Effect of Trauma Life Support Training Programs on Patient Outcomes

A Pilot Multicentre Cluster Randomised Trial to Compare the Effect of Trauma Life Support Training Programmes on Patient and Provider Outcomes

Introduction:

Trauma accounts for nearly 10% of the global burden of disease. Several trauma life support programs aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programs 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 programs 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 confidence intervals. 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.

Study Overview

• Status: Recruiting
• Conditions: Trauma Injury
• Intervention / Treatment: Other: Trauma life support training

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Gerdin Wärnberg, MD, PhD; Phone Number: +46 708 53 95 98; Email: martin.gerdin@ki.se

Study Locations

• India
  • Chandigarh, India
    • Recruiting
    • Postgraduate Institute of Medical Education & Research
  • Kolkata, India
    • Completed
    • Medica Superspecialty Hospital
  • Kolkata, India
    • Recruiting
    • Medical College
  • Kolkata, India
    • Recruiting
    • Sir Nil Ratan Sircar Medical College & Hospital
  • Mumbai, India
    • Completed
    • HBT Medical College And Dr. R N Cooper Municipal General Hospital
  • Mumbai, India
    • Completed
    • King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital
  • Mumbai, India
    • Recruiting
    • Lokmanya Tilak Municipal Medical College & General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (15 years or older) who present to the emergency department at participating hospitals with a history of trauma. History of trauma is here defined as having any of the external causes of morbidity and mortality listed in block V01-Y36, chapter XX of the International Classification of Disease version 10 (ICD-10) codebook as reason for presenting.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Advanced Trauma Life Support (ATLS); Training in ATLS for residents providing trauma care.	Other: Trauma life support training; Clusters are randomised for their residents to be trained in one of two trauma life support training programs or to continue providing standard care.
EXPERIMENTAL: Primary Trauma Care (PTC); Training in PTC for residents providing trauma care.	Other: Trauma life support training; Clusters are randomised for their residents to be trained in one of two trauma life support training programs or to continue providing standard care.
NO_INTERVENTION: Standard Care; Trauma care according to the current standard with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality within 30 days from the time of arrival to the emergency department	30 days

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Doctors For You

Publications and helpful links

General Publications

• Gerdin Warnberg M, Berg J, Bhandarkar P, Chatterjee A, Chatterjee S, Chintamani C, Fellander-Tsai L, Gadgil A, Ghag G, Hasselberg M, Juillard C, Khajanchi M, Kizhakke Veetil D, Kumar V, Kundu D, Mishra A, Patil P, Roy N, Roy A, David S, Singh R, Solomon H, Soni KD, Strommer L, Tandon M; Trauma life support training Effectiveness Research Network (TERN) collaborators. A pilot multicentre cluster randomised trial to compare the effect of trauma life support training programmes on patient and provider outcomes. BMJ Open. 2022 Apr 18;12(4):e057504. doi: 10.1136/bmjopen-2021-057504.

Helpful Links

• Trauma life support training Effectiveness Research Network website

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2022
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (ACTUAL): June 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: tern-pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final anonymized dataset and code for analysis will be released publicly.
• IPD Sharing Time Frame: During 2023
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No