Improving the diagnostic procedure for injured patients - Optimization for the questionnaire "Fragebogen Arbeit und Befinden" (OptiFAB) [Diagnostik der Unfallbetroffenen der Suva]

ISRCTN ISRCTN05534684
DOI https://doi.org/10.1186/ISRCTN05534684
Secondary identifying numbers OptiFAB
Submission date
18/08/2011
Registration date
08/12/2011
Last edited
11/07/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of the study is to improve the treatment (triage) and the diagnostic procedure for insured people with disabilities (e.g. in the mental health or work related area) after an accident.

Who can participate?
Insured people with disabilities (e.g. in the mental health or work related area) eight weeks after an accident, aged at least 18

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The intervention is a psychological intervention and/or work related intervention based on the principles of cognitive behavioral therapy. Participants in the intervention group receive individual treatment depending on their disabilities or mental health. Participants in the control group receive treatment as usual. In addition there is a third minimal intervention group. In this group randomly allocated case managers follow a standardized manual to improve the triage of the procedure of the diagnostic process. The intervention and control groups are compared in terms of well-being, work-related satisfaction, and return to the workplace.

What are the possible benefits and risks of participating?
The benefit of participation is the free of charge intervention. There are no possible risks of participation.

Where is the study run from?
University of Bern (Switzerland)

When is the study starting and how long is it expected to run for?
September 2011 to December 2013

Who is funding the study?
SUVA (Switzerland)

Who is the main contact?
Prof. Hansjörg Znoj
hansjoerg.znoj@psy.unibe.ch

Contact information

Prof Hansjörg Znoj
Scientific

Institute of Psychology
Department of Clinical Psychology and Psychotherapy
University of Bern
Gesellschaftsstrasse 49
Bern
3012
Switzerland

Phone +41 (0)31 631 45 91
Email hansjoerg.znoj@psy.unibe.ch

Study information

Study designBlinded randomized experimental intervention study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet [in German]
Scientific titleImproving the diagnostic procedure for injured patients: a randomised controlled trial
Study acronymOptiFAB
Study objectives1. A significant difference in psychological and work-related outcome is expected between groups (OptiFAB and FABpur). Specifically, it is assumed that the group with the psychological and/or work-related intervention will have better outcomes in terms of psychological functioning (well-being) and a faster reintegration into the workplace.
2. A difference in term of a better triage is expected between groups (FABplus and FABpur). As above, it is assumed that the group with a GAS training and a manual will have better and faster triage process.
Ethics approval(s)Philosophical - Human Sciences Faculty Ethics Commission of Bern (Switzerland), 08/06/2011, ref: 2011-04-172
Health condition(s) or problem(s) studiedDifferent disabilities after an accident in the area workplace and/or mental health
InterventionOptiFAB: Psychological intervention or / and work related intervention and Control group
Treatment arm OptiFAB: The intervention consists of 10-20 weekly sessions: structured setting and a combination of educational and supportive coaching elements.
FABplus: Improvement of triage process. A group of case manager receives a "Goal attainment Scale" training and a manual (summarized "the good practice" to faster the triage process)

FABpur: Treatment as usual
Intervention typeOther
Primary outcome measure1. Psychological well-being, measured using BFW/E (Berner Fragebogen zum Wohlbefinden, Grob et al., 1991; 39 Items) 8 weeks after the accident
2. Work-related satisfaction, measured using general job satisfaction (Baillod & Semmer, 1994, 4 Items) 8 weeks after the accident
3. Return to the workplace
Secondary outcome measures1. Psychosocial conditions and health, measured using:
1.1. Subjective Happiness Scale (SHS, Lyubomirsky & Lepper, 1999, 4 Items)]
1.2. Social support (SALSA, Skala zur Erfassung der sozialen Unterstützung am Arbeitsplatz, IRES-3)
1.3. Fear-Avoidance Beliefs questionnaire (FABQ-d, Staerkle et al, 2004, 16 Items)
2. Coping, self-efficacy, optimism, measured using:
2.1. CISS (short version, Kälin, 2003, 19 Items)
2.2. SWE (Selbstwirksamkeit, Schwarzer, 1993, 10Items)
2.3. LOT-R (Optimism, Glaesmer & Hoyer, 2003, 10 Items)
Data collected 8 weeks after the accident
Overall study start date01/09/2011
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsFor each group 100 participants and a total of 400 participants
Key inclusion criteriaPatients 8 weeks after an accident have to fullfil followed criteria:
1. Approved accident or occupational disease
2. Unlimited employment contract
3. There must be at least 90 days or more between accident data and employment date
4. NCM-Code > 1
5. Present inability to work
6. No unemployment
7. No full working capacity in the next two weeks
8. Identified as a potential complex case by the questionnaire Arbeit und Befinden (FAB)
9. Able to speak German
Key exclusion criteria1. Inability to communicate or lack of language skills
2. Limited employment contract
3. Between accident data and employment date are less than 90 days
4. NCM-Code < 1
5. Ability to work
6. Unemployment
7. Full working capacity in the next two weeks
8. No complex case
9. Under 18 years of age
10. Not willing to participate in the study
Date of first enrolment01/09/2011
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Switzerland

Study participating centre

University of Bern
Bern
3012
Switzerland

Sponsor information

SUVA (Switzerland)
Government

Postfach
Fluhmattstrasse 1
Luzern
6002
Switzerland

Email vmd.bereich@suva.ch
Website http://www.suva.ch/english/
ROR logo "ROR" https://ror.org/01t56m506

Funders

Funder type

Government

SUVA (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

11/07/2017: Plain English summary added.