The Effect of a Coordinated Inpatient Diabetes Education Program in the Outpatient Setting

September 21, 2010 updated by: University of Pittsburgh

The Effect of a Coordinated Inpatient Diabetes Education Program on Glycemic Control, Diabetes Self-Management, Patient Satisfaction, and Quality of Life in the Outpatient Setting

Patients will be recruited from comparable inpatient units that have been randomized as either interventional (Group 1) or control (Group 2) units. Patients in the interventional group will receive a comprehensive individualized diabetes education program coordinated by a certified diabetes educator. Patients in Group 2 will receive education from clinical staff as it is typically provided. Assessment of patient satisfaction with both inpatient and outpatient care, quality of life, and diabetes self-management skills (including emergency room visits and readmissions) will be measured using surveys completed during hospitalization and 4 months after discharge to determine any differences between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited from matched sets of inpatient units determined to be comparable in terms of staffing and types of patients admitted. One unit from each matched set will be selected as the intervention unit (Group 1) or the control unit (Group 2) as determined by a random draw.

Group 1 patients will receive the coordinated inpatient diabetes education program (IDEP). Patients will be initially evaluated by a certified diabetes educator (CDE) to assess diabetes knowledge and to set priorities for "survival skills" education. Based on this individualized evaluation, a structured education plan will be devised and implemented by the CDE. The structured education plan will be modified as needed throughout the hospital stay to utilize more appropriate educational methods based on patient availability, condition or educational needs.

Group 2 (Control) will receive diabetes education as it is presently provided in our facility by the clinical staff. The staff nurse will be alerted that the patient is a participant in the research study and will record education provided in the electronic medical records.

The modified Michigan Diabetes Research and Training Center's Brief Diabetes Knowledge Test (DKT) and the Diabetes Treatment Satisfaction Questionnaire (DTSQs), if diabetes was pre-existing, will be administered initially to all patients by a member of the research team. If appropriate, the patient will be asked by the research team to complete a Quality of Life Survey (The Medical Outcomes Survey (MOS) Short-Form 36 (SF-36) General Health Survey prior to discharge. Completion of the Diabetes Treatment Satisfaction Questionnaire - Inpatient (DTSQ-IP) will also be requested of the patient prior to discharge.

All participants will be contacted 4 months after discharge for a similar assessment of quality of life and patient satisfaction with diabetes treatment, and for an additional assessment of diabetes self-management practices which includes the number of emergency room visits and readmissions since discharge. Comparisons will be made between the two groups and between baseline and follow-up assessments.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Department of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Hospitalized patients with diabetes as defined by ADA criteria
  • Ability to understand informed consent document
  • Community-dwelling adults

Exclusion Criteria:

  • Patients using CSII (continuous subcutaneous insulin infusion)
  • Patients with Do Not Resuscitate (DNR) orders
  • Decisionally impaired patients
  • Patients admitted for 24 hour observation
  • Patients in Intensive Care settings
  • Patients with language barriers or sensory deficits mandating the need for specialized instruction
  • Patients who are pregnant
  • Patients for whom transfer to a skilled nursing or other assisted care living facilities is anticipated after discharge.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Behavioral - Intensified coordinated inpatient diabetes education program (IDEP)
Behavioral: Intensified inpatient diabetes education program (IDEP)
Assessment of educational needs and coordination of inpatient unit based education program by Certified Diabetes Educator (CDE)
No Intervention: Group 2
Diabetes education as is typically provided by clinical staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diabetes Self-Management Practices
Time Frame: 4 months post-discharge
4 months post-discharge
Patient Satisfaction
Time Frame: Discharge date, 4 months post-discharge
Discharge date, 4 months post-discharge
Quality of Life (QoL)
Time Frame: Baseline and 4 months post-discharge
Baseline and 4 months post-discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Glycemic and Metabolic Control
Time Frame: 4 months post-discharge
4 months post-discharge
Emergency Room visits; admissions
Time Frame: 4 months post-discharge
4 months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Mary T. Korytkowski, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO07030238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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