Effect of Trauma Life Support Training Programs on Patient Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2023-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Trauma Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster Randomized Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Advanced Trauma Life Support (ATLS)

Training in ATLS for residents providing trauma care.

Group Type EXPERIMENTAL

Trauma life support training

Intervention Type OTHER

Clusters are randomised for their residents to be trained in one of two trauma life support training programs or to continue providing standard care.

Primary Trauma Care (PTC)

Training in PTC for residents providing trauma care.

Group Type EXPERIMENTAL

Trauma life support training

Intervention Type OTHER

Clusters are randomised for their residents to be trained in one of two trauma life support training programs or to continue providing standard care.

Standard Care

Trauma care according to the current standard with no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No