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

May 18, 2012 updated by: Hans Blomberg, Uppsala University Hospital

Impact of Prehospital Trauma Life Support (PHTLS) Training of Ambulance Caregivers on Outcome of Traffic Injury Victims

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • County of Uppsala
      • Uppsala, County of Uppsala, Sweden, 754 05
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study Population: Motor vehicle traffic crashes were selected using the causes of injury matrix developed by the National Center for Health Statistics, Centers for Disease Control and Prevention, USA.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 PHTLS
Not exposed to PHTLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality before hospital admission.
Time Frame: Patients will be followed up to death or at least one year after inclusion.
Injury deaths not associated with a hospital admission.
Patients will be followed up to death or at least one year after inclusion.
Mortality within 30 days.
Time Frame: Patients will be followed up to death or at least one year after inclusion.
Deaths within 30 days including all deaths, prehospital and hospital, up to 30 days from the injury event.
Patients will be followed up to death or at least one year after inclusion.
Time to death among survivors to hospital admission.
Time Frame: Patients will be followed up to death or at least one year after inclusion.
Time to death among patients associated with a hospital admission.
Patients will be followed up to death or at least one year after inclusion.
Return to work among survivors to hospital discharge.
Time Frame: Patients will be followed up to occured event or at least one year after inclusion.
Number of patients returned to work per time-unit of observation after the injury event among all patients discharged from hospital, not dead, and that was working before the accident.
Patients will be followed up to occured event or at least one year after inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Collaborators

Uppsala University

Investigators

  • Principal Investigator: Rolf Gedeborg, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2012

Study Completion (ANTICIPATED)

September 1, 2012

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (ESTIMATE)

May 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2007/264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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