Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.
Trials. 2010 May 17;11:56. doi: 10.1186/1745-6215-11-56.
Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs).
This patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models.
Baseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]).
In this sample, with little room for improvement regarding evidence-based pharmacotherapy and CHF self-care, case management showed no improved health outcomes or health care utilisation. However, case management significantly improved performance and key intermediate outcomes. Our study provides evidence for the feasibility of the case management model.
ISRCTN30822978.
慢性（收缩期）心力衰竭（CHF）是一种具有较高个体和社会疾病负担的临床综合征。多方面的干预措施，如病例管理，被认为是改善患者预后的有希望的方法，但缺乏强有力的证据基础，特别是在初级保健中。本研究的目的是探讨由医生助理（DA，相当于护理角色）进行的新型 CHF 病例管理模式的有效性，并由全科医生（GP）提供支持。
这是一项患者随机对照试验（二期），包括德国 29 个小型门诊实践中的 31 名 DA 和 GP。CHF 患者接受病例管理（n=99），包括电话监测和家访，或接受常规护理（n=100）12 个月。我们获得了临床数据、医疗保健利用数据以及一般和疾病特异性生活质量（QoL，SF-36 和 KCCQ）、CHF 自我护理（EHFScBS）和护理质量（PACIC-5A）的患者报告数据。为了在随访时比较两组，我们进行了协方差分析和逻辑回归模型分析。
基线测量显示，循证药物治疗和良好的患者自我护理依从性高：93.8%和 95%的患者接受血管紧张素转换酶抑制剂（或血管紧张素-2 受体拮抗剂），72.2%和 84%的患者接受β受体阻滞剂，分别有 68%和 80%的患者同时接受这两种药物治疗。EHFScBS 评分（SD）分别为 25.4（8.4）和 25.0（7.1）。KCCQ 总总结评分（SD）分别为 65.4（22.6）和 64.7（22.7）。我们发现住院和死亡率较低。EHFScBS 评分（-3.6[-5.7；-1.6]）和 PACIC 和 5A 评分（均为 0.5[0.3；0.7/0.8]）有利于 CM，但 QoL 评分无显著组间差异（身体/精神 SF-36 总评分/KCCQ-os[95%CI]：-0.3[-3.0；2.5]/-0.1[-3.4；3.1]/1.7[-3.0；6.4]）。
在本研究样本中，由于循证药物治疗和 CHF 自我护理方面几乎没有改进的空间，病例管理并未显示出改善健康结果或医疗保健利用的效果。然而，病例管理显著改善了绩效和关键中间结果。我们的研究为病例管理模式的可行性提供了证据。
ISRCTN30822978。
