Effects of Trauma Life Support Training on Patient Outcomes: A Pilot Cluster Randomised Trial

Abstract Importance There is no high-quality evidence to show that trauma life support training programmes improve patient outcomes. Objective 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, and to estimate probable effect sizes and other measures needed for the sample size calculations of a full-scale trial. Design A pilot pragmatic three-armed parallel, cluster randomised, controlled trial between April 2022 and February 2023. Patient follow up was 30 days. Setting Tertiary care hospitals across metropolitan areas in India. Participants Adult trauma patients and residents managing these patients. Interventions ATLS ® or PTC training for residents in the intervention arms. Main Outcomes and Measures The outcomes were consent rate, lost to follow up rate, pass rate, missing data rates, differences in distribution between observed and data extracted from medical records as well as all cause and in-hospital mortality at 30 days from the time of arrival to the emergency department. Results Two hospitals were randomised to ATLS ® , two to PTC, and three to standard care. We included 376 patients and 22 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 was overall low for key variables. Data collected through observations were similar to data extracted from medical records, but there was more missing data in the extracted data. Twenty-two (16%) patients died within 30 days in the standard care arm, one (4%) patient in the ATLS ® arm, and three (5%) patients in the PTC arm. Conclusions and Relevance Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS ® , PTC, and standard care on patient outcomes will be feasible, especially if such a trial would use data and outcomes available in medical records. Key Points Question Is it feasible to conduct a cluster randomised trial comparing trauma life support training with standard care? Findings In this pilot cluster randomized trial that included 376 patients and 22 residents from seven hospitals, we found high consent rates, low lost to follow up rates, and low missing data for key variables. Meaning Conducting a full-scale cluster cluster trial comparing the effects of trauma life support training with standard care on patient outcomes will be feasible, especially if such a trial would use data and outcomes available in medical records.