School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, Australia.
Implement Sci. 2013 Aug 19;8:91. doi: 10.1186/1748-5908-8-91.
Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers.
This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs' (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial).
The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs' detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In addition to receipt of the printed guideline, practitioners in the intervention group will be invited to participate in an interactive, opinion leader-led, educational face-to-face workshop. The theory-informed intervention aims to address identified barriers to and enablers of implementation of recommendations. Researchers responsible for identifying the cohort of patients with suspected cognitive impairment, and their detection and diagnosis outcomes, will be blind to group allocation.
Australian New Zealand Clinical Trials Registry: ACTRN12611001032943 (date registered 28 September, 2011).
痴呆是一种常见且复杂的病症。虽然存在针对全科医生中痴呆患者管理的循证指南，但人们发现，痴呆的检测、诊断和披露可能存在潜在的证据实践差距。为了将指南付诸实践而实施的干预措施取得了不同程度的成功。在设计实施干预措施时，理论的应用有限，但提倡使用理论是因为其有可能产生更有效的干预措施，并有助于理解在整个试验中改变干预效果幅度的因素。本方案描述了一项随机试验的方法，该试验测试了一种基于理论的实施干预措施，如果有效，可能会使痴呆患者及其护理人员受益。
本试验旨在评估一项基于理论的干预措施对增加澳大利亚维多利亚州全科医生（GP）遵循一般实践中痴呆检测、诊断和管理临床指南的效果，与为 GP 提供指南的印刷副本相比。主要目标包括测试该干预措施是否有效，以增加疑似认知障碍患者接受符合两项关键指南建议的护理的比例：接受 i）正式认知评估，和 ii）使用经过验证的量表进行抑郁评估（试验的主要结局）。
设计为平行群组随机试验，群组为全科医生诊所。我们的目标是为每组招募 60 个诊所。使用限制随机化对诊所进行干预组和对照组的随机分组。符合纳入标准的患者和针对这些患者的 GP 检测和诊断行为将通过对干预开始后九个月的医疗记录进行电子搜索来确定和测量。对照组的从业者将收到指南的印刷副本。除了收到印刷版指南外，干预组的从业者还将被邀请参加互动的、由意见领袖主导的、面对面的教育工作坊。基于理论的干预措施旨在解决实施建议的障碍和促进因素。负责确定疑似认知障碍患者队列及其检测和诊断结果的研究人员将对分组分配保持盲态。
澳大利亚和新西兰临床试验注册中心：ACTRN12611001032943（注册日期：2011 年 9 月 28 日）。
