Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/03/2013
Date assigned
16/05/2013
Last edited
16/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Often, patients with hand injury take longer to return to work than medically necessary. Treatment in rehabilitation centers appear to be adequate in treating the injury, but may not be sufficient in supporting return to work efforts. Therefore, a new intervention (therapy) was developed to facilitate return to work in patients with a hand injury. Purpose of the current study is to describe early results of the intervention.

Who can participate?
Patients aged between 18 and 65 years who have sustained a traumatic hand injury no longer than three weeks ago and had a paid job for at least 12 hours per week and on sick leave were included. Furthermore, patients able to understand the Dutch language well enough to participate in the intervention and to complete questionnaires were included in the study. Patients with burn injuries or injuries or diseases that may influence return to work were excluded.

What does the study involve?
During an intake session, patients were asked about their injury, work, personal situation, motivation for return to work and expectations about the rehabilitation period. Patients were invited four times to the University Medical Center Groningen, department of Rehabilitation Medicine. The intervention consisted of four group sessions of 2 hours, taking place once every fortnight. Patients could enrol in the group at any session, resulting in a diverse group of 2 to 6 patients. Topics discussed during the sessions were: Social Support, Government/ Workplace Regulations, Physical Recovery & Cognitive Problems, and Professional Development & Retraining. All patients received the same treatment.
Patients were asked to fill out a survey which consisted of three questionnaires at the start of the treatment, after the last session, and five months after finishing the treatment. After each therapy session, patients were asked to rate their satisfaction with the session on a self rating scale (SRS). The SRS is a tool to monitor quality of therapy. The SRS consists of 4 questions concerning: contact with the therapist, goals and subjects of the session, approach used during the session, and satisfaction with the sessions in total.

What are the possible benefits and risks of participating?
You can benefit from the intervention since you may be able to resume work earlier. There are no risks in participating and we do not expect any side effects.

Where is the study run from?
The study is performed at the Department of Rehabilitation Medicine of the University Medical Center Groningen (lead center), Groningen and Rehabilitation Centre ‘Revalidatie Friesland’ (RF), Leeuwarden and at the rehabilitation department of the ‘Martini Hospital Groningen’ (MHG), The Netherlands.

When is the study starting and how long is it expected to run for?
Study started in January 2009 and completed in January 2011.

Who is funding the study?
The University Medical Center Groningen (UMCG) is funding the study.

Who is the main contact?
Professor Corry K. van der Sluis
c.k.van.der.sluis@umcg.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Corry van der Sluis

ORCID ID

Contact details

University Medical Centre Groningen (UMCG)
PO Box 30.001
Groningen
9700RB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Implementation of a solution-focused return to work intervention for hand-injured patients: a pilot study

Acronym

Study hypothesis

Return to work (RTW) of patients with a hand injury will be fastened by applying a newly developed solution-focused group intervention.

Ethics approval

The Medical Ethics Committees of the University Medical Center Groningen, the Netherlands, approved the study on October 1st, 2008 (file 2008.140)

Study design

Cohort study: comparison of a pilot cohort with a historic cohort

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hand injuries: injuries of bones, nerves, tendons, ligaments of carpal region or hand.

Intervention

All participants received the same treatment. Previously, a questionnaire study was conducted. The data of that study were used to form the historic cohort. This cohort was not involved in the treatment, but was used for comparison reasons.

The solution-focused group intervention:
The intervention consisted of four group sessions of 2 hours, taking place once every fortnight. The aim of the solution-focused group intervention was to support patients in their process of RTW, in this way decreasing their time off work. During an intake session, patients were asked about their injury, their work, personal situation, motivation for RTW and expectations about the rehabilitation period. Patients could enroll in the group at any session, resulting in a diverse group of 2 to 6 patients. Topics discussed during the sessions were: Social Support, Government/ Workplace Regulations, Physical Recovery & Cognitive Problems, and Professional Development & Retraining. The solution-focused approach was used as framework. Process goals were to activate patients, and to stimulate patients to take responsibility for their own recovery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Return to work. Patients notified the researchers by sending a return-form when they resumed work for at least 12 hours per week.

Secondary outcome measures

1. Health locus of control
2. Problem solving-orientation
3. Symptoms of Post-Traumatic Stress Disorder (S-PTSD)

Patients filled out a survey at inclusion (T0), after the last session (T1), and five months post-trauma (T2). The survey incorporated three questionnaires: the multidimensional Health Locus of Control Scale (MHLCS), the revised Social Problem Solving Inventory (SPSI-R) and the Self Rating Scale – Post-Traumatic Stress Disorder (SRS-PTSD). After each therapy session, patients rated satisfaction with the session on a self rating scale (SRS).

Overall trial start date

01/01/2009

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients were enrolled in rehabilitation programs at one of the three participating centers. Inclusion criteria were:
1. Traumatic hand injury that occurred within 3 weeks before inclusion
2. Having a paid job for at least 12 hours per week with taking sick leave at the moment of inclusion
3. Aged between 18 and 65 years, either sex
4. Furthermore, patients had to understand the Dutch language well enough to participate in the intervention and to complete the questionnaires.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Patients with burn injuries or injuries with other co-morbidities expected to influence RTW were excluded

Recruitment start date

01/01/2009

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen (UMCG)
Groningen
9700RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

PO Box 30.001
Groningen
9700RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Center Groningen (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes