Readmission Prevention Pilot Trial in Diabetes Patients

Diabetes Mellitus Clinical Trial

Official title:

A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243383
• Other study ID #: 24306
• Secondary ID: 5K23DK102963
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2020
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: October 1, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Rubin DJ. Hospital readmission of patients with diabetes. Curr Diab Rep. 2015 Apr;15(4):17. doi: 10.1007/s11892-015-0584-7. Review. Corrected and republished in: Curr Diab Rep. 2018 Mar 13;18(4):21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of initial hospital readmission	The number of initial hospital readmissions will be recorded.	Within 30 days after discharge
Secondary	Time to first readmission	The time to first readmission will be recorded.	Assessed at 30 days of discharge
Secondary	Incidence of emergency department (ED) visits	The number of ED visits will be recorded.	Assessed at 30 days of discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost of the intervention	The cost of nurse and physician time.	Assessed at 30 days of discharge
Secondary	Subject experience assessed by a brief questionnaire	Subject experience via a brief questionnaire will be assessed.	Assessed at 30 days of discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in A1c level	The change in A1c level from baseline to 3 months after discharge	Baseline to 3 months discharge

External Links

•   Diabetes Early Readmission Risk Indicator (DERRI)