Improving prehospital traumatic shock care: implementation and clinical effectiveness of a pragmatic, quasi-experimental trial in a resource-constrained South African setting.

OBJECTIVES: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. DESIGN:We conduct a two-arm, controlled, mixed-methods, hybrid type II study. SETTING:This study was conducted in the Western Cape Government Emergency Medical Services (EMS) system of South Africa. INTERVENTIONS: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. OUTCOME MEASURES: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. RESULTS: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). CONCLUSIONS: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.