Effect of Trauma Life Support Training Programs on Patient Outcomes
Primary Purpose
Trauma Injury
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Trauma life support training
Sponsored by
About this trial
This is an interventional treatment trial for Trauma Injury
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.
Sites / Locations
- Postgraduate Institute of Medical Education & ResearchRecruiting
- Medica Superspecialty Hospital
- Medical CollegeRecruiting
- Sir Nil Ratan Sircar Medical College & HospitalRecruiting
- HBT Medical College And Dr. R N Cooper Municipal General Hospital
- King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital
- Lokmanya Tilak Municipal Medical College & General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Advanced Trauma Life Support (ATLS)
Primary Trauma Care (PTC)
Standard Care
Arm Description
Training in ATLS for residents providing trauma care.
Training in PTC for residents providing trauma care.
Trauma care according to the current standard with no intervention.
Outcomes
Primary Outcome Measures
All cause mortality within 30 days from the time of arrival to the emergency department
Secondary Outcome Measures
Full Information
NCT ID
NCT05417243
First Posted
June 9, 2022
Last Updated
November 7, 2022
Sponsor
Karolinska Institutet
Collaborators
Doctors For You
1. Study Identification
Unique Protocol Identification Number
NCT05417243
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Doctors For You
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Advanced Trauma Life Support (ATLS)
Arm Type
Experimental
Arm Description
Training in ATLS for residents providing trauma care.
Arm Title
Primary Trauma Care (PTC)
Arm Type
Experimental
Arm Description
Training in PTC for residents providing trauma care.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Trauma care according to the current standard with no intervention.
Intervention Type
Other
Intervention Name(s)
Trauma life support training
Intervention Description
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 Outcome Measure Information:
Title
All cause mortality within 30 days from the time of arrival to the emergency department
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Gerdin Wärnberg, MD, PhD
Phone
+46 708 53 95 98
Email
martin.gerdin@ki.se
Facility Information:
Facility Name
Postgraduate Institute of Medical Education & Research
City
Chandigarh
Country
India
Individual Site Status
Recruiting
Facility Name
Medica Superspecialty Hospital
City
Kolkata
Country
India
Individual Site Status
Completed
Facility Name
Medical College
City
Kolkata
Country
India
Individual Site Status
Recruiting
Facility Name
Sir Nil Ratan Sircar Medical College & Hospital
City
Kolkata
Country
India
Individual Site Status
Recruiting
Facility Name
HBT Medical College And Dr. R N Cooper Municipal General Hospital
City
Mumbai
Country
India
Individual Site Status
Completed
Facility Name
King Edward Memorial Seth G. S. Medical College and K.E.M. Hospital
City
Mumbai
Country
India
Individual Site Status
Completed
Facility Name
Lokmanya Tilak Municipal Medical College & General Hospital
City
Mumbai
Country
India
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The final anonymized dataset and code for analysis will be released publicly.
IPD Sharing Time Frame
During 2023
Citations:
PubMed Identifier
35437251
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.
Results Reference
background
Links:
URL
https://www.tern.network/
Description
Trauma life support training Effectiveness Research Network website
Learn more about this trial
Effect of Trauma Life Support Training Programs on Patient Outcomes
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