Design and setting
We conducted a feasibility RCT comparing job retention VR (plus work self-help information) with work self-help information only in six Rheumatology occupational therapy services in England from November 2011 to July 2013. The trial was managed by Nottingham Clinical Trials Unit (CTU). Ethics approval was granted by the National Research Ethics Committee East Midlands (Nottingham 1:11/EM/0103) and University of Salford Ethics Panel.
This was a three-year study. The recruitment period was seven to ten months (i.e. varying between sites). This was reduced from 12 months because of delays in study approvals and restricted availability of research facilitators (i.e. research nurses and others employed by National Institute of Health Research (NIHR) Clinical Research Networks (CRN) and NHS Trust Research and Development departments to support study recruitment in the NHS. They are not part of the research project team and thus not supervised by the trial manager). As a result, the funder (Arthritis Research UK) recommended that the follow-up period was reduced from 12 to nine months, in order to maximise the recruitment time available. The protocol was accordingly amended to conduct follow-up at nine months.
Participants were eligible if they were: 18 years of age or over; diagnosed with RA, PsA or undifferentiated IA (i.e. persistent symmetrical synovitis without any other known cause, but the person does not yet meet diagnostic criteria for RA); in paid work (full- or part-time); able to read, write and understand English; and willing to receive VR. We also tested which criterion best established need for VR: scoring ≥10 on the RA-Work Instability Scale (RA-WIS) , (i.e. a score indicating medium to high risk of work instability and need for VR ) or stating “Yes” to “Do you have any concerns about your health affecting your ability to work over the next few years?” .
Exclusion criteria were: on extended sick leave (i.e. >three months) or unemployed (including not normally in paid employment or student); within the next 12 months, either planning to retire or take early retirement (through choice or ill health), move out of area or expecting joint replacement surgery; or already receiving or awaiting VR services.
NIHR CRN support for screening and recruitment was agreed prior to trial start. Screening was planned to be conducted by research facilitators in at least two Rheumatology out-patient clinic sessions per week at each site. If possible, a week before clinics, the healthcare team identified working age patients with RA, PsA or IA on clinic lists and research facilitators mailed out study information packs. If not, the health care team identified patients during clinic appointments and introduced them to the research facilitator. Research facilitators then screened patients in clinic. For those eligible and willing, research facilitators explained the study, obtained written consent, recorded baseline demographic data and the participant either completed the baseline questionnaire in clinic or later at home and mailed it back to the research facilitator. Research facilitators also explained how to complete a monthly calendar reporting work status and sickness absence (see Outcome Measures: absenteeism). For those receiving study information in advance, research facilitators consented patients that day in clinic. For those referred in clinic, eligible patients were allowed at least 48 h to consider participation. These patients were then telephoned by research facilitators to complete consent via telephone and mail and to remind about baseline questionnaire return.
Randomisation and allocation concealment
Following baseline questionnaire return, research facilitators randomized participants using a web-based randomisation system to receive either work self-help information only (control group) or VR plus work self-help information (intervention group). The randomization sequence was created using Stata 9.09.2 (Ralloc function by Philip Ryan v3.3.2) statistical software and was stratified by site, to ensure even occupational therapists’ workloads, with a 1:1 allocation using permuted blocks of randomly varying sizes. Treatment assignment was by the web-based randomisation system managed by Nottingham CTU. Following randomisation, research facilitators mailed the participant’s screening checklist, demographic record and baseline questionnaire to the trial manager, who then mailed the participant the work self-help information. Intervention group participants’ contact details were sent to the treating occupational therapist by an automatically generated e-mail from the randomization system. The research facilitator, trial manager, and research staff collecting, entering and analysing data were blinded to group allocation. Blinding of participants and therapists to trial arm was not possible. Occupational therapists were asked to continue with their usual VR practice with non-trial participants (see below).
NHS “usual care” for work problems for most people with RA, PsA or IA is limited. Referral to occupational therapy for VR is often patchy or non-existent. VR (when provided) consists of, on average 45 [IQR 30–90] minutes work advice (without a structured work assessment), provision of work advice booklets and signposting to other services [12, 13]. Control participants therefore received written self-help work information only, i.e. a similar control to that used by Allaire et al. . This consisted of a cover letter, self-help flowchart and two work advice booklets [14, 15]: see Additional file 1). Participants continued to receive usual Rheumatology care (i.e. regular out-patient appointments, prescribed medication, and referral by Consultants to therapy services as necessary).
Intervention group participants also received written work self-help information and usual care. Treating occupational therapists received three days VR training . Participants were seen within four weeks of referral. Direct VR consisted of up to 4.5 h of 1:1 meetings, starting with a structured work interview and ending with a telephone review. Up to 1.5 h extra contact was also possible. We planned VR to be longer than in Allaire et al.’s trial  as: therapists were providing this VR for the first time; Allaire et al. had recommended extra time for complex cases and a telephone review ; and we included optional work site visits. We paid for up to 10 h occupational therapy time (plus mileage costs for any visits) per VR group participant. This included both direct and indirect VR (i.e. non-contact time when therapists: completed treatment notes; identified solutions for work problems; liaised with team members, other agencies and employers; and travel time).
Meetings were at mutually agreed times (often early or late in the day to fit around participants’ work commitments) and locations (the occupational therapy department, participant’s home or workplace) spread over two to four months. The intervention started with a structured work interview and job discussion (i.e. an assessment of the person’s job, roles and responsibilities in relation to their condition, disease severity and activity limitations) and detailed assessment of work barriers. This was conducted using the UK Work Experience Survey-Rheumatic Conditions (WES-RC) [16–19]. This was followed by mutually agreeing priority work problems, action planning, and then a tailored, individualised programme including self-management at work, job accommodations, employment rights information and other strategies as relevant. Participants were offered a work site visit, if this was identified as relevant to their needs. VR also emphasised participants’ responsibilities in liaising with employers and included role play, as necessary, to enhance confidence requesting job accommodations (See Additional file 1).
The WORK-IA VR Resource Manual was provided to support VR delivery. (See Additional file 1) . Monitoring visits assessed treatment fidelity conducting the WES-RC, problem identification and treatment planning. Additionally, a random six WES-RCs and treatment notes were reviewed for problem identification and matching treatment to problems.
Follow-up data was collected using a questionnaire booklet at six and nine months, mailed by the trial manager. After two weeks, if not returned, a telephone reminder was given and a second questionnaire mailed, if necessary. The following outcomes and information were collected at each time point (baseline, six and nine months):
Demographic and work data: age, gender, condition duration, marital and living status (at baseline only); medication regimen; current job(s); years in current main job; whether disclosed arthritis to employer and/or work colleagues; and number of normal working hours.
Employment status: whether in full- or part-time work, on long term sick leave, or stopped working (with date when stopped and reason).
Presenteeism: these measures evaluate the effect of a condition on the quality or quantity of work productivity . Three measures evaluated different aspects:
RA- Work Instability Scale (RA-WIS): 23 true/false items measuring, at present, the degree of mismatch between functional abilities and workplace demands .
Work Activities Limitations Scale (WALS): 12 items (time frame unspecified) indicating degree of difficulty performing physical work activities, time, mental and output demands (0 = no difficulty; 3 = unable to do), with additional items for whether help or equipment are used for each .
The Work Limitations Questionnaire (WLQ): 25 items, indicating the amount of time, in the last two weeks, a person was limited in: physical work demands, time demands, mental-interpersonal demands and output demands. The four sub-scale scores and Summed score (i.e. average of the four sub-scales) range from 0 to 100%. A percentage Productivity Loss score can also be calculated .
Work self-efficacy: confidence in ability to continue working with arthritis; and ability to manage arthritis at work (0–10 numeric rating scales (NRS)).
Satisfaction with work rehabilitation advice received (0–10 NRS at six months only).
Health related outcomes
SF-12v2 Health Survey: 12 items, assessed over the last four weeks, scored as physical and mental health sub-scales .
Multi-dimensional Health Assessment Questionnaire (HAQ): the modified HAQ (eight activity limitation items); psychological status HAQ (four items); pain, fatigue and a global rating of health measured using 100 mm Visual Analogue Scales (VAS), assessed over the last week .
Hand/ wrist pain: pain in the last week during moderate activity (100 mm VAS).
Euroqol five dimensions questionnaire (EQ5D): measuring quality of life .
Health economic outcomes
A self-report measure was resource use questionnaire (use of health resources, health-related transport costs, personal and domestic care support, work support and adaptations).
Work status measures
In addition to the questionnaire booklet, participants filled out a monthly tear-off calendar, to record their work status each day (i.e. performed paid work, unable to perform paid work due to arthritis, unable to perform paid work due to other reasons, day off). This was modified from Part 1 of the Health and Labour Questionnaire . Participants were asked to return each page at month end in Freepost envelopes to the trial manager. If not returned within two weeks, the trial manager telephoned to remind return. The following work outcomes were derived from the monthly calendar:
Time to temporary or permanent job loss (days): recording on which date their contract ended, if they stopped working and, if a new job was obtained, their contract started.
Absenteeism: over nine months, the number of days sickness absence attributable to either arthritis or other causes (e.g. common ailments), not including days not normally worked.
Participants were not telephoned to obtain missing data from returned questionnaires or minimal datasets from non-responders, apart from for the absenteeism measure.
Therapists completed a VR Treatment Record of: duration of treatment contact for direct VR (i.e. with participant) and indirect VR (e.g. administration, making referrals, sourcing information, treatment planning, travel time for home/ work visits); treatment location; and travel mileage.
A statistically based sample size estimate was inapplicable for this feasibility study. Randomising 100 participants would permit estimation of the percentage of overall drop-outs to +/− 10% points at most, with 95% confidence. Drop-outs were considered those who did not attend VR or did not return follow-up questionnaires.
Analyses were mainly descriptive in order to determine if a definitive RCT is feasible. Recruitment and retention rates were summarised descriptively. For each outcome measure and trial arm, the proportion of missing data was described and the outcome at follow-up summarised (using means and standard deviations for continuous measures or frequency counts and percentages for categorical data). Where, applicable, change from baseline was also summarised and effect sizes were calculated) as mean change/standard deviation at baseline) to compare the internal responsiveness of outcomes. An effect size of 0.2 is interpreted as small, 0.5 medium and 0.8 large effect sizes . All analyses were according to randomisation allocation. Quality of Adjusted Life Years (QALYs) were calculated using EQ5D. VR duration and costs were identified from the VR Treatment Records and costed using published data .