The Impact of Prehospital Trauma Life Support (PHTLS) on Outcome of Traffic Injury

NCT ID: NCT01603537

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-09-30

Brief Summary

Trauma is the leading cause of death among persons below 60 years of age. It is a well-established belief that optimal treatment in the early phase after trauma has a major impact on mortality, and the implementation of specific educational programs for trauma care have been a widely adopted strategy aimed at improving the outcome. This strategy has high face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of the leading educational programs for prehospital emergency trauma care. However, the scientific support for improved patient outcome from courses such as PHTLS and ATLS is limited. According to a Cochrane analysis published 2010 there is no evidence to recommend advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis concerning ATLS gave similar results and a recent study indicated even worsened outcome after the implementation of ATLS. An observational study in the county of Uppsala indicated reduced mortality after the implementation of PHTLS but the estimate was uncertain due to a low overall mortality. The aim of this study is to further investigate the association between PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study population. To accomplish this the investigators will use an epidemiological semi-individual design applied to all victims of traffic injury that occurred during the implementation period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will be analyzed: Mortality before hospital admission, mortality within 30 days, time to death among survivors to hospital admission and return to work among survivors to hospital discharge.

Detailed Description

Source Population: Sweden is divided in 21 administrative regions providing health care (counties). In 2004 Sweden had a population of about 9 million inhabitants with an average population density of 20 inhabitants/km2.

The Emergency Medical Service (EMS)-System: The ambulance staff in Sweden consists of registered nurses and emergency medical technician (EMT) equivalents (nursing assistants with special ambulance training).

Statistics: Hierarchical random effects models will be used to model the binary outcomes. Cox proportional hazards models to analyze the time to event outcomes. The difference in mean predicted outcome between the PHTLS group and the non-PHTLS group will be used to estimate the absolute risk reduction.

Conditions

Traffic Accidents

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Study Groups

PHTLS

The exposure is defined from the dichotomization of the probability in each event/accident that at least one of the caring ambulance crew members was PHTLS certified.

No interventions assigned to this group

No PHTLS

Not exposed to PHTLS

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Primary incident hospital admissions due to traffic accidents or
• Death due to traffic accidents

Exclusion Criteria

• If a patient appears more than once, all but the first event will be excluded from the dataset.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Uppsala University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hans Blomberg

Medical Director of the ambulance service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolf Gedeborg, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University

Uppsala, County of Uppsala, Sweden

Countries

Sweden

References

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Reference Type: BACKGROUND

PMID: 10754963 (View on PubMed)

Trunkey DD, Lim RC Jr, Blaisdell FW. Traumatic injury. A health care crisis. West J Med. 1974 Jan;120(1):92-4. No abstract available.

Reference Type: BACKGROUND

PMID: 4812216 (View on PubMed)

Collicott PE, Hughes I. Training in advanced trauma life support. JAMA. 1980 Mar 21;243(11):1156-9.

Reference Type: BACKGROUND

PMID: 7359667 (View on PubMed)

Jayaraman S, Sethi D. Advanced trauma life support training for ambulance crews. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003109. doi: 10.1002/14651858.CD003109.pub2.

Reference Type: BACKGROUND

PMID: 20091538 (View on PubMed)

Jayaraman S, Sethi D. Advanced trauma life support training for hospital staff. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004173. doi: 10.1002/14651858.CD004173.pub3.

Reference Type: BACKGROUND

PMID: 19370594 (View on PubMed)

Drimousis PG, Theodorou D, Toutouzas K, Stergiopoulos S, Delicha EM, Giannopoulos P, Larentzakis A, Katsaragakis S. Advanced Trauma Life Support certified physicians in a non trauma system setting: is it enough? Resuscitation. 2011 Feb;82(2):180-4. doi: 10.1016/j.resuscitation.2010.10.005. Epub 2010 Nov 30.

Reference Type: BACKGROUND

PMID: 21122975 (View on PubMed)

Johansson J, Blomberg H, Svennblad B, Wernroth L, Melhus H, Byberg L, Michaelsson K, Karlsten R, Gedeborg R. Prehospital Trauma Life Support (PHTLS) training of ambulance caregivers and impact on survival of trauma victims. Resuscitation. 2012 Oct;83(10):1259-64. doi: 10.1016/j.resuscitation.2012.02.018. Epub 2012 Feb 23.

Reference Type: BACKGROUND

PMID: 22366502 (View on PubMed)

Recommended framework for presenting injury mortality data. MMWR Recomm Rep. 1997 Aug 29;46(RR-14):1-30.

Reference Type: BACKGROUND

PMID: 9301976 (View on PubMed)

Other Identifiers

Dnr 2007/264

Identifier Type: -

Identifier Source: org_study_id