Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA)
Abstract Background Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study t...
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| Format: | Article |
| Language: | English |
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BMC
2018-07-01
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| Series: | BMC Public Health |
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| Online Access: | http://link.springer.com/article/10.1186/s12889-018-5816-8 |
| _version_ | 1819133101756907520 |
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| author | Elisabeth Björk Brämberg Kristina Holmgren Ute Bültmann Hanna Gyllensten Jan Hagberg Lars Sandman Gunnar Bergström |
| author_facet | Elisabeth Björk Brämberg Kristina Holmgren Ute Bültmann Hanna Gyllensten Jan Hagberg Lars Sandman Gunnar Bergström |
| author_sort | Elisabeth Björk Brämberg |
| collection | DOAJ |
| description | Abstract Background Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders. Methods The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee’s return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity. Discussion The study is a pragmatic trial which will include analyses of the intervention’s effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care. Trial registration ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018. |
| first_indexed | 2024-12-22T09:41:57Z |
| format | Article |
| id | doaj.art-fc7ea8f6fcf04d9f9e2f1155a3388792 |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-12-22T09:41:57Z |
| publishDate | 2018-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-fc7ea8f6fcf04d9f9e2f1155a33887922022-12-21T18:30:40ZengBMCBMC Public Health1471-24582018-07-0118111110.1186/s12889-018-5816-8Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA)Elisabeth Björk Brämberg0Kristina Holmgren1Ute Bültmann2Hanna Gyllensten3Jan Hagberg4Lars Sandman5Gunnar Bergström6Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental MedicineNärhälsan, Region of Västra GötalandDepartment of Health Sciences, University Medical Center Groningen, Community and Occupational MedicineDivision of Insurance Medicine, Department of Clinical Neuroscience, Karolinska InstitutetUnit of Intervention and Implementation Research for Worker Health, Institute of Environmental MedicineNational Centre for Priorities in Health, Department of Medical and Health Sciences, Linköping UniversityUnit of Intervention and Implementation Research for Worker Health, Institute of Environmental MedicineAbstract Background Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders. Methods The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee’s return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity. Discussion The study is a pragmatic trial which will include analyses of the intervention’s effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care. Trial registration ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.http://link.springer.com/article/10.1186/s12889-018-5816-8Common mental disordersAdjustment disordersAnxiety disordersDepressionCluster-randomized trialProblem solving skills |
| spellingShingle | Elisabeth Björk Brämberg Kristina Holmgren Ute Bültmann Hanna Gyllensten Jan Hagberg Lars Sandman Gunnar Bergström Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA) BMC Public Health Common mental disorders Adjustment disorders Anxiety disorders Depression Cluster-randomized trial Problem solving skills |
| title | Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA) |
| title_full | Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA) |
| title_fullStr | Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA) |
| title_full_unstemmed | Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA) |
| title_short | Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA) |
| title_sort | increasing return to work among people on sick leave due to common mental disorders design of a cluster randomized controlled trial of a problem solving intervention versus care as usual conducted in the swedish primary health care system prosa |
| topic | Common mental disorders Adjustment disorders Anxiety disorders Depression Cluster-randomized trial Problem solving skills |
| url | http://link.springer.com/article/10.1186/s12889-018-5816-8 |
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