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Care Transitions App for Patients With Multiple Chronic Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06051058
Recruitment Status : Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 28, 2023
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Lipika Samal, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure Congestive Heart Failure Diabetes Diabetes Mellitus Chronic Kidney Diseases Behavioral: Care Transitions App Not Applicable

Detailed Description:

Care transitions are a vulnerable period for patients, leading to a 20% rate of readmissions, 11% rate of post-discharge adverse drug events, 15% rate of falls, and 29% rate of total post-discharge adverse events. Hospital discharge for patients with multiple chronic conditions (MCC) is a challenge for the hospital care teams, primary care providers (PCPs) and patients/caregivers who face the challenge of complex medication regimens, as well as patient-specific challenges in fall prevention strategies. Specific challenges include poor communication among inpatient providers, patients, and ambulatory providers, poor quality and timeliness of discharge documentation, suboptimal patient understanding of post-discharge plans of care and their ability to carry out these plans, medication discrepancies and non-adherence after discharge, failure to follow up the results of tests pending at time of discharge, failure to schedule necessary ambulatory appointments, tests, and procedures, and lack of timely follow-up with ambulatory providers.

These risks are especially important for people living with multiple chronic conditions (PLWMCC), such as diabetes (DM), congestive heart failure (CHF), and chronic kidney disease (CKD). Each of these conditions requires a complex medication regimen which is often altered during the hospital admission. Often, the medications cannot be changed back to their original dose at the time of discharge because patients are eating less than usual, have become dehydrated, and their kidney function has been affected by nephrotoxic medications. Clearance of medications such as insulin is also altered and limited physical activity in the hospital places patients at increased risk for falls after discharge. All of these factors increase the risk of adverse events in the post-discharge period. An overarching goal of the intervention is to overcome common care transition challenges by simplifying the information patients and caregivers receive and empowering them to carry out their care plans.

Previous research supports the use of mobile apps for improving health outcomes among those living with chronic illness. While many apps are available for chronic disease management, most of them focus on a single chronic illness such as diabetes or heart failure, or self-management area such as medication management, sleep, or pain and do not specifically target the period of transition from hospital to home. The intervention will fill an existing gap by developing, rigorously testing, and disseminating a comprehensive Care Transitions App for patients with MCC that will provide comprehensive care transition information for disease self-management, medication safety, and fall prevention in a format that is simple and actionable.

The investigators will conduct a pragmatic randomized controlled trial in an academic medical center (Brigham and Women's Hospital) and primary care clinics to test the effectiveness of the Care Transitions App enrolling patients age 55 or older with MCC including Diabetes, congestive heart failure, and/or chronic kidney disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Care Transitions App for Patients With Multiple Chronic Conditions
Estimated Study Start Date : August 2024
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental: Care Transitions App
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
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.

No Intervention: No Intervention: Usual Care
Usual care transition care for patients hospitalized and discharged with multiple chronic conditions.

Primary Outcome Measures :
  1. To determine the effect of the Care Transitions App on post-discharge adverse events [ Time Frame: 30 Days ]
    Overall rate of post-discharge adverse events

Secondary Outcome Measures :
  1. To determine the effect of the Care Transitions App on the 30-day readmission rate [ Time Frame: 30 Days ]
    30-day readmission rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT06051058

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Contact: Lipika Samal, MD, MPH 617-732-7063
Contact: Patricia Dykes, PhD 617-525-3003

Sponsors and Collaborators
Brigham and Women's Hospital
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Lipika Samal, MD, MPH Brigham and Women's Hospital
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Responsible Party: Lipika Samal, Principal Investigator, Brigham and Women's Hospital Identifier: NCT06051058    
Other Study ID Numbers: 2023P001447
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Heart Failure
Diabetes Mellitus
Chronic Disease
Multiple Chronic Conditions
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes