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BMC Primary Care
Published in: BMC Primary Care 1/2010

Open Access 01-12-2010 | Research article

The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

Authors: Andreas C Sönnichsen, Henrike Winkler, Maria Flamm, Sigrid Panisch, Peter Kowatsch, Gert Klima, Bernhard Fürthauer, Raimund Weitgasser

Published in: BMC Primary Care | Issue 1/2010

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Abstract

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.

Conclusion

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.

Trial Registration

Current Controlled trials Ltd., ISRCTN27414162.
Appendix
Available only for authorised users
Literature
1.
King H, Aubert RE, Herman WH: Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998, 21: 1414-1431. 10.2337/diacare.21.9.1414.CrossRefPubMed
2.
Wild S, Roglic G, Green A, Sicree R, King H: Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004, 27: 1047-1053. 10.2337/diacare.27.5.1047.CrossRefPubMed
3.
Dorner T, Rathmanner T, Lechleitner M, Schlogel R, Roden M, Lawrence K, Schwarz F, Kiefer I, Kunze M, Rieder A: Public health aspects of diabetes mellitus--epidemiology, prevention strategies, policy implications: the first Austrian diabetes report. Wien Klin Wochenschr. 2006, 118: 513-519. 10.1007/s00508-006-0666-2.CrossRefPubMed
4.
Williams R, Van Gaal L, Lucioni C: Assessing the impact of complications on the costs of Type II diabetes. Diabetologia. 2002, 45: S13-S17. 10.1007/s00125-001-0749-6.CrossRefPubMed
5.
Rakovac I, Plank J, Jeitler K, Beck P, Seereiner S, Mrak P, Bauer B, Pieber T: [Health status of type 2 diabetics in Austria - perspective of a quality improvement initiative]. Wien Med Wochenschr. 2009, 159: 126-133. 10.1007/s10354-009-0659-7.CrossRefPubMed
6.
Bodenheimer T, Wagner EH, Grumbach K: Improving primary care for patients with chronic illness. JAMA. 2002, 288: 1775-1779. 10.1001/jama.288.14.1775.CrossRefPubMed
7.
Tsai AC, Morton SC, Mangione CM, Keeler EB: A meta-analysis of interventions to improve care for chronic illnesses. Am J Manag Care. 2005, 11: 478-488.PubMedPubMedCentral
8.
Gerlach FM, Beyer M, Szecsenyi J, Raspe H: [Evaluation of disease management programs--current deficits, demands and methods]. Z Arztl Fortbild Qualitatssich. 2003, 97: 495-501.PubMed
9.
Miksch A, Laux G, Ose D, Joos S, Campbell S, Riens B, Szecsenyi J: Is there a survival benefit within a German primary care-based disease management program?. Am J Manag Care. 2010, 16: 49-54.PubMed
10.
Ecker J, Witzmann G, Gmeiner H, Aigner I, Said H: [Structured treatment of diabetes in the country]. Wien Med Wochenschr. 2005, 155: 371-375. 10.1007/s10354-005-0197-x.CrossRefPubMed
11.
Olivarius NF, Beck-Nielsen H, Andreasen AH, Horder M, Pedersen PA: Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ. 2001, 323: 970-975. 10.1136/bmj.323.7319.970.CrossRefPubMedPubMedCentral
12.
Rychetnik L, Frommer M, Hawe P, Shiell A: Criteria for evaluating evidence on public health interventions. J Epidemiol Community Health. 2002, 56: 119-127. 10.1136/jech.56.2.119.CrossRefPubMedPubMedCentral
13.
Berger M, Grüßer M: Behandlungs- und Schulungsprogramm fürTyp 2 Diabetiker, die nicht Insulin spritzen. Deutscher Ärzteverlag, Köln. 1997
14.
Weitgasser R, Aistleitner M, König C, Rakovac I, Habacher W: Diabetesschulung "Neu" für Patienten mit Typ-2-Diabetes im Land Salzburg. Diabetes, Stoffwechsel und Herz. 2009, 18: 25-27.
15.
Österreichische Diabetes Gesellschaft: [Diabetes mellitus--guidelines for general practice. Revised and expanded 2007 edition]. Wien Klin Wochenschr. 2007, 119: 5-64.
16.
Sonnichsen AC, Rinnerberger A, Url MG, Winkler H, Kowatsch P, Klima G, Furthauer B, Weitgasser R: Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial. Trials. 2008, 9: 38-10.1186/1745-6215-9-38.CrossRefPubMedPubMedCentral
17.
18.
Wears R: Advanced statistics: statistical methods for analyzing cluster and cluster-randomized data. Acad Emerg Med. 2002, 9: 330-341. 10.1111/j.1553-2712.2002.tb01332.x.CrossRefPubMed
19.
Kerry S, Bland J: Unequal cluster sizes for trials in English and Welsh general practice: implications for sample size calculations. Stat Med. 2001, 20: 377-390. 10.1002/1097-0258(20010215)20:3<377::AID-SIM799>3.0.CO;2-N.CrossRefPubMed
20.
Donner A, Klar N: Design and Analysis of Cluster Randomization Trials in Health Research. Hodder Arnold Publication, London. 2000
21.
Weingarten S, Henning J, Badamgarav E, Knight K, Hasselblad V, Gano A, Ofman J: Interventions used in disease management programmes for patients with chronic illness-which ones work? Meta-analysis of published reports. BMJ. 2002, 325: 925-932. 10.1136/bmj.325.7370.925.CrossRefPubMedPubMedCentral
22.
Ofman J, Badamgarav E, Henning J, Knight K, Gano A, Levan R, Gur-Arie S, Richards M, Hasselblad V, Weingarten S: Does disease management improve clinical and economic outcomes in patients with chronic diseases? A systematic review. Am J Med. 2004, 117: 182-192. 10.1016/j.amjmed.2004.03.018.CrossRefPubMed
23.
Knight K, Badamgarav E, Henning J, Hasselblad V, Gano A, Ofman J, Weingarten S: A systematic review of diabetes disease management programs. Am J Manag Care. 2005, 11: 242-250.PubMed
24.
Norris S, Nichols P, Caspersen C, Glasgow R, Engelgau M, Jack L, Isham G, Snyder S, Carande-Kulis V, Garfield S, et al: The effectiveness of disease and case management for people with diabetes. A systematic review. Am J Prev Med. 2002, 22: 15-38. 10.1016/S0749-3797(02)00423-3.CrossRefPubMed
25.
Braunholtz D, Edwards S, Lilford R: Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect". J Clin Epidemiol. 2001, 54: 217-224. 10.1016/S0895-4356(00)00305-X.CrossRefPubMed
26.
Linden A, Adams J, Roberts N: Generalizing disease management program results: how to get from here to there. Manag Care Interface. 2004, 17: 38-45.PubMed
27.
Zwarenstein M, Treweek S, Gagnier J, Altman D, Tunis S, Haynes B, Oxman A, Moher D: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral
28.
29.
Mattke S, Seid M, Ma S: Evidence for the effect of disease management: is $1 billion a year a good investment?. Am J Manag Care. 2007, 13: 670-676.PubMed
30.
Holman R, Paul S, Bethel M, Matthews D, Neil H: 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008, 359: 1577-1589. 10.1056/NEJMoa0806470.CrossRefPubMed
Metadata
Title
The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial
Authors
Andreas C Sönnichsen
Henrike Winkler
Maria Flamm
Sigrid Panisch
Peter Kowatsch
Gert Klima
Bernhard Fürthauer
Raimund Weitgasser
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2010
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/1471-2296-11-86

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