Feasibility of a Cluster Randomised Trial on the Effect of Trauma Life Support Training: A Pilot Study

Abstract

IntroductionTrauma life support training programmes aim to improve trauma outcomes but there is no evidence from controlled trials to show that they work. We conducted a pilot study to assess the feasibility of conducting a cluster randomised controlled trial comparing the effect of Advanced Trauma Life Support®(ATLS®) and Primary Trauma Care (PTC) with standard care on patient outcomes.Methods and analysisWe piloted a pragmatic three-armed parallel, cluster randomised, controlled trial in tertiary care hospitals across metropolitan areas in India. We included adult trauma patients and residents managing these patients. Two hospitals were randomised to ATLS®, two to PTC, and three to standard care. The feasibility outcomes were consent rate, lost to follow up rate, pass rate, missing data rates, and differences in distribution between observed and data extracted from medical records. We conducted community consultations in parallel with the pilot trial.Ethics and disseminationWe obtained ethical approval from all participating hospitals.ResultsBetween April 2022 and February 2023 we included 376 patients and 21 residents. The percentage of patients who consented to follow up was 77% and the percentage of residents who consented to training was 100%. The lost to follow up rate was 14%. The pass rate was 100%. The missing data rate ranged from 0 to 98. Data collected through observations were similar to data extracted from medical records, but there was more missing data in the extracted data.ConclusionsConducting a full-scale cluster randomised controlled trial comparing the effects of ATLS®, PTC, and standard care on patient outcomes should be feasible after incorporating key lessons from this pilot.