Non-fatal Outcome After Trauma

Trauma Clinical Trial

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Official title:

Prevalence, Recovery Patterns and Risk Factors of Non-fatal Outcome and Costs After Trauma; a Prospective Follow up Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02508675
• Other study ID #: NL50258.028.14
• Status: Enrolling by invitation
• First received: July 23, 2015
• Last updated: March 28, 2018
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: March 2018
• Source: Network Emergency Care Brabant
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The major aim of this project is to investigate the prevalence, recovery patterns and risk factors for health related quality of life functional, psychological, societal and economic outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref) questionnaire for the trauma population.

Description:

Patients aged 18 years and older admitted in a hospital in Brabant after a trauma, independent of severity or type of injury are included in the study. Patients who decease during hospital stay or transferred to another hospital outside the borders of trauma region Brabant will be excluded. Socio-demographic characteristics, functional and psychological outcome and Health Related Quality of Life (HRQoL) shortly after trauma will be measured. Subsequently the same items will be measured after 1, 3, 6, 12 and 24 months. Outcomes will be assessed using questionnaires. The primary outcome parameters are: short and long term HRQoL, functional and psychological outcome, and Healthcare and societal costs in injured patients. Secondary outcome measures are Return to Work and health care consumption.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6500
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients seen at the ED which are admitted to the ICU or ward after getting injured

• all types and severities of injury (Injury Severity Score (ISS) 1-75)

• a minimal age of 18 years old

• sufficient knowledge of the Dutch language

Exclusion Criteria:

• patients who are dead on arrival or decease in the ED

• pathological fracture (i.e., the bones are weakened by disease, for example by a tumor)

• patients who die in the hospital will drop out the study and will not be included in the analyses

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (15)

Lead Sponsor	Collaborator
Network Emergency Care Brabant	Amphia Hospital, Bernhoven Hospital, Bravis Hospital, Catharina Ziekenhuis Eindhoven, Elisabeth-TweeSteden Ziekenhuis, Elkerliek Hospital, Erasmus Medical Center, Jeroen Bosch Ziekenhuis, Maas Hospital Pantein, Maasstad Ziekenhuis, Rotterdam, Maxima Medical Center, St. Anna Ziekenhuis, Geldrop, Netherlands, Twee Steden Hospital, University of Tilburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short and longterm HRQoL	self-reported questionnaire	2 years
Primary	Functional outcome	self-reported questionnaire	2 years
Primary	Healthcare and societal costs	self-reported questionnaire and information from registries	2 years
Primary	Psychological outcome	self-reported questionnaire	2 years
Primary	Social outcome	self-reported questionnaire	2 years
Secondary	Return to work (RtW)	self-reported questionnaire	2 years
Secondary	Health care consumption	self-reported questionnaire and information from registries	2 years