NCT02165137

Brief Summary

Quality control and improvement project: Assessment and analysis of processes and outcome in trauma emergency room and major trauma patients at the Aarau trauma center (cantonal hospital) with regard to initial emergency management, hospital processes and short- and long-term (1-and 2-year) outcome of patients (subjective and objective). Comparison of processes and outcome pre- and post- project initiative. Benchmarking with the literature and by participation in the German and Swiss Trauma registry each.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

9.9 years

First QC Date

June 11, 2014

Last Update Submit

March 12, 2024

Conditions

Keywords

traumamajor traumamultiple traumaoutcomequalityprocess Managementemergency roomtrauma center

Outcome Measures

Primary Outcomes (1)

  • emergency room process times

    hours (<6)

Secondary Outcomes (6)

  • hospital mortality

    30 days

  • Euro Quality of Life Group health-related quality of life on five dimensions (EQ-5D)

    1 and 2 year follow-up

  • Trauma Outcome Profile (TOP)

    1 and 2 year follow-up

  • Quality of Life after Brain Injury (QOLIBRI)

    1 and 2 year follow-up

  • medical outcomes study Short Form-36 (SF-36)

    1 and 2 year follow-up

  • +1 more secondary outcomes

Other Outcomes (2)

  • invalidity

    at least 4 year post-injury

  • insurance payments

    at least 4 years post-injury

Study Arms (1)

trauma patients

type and severity of patients, circumstances and trauma pre- and post-injury / -quality initiative

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All emergency patients treated at Aarau Cantonal Hospital following trauma (\<24h postinjury) with suspected major trama

You may qualify if:

  • major trauma: New Injury Severity Score (NISS) \>=8
  • for longer-term outcome: only patients firm in German language and able to respond to the postal questionnaire by themselves

You may not qualify if:

  • no Trauma
  • injury \>24h before arrival at Aarau Cantonal Hospital
  • NISS\<8
  • for longer-term outcome: patients not firm in German language and not able to respond to the postal questionnaire by themselves (dead, unavailable, refusal to participate, dementia, age\<16 years ecc.); a categorising compilation of cases is supposed to exclude any possible study bias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarau Cantonal Hospital

Aarau, Canton of Aargau, 5001, Switzerland

Location

Related Publications (23)

  • Gross T, Amsler F. Prevalence and incidence of longer term pain in survivors of polytrauma. Surgery. 2011 Nov;150(5):985-95. doi: 10.1016/j.surg.2011.04.003. Epub 2011 Jun 15.

    PMID: 21676423BACKGROUND
  • Attenberger C, Amsler F, Gross T. Clinical evaluation of the Trauma Outcome Profile (TOP) in the longer-term follow-up of polytrauma patients. Injury. 2012 Sep;43(9):1566-74. doi: 10.1016/j.injury.2011.01.002. Epub 2011 Jan 20.

    PMID: 21255778BACKGROUND
  • Gross T, Attenberger C, Huegli RW, Amsler F. Factors associated with reduced longer-term capacity to work in patients after polytrauma: a Swiss trauma center experience. J Am Coll Surg. 2010 Jul;211(1):81-91. doi: 10.1016/j.jamcollsurg.2010.02.042. Epub 2010 May 15.

    PMID: 20610253BACKGROUND
  • Fueglistaler P, Amsler F, Schuepp M, Fueglistaler-Montali I, Attenberger C, Pargger H, Jacob AL, Gross T. Prognostic value of Sequential Organ Failure Assessment and Simplified Acute Physiology II Score compared with trauma scores in the outcome of multiple-trauma patients. Am J Surg. 2010 Aug;200(2):204-14. doi: 10.1016/j.amjsurg.2009.08.035. Epub 2010 Mar 15.

    PMID: 20227058BACKGROUND
  • Fuglistaler-Montali I, Attenberger C, Fuglistaler P, Jacob AL, Amsler F, Gross T. In search of benchmarking for mortality following multiple trauma: a Swiss trauma center experience. World J Surg. 2009 Nov;33(11):2477-89. doi: 10.1007/s00268-009-0193-1.

    PMID: 19693630BACKGROUND
  • Gross T, Schuepp M, Attenberger C, Pargger H, Amsler F. Outcome in polytraumatized patients with and without brain injury. Acta Anaesthesiol Scand. 2012 Oct;56(9):1163-74. doi: 10.1111/j.1399-6576.2012.02724.x. Epub 2012 Jun 26.

    PMID: 22735047BACKGROUND
  • Gross T, Morell S, Scholz SM, Amsler F. The capacity of baseline patient, injury, treatment and outcome data to predict reduced capacity to work and accident insurer costs - a Swiss prospective 4-year longitudinal trauma centre evaluation. Swiss Med Wkly. 2019 Dec 17;149:w20144. doi: 10.4414/smw.2019.20144. eCollection 2019 Dec 16.

  • Gross T, Morell S, Amsler F. To What Extent Are Main Accident-Insurer Cases Representative of All Significantly Injured? A Swiss Monocenter Perspective. J Insur Med. 2019;48(1):65-78. doi: 10.17849/insm-48-1-1-14.1. Epub 2019 Apr 24.

  • Gross T, Morell S, Amsler F. Gender-Specific Improvements in Outcome 1 and 2 Years After Major Trauma. J Surg Res. 2019 Mar;235:459-469. doi: 10.1016/j.jss.2018.10.024. Epub 2018 Nov 21.

  • Gross T, Braken P, Amsler F. Trauma center need: the American College of Surgeons' definition in contrast to Swiss highly specialized medicine regulations-a Swiss trauma center perspective. Eur J Trauma Emerg Surg. 2020 Apr;46(2):397-406. doi: 10.1007/s00068-018-1027-3. Epub 2018 Oct 13.

  • Born K, Amsler F, Gross T. Prospective evaluation of the Quality of Life after Brain Injury (QOLIBRI) score: minor differences in patients with major versus no or mild traumatic brain injury at one-year follow up. Health Qual Life Outcomes. 2018 Jul 9;16(1):136. doi: 10.1186/s12955-018-0966-z.

  • Gross T, Amsler F. One-year outcome following brain injury: a comparison of younger versus elderly major trauma patients. Arch Orthop Trauma Surg. 2018 Oct;138(10):1375-1387. doi: 10.1007/s00402-018-2974-1. Epub 2018 Jun 11.

  • Gross T, Morell S, Amsler F. Longer-term quality of life following major trauma: age only significantly affects outcome after the age of 80 years. Clin Interv Aging. 2018 Apr 30;13:773-785. doi: 10.2147/CIA.S158344. eCollection 2018.

  • Braken P, Amsler F, Gross T. Simple modification of trauma mechanism alarm criteria published for the TraumaNetwork DGU(R) may significantly improve overtriage - a cross sectional study. Scand J Trauma Resusc Emerg Med. 2018 Apr 24;26(1):32. doi: 10.1186/s13049-018-0498-x.

  • Bundi M, Meier L, Amsler F, Gross T. [Impact of weather, time of day and season on the admission and outcome of major trauma patients]. Unfallchirurg. 2018 Jan;121(1):10-19. doi: 10.1007/s00113-016-0267-0. German.

  • Gross T, Amsler F. [Long-term outcome following multiple trauma in working age : A prospective study in a Swiss trauma center]. Unfallchirurg. 2016 Nov;119(11):921-928. doi: 10.1007/s00113-014-2720-2. German.

  • Gross T, Amsler F. [Emergency room and major trauma treatment is a "loss-making business" : A Swiss trauma center experience with current DRG reimbursement]. Unfallchirurg. 2021 Sep;124(9):747-754. doi: 10.1007/s00113-020-00937-w. Epub 2020 Dec 18. German.

  • Walkner S, Amsler F, Gross T. [How often is a chest tube needed following thoracic trauma in the severely injured-and when is more needed? : Data from a Swiss trauma center for planning of resources and surgical training]. Chirurg. 2021 Aug;92(8):721-728. doi: 10.1007/s00104-020-01292-7. German.

  • Gross T, Morell S, Amsler F. Medically graded reduced capacity to work (RCW) following significant injury as explained by patient related outcome measures (PROMs): A prospective trauma center evaluation. Disabil Health J. 2021 Oct;14(4):101114. doi: 10.1016/j.dhjo.2021.101114. Epub 2021 May 10.

  • Gross T, Amsler F. Main factors predicting somatic, psychological, and cognitive patient outcomes after significant injury: a pilot study of a simple prognostic tool. BJS Open. 2021 Nov 9;5(6):zrab109. doi: 10.1093/bjsopen/zrab109.

  • Zeindler M, Amsler F, Gross T. Comparative analysis of MGAP, GAP, and RISC2 as predictors of patient outcome and emergency interventional need in emergency room treatment of the injured. Eur J Trauma Emerg Surg. 2021 Dec;47(6):2017-2027. doi: 10.1007/s00068-020-01361-w. Epub 2020 Apr 13.

  • Fiumedinisi FA, Amsler F, Gross T. Short-term outcome following significant trauma: increasing age per se has only a relatively low impact. Eur J Trauma Emerg Surg. 2021 Dec;47(6):1979-1992. doi: 10.1007/s00068-020-01357-6. Epub 2020 Apr 16.

  • Magyar CTJ, Maeder F, Diepers M, Amsler F, Gross T. Detailed information gain and therapeutic impact of whole body computed tomography supplementary to conventional radiological diagnostics in blunt trauma emergency treatment: a consecutive trauma centre evaluation. Eur J Trauma Emerg Surg. 2022 Apr;48(2):921-931. doi: 10.1007/s00068-020-01502-1. Epub 2020 Sep 30.

MeSH Terms

Conditions

Wounds and InjuriesMultiple TraumaEmergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Gross, MD, Prof.

    Aarau Cantonal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 17, 2014

Study Start

January 1, 2010

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations