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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01009528
Other study ID # 2008-41-2792
Secondary ID
Status Completed
Phase N/A
First received November 5, 2009
Last updated November 6, 2009
Start date March 2007
Est. completion date November 2009

Study information

Verified date November 2009
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine whether electronic feedback to general practitioners on quality of Type 2-Diabetes care increases the quality of care measured on process and outcome measures contained in the national guidelines. Effect evaluation will be performed using a mixed method design.


Description:

Background: In an effort to optimize diabetes care in general practice, an electronical feedback system has been developed. The system will be evaluated both quantitative and qualitative.

Method: The general practitioners (GP´s) of the Region of Southern Denmark have been randomised to either admission or no admission to the electronic feedback system. The system was launched 1/3-2007 and ran for one year prior to evaluation.

Quantitative evaluation by assessment of the following end-points: Patients Hba1c-level, number of patients who have had their hba1c-level measured within the last year, cholesterol-level and number of patients who have had an eye examination within the last year.

Qualitative evaluation by interviewing GP´s who have had admission to the system.

Qualitative data have been collected through interviews with intervention GPs, designed to uncover motivational factors as well as barriers concerning the use of feedback on chronic care in general practice. Data are being analyzed.

Quantitative data are being gathered. Perspective: This project will shed light on the value of electronic feedback systems within chronic care in general practice.

Based on this project it will be possible to set up a system for automatic electronic monitoring and feedback of the quality of care in general practice, taking motivational factors of the GP s into account during implementation.


Recruitment information / eligibility

Status Completed
Enrollment 2458
Est. completion date November 2009
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Prevalent Type 2-diabetes as confirmed by Primary Care Physician.

- Patient alive throughout the intervention period.

- GP actively working throughout the intervention period (not retired).

Exclusion criteria:

- death during intervention

- moved out of geographic area during intervention

- GP retired during intervention

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Device:
Electronic feedback system on diabetes care
An electronic feedback system was introduced in randomized primary care clinics providing an overview of quality of care. The intervention ran for 15 months.

Locations

Country Name City State
Denmark Dept. of General Medicine, Institute of Public Health, Aarhus University Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Guldberg TL, Lauritzen T, Kristensen JK, Vedsted P. The effect of feedback to general practitioners on quality of care for people with type 2 diabetes. A systematic review of the literature. BMC Fam Pract. 2009 May 6;10:30. doi: 10.1186/1471-2296-10-30. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Outcome and process measures from the danish diabetes guideline 1/3 2007-1/6 2008 No
Secondary Interview data concerning the impact of the electronic feedback system in the intervention clinics 1/3 2007-1/6 2008 No
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