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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Uppsala University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Hans Blomberg, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01603537
First received: May 15, 2012
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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.


Condition
Traffic Accidents

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Impact of Prehospital Trauma Life Support (PHTLS) Training of Ambulance Caregivers on Outcome of Traffic Injury Victims

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Mortality before hospital admission. [ Time Frame: Patients will be followed up to death or at least one year after inclusion. ] [ Designated as safety issue: No ]
    Injury deaths not associated with a hospital admission.

  • Mortality within 30 days. [ Time Frame: Patients will be followed up to death or at least one year after inclusion. ] [ Designated as safety issue: No ]
    Deaths within 30 days including all deaths, prehospital and hospital, up to 30 days from the injury event.

  • Time to death among survivors to hospital admission. [ Time Frame: Patients will be followed up to death or at least one year after inclusion. ] [ Designated as safety issue: No ]
    Time to death among patients associated with a hospital admission.

  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40000
Study Start Date: January 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603537

Locations
Sweden
Uppsala University
Uppsala, County of Uppsala, Sweden, 754 05
Sponsors and Collaborators
Uppsala University Hospital
Uppsala University
Investigators
Principal Investigator: Rolf Gedeborg, PhD Uppsala University
  More Information

Publications:
Responsible Party: Hans Blomberg, Medical Director of the ambulance service, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01603537     History of Changes
Other Study ID Numbers: Dnr 2007/264
Study First Received: May 15, 2012
Last Updated: May 18, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University Hospital:
Traumatic injuries
Prehospital Trauma Life Support
Traffic accidents

ClinicalTrials.gov processed this record on October 20, 2014