Readmission Prevention Pilot Trial in Diabetes Patients

A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: DiaTOHC Program

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Low-risk Group; 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; 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; 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
No Intervention: High-risk Group - Usual Care; Patients in the high-risk usual care group will receive the standard hospital discharge process and post-discharge followup.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Daniel Rubin, MD, MSc, Temple University

Publications and helpful links

General Publications

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

Helpful Links

• Diabetes Early Readmission Risk Indicator (DERRI)

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): July 3, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: readmission
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 24306; 5K23DK102963 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No