Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter

October 27, 2015 updated by: Kamilia S. Funder, Rigshospitalet, Denmark

In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS) was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.

In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus Hesselfeldt, conducted an observational study to investigate the possible effects on time to definitive care, secondary transfers and 30-day mortality in a "before" and "after" design.

Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day mortality significantly reduced from 29 % to 14 % in the year after implementation.

The present study is an observational cohort study with long-term follow-up of the same trauma population as mentioned above. Patients were followed until may 1st, 2014.

Primary outcome is early retirement and secondary outcomes are quality of life and mortality.

The investigators hypothesize that a greater proportion of trauma patients in the "after" period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients treated in the "before" period.

Study Overview

Status

Completed

Conditions

Wounds and Injuries

Study Type

Observational

Enrollment (Actual)

1791

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

Denmark
- - Copenhagen, Denmark, 2100
    - Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All trauma patients treated in the catchment area of PS-HEMS in a 17-month period from 1 December 2009 to 30 April 2011 (1791 patients).

Description

Inclusion Criteria:

Patients treated by a trauma team in the catchment area of PS-HEMS.

For all labor market attachment analysis the investigators only include patients between 18 to 60 years of age. For all other analysis (mortality and quality of life) there are no age limits.

Exclusion Criteria:

Patients transported by private means or by the police.
Patients who at the emergency department were categorized as non-trauma patients.

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Trauma patients before PS-HEMS The "before" period was between december 1 2009 to april 30 2010 (five months).
Traume patients after PS-HEMS The "after" period was between may 1 2010 to april 30 2011 (12 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor market attachment Time Frame: 3 - 4.5 years after trauma	Primary analysis: Risk of early retirement Secondary analysis: Risk of reduced work capability	3 - 4.5 years after trauma

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life Time Frame: 3 - 4.5 years after trauma	Health-related quality of life is measured using the Danish version of the Short Form 36 (SF-36) questionaire.	3 - 4.5 years after trauma
All cause mortality Time Frame: 3 - 4.5 years after trauma	Primary analysis: Risk of death. Secondary analysis: Predictors of death	3 - 4.5 years after trauma

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Collaborators

TrygFonden, Denmark

Investigators

Principal Investigator: Kamilia S. Funder, MD, Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Study Director: Jacob Steinmetz, MD, PhD, Trauma Center, Copenhagen University Hospital, Rigshospitalet

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

December 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria