Work

Effects of Advanced Trauma Life Support® training compared with standard care on adult trauma patient outcomes (ADVANCE TRAUMA): study protocol for a stepped-wedge cluster randomised trial

Year: 2026

Type: article

Abstract: BACKGROUND: Advanced Trauma Life Support® (ATLS®) is the most widely adopted form of trauma life support training worldwide, but there is no high-quality evidence that it can improve patient outcomes. The aim of this trial is to compare the effects of ATLS® training with standard care on outcomes in adult trauma patients. METHODS: ADVANCE TRAUMA is a batched stepped-wedge cluster randomised controlled trial in India, where ATLS® is not routinely implemented. The trial will be conducted in 30 clusters (hospitals), organised into six batches of five clusters each. All clusters transition through three phases: first, a standard care phase; second, a 1-month transition phase, during which the training is delivered; and finally, an intervention phase, for a total of 13 months. Each cluster is randomised to an implementation sequence that defines the duration of the standard care and intervention phases. The trial will include at least 4320 adult trauma patients (≥ 15 years) who present to emergency departments and are subsequently admitted or transferred for admission. The primary outcome is in-hospital mortality within 30 days of arrival at the emergency department. DISCUSSION: This will be the first large-scale trial to provide robust evidence of the effectiveness of ATLS® since the programme was initiated in 1978. Regardless of the findings, this study will have important implications for trauma life support training globally. If ATLS® training improves patient outcomes, ways to promote its use and optimise its implementation, especially in low- and middle-income countries such as India, should be explored. If patient outcomes do not improve, trauma life support training must change. TRIAL REGISTRATION: Clinical Trials Registry-India (CTRI/2024/07/071336), ClinicalTrials.gov (NCT06321419, first registered 2024-03-20).

Source: Trials

DOI: 10.1186/s13063-026-09491-z