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Clinical Trials/NCT03243383
NCT03243383
Completed
Not Applicable

A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes

Temple University1 site in 1 country263 target enrollmentSeptember 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Temple University
Enrollment
263
Locations
1
Primary Endpoint
Incidence of initial hospital readmission
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2017
End Date
October 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Age \< 18 years at the time of admission
  • Female subjects who are pregnant and/or admitted to an obstetric service
  • Current or expected admission to a critical care unit
  • 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
  • Inpatient death
  • Transfer to another hospital or subacute facility
  • Discharge to hospice or a long-term care facility
  • Discharge expected within 12 hours or admission to a short-stay unit
  • Lack of access to a phone
  • Living more than 30 miles away from Temple University Hospital (TUH)

Outcomes

Primary Outcomes

Incidence of initial hospital readmission

Time Frame: Within 30 days after discharge

The number of initial hospital readmissions will be recorded.

Secondary Outcomes

  • Incidence of emergency department (ED) visits(Assessed at 30 days of discharge)
  • Cost of post-discharge care as a sum of ED visits, readmission, and PCP visits(Assessed at 30 days of discharge)
  • Time to first readmission(Assessed at 30 days of discharge)
  • A composite of 30 day readmission and ED visits(Assessed at 30 days of discharge)
  • Subject experience assessed by a brief questionnaire(Assessed at 30 days of discharge)
  • Self-monitored blood glucose levels and frequency of testing(Assessed at 30 days of discharge)
  • Change in diabetes knowledge(Baseline to 5 weeks after discharge)
  • Cost of the intervention(Assessed at 30 days of discharge)
  • Incidence of primary care and specialist provider follow-up visits scheduled and attended(Assessed at 30 days of discharge)
  • Incidence of medication review or reconciliation post-discharge(Assessed at 30 days of discharge)
  • Change in diabetes-related distress(Baseline to 5 weeks after discharge)
  • Change in perceived social support(Baseline to 5 weeks after discharge)
  • Change in well-being(Baseline to 5 weeks after discharge)
  • Change in perceived stress(Baseline to 5 weeks after discharge)
  • Change in A1c level(Baseline to 3 months discharge)

Study Sites (1)

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