A pilot multicentre cluster randomised trial to compare the effect of trauma life support training programmes on patient and provider outcomes

Abstract

IntroductionTrauma accounts for nearly 10% of the global burden of disease. Several trauma life support programmes aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programmes on patient outcomes. We describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing advanced trauma life support (ATLS) and primary trauma care (PTC) with standard care.Methods and analysisWe will pilot a pragmatic three-armed parallel, cluster randomised controlled trial in India, where neither of these programmes are routinely taught. We will recruit tertiary hospitals and include trauma patients and residents managing these patients. Two hospitals will be randomised to ATLS, two to PTC and two to standard care. The primary outcome will be all-cause mortality at 30 days from the time of arrival to the emergency department. Our secondary outcomes will include patient, provider and process measures. All outcomes except time-to-event outcomes will be measured both as final values as well as change from baseline. We will compare outcomes in three combinations of trial arms: ATLS versus PTC, ATLS versus standard care and PTC versus standard care using absolute and relative differences along with associated CIs. We will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury and elderly. In parallel to the pilot study, we will conduct community consultations to inform the planning of the full-scale trial.Ethics and disseminationWe will apply for ethics approvals to the local institutional review board in each hospital. The protocol will be published to Clinical Trials Registry—India and ClinicalTrials.gov. The results will be published and the anonymised data and code for analysis will be released publicly.

Structured approach with primary and secondary survey for major trauma care: an overview of reviews

“…It is well recognized that this is the key to reducing mortality in severely injured patients with unstable vital signs [ 40 ]. This approach has been popularized in North America by the American College of Surgeons at the end of the twentieth century and quickly spread all over the world [ 8 , 9 , 41 ]. Interestingly, in our SRs no primary study was found from European countries of either the ATLS or the ETC courses about the improvement in trauma care.…”

“…For trauma patients, several checklists based on a structured approach have been developed to improve the early management, such as the life support checklist explored in training programmes for trauma assessment and treatment [ 5 – 7 ]. The first training programmes were introduced by the American College of Surgeons with a worldwide spread in the past 20 years: Prehospital Trauma Care (PTC) and Advanced Trauma Life Support (ATLS ® ) [ 8 ]. Moreover, a branch of the ATLS programme was established also for nurses, the Advanced Trauma Course for Nurses (ATCN ® ) [ 9 ].…”

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

“…We piloted a three-armed cluster randomised controlled trial. The protocol was published 8 . There were two intervention arms, ATLS ® and PTC training, and one standard care arm.…”

Rural trauma team development amongst medical trainees and traffic law enforcement professionals in a low-income country: A protocol for a prospective multi-center interrupted time series of interventional training

“…Trauma is a public health threat which claims an annual death toll of 4.5 million lives globally, contributing to 10% of global disease burden 1 . Over 90% of global deaths due to trauma disproportionately occur in low- and middle-income countries (LMICs) such as those in sub-Saharan Africa where trauma life support educational programs are scarce 1 . The main cause of trauma related deaths in Africa are road traffic crashes 2 .…”

“…Several trauma care educational modules have been piloted in LMICs to address the unmet human resource needs but their impact assessment has been theoretical without the skills component 15 . Moreover, other than the ongoing clinical trial on the effect of advanced life support and primary trauma courses in India 1 , such trauma education programs have not been validated in randomized controlled settings, which could have affected their clinical application 16 .…”