A pilot multicentre cluster randomised trial to compare the effect of trauma life support training programmes on patient and provider outcomes
Martin Gerdin Wärnberg, Johanna Berg, Prashant Bhandarkar, Anirban Chatterjee, Shamita Chatterjee, Chintamani Chintamani, Li Felländer-Tsai, Anita Gadgil, Geeta Ghag, Marie Hasselberg, Catherine Juillard, Monty Khajanchi, Deepa Kizhakke Veetil, Vineet Kumar, Debabrata Kundu, Anurag Mishra, Priti Patil, Nobhojit Roy, Amit Roy, Siddarth David, Rajdeep Singh, Harris Solomon, Kapil Dev Soni, Lovisa Strömmer, Megha Tandon, Trauma life support training Effectiveness Research Network (TERN) collaborators, Martin Gerdin Wärnberg, Johanna Berg, Prashant Bhandarkar, Anirban Chatterjee, Shamita Chatterjee, Chintamani Chintamani, Li Felländer-Tsai, Anita Gadgil, Geeta Ghag, Marie Hasselberg, Catherine Juillard, Monty Khajanchi, Deepa Kizhakke Veetil, Vineet Kumar, Debabrata Kundu, Anurag Mishra, Priti Patil, Nobhojit Roy, Amit Roy, Siddarth David, Rajdeep Singh, Harris Solomon, Kapil Dev Soni, Lovisa Strömmer, Megha Tandon, Trauma life support training Effectiveness Research Network (TERN) collaborators
Abstract
Introduction: Trauma 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 analysis: We 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 dissemination: We 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.
Keywords: accident & emergency medicine; education & training (see medical education & training); trauma management.
Conflict of interest statement
Competing interests: Several authors are Advanced Trauma Life Support instructors.
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
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Source: PubMed