Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA
Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.
BMJ Open. 2023 Apr 25;13(4):e060338. doi: 10.1136/bmjopen-2021-060338.
This project seeks to improve providers' practices and patient outcomes from prehospital (ie, ambulance-based) trauma care in a middle-income country using a novel implementation strategy to introduce a bundled clinical intervention.
We conduct a two-arm, controlled, mixed-methods, hybrid type II study.
This study was conducted in the Western Cape Government Emergency Medical Services (EMS) system of South Africa.
We pragmatically implemented a simplified prehospital bundle of trauma care (with five core elements) using a novel workplace-based, peer-to-peer, rapid training format. We assigned the intervention and control sites.
We assessed implementation effectiveness among EMS providers and stakeholders, using the RE-AIM framework. Clinical effectiveness was assessed at the patient level, using changes in Shock Index x Age (SIxAge). Indices and cut-offs were established a priori. We performed a difference-in-differences (D-I-D) analysis with a multivariable mixed effects model.
198 of 240 (82.5%) EMS providers participated, 93 (47%) intervention and 105 (53%) control, with similar baseline characteristics. The overall implementation effectiveness was excellent (80.6%): reach was good (65%), effectiveness was excellent (87%), implementation fidelity was good (72%) and adoption was excellent (87%). Participants and stakeholders generally reported very high satisfaction with the implementation strategy citing that it was a strong operational fit and effective educational model for their organisation. A total of 770 patients were included: 329 (42.7%) interventions and 441 (57.3%) controls, with no baseline differences. Intervention arm patients had more improved SIxAge compared with control at 4 months, which was not statistically significant (-1.4 D-I-D; p=0.35). There was no significant difference in change of SIxAge over time between the groups for any of the other time intervals (p=0.99).
In this quasi-experimental trial of bundled care using the novel workplace rapid training approach, we found overall excellent implementation effectiveness but no overall statistically significant clinical effectiveness.
本项目旨在通过一种新的实施策略，为中低收入国家的院前（即基于救护车）创伤护理引入捆绑式临床干预措施，以改善提供者的实践和患者的预后。
我们进行了一项两臂、对照、混合方法、混合 II 型研究。
这项研究在南非西开普省政府紧急医疗服务（EMS）系统中进行。
我们采用一种新颖的基于工作场所的、同伴对同伴的、快速培训模式，务实的实施了简化的院前创伤护理包（包含五个核心要素）。我们分配了干预和对照组。
我们使用 RE-AIM 框架评估 EMS 提供者和利益相关者的实施效果。使用休克指数 x 年龄（SIxAge）的变化，在患者水平上评估临床效果。指数和切点是事先确定的。我们使用多变量混合效应模型进行差异分析（D-I-D）。
共有 240 名 EMS 提供者中的 198 名（82.5%）参加了研究，93 名（47%）干预组和 105 名（53%）对照组，基线特征相似。整体实施效果非常好（80.6%）：覆盖面广（65%），效果极好（87%），实施保真度好（72%），采用率极好（87%）。参与者和利益相关者普遍对实施策略表示非常满意，称其非常适合他们的组织，并且是一种有效的教育模式。共有 770 名患者入组：329 名（42.7%）干预组和 441 名（57.3%）对照组，基线无差异。与对照组相比，干预组患者在 4 个月时 SIxAge 改善更多，但无统计学意义（-1.4 D-I-D；p=0.35）。在任何其他时间间隔，两组之间的 SIxAge 变化均无显著差异（p=0.99）。
在这项使用新颖的工作场所快速培训方法的捆绑式护理准实验试验中，我们发现整体实施效果极好，但总体临床效果无统计学意义。
