The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial.
BACKGROUND
Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care.


METHODS
All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible.


RESULTS
92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye- (71.0% vs. 51.2%, p < 0.0001), foot examinations (73.8% vs. 45.1%, p < 0.0001), and regular HbA1c checks (44.1% vs. 36.0%, p < 0.01) in the intervention group.


CONCLUSIONS
The Austrian DMP implemented by statutory health insurance improves process quality and enhances weight reduction, but does not significantly improve metabolic control for patients with type 2 diabetes mellitus. Whether the small benefit seen in secondary outcome measures leads to better patient outcomes, remains unclear.


BACKGROUND
Current Controlled trials Ltd., ISRCTN27414162.
Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Strubergasse 21, 5020 Salzburg, Austria. andreas.soennichsen@pmu.ac.at
Andreas C
AC
Sönnichsen
Henrike
H
Winkler
Maria
M
Flamm
Sigrid
S
Panisch
Peter
P
Kowatsch
Gert
G
Klima
Bernhard
B
Fürthauer
Raimund
R
Weitgasser
D000328:Adult; D001317:Austria; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000517:prevention & control / Q000628:therapy*; D019468:Disease Management; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006284:Health Plan Implementation; D006801:Humans; D008297:Male; D016730:Program Development
D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human