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

NCT02175862 | Completed DMC

• 1 other identifier: ALH1-KF-2014
• Study Type: observational
• Target: 1,791
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

Helicopter Emergency Medical Service; Trauma; Early retirement; ISS; Quality of life

Outcome Measures

Primary Outcomes (1)

• Labor market attachment

  Primary analysis: Risk of early retirement Secondary analysis: Risk of reduced work capability

  3 - 4.5 years after trauma

Secondary Outcomes (2)

• Health-related quality of life

  3 - 4.5 years after trauma

• All cause mortality

  3 - 4.5 years after trauma

Study Arms (2)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• TrygFonden, Denmark: collaborator

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (7)

• 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.

  PMID: 24176678 BACKGROUND

• 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.

  PMID: 23289798 BACKGROUND

• 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.

  PMID: 21427614 BACKGROUND

• 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.

  PMID: 19847879 BACKGROUND

• 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.

  PMID: 3812840 BACKGROUND

• 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.

  PMID: 4814394 BACKGROUND

• 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.

  PMID: 9817118 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Kamilia S. Funder, MD

  Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Jacob Steinmetz, MD, PhD

  Trauma Center, Copenhagen University Hospital, Rigshospitalet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: December 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

DK (1)