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Care Transitions App for Patients With Multiple Chronic Conditions

Primary Purpose

Heart Failure, Congestive Heart Failure, Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care Transitions App
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental: Care Transitions App

    No Intervention: Usual Care

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 18, 2023
    Last Updated
    September 24, 2023
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06051058
    Brief Title
    Care Transitions App for Patients With Multiple Chronic Conditions
    Official Title
    Care Transitions App for Patients With Multiple Chronic Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2024 (Anticipated)
    Primary Completion Date
    February 2026 (Anticipated)
    Study Completion Date
    February 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Congestive Heart Failure, Diabetes, Diabetes Mellitus, Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    798 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Care Transitions App
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    No Intervention: Usual Care
    Arm Type
    No Intervention
    Arm Description
    Usual care transition care for patients hospitalized and discharged with multiple chronic conditions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Care Transitions App
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    To determine the effect of the Care Transitions App on post-discharge adverse events
    Description
    Overall rate of post-discharge adverse events
    Time Frame
    30 Days
    Secondary Outcome Measure Information:
    Title
    To determine the effect of the Care Transitions App on the 30-day readmission rate
    Description
    30-day readmission rate
    Time Frame
    30 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lipika Samal, MD, MPH
    Phone
    617-732-7063
    Email
    lsamal@bwh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patricia Dykes, PhD
    Phone
    617-525-3003
    Email
    pdykes@bwh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lipika Samal, MD, MPH
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to make individual participant data (IPD) available to other researchers.

    Learn more about this trial

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