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Completed

NCT Number: NCT03243383

Readmission Prevention Pilot Trial in Diabetes Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

DiaTOHC Program

Other
  • 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

Primary outcomes

  1. Incidence of initial hospital readmission

    Time frame: Within 30 days after discharge

    The number of initial hospital readmissions will be recorded.

Secondary outcomes

  1. Time to first readmission

    Time frame: Assessed at 30 days of discharge

    The time to first readmission will be recorded.

  2. Incidence of emergency department (ED) visits

    Time frame: Assessed at 30 days of discharge

    The number of ED visits will be recorded.

  3. A composite of 30 day readmission and ED visits

    Time frame: Assessed at 30 days of discharge

    The composite of 30 day readmission and ED visits will be calculated and recorded.

  4. Incidence of primary care and specialist provider follow-up visits scheduled and attended

    Time frame: Assessed at 30 days of discharge

    The number of primary care provider follow-up visits scheduled and attended will be recorded.

  5. Incidence of medication review or reconciliation post-discharge

    Time frame: Assessed at 30 days of discharge

    The number of medication reviews or reconciliations post-discharge will be recorded.

  6. Cost of post-discharge care as a sum of ED visits, readmission, and PCP visits

    Time frame: Assessed at 30 days of discharge

    The cost of post-discharge care as a sum of ED visits, readmission, home health services, and outpatient provider visits

  7. Cost of the intervention

    Time frame: Assessed at 30 days of discharge

    The cost of nurse and physician time.

  8. Subject experience assessed by a brief questionnaire

    Time frame: Assessed at 30 days of discharge

    Subject experience via a brief questionnaire will be assessed.

  9. Self-monitored blood glucose levels and frequency of testing

    Time frame: Assessed at 30 days of discharge

    Number of blood glucose tests per day and incidence of hypoglycemia.

  10. Change in well-being

    Time frame: Baseline to 5 weeks after discharge

    Change in well-being from baseline to 5 weeks after discharge as measured by the World Health Organization Well-Being Index (WHO-5)

  11. Change in diabetes-related distress

    Time frame: Baseline to 5 weeks after discharge

    Change in diabetes-related distress at 5 weeks after discharge as measured by the Problem Areas in Diabetes (PAID) scale

  12. Change in perceived social support

    Time frame: Baseline to 5 weeks after discharge

    Change in perceived social support at 5 weeks after discharge as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)

  13. Change in perceived stress

    Time frame: Baseline to 5 weeks after discharge

    Change in perceived stress at 5 weeks after discharge as measured by the perceived stress scale (PSS)

  14. Change in diabetes knowledge

    Time frame: Baseline to 5 weeks after discharge

    Change in diabetes knowledge at 5 weeks after discharge as measured by the Diabetes Knowledge Test (DKT2)

  15. Change in A1c level

    Time frame: Baseline to 3 months discharge

    The change in A1c level from baseline to 3 months after discharge

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2017
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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