ATLS vs Standard Care Trial

Effects of Advanced Trauma Life Support^®^ Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial

Rationale:

Trauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.

Aim:

To compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.

Trial Population:

Adult trauma patients presenting to the emergency department of a participating hospital.

Eligibility Criteria:

Hospitals are secondary or tertiary hospitals in India that admit or refer/transfer for admission at least 400 patients with trauma per year. Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India. Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.

Ethical Considerations:

The study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records.

Funding:

Swedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297).

Special considerations:

This trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those.

Study Overview

• Status: Not yet recruiting
• Conditions: Wounds and Injuries
• Intervention / Treatment: Behavioral: Advanced Trauma Life Support training

• Study Type: Interventional
• Enrollment (Estimated): 4320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Gerdin Wärnberg, PhD; Phone Number: +46 (0)8-524 800 00; Email: martin.gerdin@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age of at least 15 years;
• trauma occurred less than 48 hours before arrival at the hospital;
• present to the emergency department of participating hospitals, with a history of trauma defined as having any of the reasons listed in the International Classification of Diseases chapter XX as the reason for presenting;
• admitted or died between arrival at the hospital and admission, or referred/transferred from the emergency department of a participating hospital to another hospital for admission; and
• managed by a participating cluster in the emergency department.

Exclusion Criteria:

• present with isolated limb injuries; or
• are directly admitted to a ward without being seen by a physician in the emergency department.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced Trauma Life Support; The intervention will be ATLS® training, a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. Physicians will be trained in an accredited ATLS® training facility in India.	Behavioral: Advanced Trauma Life Support training; Advanced Trauma Life Support (ATLS) is a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. The programme was developed by the Committee of Trauma of the American College of Surgeons. The course includes intial treatment and resuscitation, triage and interfacility transfers. Leaning is based on practical scenario-driven skill stations, lectures and includes a final performance proficiency evaluation. Physicians will be trained in an accredited ATLS training facility in India.
No Intervention: Standard care; Standard care varies across hospitals in India, but trauma patients are initially managed by casualty medical officers, surgical residents, or emergency medicine residents. They are mainly first- or second-year residents who resuscitate patients, perform interventions and refer patients for imaging or other investigations. Compared with other settings where a trauma team approach is adopted, nurses and other healthcare professionals are only involved to a limited extent during the initial management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality within 30 days of arrival at the emergency department.	30 days

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: The George Institute for Global Health, India

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Mortality; Disability; Return to work; Advanced Trauma Life Support
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: atls-vs-standard-care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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