Clinical trial NCT06321419: Effects of Advanced Trauma Life Support® on Adult Trauma Patient Outcomes
Official title: Effects of Advanced Trauma Life Support® Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wounds and Injuries
Keywords: Advanced Trauma Life Support
Mortality
Disability
Return to work
Quality of Life
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The George Institute
First posted: 2024-03-20
Enrollment: 4320
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Batched stepped-wedge cluster randomised trial. We will roll out the interventions to 30 clusters over six batches, so there will be five clusters in each batch. The clusters in each batch will be randomised to one of five implementation sequences, with one hospital randomised to each implementation sequence. All clusters will transition through three phases, first a standard care phase, then a one month transition phase during which the training is delivered, and finally an intervention phase, for a total of 13 months.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: In-hospital mortality within 30 days of arrival at the emergency department
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Hridaysamrat Balasaheb Thackre Mun. Medical college and Dr. R.N. Cooper Hospital
state: Maharashtra
city: Ludhiana
country: India
facility: Christian Medical College & Hospital
state: Punjab
city: Dehradun
country: India
facility: Himalayan Institute of Medical Sciences, Swami Rama Himalayan University
state: Uttarakhand
city: Kolkata
country: India
facility: Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKM Hospital)
state: West Bengal
city: Chandigarh
country: India
facility: Government Medical College Hospital
Study officials:
References: