Readmission Prevention Pilot Trial in Diabetes Patients

Temple University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: DiaTOHC Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03243383

5K23DK102963 (U.S. NIH Grant/Contract)

24306

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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263 participants in 3 patient groups

Low-risk Group

No Intervention group

Description:

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.

High-risk Group - Intervention

Experimental group

Description:

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).

Treatment:

Other: DiaTOHC Program

High-risk Group - Usual Care

No Intervention group

Description:

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