Early identification in primary health care of people at risk for sick leave due to work-related stress – study protocol of a randomized controlled trial (RCT)

Abstract

BackgroundEarly identification of persons at risk of sickness absence due to work-related stress is a crucial problem for society in general, and primary health care in particular. Tho date, no established method to do this exists. This project’s aim is to evaluate whether systematic early identification of work-related stress can prevent sickness absence. This paper presents the study design, procedure and outcome measurements, as well as allocation and baseline characteristics of the study population.Method/designThe study is a two-armed randomized controlled trial with follow-up at 3, 6 and 12 months. Non-sick-listed employed women and men, aged 18 to 64 years, who had mental and physical health complaints and sought care at primary health care centers (PHCC) were eligible to participate. At baseline work-related stress was measured by the Work Stress Questionnaire (WSQ), combined with feedback at consultation, at PHCC. The preventive intervention included early identification of work-related stress by the WSQ, GP training in the use of WSQ, GP feedback at consultation and finding suitable preventive measures. A process evaluation was used to explore how to facilitate future implementation and structural use of the WSQ at the PHCC. The primary outcome to compare the preventive sick leave intervention by the general practitioner (GP) versus treatment as usual is sick leave data obtained from the Swedish Social Insurance Agency register.DiscussionEarly screening for sick leave due to work-related stress makes it possible not only to identify those at risk for sick leave, but also to put focus on the patient’s specific work-related stress problems, which can be helpful in finding suitable preventive measures. This study investigates if use of the WSQ by GPs at PHCCs, combined with feedback at consultation, prevents future sickness absence.Trial registrationClinicalTrials.gov. Identifier: NCT02480855. Registered 20 May 2015

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“…The study is a randomised controlled trial [20], which is part of the TIDAS-project within the New Ways research program at the Sahlgrenska Academy, University of Gothenburg, Sweden. The project has been approved by the Regional Ethical Review Board in Gothenburg .…”

“…Registered 20 May 2015. The details of the data collection have been more closely described in the study protocol [20].…”

“…Because the sample size was calculated based on the primary endpoint of the RCT, the sample size for this secondary analysis was not calculated. [20]. The calculation was performed to determine the number of participants needed to detect at least a 15% difference between the intervention group and the control group concerning the number of registered sick leave days during 12 months after inclusion.…”

“…With a two-sided t test, statistical significance of p < 0.05 and 80% power, at least 135 participants were needed in each group. The variable registered sick leave was chosen since it was the primary outcome of the randomized control trial [20].…”

“…The present study is part of a randomised controlled trial with the overall aim to evaluate if a systematic use of the Work Stress Questionnaire (WSQ) combined with feedback at consultation, could be used by healthcare professionals in primary health care to prevent sickness absence [20,21]. Prior publications from the study are the study protocol [21] and an analysis the interventions effect on sickness absence [21].…”