Clinical trial NCT05417243: Effect of Trauma Life Support Training Programs on Patient Outcomes
Official title: A Pilot Multicentre Cluster Randomised Trial to Compare the Effect of Trauma Life Support Training Programmes on Patient and Provider Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma Injury
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Doctors For You
First posted: 2022-06-14
Enrollment: 306
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: All cause mortality within 30 days from the time of arrival to the emergency department
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
city: Kolkata
country: India
facility: Medica Superspecialty Hospital
city: Kolkata
country: India
facility: Medical College
city: Kolkata
country: India
facility: Sir Nil Ratan Sircar Medical College & Hospital
city: Mumbai
country: India
facility: HBT Medical College And Dr. R N Cooper Municipal General Hospital
city: Mumbai
country: India
facility: King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal Medical College & General Hospital
Study officials:
References:
citation: 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.