Skip to content

Readmission Prevention Pilot Trial in Diabetes Patients

A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03243383
Enrollment
263
Registered
2017-08-09
Start date
2017-09-07
Completion date
2019-10-01
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

readmission

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.

Interventions

OTHERDiaTOHC Program

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

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of initial hospital readmissionWithin 30 days after dischargeThe number of initial hospital readmissions will be recorded.

Secondary

MeasureTime frameDescription
Change in perceived social supportBaseline to 5 weeks after dischargeChange in perceived social support at 5 weeks after discharge as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Time to first readmissionAssessed at 30 days of dischargeThe time to first readmission will be recorded.
Incidence of emergency department (ED) visitsAssessed at 30 days of dischargeThe number of ED visits will be recorded.
A composite of 30 day readmission and ED visitsAssessed at 30 days of dischargeThe composite of 30 day readmission and ED visits will be calculated and recorded.
Incidence of primary care and specialist provider follow-up visits scheduled and attendedAssessed at 30 days of dischargeThe number of primary care provider follow-up visits scheduled and attended will be recorded.
Incidence of medication review or reconciliation post-dischargeAssessed at 30 days of dischargeThe number of medication reviews or reconciliations post-discharge will be recorded.
Cost of post-discharge care as a sum of ED visits, readmission, and PCP visitsAssessed at 30 days of dischargeThe cost of post-discharge care as a sum of ED visits, readmission, home health services, and outpatient provider visits
Change in diabetes-related distressBaseline to 5 weeks after dischargeChange in diabetes-related distress at 5 weeks after discharge as measured by the Problem Areas in Diabetes (PAID) scale
Subject experience assessed by a brief questionnaireAssessed at 30 days of dischargeSubject experience via a brief questionnaire will be assessed.
Self-monitored blood glucose levels and frequency of testingAssessed at 30 days of dischargeNumber of blood glucose tests per day and incidence of hypoglycemia.
Change in well-beingBaseline to 5 weeks after dischargeChange 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 stressBaseline to 5 weeks after dischargeChange in perceived stress at 5 weeks after discharge as measured by the perceived stress scale (PSS)
Change in diabetes knowledgeBaseline to 5 weeks after dischargeChange in diabetes knowledge at 5 weeks after discharge as measured by the Diabetes Knowledge Test (DKT2)
Change in A1c levelBaseline to 3 months dischargeThe change in A1c level from baseline to 3 months after discharge
Cost of the interventionAssessed at 30 days of dischargeThe cost of nurse and physician time.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026