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

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00657800
First received: April 8, 2008
Last updated: September 21, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention
Diabetes
 Behavioral: Intensified inpatient diabetes education program (IDEP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Diabetes Self-Management Practices [ Time Frame: 4 months post-discharge ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction [ Time Frame: Discharge date, 4 months post-discharge ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) [ Time Frame: Baseline and 4 months post-discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic and Metabolic Control [ Time Frame: 4 months post-discharge ] [ Designated as safety issue: Yes ]
  • Emergency Room visits; admissions [ Time Frame: 4 months post-discharge ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 60
Study Start Date: December 2007
Study Completion Date: September 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657800

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

No publications provided

Responsible Party: Mary T. Korytkowski, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00657800     History of Changes
Other Study ID Numbers: PRO07030238
Study First Received: April 8, 2008
Last Updated: September 21, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on February 27, 2015