitional care plan (e.g., after hospital care plan, including education, medications, follow-up appointments, warning signs to watch for, nutrition, and other care plan activities), 3) a new module for patients with MCC (diabetes, congestive heart failure, and chronic kidney disease) including condition-specific post-discharge care plans with relevant symptom management activities, 4) a new post-discharge report module which summarizes key care transition findings and allows for patients to enter notes and questions for their providers and their own goals for recovery.

Conditions

Heart Failure; Congestive Heart Failure; Diabetes; Diabetes Mellitus; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• To determine the effect of the Care Transitions App on post-discharge adverse events

  Overall rate of post-discharge adverse events

  30 Days

Secondary Outcomes (1)

• To determine the effect of the Care Transitions App on the 30-day readmission rate

  30 Days

Study Arms (2)

Experimental: Care Transitions App

EXPERIMENTAL

Use of the Care Transitions App to support the care transition for patients hospitalized and discharged with multiple chronic conditions will be compared to usual care.

Behavioral: Care Transitions App

No Intervention: Usual Care

NO INTERVENTION

Usual care transition care for patients hospitalized and discharged with multiple chronic conditions.

Interventions

Care Transitions App BEHAVIORAL

Patients in the intervention arm will be randomized to receive the Care Transitions App and utilize it to support their care transition care plan for multiple chronic conditions.

Experimental: Care Transitions App

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (55+) with a Brigham PCP or appointment in one of the 15 locations discharging from a BWH general medicine unit
• Discharging to home, home health care service or assisted living
• Fluent in spoken English in patient or healthcare proxy
• Patients with at least one of the conditions listed below + one additional chronic condition on the problem list.
• Patient with heart failure on the problem list
• Patient with type 2 diabetes on the problem list
• Patient with chronic kidney disease on the problem list

You may not qualify if:

• Adult patients (55+) with Westwood, Pembroke, or Transition Clinic PCP admitted to ICU, OBGYN, Surgical, Cardiology, Oncology, Orthopedics, or other Specialty Unit
• Pregnant
• Prisoner, institutionalized individual or in police custody
• Discharge planned within 3 hours of screening
• Patient too ill to participate or with active psychosis/serious mental illness, delirium, or severe dementia
• Not fluent in spoken English in patient and health proxy
• Unlikely to be discharged to home
• Lacks a device capable of accessing the app
• Lack of a working telephone for 30-day follow-up

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lipika Samal, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lipika Samal, MD, MPH

CONTACT

617-732-7063; lsamal@bwh.harvard.edu

Patricia Dykes, PhD

CONTACT

617-525-3003; pdykes@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The design is a randomized trial with patients recruited inpatient from Brigham and Women's Hospital and nested within primary care practices in the MGB healthcare system. The unit of randomization is the patient.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 22, 2023
• Study Start: October 8, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)