Evaluating Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study: A Parallel, 4-Arm Randomized Controlled Trial

BACKGROUND: Hemorrhage is a significant source of preventable death in the US. Bystander hemorrhage control training is crucial, yet resource-intensive to scale and has longitudinal knowledge decay. Efficacy of point-of-care (POC) instructional modalities to address these challenges was compared vs in-person training for tourniquet application by laypeople longitudinally. STUDY DESIGN: Parallel randomized controlled trial evaluating tourniquet application on limb hemorrhage simulators by direct observation checklist and simulated hemorrhage arrest using undergraduate students. Four arms included POC audiovisual (group 1, n = 36), POC flashcard (group 2, n = 48), in-person training (group 3, n = 33), and control without POC instructions or training (group 4, n = 41). POC materials were available at follow-up, given the inherent nature of POC instructional material integration with devices, whereas in-person training had no retraining at follow-up to assess skill decay, using per-protocol analysis with Wilcoxon rank-sum tests. Secondary outcomes included participant confidence, failure reason, and completion time. RESULTS: Two hundred seventeen participants were recruited, 204 enrolled (38 excluded for earlier or interval hemorrhage control training), and 8 lost to follow-up (5.06%) for 158 trial participants. At 6-month follow-up, there was no difference in performance between POC and in-person training by checklist, with in-person training demonstrating 48.5% (95% CI 31.2% to 66.1%) vs POC audiovisual 63.9% (95% CI 46.2% to 78.7%, p = 0.203), or by simulated hemorrhage arrest; in-person training of 72.7% (95% CI 54.2% to 86.1%) vs POC audiovisual of 77.8% (95% CI 60.4% to 89.3%, p = 0.635). At follow-up, both POC arm confidence levels exceeded in-person training (p = 0.02), despite longer completion time (p < 0.001). CONCLUSIONS: POC instruction may be as effective as in-person training for tourniquet application by laypeople longitudinally, suggesting a potential alternative to disseminate hemorrhage control devices, addressing in-person training scalability challenges.