Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06051058 |
| Other study ID # |
2023P001447 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2024 |
| Est. completion date |
February 2026 |
Study information
| Verified date |
September 2023 |
| Source |
Brigham and Women's Hospital |
| Contact |
Lipika Samal, MD, MPH |
| Phone |
617-732-7063 |
| Email |
lsamal[@]bwh.harvard.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
