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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657800
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : September 22, 2010
Information provided by:
University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Intensified inpatient diabetes education program (IDEP) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : December 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : September 2010

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

Primary Outcome Measures :
  1. Diabetes Self-Management Practices [ Time Frame: 4 months post-discharge ]
  2. Patient Satisfaction [ Time Frame: Discharge date, 4 months post-discharge ]
  3. Quality of Life (QoL) [ Time Frame: Baseline and 4 months post-discharge ]

Secondary Outcome Measures :
  1. Glycemic and Metabolic Control [ Time Frame: 4 months post-discharge ]
  2. Emergency Room visits; admissions [ Time Frame: 4 months post-discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657800

United States, Pennsylvania
University of Pittsburgh Department of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Mary T. Korytkowski, MD University of Pittsburgh

Responsible Party: Mary T. Korytkowski, University of Pittsburgh Identifier: NCT00657800     History of Changes
Other Study ID Numbers: PRO07030238
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: September 2010

Keywords provided by University of Pittsburgh:
diabetes, inpatient, education,

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases