Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Strubergasse 21, 5020 Salzburg, Austria.
BMC Fam Pract. 2010 Nov 5;11:86. doi: 10.1186/1471-2296-11-86.
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.
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.
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.
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.
Current Controlled trials Ltd., ISRCTN27414162.
疾病管理计划（DMP）成本高昂，并给全科医生（GP）增加了额外的工作负担。关于其有效性的数据尚无定论。因此，我们进行了一项集群随机对照试验，以评估奥地利 2 型糖尿病 DMP 对成年初级保健患者糖化血红蛋白和护理质量的有效性。
邀请萨尔斯堡省的所有全科医生参加。在按地区进行集群随机分组后，从 2007 年 7 月至 11 月连续招募所有 2 型糖尿病患者。干预组实施了主要由医生和患者教育、标准化文件记录和治疗目标协议组成的 DMP，而对照组则接受常规护理。我们旨在证明干预在代谢控制和过程质量方面的优越性。主要结局指标是一年后糖化血红蛋白的变化。次要结局指标是住院天数、血压、血脂、体重指数（BMI）、参加患者教育和定期遵循指南的检查。无法进行盲法。
92 名医生招募了 1489 名患者（649 名干预组，840 名对照组）。经过 401±47 天后，590 名干预组患者和 754 名对照组患者有完整的数据。在所有 1489 名患者的意向治疗分析（ITT）中，干预组的糖化血红蛋白降低了 0.41%，对照组降低了 0.28%。差异为-0.13%（95%CI-0.24；-0.02），p=0.026。调整基线值和聚类效应后的混合模型分析（调整后的平均差异-0.03（95%CI-0.15；0.09，p=0.607））。在 ITT 中，调整后，干预组的 BMI 和胆固醇显著低于对照组（-0.53kg/m²；95%CI-1.03；-0.02；p=0.014 和-0.10mmol/L；95%CI-0.21；-0.003；p=0.043）。此外，更多的患者接受了患者教育（49.5%对 20.1%，p<0.0001）、眼部检查（71.0%对 51.2%，p<0.0001）、足部检查（73.8%对 45.1%，p<0.0001）和定期糖化血红蛋白检查（44.1%对 36.0%，p<0.01）。
由法定健康保险实施的奥地利 DMP 提高了过程质量并增强了减肥效果，但并未显著改善 2 型糖尿病患者的代谢控制。在次要结局指标中看到的微小益处是否会导致患者结局更好，尚不清楚。
当前对照试验有限公司，ISRCTN27414162。
Zotero 插件