Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care
PRIMA
1 other identifier
interventional
132
1 country
1
Brief Summary
The aim of this project is to develop a model for return to work (RTW) for patients sick listed due to stress related mental disorders, which takes into account each patient's specific situation; includes the workplace, and is well adapted to the Swedish primary care setting. In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and private primary care centers will be offered a one-day training about work and workability for patients with stress related mental disorders. Also, the participants will be trained in a specific method that includes the patient's employer early in the rehabilitation process The project has a quasi-experimental and longitudinal design. The intervention will be conducted on 15 different primary care centers, which will be matched with a comparison group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18 months after sick-listing. The hypothesis is that patients who are sick-listed at primary care centers that completely or partially implemented the specific method on average will return earlier to work than patients sick-listed at primary care centers that did not implement the method. Alongside studying if the intervention has an effect on the patients' RTW over time, the investigators aim to investigate the mechanisms explaining the effects and the individual and organizational level (primary care units) circumstances necessary for these mechanisms to be triggered. To gain deeper knowledge about mechanisms and context, the investigators will conduct interviews with the treatment staff and collect registry data about the primary care units.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJune 12, 2020
June 1, 2020
2.1 years
November 1, 2016
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
Three measurement time points. First measurement will occur 6 months from baseline.
Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
Second measurement time point will occur at 12 months from baseline.
Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
Third measurement time point will occur at 18 months from baseline.
Study Arms (2)
Work-related measures
ACTIVE COMPARATOR* One-day training for GP:s and rehabilitation coordinators * A treatment protocol which includes contact with the patient's employer * Clinical support from the Institute of Stress Medicine
Treatment as usual
NO INTERVENTIONInterventions
After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of International Classification of Diseases (ICD)10 F43
- Has an employment
- Good command in spoken and written Swedish
You may not qualify if:
- Participants must not have been on long term sick-leave (\>60 days) during the last three years, regardless of causative diagnosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vastra Gotaland Regionlead
- Göteborg Universitycollaborator
Study Sites (1)
Unknown Facility
Gothenburg, Sweden
Related Publications (2)
Beno A, Bertilsson M, Holmgren K, Glise K, Pousette A, Segerfelt K, Bjork L. Does employer involvement in primary health care enhance return to work for patients with stress-related mental disorders? a cluster randomized controlled trial. BMC Prim Care. 2023 Sep 20;24(1):195. doi: 10.1186/s12875-023-02151-0.
PMID: 37730561DERIVEDBjork L, Glise K, Pousette A, Bertilsson M, Holmgren K. Involving the employer to enhance return to work among patients with stress-related mental disorders - study protocol of a cluster randomized controlled trial in Swedish primary health care. BMC Public Health. 2018 Jul 6;18(1):838. doi: 10.1186/s12889-018-5714-0.
PMID: 29976181DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Björk
the Institute of Stress Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2016
First Posted
January 16, 2017
Study Start
December 1, 2016
Primary Completion
January 1, 2019
Study Completion
May 1, 2020
Last Updated
June 12, 2020
Record last verified: 2020-06