Clinical trial NCT02175862: Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter
Official title: Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Keywords: Helicopter Emergency Medical Service
Trauma
Early retirement
ISS
Quality of life
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2014-06-26
Enrollment: 1791
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Labor market attachment
timeFrame: 3 - 4.5 years after trauma
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 3 - 4.5 years after trauma
measure: All cause mortality
timeFrame: 3 - 4.5 years after trauma
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
name: Kamilia S. Funder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trauma Center, Copenhagen University Hospital, Rigshospitalet
name: Jacob Steinmetz, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kuhlman MB, Lohse N, Sorensen AM, Larsen CF, Christensen KB, Steinmetz J. Impact of the severity of trauma on early retirement. Injury. 2014 Mar;45(3):618-23. doi: 10.1016/j.injury.2013.09.007. Epub 2013 Sep 16.
citation: Hesselfeldt R, Steinmetz J, Jans H, Jacobsson ML, Andersen DL, Buggeskov K, Kowalski M, Praest M, Ollgaard L, Hoiby P, Rasmussen LS. Impact of a physician-staffed helicopter on a regional trauma system: a prospective, controlled, observational study. Acta Anaesthesiol Scand. 2013 May;57(5):660-8. doi: 10.1111/aas.12052. Epub 2013 Jan 7.
citation: Overgaard M, Hoyer CB, Christensen EF. Long-term survival and health-related quality of life 6 to 9 years after trauma. J Trauma. 2011 Aug;71(2):435-41. doi: 10.1097/TA.0b013e31820e7ec3.
citation: Ringburg AN, Polinder S, Meulman TJ, Steyerberg EW, van Lieshout EM, Patka P, van Beeck EF, Schipper IB. Cost-effectiveness and quality-of-life analysis of physician-staffed helicopter emergency medical services. Br J Surg. 2009 Nov;96(11):1365-70. doi: 10.1002/bjs.6720.
citation: MacKenzie EJ, Shapiro S, Smith RT, Siegel JH, Moody M, Pitt A. Factors influencing return to work following hospitalization for traumatic injury. Am J Public Health. 1987 Mar;77(3):329-34. doi: 10.2105/ajph.77.3.329.
citation: Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
citation: Bjorner JB, Damsgaard MT, Watt T, Groenvold M. Tests of data quality, scaling assumptions, and reliability of the Danish SF-36. J Clin Epidemiol. 1998 Nov;51(11):1001-11. doi: 10.1016/s0895-4356(98)00092-4.