Non-fatal Outcome After Trauma

• Conditions: Trauma

• Registration Number: NCT02508675
• Lead Sponsor: Network Emergency Care Brabant

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-24
• Study First Posted: 2015-07-27
• Study Start: 2015-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healthcare and societal costs	2 years	self-reported questionnaire and information from registries
Short and longterm HRQoL	2 years	self-reported questionnaire
Functional outcome	2 years	self-reported questionnaire
Psychological outcome	2 years	self-reported questionnaire
Social outcome	2 years	self-reported questionnaire

Secondary Outcome Measures

Name	Time	Method
Return to work (RtW)	2 years	self-reported questionnaire
Health care consumption	2 years	self-reported questionnaire and information from registries