Inpatient or outpatient occupational rehabilitation: what works best for whom?

• Register: ISRCTN
• Last refreshed on: 24 January 2022
• Main ID: ISRCTN12033424
• Date of registration: 20/11/2014
• Prospective Registration: No
• Primary sponsor: AiR - the National Centre for Occupational Rehabilitation (Norway)
• Public title: Inpatient or outpatient occupational rehabilitation: what works best for whom?
• Scientific title: Comparing effects of two interdisciplinary occupational rehabilitation programs for people with musculoskeletal disorders, common mental disorders, or both: a nonrandomized clinical trial with a concurrent process evaluation
• Date of first enrolment: 10/04/2014
• Target sample size: 680
• Recruitment status: Ongoing
• URL: https://www.isrctn.com/ISRCTN12033424
• Study type: Interventional
• Study design: Convergent parallel design where the quantitative and qualitative research questions, data collection, and data analysis will be separate in the investigation of the main outcome but will be combined for the conclusion of the study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Norway

Contacts

• Name: Chris Jensen

• Name: Monica Eftedal

Key inclusion & exclusion criteria

Inclusion criteria:
1. MSDs or common mental health problems such as stress, anxiety and depression, or a combination of these. The participants may have other health complaints in addition (e.g. diabetes, coronary diseases, mild/moderate COPD)
2. In need of a service beyond what the locale health service can provide
3. Age between 18 ? 55 years
4. At least 6 weeks sick-leave during the last 12 months related to actual health complaints
5. Fluent in Norwegian and able to fill out a questionnaire

Exclusion criteria:
1. Severe psychological disorders (e.g. schizophrenia and other psychotic disorder, bipolar disorder, personality disorders)
2. A progressive disorder that most likely involves a rapid reduction in work ability
3. Conditions where there is a medical contraindication for physical activity
4. Pregnancy
5. Substance addiction
6. Applying for disability pension
7. Never been working, or never been in employment


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Musculoskeletal disorders (MSD) and/or common mental health problems, co-morbidity
Mental and Behavioural Disorders

Intervention(s)

Current as of 06/03/2019:
In the first part of the study, 2014-2018, participants are randomised into one of two groups. Those in group 1 receive treatment in an outpatient occupational rehabilitation clinic at Sykehuset Telemark in Porsgrunn. Those in group 2 receive treatment in an inpatient occupational rehabilitation clinic in Rauland.
In the second part of the study, 2018-2021, the participants get their treatment at the clinic they are referred to by their general practitioners, without randomisation.

Previous:
Participants are randomly allocated into one of two groups.

1. Outpatient: Interventions and education are individually tailored.
1.1. Interdisciplinary work ability assessment
1.2. Goal setting RTW: meeting between team and patient, 1 hour
1.3. Cognitive approaches, one to one or in groups, 1-10 hours
1.4. Physical exercise, one to one or in groups, 1-10 hours
1.5. Education and lecturing regarding self-care and pain management, 2x4 hours
1.6. Individual counselling work capacity and RTW with work counselor, 1 hour
1.7. Contact with workplace and other stakeholders through meetings and phone
1.8. Collaboration with local services to offer physical exercise, cognitive therapy or follow-up at the work place if needed
1.9. Follow up by an individual coordinator.
2. Inpatient:
2.1. Interdisciplinary work ability assessment
2.2. Goal setting RTW: Group-based process work, 6 hours
2.3. Cognitive approaches, individual consultation and coaching, 4-15 hours

Primary Outcome(s)

1. Stable return to work; defined as 4 weeks without relapse, register data
2. Trajectories in and out of work (full/partial work participation, sickness benefits, work assessment allowances or disability pension), register data

The participants are followed with register data until 5 years after inclusion in the project.

Secondary Outcome(s)

1. Cost-effectiveness/utility/benefit, SF-6D and register data
2. Quality of life; health, SF-36
3. Work ability, work ability index (WAI)
4. Readiness for return to work Readiness for return-to-work (RRTW)
5. Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19)
6. Return to work fear avoidance, Fear-Avoidance Belief Questionnaire

Survey data collected at baseline, 4 weeks, 3, 6, 12 and 24 months. The participants are followed with register data until 5 years after inclusion in the project.

Added 07/03/2019:
Non-randomised groups: Survey data are collected at baseline, end of program and at 6 and 12 months. Only SF-6D and WAI are used at 6 and 12 months.
7. The themes from 1.2 to 1.6 are also covered in interviews with participants. They are also interviewed regarding their expectations and evaluation of the rehabilitation program they have participated in; collaboration between key stakeholders in their RTW process; and their experiences of barriers and facilitators in their RTW process. The participants are interviewed at baseline, end of the intervention, and about 6 and 12 months after inclusion in the project.

Secondary ID(s)

Project number: 2013126, Helse Sør-Øst RHF

Nil known

Source(s) of Monetary Support

AiR - the National Centre for Occupational Rehabilitation (Norway), The South- East Regional Health Authority (Helse Sør-Øst RHF) (Norway), Kommunal Landspensjonskasse (KLP) (Norway)

Ethics review

Status:
Approval date:
Contact:

Local medical ethics committee REK, Norway, 03/01/2014, ref. 2011/934 REK vest

Results

• Results available: Yes
• Date Completed: 31/12/2026