Clinical trial NCT02508675: Non-fatal Outcome After Trauma
Official title: Prevalence, Recovery Patterns and Risk Factors of Non-fatal Outcome and Costs After Trauma; a Prospective Follow up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Keywords: injury
risk factors
outcome
costs
Lead sponsor: Network Emergency Care Brabant
Sponsor class: OTHER
Collaborators: name: Elisabeth-TweeSteden Ziekenhuis
name: Erasmus Medical Center
name: Tilburg University
name: Amphia Hospital
name: Catharina Ziekenhuis Eindhoven
name: Bravis Hospital
name: Elkerliek Hospital
name: Maas Hospital Pantein
name: St. Anna Ziekenhuis, Geldrop, Netherlands
name: Jeroen Bosch Ziekenhuis
name: Maxima Medical Center
name: Twee Steden Hospital
name: Bernhoven Hospital
name: Maasstad Hospital
First posted: 2015-07-27
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients seen at the Emergency Department (ED) which are admitted to the Intensive Care Unit (ICU) or ward after getting injured, with a minimal age of 18 years old.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short and longterm HRQoL
timeFrame: 2 years
measure: Functional outcome
timeFrame: 2 years
measure: Healthcare and societal costs
timeFrame: 2 years
measure: Psychological outcome
timeFrame: 2 years
measure: Social outcome
timeFrame: 2 years
Secondary outcomes:
measure: Return to work (RtW)
timeFrame: 2 years
measure: Health care consumption
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: St. Elisabeth Hospital, Tilburg, The Netherlands
name: Koen W Lansink, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Network Emergency Care Brabant
name: Mariska A de Jongh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Munter L, van de Ree CLP, van der Jagt OP, Gosens T, Maas HAAM, de Jongh MAC. Trajectories and prognostic factors for recovery after hip fracture: a longitudinal cohort study. Int Orthop. 2022 Dec;46(12):2913-2926. doi: 10.1007/s00264-022-05561-4. Epub 2022 Sep 6.
citation: de Munter L, Polinder S, Havermans RJM, Steyerberg EW, de Jongh MAC. Prognostic factors for recovery of health status after injury: a prospective multicentre cohort study. BMJ Open. 2021 Jan 6;11(1):e038707. doi: 10.1136/bmjopen-2020-038707.
citation: Brouwers L, de Jongh MAC, de Munter L, Edwards M, Lansink KWW. Prognostic factors and quality of life after pelvic fractures. The Brabant Injury Outcome Surveillance (BIOS) study. PLoS One. 2020 Jun 11;15(6):e0233690. doi: 10.1371/journal.pone.0233690. eCollection 2020.
citation: Kruithof N, Polinder S, de Munter L, van de Ree CLP, Lansink KWW, de Jongh MAC; BIOS-group. Health status and psychological outcomes after trauma: A prospective multicenter cohort study. PLoS One. 2020 Apr 21;15(4):e0231649. doi: 10.1371/journal.pone.0231649. eCollection 2020.
citation: de Munter L, Polinder S, Haagsma JA, Kruithof N, van de Ree CLP, Steyerberg EW, de Jongh M. Prevalence and Prognostic Factors for Psychological Distress After Trauma. Arch Phys Med Rehabil. 2020 May;101(5):877-884. doi: 10.1016/j.apmr.2019.10.196. Epub 2019 Dec 23.
citation: van de Ree CLP, Landers MJF, Kruithof N, de Munter L, Slaets JPJ, Gosens T, de Jongh MAC. Effect of frailty on quality of life in elderly patients after hip fracture: a longitudinal study. BMJ Open. 2019 Jul 18;9(7):e025941. doi: 10.1136/bmjopen-2018-025941.
citation: Kruithof N, Haagsma JA, Karabatzakis M, Cnossen MC, de Munter L, van de Ree CLP, de Jongh MAC, Polinder S. Validation and reliability of the Abbreviated World Health Organization Quality of Life Instrument (WHOQOL-BREF) in the hospitalized trauma population. Injury. 2018 Oct;49(10):1796-1804. doi: 10.1016/j.injury.2018.08.016. Epub 2018 Aug 23.
citation: de Jongh MA, Kruithof N, Gosens T, van de Ree CL, de Munter L, Brouwers L, Polinder S, Lansink KW; BIOS-group. Prevalence, recovery patterns and predictors of quality of life and costs after non-fatal injury: the Brabant Injury Outcome Surveillance (BIOS) study. Inj Prev. 2017 Feb;23(1):59. doi: 10.1136/injuryprev-2016-042032. Epub 2016 May 6.