Monash Institute of Health Services Research, Monash University, Melbourne, Australia.
Implement Sci. 2008 Feb 22;3:11. doi: 10.1186/1748-5908-3-11.
Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.
This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.
METHODS/DESIGN: This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.
可靠研究产生的证据并未频繁应用于临床实践。循证临床实践指南是实现这一目标的潜在手段。最近对指南传播实施策略的系统评价得出的结论是，缺乏关于促进指南采用的有效策略的证据。该综述及其他研究的建议表明，使用基于理论的干预措施可能更有效，因为这些措施可能比非基于理论的干预措施更有效。最近在澳大利亚为急性腰痛的管理制定了循证临床实践指南。这为在维多利亚州的普通实践中为一种常见疾病制定和测试基于理论的实施干预措施提供了机会，这种疾病的负担很重，在初级保健环境中存在实践证据差距。
本研究旨在测试一种基于理论的干预措施在澳大利亚维多利亚州普通实践中实施急性腰痛临床实践指南的有效性。具体而言，我们的主要目标是确定该干预措施是否能有效降低转诊进行普通 X 光检查的患者比例，并改善患者在咨询后三个月的残疾平均水平。
方法/设计：本研究方案详细描述了一项群组随机对照试验的细节。92 家普通实践（群组），其中包括至少一名同意参与的普通医生，将使用限制随机化方法随机分为干预组或对照组。年龄在 18 岁或以上、因急性非特异性腰痛就诊且持续时间少于三个月的患者将有资格入组。每个普通实践平均将招募 25 名患者，共招募 2300 名患者。对照组中的普通医生将通过现有的传播策略获得指南。干预组中的医生将受邀参加以行为理论为基础的面对面促进研讨会。调查人员（不参与干预措施的提供）、患者、结果评估者和研究统计员将对分组分配保持盲态。
