Readmission Prevention Pilot Trial in Diabetes Patients

NCT03243383 | Completed

• 2 other identifiers: 243065K23DK102963
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

readmission

Outcome Measures

Primary Outcomes (1)

• Incidence of initial hospital readmission

  The number of initial hospital readmissions will be recorded.

  Within 30 days after discharge

Secondary Outcomes (15)

• Time to first readmission

  Assessed at 30 days of discharge

• Incidence of emergency department (ED) visits

  Assessed at 30 days of discharge

• A composite of 30 day readmission and ED visits

  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

Study Arms (3)

Low-risk Group

NO INTERVENTION

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

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

High-risk Group - Usual Care

NO INTERVENTION

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

Interventions

DiaTOHC Program 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 - Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (3)

• Rubin DJ, Handorf EA, Golden SH, Nelson DB, McDonnell ME, Zhao H. DEVELOPMENT AND VALIDATION OF A NOVEL TOOL TO PREDICT HOSPITAL READMISSION RISK AMONG PATIENTS WITH DIABETES. Endocr Pract. 2016 Oct;22(10):1204-1215. doi: 10.4158/E161391.OR.

  PMID: 27732098 BACKGROUND

• Rubin DJ. Hospital readmission of patients with diabetes. Curr Diab Rep. 2015 Apr;15(4):17. doi: 10.1007/s11892-015-0584-7.

  PMID: 25712258 BACKGROUND

• Rubin DJ, Donnell-Jackson K, Jhingan R, Golden SH, Paranjape A. Early readmission among patients with diabetes: a qualitative assessment of contributing factors. J Diabetes Complications. 2014 Nov-Dec;28(6):869-73. doi: 10.1016/j.jdiacomp.2014.06.013. Epub 2014 Jun 28.

  PMID: 25087192 BACKGROUND

Related Links

• Diabetes Early Readmission Risk Indicator (DERRI)

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daniel Rubin, MD, MSc

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 9, 2017
• Study Start: September 7, 2017
• Primary Completion: July 3, 2019
• Study Completion: October 1, 2019
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)