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.|
|ClinicalTrials.gov Identifier: NCT06051058|
Recruitment Status : Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 28, 2023
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Congestive Heart Failure Diabetes Diabetes Mellitus Chronic Kidney Diseases||Behavioral: Care Transitions App||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||798 participants|
|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|
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.
- 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
- To determine the effect of the Care Transitions App on the 30-day readmission rate [ Time Frame: 30 Days ]30-day readmission rate
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 ClinicalTrials.gov identifier (NCT number): NCT06051058
|Contact: Lipika Samal, MD, MPHfirstname.lastname@example.org|
|Contact: Patricia Dykes, PhDemail@example.com|
|Principal Investigator:||Lipika Samal, MD, MPH||Brigham and Women's Hospital|