Readmission Prevention Pilot Trial in Diabetes Patients

Study Overview
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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.

Official Title
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A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: DiaTOHC Program


Participation Criteria
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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: 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) Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Low-risk Group<br>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. | |
| Experimental: High-risk Group - Intervention<br>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). | Other: DiaTOHC Program<br>* Patient-centered education 1a) Standardized diabetes discharge instructions and education 1b) Comprehensive discharge plan review Peri-discharge coordination of care A1c-based adjustment of diabetes therapy Post-discharge support<br>|
| No Intervention: High-risk Group - Usual Care<br>Patients in the high-risk usual care group will receive the standard hospital discharge process and post-discharge followup. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of initial hospital readmission | The number of initial hospital readmissions will be recorded. | Within 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first readmission | The time to first readmission will be recorded. | Assessed at 30 days of discharge | 
| Incidence of emergency department (ED) visits | The number of ED visits will be recorded. | Assessed at 30 days of discharge | 
| A composite of 30 day readmission and ED visits | The composite of 30 day readmission and ED visits will be calculated and recorded. | Assessed at 30 days of discharge | 
| Incidence of primary care and specialist provider follow-up visits scheduled and attended | The number of primary care provider follow-up visits scheduled and attended will be recorded. | Assessed at 30 days of discharge | 
| Incidence of medication review or reconciliation post-discharge | The number of medication reviews or reconciliations post-discharge will be recorded. | Assessed at 30 days of discharge | 
| Cost of post-discharge care as a sum of ED visits, readmission, and PCP visits | The cost of post-discharge care as a sum of ED visits, readmission, home health services, and outpatient provider visits | Assessed at 30 days of discharge | 
| Cost of the intervention | The cost of nurse and physician time. | Assessed at 30 days of discharge | 
| Subject experience assessed by a brief questionnaire | Subject experience via a brief questionnaire will be assessed. | Assessed at 30 days of discharge | 
| Self-monitored blood glucose levels and frequency of testing | Number of blood glucose tests per day and incidence of hypoglycemia. | Assessed at 30 days of discharge | 
| Change in well-being | Change in well-being from baseline to 5 weeks after discharge as measured by the World Health Organization Well-Being Index (WHO-5) | Baseline to 5 weeks after discharge | 
| Change in diabetes-related distress | Change in diabetes-related distress at 5 weeks after discharge as measured by the Problem Areas in Diabetes (PAID) scale | Baseline to 5 weeks after discharge | 
| Change in perceived social support | Change in perceived social support at 5 weeks after discharge as measured by the Multidimensional Scale of Perceived Social Support (MSPSS) | Baseline to 5 weeks after discharge | 
| Change in perceived stress | Change in perceived stress at 5 weeks after discharge as measured by the perceived stress scale (PSS) | Baseline to 5 weeks after discharge | 
| Change in diabetes knowledge | Change in diabetes knowledge at 5 weeks after discharge as measured by the Diabetes Knowledge Test (DKT2) | Baseline to 5 weeks after discharge | 
| Change in A1c level | The change in A1c level from baseline to 3 months after discharge | Baseline to 3 months discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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readmission