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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175862
• Other study ID #: ALH1-KF-2014
• Status: Completed
• Phase: N/A
• First received: June 25, 2014
• Last updated: October 27, 2015
• Start date: December 2009
• Est. completion date: May 2014

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1791
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Wounds and Injuries

Locations

Country	Name	City	State
Denmark	Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View 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. — View Citation

Hesselfeldt R, Steinmetz J, Jans H, Jacobsson ML, Andersen DL, Buggeskov K, Kowalski M, Praest M, Øllgaard L, Höiby 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. — View Citation

Kuhlman MB, Lohse N, Sørensen 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. — View 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. — View Citation

Overgaard M, Høyer 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Labor market attachment	Primary analysis: Risk of early retirement Secondary analysis: Risk of reduced work capability	3 - 4.5 years after trauma	No
Secondary	Health-related quality of life	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	No
Secondary	All cause mortality	Primary analysis: Risk of death. Secondary analysis: Predictors of death	3 - 4.5 years after trauma	No