Clinical trial NCT04196634: Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions
Official title: Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Pain Disorder
Keywords: Risk Assessment
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Norwegian Labour and Welfare Administration
First posted: 2019-12-12
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People on sick leave due to musculoskeletal pain conditions in Norway were invited to participate. Eligible participants had to log on to their personal sickness absence website at the Norwegian Welfare and Labor Administration to be able to see a link to the project.

Brief summary: Musculoskeletal (MSK) conditions are a leading cause of years lived with disability worldwide and for the last decade they have also been the most common cause of sickness absence and disability pension in Norway.

Although most sickness absence is short-termed, a small proportion of people with MSK conditions are on long-term sick leave, contributing to large cost due to disbursement of benefits, productivity loss and extensive use of health care. There is growing evidence that long-term sickness absence is harmful to mental and physical health, with a reduced probability of return to work (RtW) with prolonged sickness absence. Thus, focusing on early RtW in people on sick leave due to MSK conditions is important to reduce the burden on both the individual and the society. However, to provide interventions to reduce the duration of sickness absence to all people on sick leave would require enormous resources. By targeting those at risk of long-term sickness absence, resources may be used differently, e.g. more resource-saving. By using information on modifiable risk factors from simple risk assessment tools, health care providers and other stakeholders may facilitate RtW in a better way.

The overall purposes of this project are 1) to identify the most accurate screening tool to identify people at a high risk of prolonged sickness absence due to a MSK condition, and 2) to investigate severity of MSK health, health-related quality-of-life, health care consumption, and costs across different risk profiles in people on sick leave due to MSK conditions. We will use registered data on sickness absence from 1 year before to 1 year after inclusion in the study.

Detailed description: Main aims are:

* To compare the predictive ability of the STarT MSK tool and the ÖMPSQ-SF, and other established risk factors for long-term sickness absence (e.g. symptoms of depression and emotional distress, low motivation for returning to work, low self-efficacy, work expectancies) for identifying prolonged sickness absence at 6- and 12-months follow-up due to MSK conditions
* To develop a prognostic model to predict risk of prolonged sickness absence at 12-month follow-up in people with MSK conditions
* To assess predictors for high costs (productivity loss and health care use) at 6- and 12-months follow-up in people on sick leave due to MSK conditions

The study will also include additional methodological and descriptive aims.

Prior to the data collection we translated and culturally adapted the Keele STarT MSK and MSK-HQ following the Beaton guidelines.

The study is conducted within the Norwegian Welfare and Labor Administration (NAV) system in collaboration with OsloMet - Oslo Metropolitan University. Data on sickness absence from the NAV registry will be retrieved prospectively in the period from study inclusion to 12 months follow-up, and retrospectively 12 months prior to inclusion in the study.

Previous studies show that 30-40% of people with MSK conditions have not RtW after 3 to 12 months. In order to conduct analyses including 15- 20 predictor variables, we aim at including 500-600 people on sick leave due to MSK conditions. As the main outcomes are collected through registries, we do not expect any dropouts.

Eligibility criteria: Inclusion Criteria:

* People older than 18 years on sick leave due to musculoskeletal pain for at least 4 weeks

Exclusion Criteria:

* People on sick leave for other pain conditions or diseases
* People not able to read or write Norwegian or English

Primary outcomes:
measure: Sickness absence days
timeFrame: 12 months
measure: Time to sustainable return to work
timeFrame: 12 months
measure: Probability of return to work
timeFrame: 12 months
measure: Proportion who have returned to work
timeFrame: 12 months
measure: Health care costs
timeFrame: 12 months
measure: Sickness absence costs
timeFrame: 12 months
Secondary outcomes:
measure: Musculoskeletal Health Questionnaire (MSK-HQ)
timeFrame: Baseline and 4 weeks
measure: EuroQol 5 Dimensions (EQ5D-5L)
timeFrame: Baseline and 4 weeks
measure: Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)
timeFrame: Baseline and 4 weeks
measure: Sickness absence days
timeFrame: 6 months
measure: Time to sustainable return to work
timeFrame: 6 months
measure: Proportion who have returned to work
timeFrame: 6 months
measure: Probability of return to work
timeFrame: 6 months
measure: Health care costs
timeFrame: 6 months
measure: Sickness absence costs
timeFrame: 6 months
Other outcomes:
measure: Keele STarT MSK Screening tool
timeFrame: Baseline and 4 weeks
measure: Örebro Musculoskeletal Pain Screening Questionnaire short form (ÖMPSQ -sf)
timeFrame: Baseline and 4 weeks
measure: Work conflict
timeFrame: Baseline and 4 weeks
measure: Work satisfaction
timeFrame: Baseline and 4 weeks
measure: Work ability
timeFrame: Baseline and 4 weeks
measure: Return to work expectancy
timeFrame: Baseline and 4 weeks
measure: Demographic variables
timeFrame: Baseline
measure: Change in condition
timeFrame: 4 weeks
Locations:
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
affiliation: Oslo Metropolitan University
name: Margreth Grotle, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munk Killingmo R, Tveter AT, Smastuen MC, Storheim K, Grotle M. Comparison of self-reported and public registered absenteeism among people on long-term sick leave due to musculoskeletal disorders: criterion validity of the iMTA Productivity Cost Questionnaire. Eur J Health Econ. 2021 Aug;22(6):865-872. doi: 10.1007/s10198-021-01294-0. Epub 2021 Jun 1.
citation: Tveter AT, Oiestad BE, Rysstad TL, Aanesen F, Tingulstad A, Smastuen MC, Grotle M. Risk assessment for prolonged sickness absence due to musculoskeletal disorders: protocol for a prospective cohort study. BMC Musculoskelet Disord. 2020 May 25;21(1):326. doi: 10.1186/s12891-020-03354-7.