Clinical Trials and Evaluation Unit, Royal Brompton Hospital, Sydney Street, SW7 6NP, UK.
Trials. 2010 Jan 14;11:5. doi: 10.1186/1745-6215-11-5.
Acute coronary syndromes, including myocardial infarction and unstable angina, are important causes of premature mortality, morbidity and hospital admissions. Acute coronary syndromes consume large amounts of health care resources, and have a major negative economic and social impact through days lost at work, support for disability, and coping with the psychological consequences of illness. Several registries have shown that evidence based treatments are under-utilised in this patient population, particularly in high-risk patients. There is evidence that systematic educational programmes can lead to improvement in the management of these patients. Since application of the results of important clinical trials and expert clinical guidelines into clinical practice leads to improved patient care and outcomes, we propose to test a quality improvement programme in a general group of hospitals in Europe.
METHODS/DESIGN: This will be a multi-centre cluster-randomised study in 5 European countries: France, Spain, Poland, Italy and the UK. Thirty eight hospitals will be randomised to receive a quality improvement programme or no quality improvement programme. Centres will enter data for all eligible non-ST segment elevation acute coronary syndrome patients admitted to their hospital for a period of approximately 10 months onto the study database and the sample size is estimated at 2,000-4,000 patients. The primary outcome is a composite of eight measures to assess aggregate potential for improvement in the management and treatment of this patient population (risk stratification, early coronary angiography, anticoagulation, beta-blockers, statins, ACE-inhibitors, clopidogrel as a loading dose and at discharge). After the quality improvement programme, each of the eight measures will be compared between the two groups, correcting for cluster effect.
If we can demonstrate important improvements in the quality of patient care as a result of a quality improvement programme, this could lead to a greater acceptance that such programmes should be incorporated into routine health training for health professionals and hospital managers.
Clinicaltrials.gov NCT00716430.
急性冠脉综合征,包括心肌梗死和不稳定型心绞痛,是导致过早死亡、发病率和住院率升高的重要原因。急性冠脉综合征消耗大量医疗资源,对经济和社会造成重大负面影响,包括工作缺勤、残疾支持以及应对疾病的心理后果。多项注册研究表明,这种患者人群的证据为基础的治疗方法利用不足,高危患者尤其如此。有证据表明,系统的教育计划可以改善这些患者的管理。由于将重要临床研究和专家临床指南的结果应用于临床实践可以改善患者的护理和结局,因此我们提议在欧洲的一般医院群体中测试一个质量改进计划。
方法/设计:这将是一项在 5 个欧洲国家(法国、西班牙、波兰、意大利和英国)进行的多中心聚类随机研究。38 家医院将被随机分为接受质量改进计划或不接受质量改进计划的两组。各中心将在大约 10 个月的时间内,将所有符合条件的非 ST 段抬高急性冠脉综合征患者的数据输入研究数据库,估计样本量为 2000-4000 例。主要结局是评估该患者人群管理和治疗整体改进潜力的八项措施的综合指标(风险分层、早期冠状动脉造影、抗凝、β受体阻滞剂、他汀类药物、ACE 抑制剂、氯吡格雷负荷剂量和出院时剂量)。在质量改进计划之后,将校正聚类效应后,比较两组之间的八项措施中的每一项。
如果我们能够证明质量改进计划导致患者护理质量的重要改善,这可能会导致更大程度地接受此类计划应纳入卫生专业人员和医院管理人员的常规卫生培训。
Clinicaltrials.gov NCT00716430。