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Rheumatology
Protocol
Testing the efficacy of WORK-ON: vocational rehabilitation for people with chronic inflammatory arthritis in Denmark—protocol for a randomised controlled trial
  1. Christina Merete Tvede Madsen1,2,
  2. Jette Primdahl2,3,4,
  3. Jeanette Reffstrup Christensen5,6,7
  1. 1 The Danish Center for Expertise in Rheumatology, Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark Faculty of Health Sciences, Soenderborg, Denmark
  2. 2 Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
  3. 3 The Danish Center for Expertise in Rheumatology, Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Soenderborg, Denmark
  4. 4 Hospital Sønderjylland, University Hospital of Southern Denmark, Aabenraa, Denmark
  5. 5 Research Unit of General Practice, Aarhus, Denmark
  6. 6 DRIVEN – Danish Centre for Motivational and Behavior Science, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
  7. 7 Research unit of General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark
  1. Correspondence to Christina Merete Tvede Madsen; cmadsen{at}danskgigthospital.dk

Abstract

Introduction Among people with chronic inflammatory arthritis (IA), up to 40% lose their job in the first few years after diagnosis of this condition and are hence at high risk of being permanently excluded from the labour market. Therefore, we developed a new context-specific vocational rehabilitation (VR) for people with IA. This 6 month VR (WORK-ON) includes the following: (1) an initial assessment and goal setting by a coordinating occupational therapist, who supports cooperation and coordination between relevant partners and navigation across primary and secondary care, (2) four group sessions with peers and (3) individual sessions with a social worker, nurse or physiotherapist. The objective of this trial is to test the overall efficacy of WORK-ON as an add-on to usual care and compare it with usual care provided to a control group.

Methods and analysis A randomised controlled trial has been planned. Patients with IA, aged at least 18 years and experiencing job insecurity will be randomised to one of two groups: (1) the intervention group receiving WORK-ON VR as an add-on to usual care and (2) the control group receiving usual care. The primary outcome is the difference in work ability 12 months after baseline, which will be measured using the Work Ability Index single item. The key secondary outcome measures are absenteeism, presenteeism, overall work impairment, activity impairment and job loss measured at baseline and at 6, 12, 18 and 30 month follow-up. Secondary outcome measures are quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain, which will be measured at baseline and at 6 and 12 month follow-up.

Ethics and dissemination The Regional Committees on Health Research Ethics in Southern Denmark waived the requirement for a formal approval (Journal number S-20232000-3). The participants will provide informed consent prior to participating in the trial.

Trial registration number NCT06299917.

  • Job Satisfaction
  • RHEUMATOLOGY
  • Work Satisfaction
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https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2024-089050

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • The WORK-ON intervention was thoroughly developed and feasibility tested using the Medical Research Council’s framework for development and testing of complex interventions.

    • The WORK-ON intervention is preventive and targets patients with inflammatory arthritis who consider they are at risk of losing their job.

    • The WORK-ON intervention may be followed by a cost-effectiveness analysis.

    • There may be a risk of exclusion of patients with a lower social status.

    Introduction

    Worldwide, the prevalence of rheumatoid arthritis (RA) is 0.21%,1 of psoriatic arthritis (PsA) 0.13%2 and of axial spondyloarthritis (axSpA) 0.3%–1.4%.3 We refer to these diagnoses together as chronic inflammatory arthritis (IA). More women than men are diagnosed with RA.4 5 The prevalence of RA in Denmark is 0.6%, and the global prevalence has ranged from 0.38% to 0.67%. The mean age for people with RA is 61 years.5–7 For PsA, women and men are equally affected, the prevalence in Denmark is 0.22%, the global prevalence is 0.01% to 0.19% and the mean age for people with PsA is 47.8 9 For axSpA, the prevalence in Denmark is 1.5%10 and the global prevalence is 0.20% to 1.61%.9 Men are over-represented, and the mean age for people diagnosed with axSpA is 33.11 Despite major advances in the pharmacological treatment, people with IA still have unmet needs.12 Many experience pain, fatigue, sleep problems, psychological distress, physical limitations and problems with participation in everyday activities, including paid work.13 14

    Up to 40% lose their job in the first few years after IA is diagnosed.15 16 Several factors affect the risk for unemployment and job loss such as long-term sick leave, disease activity, job type, personal factors, socioeconomic status and age.15 17 18 After becoming unemployed, people with rheumatic and musculoskeletal diseases, including IA, are less likely to return to work.19–23 Therefore, early identification of people with IA experiencing reduced work ability and early implementation of supportive interventions, are crucial to enable people with IA to remain in paid employment.22 23

    Rheumatic and musculoskeletal diseases account for up to 60% of prolonged sick leave and work disability in Europe.22 The latest numbers from 2013 shows that people in Denmark with RA were absent from work for 5.6 more days than those without RA.24 This corresponds to more than 50 000 days of sickness absence per year and a productivity loss of DKK67.3 million (approximately €9 million).24

    Being able to work is of great importance to individuals’ identity and quality of life.25–27 People with IA often struggle to find a balance between their disease, paid work and other aspects of everyday life.26 28 A systematic review on job loss prevention interventions among people with IA found that strategies such as job accommodation, job coaching, physical exercise and vocational counselling may have an effect on job loss, work ability and sick leave.14 The review showed inconsistency in the results in the included studies, which may be due to heterogeneity in the content and duration of the interventions and outcome measures used. Furthermore, the interventions were sparsely described in the included studies and therefore difficult to replicate. Given that vocational rehabilitation (VR) depends on the context and that countries have different social security systems, the review pointed to the need for context-specific VR tailored for people with IA.14

    Therefore, we developed a VR called ‘WORK-ON’ for people with IA, who considered that they were at risk of losing their job within the following 2 years.29 The development of WORK-ON was based on the Medical Research Council’s updated framework for developing and evaluating complex interventions.30 The development process involved relevant stakeholders, including patient research partners (PRPs) and various professionals from the hospital and municipalities.

    In 2022–2023, we tested the feasibility of the WORK-ON intervention in 19 participants.31 Based on the results from this study, as well as qualitative evaluations with patients and rehabilitation clinicians (not yet published), we have slightly adjusted the initial version of WORK-ON.29 The adjustments include an additional group session, an increased focus on the reduction of sick leave, the management of fatigue and the involvement of the participants’ employers. Based on the adjustments and the results from the feasibility study, the aim of the present study is to test the efficacy of the adjusted WORK-ON intervention as an add-on to usual care and compare it with usual care in a randomised controlled trial (RCT).

    Methods and analysis

    This study protocol was developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guideline.32 33 The trial is planned as an RCT with a two-group parallel design.

    Study hypothesis

    Building on the findings from our feasibility study, we hypothesise that WORK-ON will be effective in increasing work ability at 6, 12, 18 and 30 month follow-up. Work ability and job loss are associated and work ability can be considered as a proxy for job loss.31 34 The primary outcome is the difference between the two groups in work ability at 12 months, measured by the Work Ability Index (WAI) single item. The key secondary outcomes are decreases in sickness absence and job loss at 12, 18 and 30 month follow-up. For secondary outcomes, we expect an improvement in quality of life, fatigue, mental well-being, physical activity level and pain measured at 6 and 12 months after baseline. Furthermore, the association between work hours per week, compensatory schemes, work ability and job loss at 12, 18 and 30 month follow-up will be investigated.

    Study setting

    The WORK-ON RCT will be conducted at the Danish Hospital for Rheumatic Diseases (DHR), which is a specialised hospital for rheumatic diseases and rehabilitation. The hospital has an outpatient department and offers inpatient rehabilitation for patients with rheumatic diseases.

    Patient and public involvement

    Four PRPs, all diagnosed with IA have been involved in the development and the feasibility test of WORK-ON. The details are described elsewhere.29 31 In the WORK-ON RCT, these four PRPs will be involved in all aspects of the study. They will continue to assist in tasks such as reading and providing feedback on documents provided to participants who contain information on the study and lay descriptions of the RCT for funding applications. Furthermore, before initiating the RCT study, the PRPs will read and try to fill the questionnaires to ensure that all the questions are appropriate, relevant and easily understandable. The PRPs will also be involved in discussions about recruitment and in interpretation and dissemination of the results and will be offered coauthorship on publications deriving from the trial. The involvement of PRPs will be reported in accordance with the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) guidelines.35

    Inclusion criteria

    • Aged 18–65 years.

    • Diagnosed with RA, PsA or axSpA by a rheumatologist.

    • Undertakes paid work (full-time or part-time work or studying).

    • Able to read and understand Danish.

    • Answers ‘unlikely’ or ‘not certain’ to question #6 from the WAI questionnaire: ‘Do you believe, according to your present state of health, that you will be able to do your current job 2 years from now?’36

    • Willing to participate in an RCT of the modified WORK-ON VR.

    Exclusion criteria

    • Planned or present adjustments of the pharmacological antirheumatic treatment (disease-modifying antirheumatic drugs, glucocorticoid) within the last 3 months.

    • Presence of morbidities other than IA that may explain reduced work ability.

    • Is under examination for comorbidities that influence work ability.

    • Major surgery was conducted within the past 6 months, or a surgery has been planned.

    • Is unable to understand or speak Danish at a sufficient level to participate.

    • Has cognitive or psychological impairments that may affect participation.

    • Planned or ongoing participation in another rehabilitation programme (apart from physiotherapy).

    • Has participated in the WORK-ON feasibility study.

    • Retirement application process is ongoing or plans to retire within the next 5 years.

    • Has taken long-term sick leave (>4 weeks).

    Randomisation and blinding

    Participants will be allocated 1:1 to either the WORK-ON VR (the intervention group) or usual care (the control group) stratified by diagnosis. Typically, block randomisation is used to secure a balanced randomisation to the two groups and to ensure that the randomisation is unpredictable. An algorithm calculates the balance within and between blocks.37 Block randomisation and data collection will be performed using the Research Electronic Data Capture (REDCap) hosted by the Open Patient data Explorative Network (OPEN).38 OPEN is a safe storage and analysis environment in the Region of Southern Denmark. REDCap is a secure web application to be used for randomisation and for building and managing online surveys. Given the nature of the intervention, neither the rehabilitation clinicians nor the participants can be blinded. The statistical analyses will be performed blinded to group allocation to reduce this potential bias.

    Adverse events

    All participants will continue receiving usual care regardless of the group to which they are allocated, and any unintended events will be registered in the medical journal at the DHR throughout the trial period. This journal will be read after the participant completes the intervention. No health or safety risks associated with participation in the WORK-ON feasibility test have been identified. Therefore, we consider that the risk of adverse events is low.

    Recruitment

    Before each outpatient consultation at the DHR, all patients with IA need to complete questionnaires, which are collected in the national rheumatology quality database, DANBIO.39 Patients can complete these either using a touchscreen in the hospital’s waiting area or on their own mobile phone, tablet or computer at home. An initial screening for eligible patients will be performed using DANBIO. For patients with a diagnosis of RA, axSpA or PsA and age≥18, the regular questionnaires at the current visit will be followed by a question regarding whether they are in paid work/studying. If they reply ‘yes’, they will be asked question #6 from the WAI questionnaire:36 ‘Do you believe, according to your present state of health, that you will be able to do your current job 2 years from now?’ If a patient answers ‘unlikely’ or ‘not certain’, a pop-up text with brief information about WORK-ON will be displayed on the screen. If the patients indicate that they are interested to hear more about the trial, they will be prompted to insert their phone number and email address. Rheumatologists and nurses in the outpatient clinic will also be requested to identify their patients who are eligible to participate in the WORK-ON RCT. Then, interested patients will be contacted on phone within the following week by a project member in order to offer more information about the study. Patients who are still interested in participating in the study will be screened for eligibility by a project member in accordance with the remaining inclusion and exclusion criteria. Those who meet all the eligibility criteria will be sent the participant information via email to allow them time for consideration before they give their written consent. Then, patients who confirm their willingness to participate in this study will be requested to provide their written consent, which will be collected through REDCap (see figure 1).

    Figure 1
    Figure 1

    Flowchart of the study. VR, vocational rehabilitation; WAI, Work Ability Index.

    Control group

    Usual care will comprise planned outpatient consultations every 3–12 months, depending on the patient’s needs, provided alternately by a rheumatologist and rheumatology nurses. In addition, the participants will have access to support from the rheumatology nurses via a telephone helpline. The planned consultations will include a review of blood tests; joint examinations; a review of completed questionnaires in DANBIO;39 a review of the side effects of, and adherence to, the pharmacological treatment and an evaluation of whether pharmacological adjustment is necessary. The nurses will occasionally provide limited patient education on the management of the disease, medications and symptoms, which will be tailored to the specific patient. Furthermore, the participants in the control group will be offered pamphlets for their employer and colleagues, titled ‘Dear employer—I have arthritis’ and ‘Dear colleague—I have been diagnosed with arthritis’. The pamphlets were developed at the Danish Center for Expertise in Rheumatology at the DHR in 2023 and describe some of the challenges people with IA may face at work.40

    The intervention group

    WORK-ON is offered as an add-on to usual care. The 6 month VR will include consultations with a coordinating occupational therapist (OT), group sessions and need-based individual consultations with different rehabilitation clinicians29 31 (see figure 2).

    Figure 2
    Figure 2

    The WORK-ON intervention.

    Coordinating occupational therapist

    Consultations with the coordinating OT, who will perform an initial 2 hour physical consultation at the DHR with an initial assessment and goal setting process, are mandatory. The coordinating OT has experience with the rehabilitation of patients with IA and the challenges they face in the labour market. The 2 hour consultation includes an interview guided by the Work Experience Survey for Patients with Rheumatic Conditions, which is a survey targeting problems at work.41 Guided by this Survey, an assessment will be performed of the participants’ work barriers, activity limitations, roles and tasks in relation to their work and at home, values and balance in activities in everyday life. Goal setting and prioritisation of activities will be performed using the Canadian Occupational Performance Measure.42 The participants’ wish regarding involvement of relatives will be clarified.

    The participants will be able to contact the coordinating OT through a phone call or an email at agreed-upon hours (also outside the participants’ working hours). The coordinating OT will support the participants to establish contact with relevant partners and to navigate offers in the municipality (ie, the municipal jobcentre). The participant will be encouraged to involve their employer, and the coordinating OT will participate in meetings between the participant and their employer, if the participant agrees. The coordinating OT will also assess whether a workplace assessment or specific aids are required. In Denmark, an OT at the municipal jobcentre performs workplace assessments and assessment for specific aids, and the coordinating OT will help establish contact. These participants will also be offered the pamphlets given to the control group, titled ‘Dear employer—I have arthritis’ and ‘Dear colleague—I have been diagnosed with arthritis’, for easing dialogue about IA and the challenges they experience at work. In addition, each participant’s need for individual offers (eg, individual support from a physiotherapist, nurse or social worker) will be evaluated together by the participant and the OT.

    The coordinating OT will provide individual support in relation to the agreed-upon goals, and personal challenges at home and at work that limit their work ability. The coordinating OT will also assess and guide in the need for hand exercises, small aids and bandages and guidance on ergonomic positions in relation to work, pain and sleep.

    A final follow-up consultation (for a maximum of 2 hours, including documentation) with the participant and relevant partners (eg, social workers, consultants from the municipality jobcentre, employers or relatives) will be planned to evaluate and to discuss future needs for rehabilitation or self-management support.

    The coordinating OT and the participant can use up to 10 hours throughout the 6 months, including the initial assessment and goal setting, the final follow-up consultation, individual support including the initial assessment and follow-up.

    Twelve months after baseline, the coordinating OT will invite the participant for a follow-up consultation via phone (for maximum 45 min, including documentation) to discuss the participant’s challenges and goals and will enquire about any further difficulties in relation to work.

    Group sessions

    Four 2 hour group sessions will be held to provide self-management support and to give the participants the opportunity for peer support. This part is mandatory. The coordinating OT who has conducted the initial assessment and goal setting with 7–10 participants will host the group sessions together with a social worker, a nurse or a physiotherapist to secure coherence. The first three group sessions will be held at 1 week intervals after the initial assessment and goal setting consultation. The fourth group session will be held by the end of the 6 month VR and before the final follow-up consultation with the coordinating OT. The group sessions encompass:

    1. Legislative offers. The first session will focus on legislative offers and will be held by a social worker and the coordinating OT. The focus will be on the general legislative offers for patients with IA, such as various opportunities for support and compensatory schemes, offers in the municipal jobcentre and possibilities for a flexi-job. A flexi-job is an offer individuals can apply for in Denmark. The municipality pays a subsidy to the employer for citizens who have decreased work ability and are only able to work for less than half the usual time (in Denmark, a full-time job is for 37 hours/week). Furthermore, they will discuss the participants’ values in relation to work and everyday life, guided by the Bulls Eye’s Exercise that helps prioritise values as part of the Focused and Accepted Commitment Therapy approach.43

    2. Acceptance of the disease in relation to work. The second session will be held by the coordinating OT and a rheumatology nurse with experience in rheumatology rehabilitation. They will focus on dealing with lack of understanding from the employer or colleagues at the workplace, providing information and understanding about the disease, including fatigue management.

    3. Self-management strategies. An experienced rheumatology physiotherapist and the coordinating OT will hold the third session. The focus will be on managing fatigue, managing energy and balancing work as part of everyday life; pain management; physical activity and energy-saving techniques.

    4. Follow-up. A rheumatology nurse and the coordinating OT will hold the fourth session. The focus will be on how the participants have achieved their goals, follow-up on the Bulls Eye’s Exercise, ways to retain new habits and follow-up on the second session regarding acceptance of the disease in relation to work.

    Individual consultations

    If needed, the patient will be offered up to eight consultations (each lasting 60 min, including documentation) with relevant rehabilitation clinicians to achieve their goals. This part is optional and will involve the following:

    • Social worker: discussion on specific legislative offers of relevance for the individual participant.

    • Rheumatology nurse: provision of information about the disease, comorbidities, treatment, side effects of, adherence to and concerns about the pharmacological treatment, as well as about ways to manage pain, fatigue and sleep problems.

    • Rheumatology physiotherapist: provision of information about individually tailored physical activity and exercise; discussions about motivation for, and barriers to, exercise and where and how to be physically active and examination of the feet and guidance regarding foot health and footwear.

    WORK-ON is not expected to interfere with usual care.

    Outcomes and data collection

    Sociodemographic and disease-related information will be collected at baseline (table 1). The primary outcome measure, work ability measured by the WAI single item, will be measured at baseline, 6 and 12 months after baseline through a questionnaire, and 18 and 30 months after baseline through a phone call (table 2).

    View this table:
    Table 1

    Demographic data

    View this table:
    Table 2

    SPIRIT flowchart: schedule of assessments

    Key secondary outcome measures will be measured at baseline and 6, 12, 18 and 30 months after baseline and consist of the questionnaire for Work Productivity and Impairment: General Health (WPAI:GH),44 WAI questions 2 and 6 and number of work hours per week. In addition, the number of days and hours of sickness absence will be collected through text messages with a 1 month interval after baseline during the 6 month WORK-ON intervention period. Job loss will be measured at 12, 18 and 30 months after baseline (table 2 and table 3).

    View this table:
    Table 3

    Outcome measures

    The secondary outcome measures comprise the Occupational Balance Questionnaire (OBQ),45 46 health-related quality of life (European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)),47 fatigue measured by the Bristol Rheumatoid Arthritis Fatigue questionnaire numerical rating scales (NRSv2) for fatigue severity, impact and coping,48 the WHO-5 Well-being Index,49 questions about physical activity level and sleep problems (how the patient sleeps and if rested after sleep) from a Danish National Health Profile41 and pain measured on a visual analogue scale (0–10)42 (table 1). For an overview of the data collection and outcomes, see tables 1–3.

    Sample size

    At DHR, approximately 1800 patients with IA are connected to the outpatient department, and it is estimated that 50% undertake paid work. From the feasibility test results, we assume that 20% consider themselves to be at risk of losing their job, leading to 180 potential participants. Based on the feasibility study, we assume that one-third of these individuals will meet the inclusion criteria and agree to participate. In addition, we anticipate a low dropout rate of 10% based on the feasibility test. Assuming a SD of 3 points on the Work Ability single item scale, a statistical power of 80% and a significance level (alpha) of 0.05, the study is designed to detect a difference of 2.5 points on the Work Ability single-item scale.34 Thus, at least 25 participants are needed in each group. With an estimated 10% dropout rate, 28 participants are needed in each group. Preliminary results from the feasibility test showed that, on average, it is feasible to include 1–2 participants per week. Therefore, the recruitment period is expected to be 1 year, at maximum.

    Statistics

    Results from descriptive statistics will be reported by group as means and SD, or medians and IQR ranges, depending on the distribution of the empirical data. Categorical variables will be reported as absolute counts and proportions (percentages) for each group. Differences in the primary and key secondary continuous outcomes will be analysed according to the intention-to-treat population using repeated-measures linear mixed models, including a factor for the treatment group (two levels) and time, the interaction between both, and adjustments for baseline values and the stratification factor (diagnosis). For all mixed models, participant-specific random intercepts will be included, as well as random slopes if these improve the model fit significantly. The binary outcomes will be analysed using logistic mixed models, including a factor for the group and adjustment for the stratification factor. ORs with 95% CIs will be estimated, converted into approximate risk ratios and interpreted as number needed to treat when appropriate. Mixed models incorporate all available data, making them particularly advantageous in handling missing data, assuming the missing data are missing at random. The intention-to-treat analysis will be followed by a per-protocol analysis. P-values<0.05 are considered significant. All p-values and 95% CIs will be two sided. We will not apply explicit adjustments for multiplicity but will perform prioritised analyses of key secondary outcomes. Before enrolment of the last participant, a full statistical analysis plan will be developed in collaboration with a statistician and uploaded to Clinicaltrials.gov.

    Ethics and dissemination

    The participants will be informed verbally and in writing about the study before they provide their written consent to participate prior to the first consultation. The leaflet, ‘Research subjects’ rights in health science research’, published by the Danish National Committee on Health Research Ethics, will be provided to all participants. The Regional Committees on Health Research Ethics waived the need for a formal approval (Journal number S-20232000-3). Data will be stored and managed in the research support system, OPEN, hosted by the Region of Southern Denmark. OPEN adheres to the European General Data Protection Regulations and the Danish data protection law.50 51

    Perspectives

    If the results from the RCT are significant, we will conduct cost-effectiveness and cost-utility analyses, in collaboration with health economists at the University of Southern Denmark. The cost-utility analysis will apply quality-adjusted life years, making use of the EQ-5D-5L instrument, based on Danish societal weights for the calculation of quality-adjusted life year.47 The cost-effectiveness analysis will apply days of sickness absenteeism and work ability as effect measures.

    The results from this RCT can be generalised to other settings with competencies in rehabilitation and where access to the interdisciplinary team can be organised and proper reimbursement is available.

    Ethics statements

    Patient consent for publication

    Acknowledgments

    We would like to give a special thanks to all patient research partners, rehabilitation clinicians, as well as researchers who contributed to the adjustment of WORK-ON.

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    Footnotes

    • Contributors The first author, CMTM, took the lead in writing the manuscript in cooperation with the other two authors, JP and JRC. All three authors read and approved the final manuscript. CMTM is responsible for the overall content as guarantor.

    • Funding This work is supported by The Danish Association of Occupational Therapists, The Danish Rheumatism Association and the Schaufuss Foundation. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.