Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting 'high impact' clinical practice recommendations in general practice.
Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting 'high impact' clinical practice recommendations in general practice.
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DOI：
10.1186/s13012-016-0387-5
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发表时间：
2016-02-29
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通讯作者：
ASPIRE programme
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作者：
Willis TA;Hartley S;Glidewell L;Farrin AJ;Lawton R;McEachan RR;Ingleson E;Heudtlass P;Collinson M;Clamp S;Hunter C;Ward V;Hulme C;Meads D;Bregantini D;Carder P;Foy R;ASPIRE programme
在一般实践中，证据与实践之间存在公认的差距，这为实施提供了特别的挑战。我们之前筛选了临床指南建议，以得出一组“高影响”指标，这些指标基于以下标准，包括显著患者获益的潜力、改进实践的范围和使用常规收集的数据进行测量的适应性。我们的目标是评估多方面、适应性强的一揽子干预措施的有效性和成本效益，以在一般实践中实施四项有针对性、高影响力的建议。研究计划行动支持实践实施研究证据（ASPIRE）包括一对实用的集群随机试验，使用平衡的不完全块设计。集群是英国西约克郡的一般做法，采用“选择退出”招聘流程。适应每一项建议的一揽子干预措施包括结合审计和反馈、教育外展访问和计算机化提示，以及根据确定的需求和改变的障碍选择的嵌入改变行为技术。在试验1中，实践被随机分配到针对糖尿病控制或风险处方的适应性干预措施中，而在试验2中，实践被随机分配到针对心血管事件风险患者的血压控制或房颤抗凝的适应性干预措施中。各自的主要终点包括实现2型糖尿病患者血红蛋白A1c （HbA1c）、血压和胆固醇的所有推荐目标水平、风险处方的综合指标、实现特定患者群体的推荐血压目标和房颤患者的抗凝处方。我们还将实践随机分配到第五个非干预对照组，以进一步评估霍桑效应。使用随机化后1年常规收集的数据评估结果。经济模型将估算干预的成本效益。一项涉及八种非试验做法的过程评价将审查干预措施的实施、行动机制和意外后果。ASPIRE将提供“真实世界”的证据，证明针对高影响力建议的适应性干预方案的效果、成本效益和交付情况。通过在四个不同的临床主题中实施适应性干预方案，并使用“选择退出”招募，我们的研究结果将提供更广泛的普遍性证据。ISRCTN91989345本文在线版本（doi:10.1186/s13012-016-0387-5）含有补充资料，授权用户可自行查阅。
There are recognised gaps between evidence and practice in general practice, a setting which provides particular challenges for implementation. We earlier screened clinical guideline recommendations to derive a set of ‘high impact’ indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted, adaptable intervention package to implement four targeted, high impact recommendations in general practice. The research programme Action to Support Practice Implement Research Evidence (ASPIRE) includes a pair of pragmatic cluster-randomised trials which use a balanced incomplete block design. Clusters are general practices in West Yorkshire, United Kingdom (UK), recruited using an ‘opt-out’ recruitment process. The intervention package adapted to each recommendation includes combinations of audit and feedback, educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. In trial 1, practices are randomised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation. The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c (HbA1c), blood pressure and cholesterol in patients with type 2 diabetes, a composite indicator of risky prescribing, achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation. We are also randomising practices to a fifth, non-intervention control group to further assess Hawthorne effects. Outcomes will be assessed using routinely collected data extracted 1 year after randomisation. Economic modelling will estimate intervention cost-effectiveness. A process evaluation involving eight non-trial practices will examine intervention delivery, mechanisms of action and unintended consequences. ASPIRE will provide ‘real-world’ evidence about the effects, cost-effectiveness and delivery of adapted intervention packages targeting high impact recommendations. By implementing our adaptable intervention package across four distinct clinical topics, and using ‘opt-out’ recruitment, our findings will provide evidence of wider generalisability. ISRCTN91989345 The online version of this article (doi:10.1186/s13012-016-0387-5) contains supplementary material, which is available to authorized users.