Thiruganasambandamoorthy Venkatesh, Keller Maria, Nguyen Phuong Anh Iris, Gupta Preeti, Ghaedi Bahareh, Cao George Z Q, Cheung Warren J, Khatiwada Bikalpa, Nemnom Marie-Joe, Yadav Krishan, Eagles Debra, Brehaut Jamie, Tarhuni Wadea, Rouleau Genevieve, Desveaux Laura, Taljaard Monica
Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.
The Ottawa Hospital Research Institute, Clinical Epidemiology Unit, The Ottawa Hospital, Ottawa, ON, Canada.
CJEM. 2023 Oct;25(10):808-817. doi: 10.1007/s43678-023-00570-7. Epub 2023 Aug 31.
We developed the Canadian Syncope Pathway (CSP) based on the Canadian Syncope Risk Score (CSRS) to aid emergency department (ED) syncope management. This pilot implementation study assessed patient inclusion, length of transition period, as well as process measures (engagement, reach, adoption, and fidelity) to prepare for multicenter implementation.
A non-randomized stepped wedge trial at two hospitals was conducted over a 7-month period. After 2-3 months in the control condition, the hospitals crossed over in a stepwise fashion to the intervention condition. Study participants were ED and non-ED physicians, or their delegates, and patients (aged ≥ 18 years) with syncope. We aimed to analyze patient characteristics, ED management including disposition decision, and CSRS recommendations application for all eligible patients during the intervention period. Our targets were 95% inclusion rate, 70% adoption (proportion of physicians who applied the pathway), 60% reach (intervention applied to eligible patients) and 70% fidelity (appropriate recommendations application) for all eligible patients. Clinical Trials registration NCT04790058.
1002 eligible patients (mean age 56.6 years; 51.0% males) were included: 349 patients during the control and 653 patients during the intervention period. Physician engagement varied from 39.7% to 97.1% for presentation at meetings. Process measures for the first month and the end of the intervention were: adoption 70.7% (58/82) and 84.4% (103/122), reach 67.5% (108/160) and 55.0% (359/653), fidelity among patients with physician data form completion 86.3% (88/102) and 88.3% (294/333), versus fidelity among all eligible patients 83.8% (134/160) and 83.3% (544/653) respectively with no significant differences in fidelity at one month and the end of the intervention period.
In this pilot study, we achieved all prespecified benchmarks for proceeding to the multicenter CSP implementation except reach. Our results indicate a 1-month transition period will be adequate though regular reminders will be needed during full-scale implementation.
我们基于加拿大晕厥风险评分(CSRS)制定了加拿大晕厥诊疗路径(CSP),以协助急诊科(ED)对晕厥进行管理。这项试点实施研究评估了患者纳入情况、过渡期时长以及流程指标(参与度、覆盖范围、采用率和保真度),为多中心实施做准备。
在两家医院进行了为期7个月的非随机阶梯楔形试验。在对照状态下持续2至3个月后,各医院逐步过渡到干预状态。研究参与者包括急诊科和非急诊科医生或其代表,以及晕厥患者(年龄≥18岁)。我们旨在分析干预期间所有符合条件患者的特征、急诊科管理情况(包括处置决定)以及CSRS建议的应用情况。我们的目标是所有符合条件患者的纳入率达到95%、采用率达到70%(应用该诊疗路径的医生比例)、覆盖范围达到60%(对符合条件的患者应用干预措施)以及保真度达到70%(正确应用建议)。临床试验注册号NCT04790058。
共纳入1002例符合条件的患者(平均年龄56.6岁;男性占51.0%):对照期349例患者,干预期653例患者。医生在会议上的参与度从39.7%到97.1%不等。干预第一个月和结束时的流程指标如下:采用率分别为70.7%(58/82)和84.4%(103/122),覆盖范围分别为67.5%(108/160)和55.0%(359/653),填写医生数据表格的患者的保真度分别为86.3%(88/102)和88.3%(294/333),而所有符合条件患者的保真度分别为83.8%(134/160)和83.3%(544/653),在干预第一个月和结束时保真度无显著差异。
在这项试点研究中,除覆盖范围外,我们达到了推进多中心CSP实施的所有预先设定的基准。我们的结果表明,1个月的过渡期就足够了,不过在全面实施期间需要定期提醒。