Clinical trial NCT03243383: Readmission Prevention Pilot Trial in Diabetes Patients
Official title: A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: readmission
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-08-09
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of initial hospital readmission
timeFrame: Within 30 days after discharge
Secondary outcomes:
measure: Time to first readmission
timeFrame: Assessed at 30 days of discharge
measure: Incidence of emergency department (ED) visits
timeFrame: Assessed at 30 days of discharge
measure: A composite of 30 day readmission and ED visits
timeFrame: Assessed at 30 days of discharge
measure: Incidence of primary care and specialist provider follow-up visits scheduled and attended
timeFrame: Assessed at 30 days of discharge
measure: Incidence of medication review or reconciliation post-discharge
timeFrame: Assessed at 30 days of discharge
measure: Cost of post-discharge care as a sum of ED visits, readmission, and PCP visits
timeFrame: Assessed at 30 days of discharge
measure: Cost of the intervention
timeFrame: Assessed at 30 days of discharge
measure: Subject experience assessed by a brief questionnaire
timeFrame: Assessed at 30 days of discharge
measure: Self-monitored blood glucose levels and frequency of testing
timeFrame: Assessed at 30 days of discharge
measure: Change in well-being
timeFrame: Baseline to 5 weeks after discharge
measure: Change in diabetes-related distress
timeFrame: Baseline to 5 weeks after discharge
measure: Change in perceived social support
timeFrame: Baseline to 5 weeks after discharge
measure: Change in perceived stress
timeFrame: Baseline to 5 weeks after discharge
measure: Change in diabetes knowledge
timeFrame: Baseline to 5 weeks after discharge
measure: Change in A1c level
timeFrame: Baseline to 3 months discharge
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Daniel Rubin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.4158/E161391.OR.
citation: Rubin DJ. Hospital readmission of patients with diabetes. Curr Diab Rep. 2015 Apr;15(4):17. doi: 10.1007/s11892-015-0584-7.
citation: 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.