Readmission Prevention Pilot Trial in Diabetes Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2019-10-01

Brief Summary

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Post-discharge hospital utilization, i.e., readmissions within 30 days of discharge (30d readmissions) and emergency department (ED) visits, are a high-priority quality measure and target for cost reduction. Patients with diabetes are disproportionately over-represented in 30d readmissions, especially among racial minorities and urban populations. We have developed and validated a tool, the Diabetes Early Readmission Risk Indicator (DERRI), to predict 30d readmission risk among diabetes patients, which is a critical prerequisite for targeting limited resources for reducing readmission risk to those most in need. Currently, there are no proven interventions to reduce the risk of 30d readmission specifically among patients with diabetes. This proposal will assess the feasibility and acceptability of a novel, multifactorial intervention, the Diabetes Transition of Hospital Care Program (DiaTOHC), designed to reduce post-discharge hospital utilization rates in a pilot randomized controlled trial. The intervention will include inpatient diabetes and discharge education, comprehensive discharge planning and coordination of care, A1c-based adjustment of diabetes therapy, and post-discharge support. Hospitalized patients with diabetes identified as high risk for readmission based on the DERRI will be randomized to the intervention or the control group, which will receive usual care. Such work is highly relevant in the current era of soaring health care costs and national health care reform.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low-risk Group

Low-risk as determined by the predicted risk of readmission by the DERRI. The low-risk group will be followed in a prospective, observational arm of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

High-risk Group - Intervention

High-risk as determined by the predicted risk of readmission by the DERRI. Subjects in the high-risk group will be randomly assigned to receive either the intervention (DiaTOHC Program) or usual care (control).

Group Type EXPERIMENTAL

DiaTOHC Program

Intervention Type OTHER

1. Patient-centered education 1a) Standardized diabetes discharge instructions and education 1b) Comprehensive discharge plan review
2. Peri-discharge coordination of care
3. A1c-based adjustment of diabetes therapy
4. Post-discharge support

High-risk Group - Usual Care

Patients in the high-risk usual care group will receive the standard hospital discharge process and post-discharge followup.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DiaTOHC Program

1. Patient-centered education 1a) Standardized diabetes discharge instructions and education 1b) Comprehensive discharge plan review
2. Peri-discharge coordination of care
3. A1c-based adjustment of diabetes therapy
4. Post-discharge support

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1\. Diabetes, defined by pre-admission use of a diabetes-specific medication and/or documentation of the diagnosis in the medical record.

Exclusion Criteria

1. Age \< 18 years at the time of admission
2. Female subjects who are pregnant and/or admitted to an obstetric service
3. Current or expected admission to a critical care unit
4. Binge drinking (5 or more alcoholic drinks for males or 4 or more alcoholic drinks for females on the same day) or drug abuse within 3 months before admission
5. Inpatient death
6. Transfer to another hospital or subacute facility
7. Discharge to hospice or a long-term care facility
8. Discharge expected within 12 hours or admission to a short-stay unit
9. Lack of access to a phone
10. Living more than 30 miles away from Temple University Hospital (TUH)
11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No