Readmission Prevention Pilot Trial in Diabetes Patients
- Conditions
- Diabetes Mellitus
- Interventions
- Other: DiaTOHC Program
- Registration Number
- NCT03243383
- Lead Sponsor
- Temple University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- Diabetes, defined by pre-admission use of a diabetes-specific medication and/or documentation of the diagnosis in the medical record.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-risk Group - Intervention DiaTOHC Program 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).
- Primary Outcome Measures
Name Time Method Incidence of initial hospital readmission Within 30 days after discharge The number of initial hospital readmissions will be recorded.
- Secondary Outcome Measures
Name Time Method Incidence of emergency department (ED) visits Assessed at 30 days of discharge The number of ED visits will be recorded.
Cost of post-discharge care as a sum of ED visits, readmission, and PCP visits Assessed at 30 days of discharge The cost of post-discharge care as a sum of ED visits, readmission, home health services, and outpatient provider visits
Time to first readmission Assessed at 30 days of discharge The time to first readmission will be recorded.
A composite of 30 day readmission and ED visits Assessed at 30 days of discharge The composite of 30 day readmission and ED visits will be calculated and recorded.
Subject experience assessed by a brief questionnaire Assessed at 30 days of discharge Subject experience via a brief questionnaire will be assessed.
Self-monitored blood glucose levels and frequency of testing Assessed at 30 days of discharge Number of blood glucose tests per day and incidence of hypoglycemia.
Change in diabetes knowledge Baseline to 5 weeks after discharge Change in diabetes knowledge at 5 weeks after discharge as measured by the Diabetes Knowledge Test (DKT2)
Cost of the intervention Assessed at 30 days of discharge The cost of nurse and physician time.
Incidence of primary care and specialist provider follow-up visits scheduled and attended Assessed at 30 days of discharge The number of primary care provider follow-up visits scheduled and attended will be recorded.
Incidence of medication review or reconciliation post-discharge Assessed at 30 days of discharge The number of medication reviews or reconciliations post-discharge will be recorded.
Change in diabetes-related distress Baseline to 5 weeks after discharge Change in diabetes-related distress at 5 weeks after discharge as measured by the Problem Areas in Diabetes (PAID) scale
Change in perceived social support Baseline to 5 weeks after discharge Change in perceived social support at 5 weeks after discharge as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Change in well-being Baseline to 5 weeks after discharge Change in well-being from baseline to 5 weeks after discharge as measured by the World Health Organization Well-Being Index (WHO-5)
Change in perceived stress Baseline to 5 weeks after discharge Change in perceived stress at 5 weeks after discharge as measured by the perceived stress scale (PSS)
Change in A1c level Baseline to 3 months discharge The change in A1c level from baseline to 3 months after discharge
Trial Locations
- Locations (1)
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States