Peters-Klimm Frank, Campbell Stephen, Müller-Tasch Thomas, Schellberg Dieter, Gelbrich Goetz, Herzog Wolfgang, Szecsenyi Joachim
Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.
Trials. 2009 Aug 13;10:68. doi: 10.1186/1745-6215-10-68.
Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes.
This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted.
There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2-13; p = 0.02).
The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care.
ISRCTN08601529.
慢性（收缩性）心力衰竭（CHF）是一种常见且使人丧失能力的病症。在初级保健中遵循循证指南已被证明可改善健康结局。目的是探讨针对全科医生（GP）的多学科教育干预（培训培训师 = TTT）对患者和诊疗效果的影响。
本文介绍了该试验的主要发现，并讨论了在TTT试验实施过程中吸取的经验教训。初级保健机构被随机分配到TTT干预组或对照组。37名全科医生（18名TTT组，19名对照组）被随机分组，168名确诊为CHF的患者（91名TTT组，77名对照组）被纳入研究。干预组的全科医生参加了四次关于临床实践指南和药物治疗反馈的会议。主要结局是使用SF - 36身体功能量表评估患者在七个月时自我报告的生活质量。次要结局包括其他SF - 36量表、堪萨斯城心肌病问卷（KCCQ）、总死亡率、心力衰竭住院次数、处方情况、抑郁症（PHQ - 9）、行为改变（欧洲心力衰竭自我护理行为量表）、患者感知的护理质量（EUROPEP）以及使用NT - proBNP水平评估的心力衰竭改善情况。由于未达到招募目标，因此进行了探索性分析。
两组在许多结局方面基线达成情况良好。在七个月时，主要结局指标在两组之间无显著平均差异（-3.3，95%CI -9.7至3.1，p = 0.30）。次要结局中唯一的差异与干预组全科医生开具醛固酮拮抗剂的情况有关，随访时组间差异显著（42%对24%，调整后OR = 4.0，95%CI 1.2 - 13；p = 0.02）。
该干预未改变主要结局或大多数次要结局。未达到招募目标，机构和患者招募不足以及参与的全科医生存在选择偏倚，使得无法得出明确结论，但置信区间表明该干预在本样本中无效。我们描述了从开展该试验中吸取的经验教训，以便为未来初级保健中的验证性试验进行规划和实施。
ISRCTN08601529。
