Effect of Trauma Life Support Training Programs on Patient Outcomes

Trauma Injury Clinical Trial

Official title:

A Pilot Multicentre Cluster Randomised Trial to Compare the Effect of Trauma Life Support Training Programmes on Patient and Provider Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417243
• Other study ID #: tern-pilot
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2022
• Source: Karolinska Institutet
• Contact: Martin Gerdin Wärnberg, MD, PhD
• Phone: +46 708 53 95 98
• Email: martin.gerdin[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Trauma Injury
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Medica Superspecialty Hospital	Kolkata
India	Medical College	Kolkata
India	Sir Nil Ratan Sircar Medical College & Hospital	Kolkata
India	HBT Medical College And Dr. R N Cooper Municipal General Hospital	Mumbai
India	King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital	Mumbai
India	Lokmanya Tilak Municipal Medical College & General Hospital	Mumbai

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Doctors For You

Country where clinical trial is conducted

India, 

References & Publications (1)

Gerdin Wärnberg M, Berg J, Bhandarkar P, Chatterjee A, Chatterjee S, Chintamani C, Felländer-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, Strömmer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality within 30 days from the time of arrival to the emergency department		30 days

External Links

•   Trauma life support training Effectiveness Research Network website