Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions

Musculoskeletal Pain Disorder Clinical Trial

Official title:

Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04196634
• Other study ID #: NSD 861249
• Status: Active, not recruiting
• Start date: November 1, 2018
• Est. completion date: September 2023

Study information

• Verified date: August 2022
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 560
• Est. completion date: September 2023
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Musculoskeletal Pain
• Musculoskeletal Pain Disorder
• Rheumatic Diseases
• Somatoform Disorders

Intervention

Other:
• Risk assessment
People on sick leave due to musculoskeletal conditions will be screened for potential risk factors for prolonged sickness absence. No intervention will be given.

Locations

Country	Name	City	State
Norway	Oslo Metropolitan University	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Norwegian Labour and Welfare Administration

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Keele STarT MSK Screening tool	The STarT MSK consists of 10 items and the scores are summarized to a 0-12 score, with risk groups being categorized as follow: 0-4= low risk; 5-8= medium risk; 9-12= high risk of developing long-term pain or disability.	Baseline and 4 weeks
Other	Örebro Musculoskeletal Pain Screening Questionnaire short form (ÖMPSQ -sf)	ÖMPSQ-sf contains 10 questions that are summed up to 0 to 100 score, with higher score indicating higher risk developing work disability.	Baseline and 4 weeks
Other	Work conflict	Single question on work conflict: "Did you experience conflict(s) with your employer before you got sick-listed?" (Yes/No)	Baseline and 4 weeks
Other	Work satisfaction	Measured with a single question: "If you take into consideration your work routines, management, salary, promotion possibilities and work mates, how satisfied are you with your job?" Measured on a numeric rating scale, 0=Not satisfied at all, 10=Completely satisfied; Measured with a single question: "Do you want to return to the same work/position or do you wish you had another work/position?" Answered with: Same work/position / Another work/position.	Baseline and 4 weeks
Other	Work ability	Measured with a single question from the Work Ability Index: "Assume that your work ability at its best has a value of 10 ponts. How many points would you give to your current work ability?" Measured on a numeric rating scale where 0 means that you cannot currently work at all, 10 means that your work ability is at its best right now.	Baseline and 4 weeks
Other	Return to work expectancy	Measured with a single question: "For how long do you believe you will be sick listed from today?" Answered with: Not at all / Less than 1 month / 1-2 months / 2-4 months / 4-10 months / More than 10 months	Baseline and 4 weeks
Other	Demographic variables	Gender, age, diagnosis	Baseline
Other	Change in condition	7-point global rating of change: "Could you please state the amount of change concerning your musculoskeletal symptoms compared to when you first filled out this questionnaire". Answered with: Much better / Better / Slightly better / Unchanged / Slightly worse / Worse / Much worse	4 weeks
Primary	Sickness absence days	Total number of absence days during 12 months of follow-up adjusted for percentage of work and percentage of sickness absence. Register data from the national health and welfare services	12 months
Primary	Time to sustainable return to work	The time until full sustainable return to work, i.e. at least 4 weeks without relapse during 12 months of follow-up. Register data from the national health and welfare services	12 months
Primary	Probability of return to work	Probability of working (i.e. not receiving medical benefits) each month during 12 months of follow-up, measured as repeated events. Register data from the national health and welfare services	12 months
Primary	Proportion who have returned to work	Proportion of people with sustainable return to work (at least 4 weeks) at 12 months. Register data from the national health and welfare services	12 months
Primary	Health care costs	Use of health care will be collected from public registries including Norwegian Patient Registry (NPR), Municipal Patient and User Registry (KPR) and Control and Payment of Health Refunds (KUHR).	12 months
Primary	Sickness absence costs	Sickness absence costs will be calculated based on data from the NAV registry	12 months
Secondary	Musculoskeletal Health Questionnaire (MSK-HQ)	14 questions scored on a 0-4-point scale, summed up to a 0 to 56 points score, with higher score indicating better musculoskeletal health.	Baseline and 4 weeks
Secondary	EuroQol 5 Dimensions (EQ5D-5L)	The EQ5D-5L covers five domains: mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression, scored on a 5-point scale from 0 (worst imaginable health) to 5 (best imaginable health). Responses can be transformed into an index ranging from -0.59 to 1, where -0.59 represents worst possible state and 1 represents perfect health. The EQ5D Visual Analogue Scale (VAS) is also included, which is a question asking about the respondent's self-rated health on a vertical 0 to 100 visual analog scale, with 100 being best health.	Baseline and 4 weeks
Secondary	Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)	Measure and value health-related productivity loss for both paid and unpaid work. The instrument is found to be suitable for measuring absenteeism from paid work and productivity loss related to unpaid labor. Nine questions related to paid work and three questions related to unpaid work.	Baseline and 4 weeks
Secondary	Sickness absence days	Total number of absence days during 6 months of follow-up adjusted for percentage of work and percentage of sickness absence. Register data from the national health and welfare services	6 months
Secondary	Time to sustainable return to work	The time until full sustainable return to work, i.e. at least 4 weeks without relapse during 6 months of follow-up. Register data from the national health and welfare services	6 months
Secondary	Proportion who have returned to work	Proportion of people with sustainable return to work (at least 4 weeks) at 6 months. Register data from the national health and welfare services	6 months
Secondary	Probability of return to work	Probability of working (i.e. not receiving medical benefits) each month during 6 months of follow-up, measured as repeated events. Register data from the national health and welfare services	6 months
Secondary	Health care costs	Use of health care will be collected from public registries including Norwegian Patient Registry (NPR), Municipal Patient and User Registry (KPR) and Control and Payment of Health Refunds (KUHR).	6 months
Secondary	Sickness absence costs	Sickness absence costs will be calculated based on data from the NAV registry	6 months