Effect of Trauma Life Support Training Programs on Patient Outcomes

Not Applicable

Recruiting

• Conditions: Trauma Injury
• Interventions: Other: Trauma life support training

• Registration Number: NCT05417243
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-23
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-09
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 306

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Trauma Care (PTC)	Trauma life support training	Training in PTC for residents providing trauma care.
Advanced Trauma Life Support (ATLS)	Trauma life support training	Training in ATLS for residents providing trauma care.

Primary Outcome Measures

Name	Time	Method
All cause mortality within 30 days from the time of arrival to the emergency department	30 days

Trial Locations

Locations (7)

Medical College; 🇮🇳 Kolkata, India

HBT Medical College And Dr. R N Cooper Municipal General Hospital; 🇮🇳 Mumbai, India

Postgraduate Institute of Medical Education & Research; 🇮🇳 Chandigarh, India

Medica Superspecialty Hospital; 🇮🇳 Kolkata, India

Sir Nil Ratan Sircar Medical College & Hospital; 🇮🇳 Kolkata, India

King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital; 🇮🇳 Mumbai, India

Lokmanya Tilak Municipal Medical College & General Hospital; 🇮🇳 Mumbai, India