A mixed-methods intervention and training development study for the Work And Vocational advicE (WAVE) trial (Clinical Trials: NCT04543097)

A mixed-methods intervention and training development study for the Work And Vocational advicE (WAVE) trial (Clinical Trials: NCT04543097) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A mixed-methods intervention and training development study for the Work And Vocational advicE (WAVE) trial (Clinical Trials: NCT04543097) Gail Sowden, Ira Madan, Carolyn A Chew-Graham, Karen Walker-Bone, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6255102/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose : In the UK, people taking sickness absence have limited access to early vocational advice from independent practitioners, despite this being recommended as part of clinical care. This paper describes the development and content of a vocational advice intervention and associated training and mentoring programme. Methods : This was a mixed-methods intervention and training development study commencing with a review of current best practice. Expert advisory and patient group meetings were conducted to review components of the draft logic model; content and framework for delivery of the vocational advice intervention, and to inform the development and content of the training and mentoring programme for those delivering the intervention. Results : From the literature, and based on behaviour change theories, the derived logic model included treatment targets of: health; cognitions; behaviours; emotions; and occupational targets. Intervention processes included: problem-solving; goal setting; psychoeducation; reassurance; graded activity; RTW planning; and work modification. The framework for delivery was by telephone using case-management and stepped care. The logic model, treatment targets, intervention processes and delivery framework were discussed and approved by patients and expert advisors. The training programme was aligned to the content of the intervention and designed to be delivered online over 3 days with monthly online group mentoring. Conclusions : A vocational advice intervention and associated training programme were developed and delivered for the WAVE trial, to be used with adults in receipt of a fit note for any health condition in primary care. Future work will evaluate the effectiveness of the intervention. Registration Clinical Trials: NCT04543097 Vocational advice primary care return-to-work case-management occupational health training programme Figures Figure 1 Figure 2 Introduction Employment has benefits for health[1]. People who have prolonged disability for work have: poorer quality of life; poorer mental health with increased risk of suicide; shorter life expectancy; higher levels of pain; require more social care; and use more healthcare[2–6]. However, absence from the workplace because of sickness is rising in the UK and Europe, with 185.6 million working days lost in the UK alone due sickness in 2022[7,8]. Work disability can be prevented through early, integrated vocational intervention[9–12]. Access to occupational health services, however, and the types of advice and support they provide varies between countries[13] and is particularly limited within some health systems, notably the UK[1], where most sickness absence is managed in the health service, predominantly through primary care[14,15]. Healthcare practitioners report that they find it difficult to provide appropriate advice and support within their role[16], and consequently patients often struggle to manage their health and work themselves. There have been many policy documents spanning several years clearly outlining the challenges of supporting people to remain in work and proposing roadmaps and plans to address these challenges[17–20] with some support for trial initiatives in practice both in the past and currently underway[21–23]. All the policies suggest that support for managing health that impacts on work should function in an integrated way within existing health services, and there is evidence that this works internationally[9–12]. Despite this understanding, there is a gap in provision of evidence based vocational advice. Consequently, the UK Government has advocated the development and testing of new models to deliver vocational advice within the healthcare setting including exploring ways to expand the workforce providing vocational advice and the use of remote or digital methods of intervention delivery[18] these models may be considered complex interventions. Complex interventions, such as that planned within the WAVE trial, should have a theoretical framework around which the logic model is built. The WAVE trial aimed to change participants’ behaviours in the context of their work and therefore behaviour change theories should be explored. Self-efficacy is a key component in many psychological behaviour change models (e.g. Social Cognitive Theory, Protection Motivation Theory, Health Action Process Approach)[24–26] and has been consistently associated with positive behaviour change[27] and RTW[18]. Current thinking suggests that intervention development should draw on multiple theories and behaviour change techniques rather than focusing on only one, to avoid missing a relevant element and as such behaviour change theories need to be incorporated in any intervention development[28–30]. The Work And Vocational advicE (WAVE) trial set out to address some of these challenges through a pragmatic, multicentre randomised controlled trial of the addition of a brief vocational advice (VA) intervention to usual primary care for adults with a fit note and at least two weeks absence but not more than six-months absence[31]. This paper describes the development and content of the WAVE early vocational advice intervention, which was based on an intervention designed and delivered to people experiencing musculoskeletal conditions in the Study of Work and Pain (SWAP) trial[9]. This paper also describes the associated training programme, that was created to train and support Vocational Support Workers (VSWs) in delivering the intervention. Reporting is supported by the TiDieR Checklist[32]. Aims To describe the development and content of the WAVE VA intervention and associated training programme. Specifically, this paper details: The creation of a logic model (a table or graphic which represents the theory of how an intervention is anticipated to effect change in key outcomes) informed by behaviour change theories [33] The development and content of the VA intervention and the framework for delivery The development, content and delivery of the associated training and mentoring programme to equip VSWs delivering the intervention with the attitudes, knowledge, skills and confidence to collaboratively identify and overcome obstacles to RTW Methods We used mixed-methods to develop the intervention and training, adapting both from those designed and delivered in the Study of Work And Pain (SWAP) trial[34] for adults receiving a fit note for musculoskeletal conditions, so that it was suitable for participants in the WAVE trial receiving a fit note for any condition. The research team identified current best practice in the content and delivery of vocational advice through reviewing current literature and policy documents to determine existing current best practice and relevant behaviour change theories. Given the WAVE trial was to include those with musculoskeletal, mental health and other conditions, it was important to involve both expert advisors (via an Expert Advisory Group (EAG)) and patient and public advisors with musculoskeletal, mental health and other conditions, or experience of managing health and work (via a Patient and Public Involvement and Engagement Group (PPIE)). The Medical Research Council framework for the development of complex interventions[35] guided the work and ensured that the experiences, opinions and knowledge of our EAG and PPIE groups were integral to this process. Review of current best practice A review of current best practice was undertaken. Reviews of best practice (or “best evidence”) can support the prioritisation of evidence with the aim of ensuring that conclusions can be applied over a long period[36–38]. A search of current UK and international research, policy documents and grey literature produced/published between January 1990 and June 2019 was undertaken and focussed on studies and reports of best practice in facilitating people with health conditions to achieve a safe and sustained RTW. Search terms included ‘vocational advice, vocational case management, occupational health, vocational rehabilitation, RTW’ and variations of these terms. All literature identified was included in a “best evidence set” and literature was prioritised considering applicability in the first instance so that information most relevant to the WAVE setting (primary care) and population (people receiving a fit note and absent from work between two-weeks and six-months) were given more weight[36]. The learning from the review of current best practice was collated and combined with the content of the SWAP intervention[34] and discussions between team members identified the key evidence relating to both the intervention and the training programme. This evidence was then used to develop a draft version of the underpinning logic model, and the content of the WAVE intervention and associated training programme. Expert Advisory Group (EAG) An EAG meeting including five participants was convened including one each of an occupational health physician, specialist occupational physiotherapist, representative from an organisation which brings together professional bodies around health, safety and wellbeing at work, and academics with experience in vocational rehabilitation education. Potential participants were identified through the research teams networks or through searches based on their experience and expertise in health and work. Invitations were sent via email and those responding positively were invited to a face-to-face meeting at Keele University. The objectives of the meeting were to: Review the draft logic model underpinning the VA intervention Review the proposed content and framework for delivery of the intervention Consider the role of additional resources to support the intervention, including information for participants and employers about the role of VSWs. Each objective was fulfilled by due consideration of both the review of current best practice from the literature and the professional expertise of the EAG. The research team facilitated discussions, exploring points of difference between the expert advisors and clarifying areas of inconsistency or disagreement. Throughout the meeting, notes were taken to ensure that the main content and suggestions were recorded, these were summarised and reflected to the group to ensure accuracy. These notes informed adaptations to the logic model, the intervention content and framework for delivery and the training programme, detailed in the results, below. Patient and Public Involvement and Engagement (PPIE) Group Two PPIE group meetings were convened (June 2019 and November 2019) including 6 participants with a range of health conditions, including musculoskeletal pain and mental health as well as other conditions) and working experiences including currently employed, currently self-employed and retired due to ill-health. Participants were identified from the Keele Research Users Group and meetings were held face-to-face to support discussion between participants as well as between the researchers and participants. At the initial meeting, key questions relating to the draft intervention and training programme were: Would you be happy for vocational advice to be offered through your general practice? Would you be happy to speak to a vocational support worker by phone only? Would you like to make use of technology (for example video conferencing) to speak face-to-face with a vocational support worker? What do you think of the proposed content of the vocational advice intervention and training programme? Participants were provided with an agenda in advance of the meeting so they could prepare for the discussion. Time was allocated to each question and the researchers ensured that all participants were supported to join the group discussions. Researchers also facilitated the discussion by actively listening to participants and clarifying points if necessary. Detailed notes about key discussions were taken during these meetings, with main points summarised at the end of the meeting and checked for accuracy. After the meeting all participants received a feedback letter from the research team describing the impact of the meeting on the planned intervention and training. The PPIE team were also engaged in later aspects of the trial where they supported with reviews of all participant documentation and feasibility and trial outcomes. Bringing together EAG and PPIE discussions On completion of both the EAG and PPIE meetings the detailed notes were considered by the research team. Key points were identified and used to finalise the intervention and training programme, and where necessary changes were made to the draft plans based on the findings. Where there were areas of difference between the EAG and PPIE views, the researchers also considered the evidence from current best practice for any suggested changes or amendments, however there were no areas where there was disagreement to such an extent that further meetings or feedback was required. Results Development and content of the VA intervention As a result of the review of current best practice, EAG and PPIE group meetings, the underpinning logic model (Figure 1) and content of the intervention and the training programme was finalised. Treatment targets and intervention processes in the Logic Model Treatment targets identified through the review of current best practice were brought to both the PPIE and EAG meetings. Evidence suggested that the intervention needed to address cognitions, beliefs, emotions and behaviours, as well as health, physical and psychological work demands and the work environment (all of which have been demonstrated to be important when considering obstacles to RTW)[39–41]. Through the evidence identified from the review and in discussion with the PPIE and EAG groups the treatment targets were finalised (see Figure 1 and Table 1). Table 1: Description of the treatment targets of the vocational advice intervention Treatment target Sources of evidence Health : Severity of symptoms, healthcare needs not being met; healthcare provision or engagement delaying or not facilitating RTW; [42–45] Cognitions (thought processes ): e.g. Beliefs effect of work on health; RTW self-efficacy (RTW SE) [46,47] Behaviours : e.g. Low physical activity and/or participation in everyday life; difficulty in identifying obstacles to RTW, difficulty in problem solving and failure to implement solutions [48–50] Emotions : e.g. Worry/anxiety about RTW; anger/frustration with workplace; fear of work-related activities; fear of stigma [26] Occupational: lack of workplace contact; poor communication, difficulties accessing the workplace or managing the demands of work. Inability to solve interpersonal conflicts at work. Lack of adjustments in the workplace [51,52] Again, through the review of current best practice, PPIE and EAG meetings the intervention processes, or methods by which the VA intervention could be delivered, were finalised (see Figure 1 and Table 2). Each of these processes could be used alone, or in combination with each other to deliver vocational advice tailored to each individual participants’ treatment targets (or obstacles to RTW, see table 1). When considering which intervention processes to include in the WAVE VA intervention those shown to be effective for both musculoskeletal and mental health conditions were prioritised. Table 2: Description of the intervention processes of the vocational advice intervention Process Approach and/or rationale Source of evidence from review of current best practice Goal setting Eliciting, clarifying, reviewing and amending RTW goals [48] Problem-solving Having identified modifiable obstacles to facilitate problem-solving, action planning and regular review to address modifiable obstacles to work that are clinical, psychosocial and organisational (akin to the Flags model) [53,54] Case management (health) Communication, collaboration, and coordination with healthcare where there are health related obstacles to RTW e.g. liaising with GP/other healthcare professionals to facilitate referrals, timely access to and a health and work focus to health care services, sharing return to work plans and goals [28,55] Psychoeducation and reassurance Addressing unhelpful beliefs about work and about health in the context of work through guided discovery and the provision of evidence-based messages about the relationship between work and health. Drawing on their strengths and holding a future focus to engender participants to have a positive but realistic outlook and to take a solution focussed and assets-based approach (what they can do, previous mastery experiences and next steps, rather than what they can’t do). Empowering the participant to take responsibility for their work and health situation, to be central to and own the RTW process. Without this and their commitment to the RTW plan, a successful outcome is unlikely. [55] Graded activity/exposure Phased travel/activities of daily living (behavioural activation), facilitation of graded activity (for people with musculoskeletal conditions) (NICE 2019) and exposure to reduce fear-avoidance beliefs and behaviours and reduce workplace related anxiety [53,56,57] Case-management (work) Communication, collaboration, and coordination with work, encouraging contact with the workplace [28] RTW planning and implementation Collaboratively agreed and individualised written RTW plans to overcome obstacles to RTW, detailing the next steps, persons responsible, agreed timelines and any transitional work arrangements. Implementation of RTW plans, progress monitoring, review and adjustment of plans and RTW date [53,58,59] Work modification (temporary or permanent) Facilitating reasonable adjustments/work accommodations, where indicated. Temporary ones might include a gradual return to the original job using staged increases in hours and days worked, a return to partial duties, modifications to the workplace or work equipment, or a temporary/permanent redeployment to another job, as appropriate. Whilst the evidence supports gradual RTW for people with physical health conditions, there is less evidence to support this for people with mental ill-health conditions and some literature suggests tailored plans might in fact delay RTW. Therefore, like all techniques this should be used judiciously, progress carefully monitored, and changes made where indicated. It is recognised that many people on sick leave have both physical and mental ill health [1,48,53,58,59] Signposting to other services and resources Making participants aware of services, resources, information and support (e.g., with workplace problems such as bullying and harassment, interpersonal conflict or wider socio-economic factors such as housing or debt, local services and support groups for specific health conditions, other healthcare services) [60] Refining the Logic Model The draft logic model was discussed at both the PPIE group and EAG. A list of the proposed WAVE intervention components, including treatment targets (obstacles to work), the anticipated intervention processes that the VSWs were expected to utilise, and mediating factors were presented. The PPIE group and EAG felt the treatment targets were appropriate and the intervention processes suitable (e.g., use of goal setting, problem-solving etc.). The PPIE group felt that goal setting and developing skills in communicating with line managers/employers would be particularly important in supporting RTW. They raised the question of whether the intervention should also target broader lifestyle factors such as diet, smoking and sleep, lifestyle factors were not raised specifically by the EAG. Therefore, the research team drew on the evidence review to support decision making about whether lifestyle factors should be included. The evidence review indicated that interventions aimed at diet or smoking had no discernible effect on RTW outcomes. However, there was some evidence that improved sleep quality, quantity or changes in sleep patterns were associated with better mental health and perhaps RTW outcomes. Therefore, the logic model and intervention were updated to include sleep as a treatment target and training material and resources were provided to the VSWs to support this. Figure 1 provides a pictorial representation of the final logic model including all amendments identified through the PPIE and EAG meetings and evidence from the review of current best practice. Theory underpinning the WAVE VA intervention The Behaviour Change Wheel (BCW) was used to structure the intervention development. The BCW consists of several layers: the inner wheel is the COM-B (Capability, Opportunity, and Motivation affecting Behaviour), which considers the need to ensure participants are Capable of change (specifically through increasing self-efficacy in this instance, as identified within the SWAP trial and wider evidence[9,24,26]) but also providing them with the Motivation to RTW and to support participants to identify the Opportunities that will support RTW[30]. The treatment targets included in the logic model (figure 1) represent the “targets for intervention” and encompass physical, psychological, social and reflective targets with the intervention processes (“intervention functions”) on the behaviour change wheel concerning how capability, opportunity and motivation are influenced. It is important for those delivering the intervention to be aware of “policy categories” that influence behaviour change and policy categories specifically focused on health and work were included in the training (discussed below). WAVE Return to work Assessment and action Plans (WRAPs) Case Report Forms referred to as WRAPs were developed for use during and after intervention sessions. These plans were constructed as templates (paper or electronic) with mandatory sections for recording the content of the health and work assessment, the obstacles identified, the strategies recommended, the nature and amount of contact the VSW had with the participant, the steps the VSW delivered, the work outcome and the reason the VA intervention ended. They were designed to form a record for the VSW to ensure continuity in follow-up consultation(s). The WRAP included action plans and written structured RTW plans. Part of the WRAP was designed as the standardised WAVE trial Case Report Form which ensured consistent documentation about the delivered intervention and allowed intervention fidelity to be assessed. The information and resources to be used by the VSWs to support delivery of the intervention There was discussion in the PPIE and EAG groups about information leaflets developed for the WAVE trial and whether additional resources were required. A set of information leaflets were developed including one focused on sleep hygiene, and participant and employer leaflets explaining the VSW role. PPIE and EAG discussions supported changes to the length and terminology used in these resources, improving structure and clarity. The trial’s information was supplemented by already published evidence-based resources that were considered by the PPIE/EAG groups as potentially beneficial alongside the VA intervention. The resources included information about generic health and work topics[61–64]. Framework for delivery of the VA intervention The WAVE VA intervention was developed so that it could be delivered via telephone or videoconferencing, using a stepped care delivery model and the principles of case-management. Evidence supporting the framework for delivery was identified through the review of current best evidence and brought to both the EAG and PPIE meetings to sense check and confirm suitability table 3 describes the framework for delivery of the VA intervention. Table 3: Framework for the delivery of the Vocational Advice Intervention Framework component Evidence PPIE/EAG comments The role of telephone and videoconference consultations Evidence suggests that telephone consultations with a work focus can be effective and can facilitate a RTW [60]. The PPIE group felt comfortable with the intervention being delivered over the phone and many felt that videoconferencing would be feasible. Case-management There is good evidence that case-management can support communication, collaboration, and coordination of action planning between the different RTW stakeholders [29,60,65,66]. Both the PPIE and EAG members felt that case management was of benefit with the PPIE members reporting that having a single point of contact would be helpful and the EAG noting that case management was a commonly used method in their practice. Stepped care model Stepped care can be effective in improving RTW outcomes [9,34,67]. The EAG discussed the definition of stepped care and whether the steps should be based on the type of contact provided (phone/face-to-face/videoconferencing/workplace visit) or the amount of contact (dose) provided by the VSWs. It was recognised that the method of delivery may be influenced by geography (living further away from the VSW) or participant or VSW choice, rather than by the complexity of the work situation and therefore the dose of intervention required. Stepped care The level of intervention and the number of contacts with the VSW was designed to be tailored to the needs of each participant, with all participants being offered Step 1, and the decision to progress to further steps to be based on discussion between the participant and the VSW. Figure 2 provides a summary of the stepped care element of the VA intervention reproduced from the protocol[31]. Step 1: Telephone consultation to discuss the participant’s health and work situation . In this step, VSWs explain and define their role, including how this differentiates from, and supplements, the roles of other professionals. An assessment will be undertaken of participants’ health and work situation and, with participants, obstacles to RTW identified. Together with the participant the VSW will identify solutions to modifiable obstacles, facilitate the development of a RTW plan detailing next steps, the RTW date (where possible) and discuss any follow-up contact. The VSWs will also provide evidence-based information and support depending on participants’ needs where appropriate. If RTW is not achieved participants will be offered Step 2. Step 2: Review of progress, further exploration of obstacles and review of the RTW plan . Participants will be invited to a face-to-face or videoconference meeting. The VSW and participant will revisit the previously agreed RTW plan and current or new obstacles to collaborate in developing a revision, set a new RTW date and agree any follow up contact. Acting as the case-manager and with the permission of the participant, the VSW may facilitate communication between all parties involved in RTW. If RTW is again not achieved, participants will be offered Step 3. Step 3: Workplace contact. Step 3 includes the provision of additional support to develop practical strategies to facilitate RTW with the participant and also the VSW making direct contact with the participant’s workplace (with participant consent and involvement). Workplace contact by the VSW will be offered and could take place by email, phone, videoconference or in person, and involve a discussion with the participant’s employer about the RTW plan and potential adjustments to support RTW. Development and content of the training programme Documented training programmes, identified as part of the review of current best practice, focused on vocational case management, occupational health and vocational rehabilitation, relevant codes of practice and standards[68], competencies[69,70], and recommendations for training[71] were used to inform the VSW training programme. A draft training programme was reviewed by the EAG and PPIE groups, the teams reviewed the content and compared these across the proposed intervention content to ensure that there were no gaps in the training. The best evidence review suggested that common competencies required by VSWs include: 1) relevant knowledge base e.g. of medical conditions, obstacles to RTW, business and legal aspects; 2) organisational/administrative skills; 3) assessment skills (e.g. of health, ergonomic and workplace factors; 4) communication skills, including facilitating communication and agreement among stakeholders; 5) Problem-solving skills (e.g. health, work and social obstacles); 5) planning for transitional duty; 6) RTW facilitation skills; and 7) managing the RTW process[69,70,72]. The training programme was designed to equip VSWs with the attitudes, knowledge, skills and confidence to deliver the VA intervention designed as part of the WAVE trial (detailed in figure 1). Elements of the training programme were aligned with the treatment targets, ensuring VSWs were aware of what these could be, how to identify them and what strategies might be best aligned to supporting participants to address these treatment targets. Training was also aligned to the intervention process, providing VSWs with the skills to use a range of techniques aimed at supporting behaviour change around work and to facilitate RTW including an understanding of the wider policy implications around health and work. Lastly, training included the practical skills VSWs would require to deliver and record the consultation in line with the trial protocol. The content of the training programme is detailed in the supplementary file along with details of the VSWs who provided the WAVE trial. Delivery of the VSW training programme Training was delivered online (to comply with Covid-19 restrictions that came into place at the time) by members of the WAVE trial team providing clinical expertise in occupational health, rheumatology, general practice, physiotherapy and vocational case-management. The training was delivered over three days (20 hours) with a half day refresher session held online just prior to trial commencement. Prior to commencing training, all VSWs were asked to complete self-directed learning focused on some of the key topics and concepts to be covered. This self-directed learning included reading peer reviewed publications about RTW self-efficacy[73] and the impact of mental health difficulties on work, and completing online learning modules exploring work and health, how to support those with musculoskeletal pain to stay at or return-to-work, understanding the concept of motivational interviewing and current advice on supporting those with Long Covid. The training involved a mix of facilitated learning methods including: interactive presentations where VSWs were asked to share their thoughts and experiences and engage in problem-solving activities; case-study scenarios to demonstrate the application of learning to real-life situations. Role-play using actors brought the learning together and created opportunities for the VSWs to try out the skills and receive feedback. Training was supported with written resources to support VSWs’ learning. All VSWs completed an evaluation assessing their knowledge, self-reported behaviour and confidence in delivering the intervention (full details provided in the supplementary file). Throughout the WAVE trial, monthly, one-hour online mentoring sessions were provided to the VSWs by the training team, to ensure that all VSWs had access to a professional experienced in delivering vocational advice. Mentoring has been used successfully in trials of complex interventions, including interventions targeting work outcomes [9,74], the importance of mentoring in the development of competencies in RTW coordination has been emphasised[75]. Mentoring sessions included the VSWs delivering the intervention, members of the trial team including trial management and those with clinical experience of managing health and work. The supervision aimed to: Provide the VSWs with peer learning and support, including about WAVE trial processes Support the VSWs to put the training into practice, supporting fidelity in delivery of the intervention. enable sharing of additional information and resources to support the VSWs to deliver the intervention (e.g. relating to Long-Covid and return to work) Consolidate and further develop their knowledge, skills and behaviours to enable them to deliver the WAVE intervention Resolve practical challenges. Discussion This paper describes a mixed-methods intervention and training development study for the VA intervention delivered in the WAVE trial. A review of current best practice identified treatment targets alongside intervention processes which formed the basis of the logic model underpinning the VA intervention. Additionally, the framework by which the VA intervention would be delivered was guided by current best practice with the intervention planned to be delivered by phone (with videoconferencing or face-to-face meetings where necessary and where appropriate given lockdowns due to Covid-19), using case management and stepped care. The review of current best practice also identified the topics to be included in the VSW training and mentoring programme which were aligned to the proposed VA intervention. The draft logic model, framework for intervention delivery and VSW training and mentoring programme were all taken to EAG and PPIE meetings to ensure that all content was appropriate, that no content was missing and in the PPIE meetings that participants felt comfortable with the proposed methods of delivering the intervention. These EAG and PPIE meetings allowed the logic model, content and framework of the VA intervention and the training and mentoring programme to be finalised. Comparison with wider literature The WAVE trial intervention and training programme were developed from a review of current best practice, EAG and PPIE meetings and supported by an intervention developed for the SWAP trial[ 9 ] with modification to support people with any ill-health, not only musculoskeletal pain. The WAVE trial training was subsequently modified for the “MI NAV” trial[ 76 ] where it was used as part of a stratified care approach and amended to fit the Norwegian health and work context. The MI NAV trial reported that whilst there was a seven-day difference between those receiving usual care and those receiving each intervention (motivational interviewing and vocational advice) this difference was not statistically significant. The authors report that the stratified element of the trial whereby those assessed as low risk were offered one or two vocational advice sessions, and the extended duration of absence that participants had, of at least seven weeks, may have impacted on the results[ 76 ]. An examination of the mechanisms of the MI NAV trial demonstrated that changing a persons’ expectation of RTW may have supported a reduction in absence[ 77 ] which is a key part of the WAVE trial intervention. The UK “ROWTATE” trial (trial results not yet reported) aims to support trauma survivors to RTW and has utilised similar methods for intervention delivery including a case management model, workplace accommodations and employer engagement[ 78 ]. Lastly, a recent realist literature review exploring programme theory for early intervention in vocational rehabilitation identified nine mechanisms and three outcomes that support RTW including: exploring options; optimising self-efficacy; staying connected; setting goals; engaging employers and flexing roles[ 79 ], all of which form the content of the WAVE intervention and give further confidence in the approach developed here. Strengths and limitations The development of the WAVE intervention and associated training programme has several strengths. The MRC framework for the development of complex interventions was followed[ 33 , 35 ], learning from a previous trial was incorporated[ 9 ] in addition to an underpinning review of current best practice, furthermore the intervention development process integrated the experiences, opinions and knowledge of our PPIE and EAG groups. The PPIE and EAG groups represented a broad range of experiences and in the PPIE group a range of health conditions and employment statuses. We were able to elicit a wide range of views enabling a good understanding of people’s needs when they are absent from work as well as those engaged in delivering vocational advice and employers. The use of underpinning behaviour change theories is a further strength ensuring that the intervention is developed in a way that is most likely to affect positive change on the key outcome of RTW. The RTW process is complex and requires people to take some responsibility for their RTW supported by the VSW and other stakeholders where relevant. Ensuring that VSWs build a rapport with people, adhere to the mechanisms of intervention delivery and use the embedded behaviour change techniques is paramount to a successful intervention. Lastly, this intervention focuses on the provision of early support for sickness absence, with the goal of preventing long-term absence. It is widely believed that intervening early before absence becomes long term (usually defined as greater than 4 weeks of absence[ 53 ]) is better for individuals, employers and brings economic benefits as demonstrated by both the SWAP trial[ 9 ] and the EASY study[ 80 ] and a recent systematic review[ 81 ]. A limitation to the intervention development was that we did not undertake intervention mapping or carry out a formal systematic review of the literature. The rationale for this was that the WAVE trial target population was mixed in terms of health condition and duration of absence, therefore the scope of intervention mapping and systematic review of the literature would not have been feasible. Whilst these formal methods were not used, we are confident that the underpinning logic model developed to support the WAVE trial vocational advice intervention includes appropriate treatment targets and anticipated mechanisms required for successful delivery of vocational advice as evidenced in other studies on the same topic[ 79 , 81 – 84 ]. Secondly, whilst we had a diverse group of participants in both our PPIE and EAG groups there were undoubtedly some underrepresented groups, for example those from ethnic minorities and those from lower socioeconomic groups. The relevance and acceptability of the intervention developed needs to be understood from the perspective of these groups, although the qualitative study as part of the WAVE trial will address this to some extent (Harrison et al , under review). Recent publications have set out strategies to improve diversity within future research and adopting these strategies will go some way to addressing this issue in future studies[ 85 ]. Conclusion This paper reports the development and content of the WAVE VA intervention and associated training programme for VSWs. The study has resulted in the creation of a logic model informed by behaviour change theory, the content of a VA intervention and the framework through which the intervention can be delivered. Lastly, an associated training and mentoring programme has been developed to equip VSWs with the attitudes, knowledge, skills and confidence to collaboratively identify and overcome obstacles to RTW. Given the high profile that sickness absence currently has, the WAVE trial[ 31 ] and its component parts such as the intervention, will have important implications for policy makers. Declarations Funding The WAVE trial was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR 17/94/49). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182). CCG is part funded by West Midlands Applied Research Collaboration (WM ARC). Authors’ contributions The WAVE vocational advice intervention and the training programme for VSWs in the intervention was developed and/or influenced by all authors. Training and mentoring of VSWs was delivered and supported by GS, IM, KW-B, CC-G, GW-J, KC, SAL, GM, BS. Competing interests GW-J holds a post with the West Midlands Regional Research Delivery Network. 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Development of a vocational rehabilitation intervention to support return-to-work and well-being following major trauma: a person-based approach. BMJ Open. 2024;14:e085724. National Health Service England. Increasing diversity in research participation: A good practice guide for engaging with underrepresented groups. 2023 Feb. Additional Declarations Competing interest reported. GW-J holds a post with the West Midlands Regional Research Delivery Network. Supplementary Files WAVEinterventionandtrainingpaperSupplementaryFileV1.0.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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GW-J holds a post with the West Midlands Regional Research Delivery Network.","formattedTitle":"A mixed-methods intervention and training development study for the Work And Vocational advicE (WAVE) trial (Clinical Trials: NCT04543097)","fulltext":[{"header":"Introduction","content":"\u003cp\u003eEmployment has benefits for health[1]. People who have prolonged disability for work have: poorer quality of life; poorer mental health with increased risk of suicide; shorter life expectancy; higher levels of pain; require more social care; and use more healthcare[2\u0026ndash;6]. However, absence from the workplace because of sickness is rising in the UK and Europe, with 185.6 million working days lost in the UK alone due sickness in 2022[7,8]. Work disability can be prevented through early, integrated vocational intervention[9\u0026ndash;12]. Access to occupational health services, however, and the types of advice and support they provide varies between countries[13] and is particularly limited within some health systems, notably the UK[1], where most sickness absence is managed in the health service, predominantly through primary care[14,15]. Healthcare practitioners report that they find it difficult to provide appropriate advice and support within their role[16], and consequently patients often struggle to manage their health and work themselves. There have been many policy documents spanning several years clearly outlining the challenges of supporting people to remain in work and proposing roadmaps and plans to address these challenges[17\u0026ndash;20] with some support for trial initiatives in practice both in the past and currently underway[21\u0026ndash;23]. All the policies suggest that support for managing health that impacts on work should function in an integrated way within existing health services, and there is evidence that this works internationally[9\u0026ndash;12]. Despite this understanding, there is a gap in provision of evidence based vocational advice. Consequently, the UK Government has advocated the development and testing of new models to deliver vocational advice within the healthcare setting including exploring ways to expand the workforce providing vocational advice and the use of remote or digital methods of intervention delivery[18] these models may be considered complex interventions.\u003c/p\u003e\n\u003cp\u003eComplex interventions, such as that planned within the WAVE trial, should have a theoretical framework around which the logic model is built. The WAVE trial aimed to change participants\u0026rsquo; behaviours in the context of their work and therefore behaviour change theories should be explored. Self-efficacy is a key component in many psychological behaviour change models (e.g. Social Cognitive Theory, Protection Motivation Theory, Health Action Process Approach)[24\u0026ndash;26] and has been consistently associated with positive behaviour change[27]\u0026nbsp;and RTW[18]. Current thinking suggests that intervention development should draw on multiple theories and behaviour change techniques rather than focusing on only one, to avoid missing a relevant element and as such behaviour change theories need to be incorporated in any intervention development[28\u0026ndash;30].\u003c/p\u003e\n\u003cp\u003eThe Work And Vocational advicE (WAVE) trial set out to address some of these challenges through a pragmatic, multicentre randomised controlled trial of the addition of a brief vocational advice (VA) intervention to usual primary care for adults with a fit note and at least two weeks absence but not more than six-months absence[31]. This paper describes the development and content of the WAVE early vocational advice intervention, which was based on an intervention designed and delivered to people experiencing musculoskeletal conditions in the Study of Work and Pain (SWAP) trial[9]. This paper also describes the associated training programme, that was created to train and support Vocational Support Workers (VSWs) in delivering the intervention. Reporting is supported by the TiDieR Checklist[32].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAims\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo describe the development and content of the WAVE VA intervention and associated training programme. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSpecifically, this paper details:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eThe creation of a logic model (a table or graphic which represents the theory of how an intervention is anticipated to effect change in key outcomes) informed by behaviour change theories [33]\u003c/li\u003e\n \u003cli\u003eThe development and content of the VA intervention and the framework for delivery\u003c/li\u003e\n \u003cli\u003eThe development, content and delivery of the associated training and mentoring programme to equip VSWs delivering the intervention with the attitudes, knowledge, skills and confidence to collaboratively identify and overcome obstacles to RTW\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Methods","content":"\u003cp\u003eWe used mixed-methods to develop the intervention and training, adapting both from\u0026nbsp;those designed and delivered in the Study of Work And Pain (SWAP) trial[34] for adults receiving a fit note for musculoskeletal conditions, so that it was suitable for participants in the WAVE trial receiving a fit note for any condition. The research team identified current best practice in the content and delivery of vocational advice through reviewing current literature and policy documents to determine existing current best practice and relevant behaviour change theories. Given the WAVE trial was to include those with musculoskeletal, mental health and other conditions, it was important to involve both expert advisors (via an Expert Advisory Group (EAG)) and patient and public advisors with musculoskeletal, mental health and other conditions, or experience of managing health and work (via a Patient and Public Involvement and Engagement Group (PPIE)). The Medical Research Council framework for the development of complex interventions[35] guided the work and ensured that the experiences, opinions and knowledge of our EAG and PPIE groups were integral to this process.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eReview of current best practice\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA review of current best practice was undertaken. Reviews of best practice (or \u0026ldquo;best evidence\u0026rdquo;) can support the prioritisation of evidence with the aim of ensuring that conclusions can be applied over a long period[36\u0026ndash;38]. A search of current UK and international research, policy documents and grey literature produced/published between January 1990 and June 2019 was undertaken and focussed on studies and reports of best practice in facilitating people with health conditions to achieve a safe and sustained RTW. Search terms included \u0026lsquo;vocational advice, vocational case management, occupational health, vocational rehabilitation, RTW\u0026rsquo; and variations of these terms. All literature identified was included in a \u0026ldquo;best evidence set\u0026rdquo; and literature was prioritised considering applicability in the first instance so that information most relevant to the WAVE setting (primary care) and population (people receiving a fit note and absent from work between two-weeks and six-months) were given more weight[36]. The learning from the review of current best practice was collated and combined with the content of the SWAP intervention[34] and discussions between team members identified the key evidence relating to both the intervention and the training programme. This evidence was then used to develop a draft version of the underpinning logic model, and the content of the WAVE intervention and associated training programme.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eExpert Advisory Group (EAG)\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAn EAG meeting including five participants was convened including one each of an occupational health physician, specialist occupational physiotherapist, representative from an organisation which brings together professional bodies around health, safety and wellbeing at work, and academics with experience in vocational rehabilitation education. Potential participants were identified through the research teams networks or through searches based on their experience and expertise in health and work. Invitations were sent via email and those responding positively were invited to a face-to-face meeting at Keele University.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe objectives of the meeting were to:\u0026nbsp;\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eReview the draft logic model underpinning the VA intervention\u003c/li\u003e\n \u003cli\u003eReview the proposed content and framework for delivery of the intervention\u003c/li\u003e\n \u003cli\u003eConsider the role of additional resources to support the intervention, including information for participants and employers about the role of VSWs.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eEach objective was fulfilled by due consideration of both the review of current best practice from the literature and the professional expertise of the EAG. The research team facilitated discussions, exploring points of difference between the expert advisors and clarifying areas of inconsistency or disagreement. Throughout the meeting, notes were taken to ensure that the main content and suggestions were recorded, these were summarised and reflected to the group to ensure accuracy. These notes informed adaptations to the logic model, the intervention content and framework for delivery and the training programme, detailed in the results, below.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePatient and Public Involvement and Engagement (PPIE) Group\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTwo PPIE group meetings were convened (June 2019 and November 2019) including 6 participants with a range of health conditions, including musculoskeletal pain and mental health as well as other conditions) and working experiences including currently employed, currently self-employed and retired due to ill-health. Participants were identified from the Keele Research Users Group and meetings were held face-to-face to support discussion between participants as well as between the researchers and participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt the initial meeting, key questions relating to the draft intervention and training programme were:\u0026nbsp;\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eWould you be happy for vocational advice to be offered through your general practice?\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eWould you be happy to speak to a vocational support worker by phone only? Would you like to make use of technology (for example video conferencing) to speak face-to-face with a vocational support worker?\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eWhat do you think of the proposed content of the vocational advice intervention and training programme?\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eParticipants were provided with an agenda in advance of the meeting so they could prepare for the discussion. Time was allocated to each question and the researchers ensured that all participants were supported to join the group discussions. Researchers also facilitated the discussion by actively listening to participants and clarifying points if necessary. Detailed notes about key discussions were taken during these meetings, with main points summarised at the end of the meeting and checked for accuracy. After the meeting all participants received a feedback letter from the research team describing the impact of the meeting on the planned intervention and training. The PPIE team were also engaged in later aspects of the trial where they supported with reviews of all participant documentation and feasibility and trial outcomes. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eBringing together EAG and PPIE discussions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOn completion of both the EAG and PPIE meetings the detailed notes were considered by the research team. Key points were identified and used to finalise the intervention and training programme, and where necessary changes were made to the draft plans based on the findings. Where there were areas of difference between the EAG and PPIE views, the researchers also considered the evidence from current best practice for any suggested changes or amendments, however there were no areas where there was disagreement to such an extent that further meetings or feedback was required.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDevelopment and content of the VA intervention\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs a result of the review of current best practice, EAG and PPIE group meetings, the underpinning logic model (Figure 1)\u0026nbsp;and content of the intervention and the training programme was finalised.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTreatment targets and intervention processes in the Logic Model\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTreatment targets identified through the review of current best practice were brought to both the PPIE and EAG meetings. Evidence suggested that the intervention needed to address cognitions, beliefs, emotions and behaviours, as well as health, physical and psychological work demands and the work environment (all of which have been demonstrated to be important when considering obstacles to RTW)[39\u0026ndash;41]. Through the evidence identified from the review and in discussion with the PPIE and EAG groups the treatment targets were finalised (see Figure 1 and Table 1).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eTable 1: Description of the treatment targets of the vocational advice intervention\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 501px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment target\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSources of evidence\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 501px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eHealth\u003c/strong\u003e: Severity of symptoms, healthcare needs not being met; healthcare provision or engagement delaying or not facilitating RTW;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e[42\u0026ndash;45]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 501px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCognitions (thought processes\u003c/strong\u003e): e.g. Beliefs effect of work on health; RTW self-efficacy (RTW SE)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e[46,47]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 501px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBehaviours\u003c/strong\u003e: e.g. Low physical activity and/or participation in everyday life; difficulty in identifying obstacles to RTW, difficulty in problem solving and failure to implement solutions\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e[48\u0026ndash;50]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 501px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmotions\u003c/strong\u003e: e.g. Worry/anxiety about RTW; anger/frustration with workplace; fear of work-related activities; fear of stigma\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e[26]\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 501px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eOccupational:\u0026nbsp;\u003c/strong\u003elack of workplace contact; poor communication, difficulties accessing the workplace or managing the demands of work. Inability to solve interpersonal conflicts at work. Lack of adjustments in the workplace\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e[51,52]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAgain, through the review of current best practice, PPIE and EAG meetings the intervention processes, or methods by which the VA intervention could be delivered, were finalised (see Figure 1 and Table 2). Each of these processes could be used alone, or in combination with each other to deliver vocational advice tailored to each individual participants\u0026rsquo; treatment targets (or obstacles to RTW, see table 1). When considering which intervention processes to include in the WAVE VA intervention those shown to be effective for both musculoskeletal and mental health conditions were prioritised.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eTable 2: Description of the intervention processes of the vocational advice intervention\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eProcess\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eApproach and/or rationale\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSource of evidence from review of current best practice\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eGoal setting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eEliciting, clarifying, reviewing and amending RTW goals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[48]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eProblem-solving\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eHaving identified modifiable obstacles to facilitate problem-solving, action planning and regular review to address modifiable obstacles to work that are clinical, psychosocial and organisational (akin to the Flags model)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[53,54]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eCase management (health)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eCommunication, collaboration, and coordination with healthcare where there are health related obstacles to RTW e.g. liaising with GP/other healthcare professionals to facilitate referrals, timely access to and a health and work focus to health care services, sharing return to work plans and goals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[28,55]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003ePsychoeducation and reassurance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eAddressing unhelpful beliefs about work and about health in the context of work through guided discovery and the provision of evidence-based messages about the relationship between work and health. Drawing on their strengths and holding a future focus to engender participants to have a positive but realistic outlook and to take a solution focussed and assets-based approach (what they can do, previous mastery experiences and next steps, rather than what they can\u0026rsquo;t do). Empowering the participant to take responsibility for their work and health situation, to be central to and own the RTW process. Without this and their commitment to the RTW plan, a successful outcome is unlikely.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[55]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eGraded activity/exposure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003ePhased travel/activities of daily living (behavioural activation), facilitation of graded activity (for people with musculoskeletal conditions) (NICE 2019) and exposure to reduce fear-avoidance beliefs and behaviours and reduce workplace related anxiety\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[53,56,57]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eCase-management (work)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eCommunication, collaboration, and coordination with work, encouraging contact with the workplace\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[28]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eRTW planning and implementation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eCollaboratively agreed and individualised written RTW plans to overcome obstacles to RTW, detailing the next steps, persons responsible, agreed timelines and any transitional work arrangements. Implementation of RTW plans, progress monitoring, review and adjustment of plans and RTW date\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[53,58,59]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eWork modification (temporary or permanent)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eFacilitating reasonable adjustments/work accommodations, where indicated. Temporary ones might include a gradual return to the original job using staged increases in hours and days worked, a return to partial duties, modifications to the workplace or work equipment, or a temporary/permanent redeployment to another job, as appropriate. Whilst the evidence supports gradual RTW for people with physical health conditions, there is less evidence to support this for people with mental ill-health conditions and some literature suggests tailored plans might in fact delay RTW. Therefore, like all techniques this should be used judiciously, progress carefully monitored, and changes made where indicated. It is recognised that many people on sick leave have both physical and mental ill health\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp class=\"MsoNormal\" align=\"center\"\u003e\u003cspan lang=\"EN-GB\"\u003e[1,48,53,58,59]\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eSignposting to other services and resources\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 385px;\"\u003e\n \u003cp\u003eMaking participants aware of services, resources, information and support (e.g., with workplace problems such as bullying and harassment, interpersonal conflict or wider socio-economic factors such as housing or debt, local services and support groups for specific health conditions, other healthcare services)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e[60]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003eRefining the Logic Model\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe draft logic model was discussed at both the PPIE group and EAG. A list of the proposed WAVE intervention components, including treatment targets (obstacles to work), the anticipated intervention processes that the VSWs were expected to utilise, and mediating factors were presented. The PPIE group and EAG felt the treatment targets were appropriate and the intervention processes suitable (e.g., use of goal setting, problem-solving etc.). The PPIE group felt that goal setting and developing skills in communicating with line managers/employers would be particularly important in supporting RTW. They raised the question of whether the intervention should also target broader lifestyle factors such as diet, smoking and sleep, lifestyle factors were not raised specifically by the EAG. Therefore, the research team drew on the evidence review to support decision making about whether lifestyle factors should be included. The evidence review indicated that interventions aimed at diet or smoking had no discernible effect on RTW outcomes. However, there was some evidence that improved sleep quality, quantity or changes in sleep patterns were associated with better mental health and perhaps RTW outcomes. Therefore, the logic model and intervention were updated to include sleep as a treatment target and training material and resources were provided to the VSWs to support this. Figure 1 provides a pictorial representation of the final logic model including all amendments identified through the PPIE and EAG meetings and evidence from the review of current best practice.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheory underpinning the WAVE VA intervention\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe Behaviour Change Wheel (BCW) was used to structure the intervention development. The BCW consists of several layers: the inner wheel is the COM-B (Capability, Opportunity, and Motivation affecting Behaviour), which considers the need to ensure participants are Capable of change (specifically through increasing self-efficacy in this instance, as identified within the SWAP trial and wider evidence[9,24,26]) but also providing them with the Motivation to RTW and to support participants to identify the Opportunities that will support RTW[30]. The treatment targets included in the logic model (figure 1) represent the \u0026ldquo;targets for intervention\u0026rdquo; and encompass physical, psychological, social and reflective targets with the intervention processes (\u0026ldquo;intervention functions\u0026rdquo;) on the behaviour change wheel concerning how capability, opportunity and motivation are influenced. It is important for those delivering the intervention to be aware of \u0026ldquo;policy categories\u0026rdquo; that influence behaviour change and policy categories specifically focused on health and work were included in the training (discussed below).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eWAVE Return to work Assessment and action Plans (WRAPs)\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eCase Report Forms referred to as WRAPs were developed for use during and after intervention sessions. These plans were constructed as templates (paper or electronic) with mandatory sections for recording the content of the health and work assessment, the obstacles identified, the strategies recommended, the nature and amount of contact the VSW had with the participant, the steps the VSW delivered, the work outcome and the reason the VA intervention ended. They were designed to form a record for the VSW to ensure continuity in follow-up consultation(s). The WRAP included action plans and written structured RTW plans. Part of the WRAP was designed as the standardised WAVE trial Case Report Form which ensured consistent documentation about the delivered intervention and allowed intervention fidelity to be assessed.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eThe information and resources to be used by the VSWs to support delivery of the intervention\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThere was discussion in the PPIE and EAG groups about information leaflets developed for the WAVE trial and whether additional resources were required. A set of information leaflets were developed including one focused on sleep hygiene, and participant and employer leaflets explaining the VSW role. PPIE and EAG discussions supported changes to the length and terminology used in these resources, improving structure and clarity. The trial\u0026rsquo;s information was supplemented by already published evidence-based resources that were considered by the PPIE/EAG groups as potentially beneficial alongside the VA intervention. The resources included information about generic health and work topics[61\u0026ndash;64].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFramework for delivery of the VA intervention\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe WAVE VA intervention was developed so that it could be delivered via telephone or videoconferencing, using a stepped care delivery model and the principles of case-management. Evidence supporting the framework for delivery was identified through the review of current best evidence and brought to both the EAG and PPIE meetings to sense check and confirm suitability table 3 describes the framework for delivery of the VA intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eTable 3: Framework for the delivery of the Vocational Advice Intervention\u0026nbsp;\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFramework component\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEvidence\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePPIE/EAG comments\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003e\u003cem\u003eThe role of telephone and videoconference consultations\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eEvidence suggests that telephone consultations with a work focus can be effective and can facilitate a RTW [60].\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eThe PPIE group felt comfortable with the intervention being delivered over the phone and many felt that videoconferencing would be feasible.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003e\u003cem\u003eCase-management\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eThere is good evidence that case-management can support communication, collaboration, and coordination of action planning between the different RTW stakeholders [29,60,65,66].\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eBoth the PPIE and EAG members felt that case management was of benefit with the PPIE members reporting that having a single point of contact would be helpful and the EAG noting that case management was a commonly used method in their practice.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003e\u003cem\u003eStepped care model\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eStepped care can be effective in improving RTW outcomes [9,34,67].\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 200px;\"\u003e\n \u003cp\u003eThe EAG discussed the definition of stepped care and whether the steps should be based on the type of contact provided (phone/face-to-face/videoconferencing/workplace visit) or the amount of contact (dose) provided by the VSWs. It was recognised that the method of delivery may be influenced by geography (living further away from the VSW) or participant or VSW choice, rather than by the complexity of the work situation and therefore the dose of intervention required.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003eStepped care\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe level of intervention and the number of contacts with the VSW was designed to be tailored to the needs of each participant, with all participants being offered Step 1, and the decision to progress to further steps to be based on discussion between the participant and the VSW. Figure 2 provides a summary of the stepped care element of the VA intervention reproduced from the protocol[31].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eStep 1: Telephone consultation to discuss the participant\u0026rsquo;s health and work situation\u003c/u\u003e. In this step, VSWs explain and define their role, including how this differentiates from, and supplements, the roles of other professionals. An assessment will be undertaken of participants\u0026rsquo; health and work situation and, with participants, obstacles to RTW identified. Together with the participant the VSW will identify solutions to modifiable obstacles, facilitate the development of a RTW plan detailing next steps, the RTW date (where possible) and discuss any follow-up contact. The VSWs will also provide evidence-based information and support depending on participants\u0026rsquo; needs where appropriate. If RTW is not achieved participants will be offered Step 2.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eStep 2: Review of progress, further exploration of obstacles and review of the RTW plan\u003c/u\u003e. Participants will be invited to a face-to-face or videoconference meeting. The VSW and participant will revisit the previously agreed RTW plan and current or new obstacles to collaborate in developing a revision, set a new RTW date and agree any follow up contact. Acting as the case-manager and with the permission of the participant, the VSW may facilitate communication between all parties involved in RTW. If RTW is again not achieved, participants will be offered Step 3.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eStep 3: Workplace contact.\u003c/u\u003e Step 3 includes the provision of additional support to develop practical strategies to facilitate RTW with the participant and also the VSW making direct contact with the participant\u0026rsquo;s workplace (with participant consent and involvement). Workplace contact by the VSW will be offered and could take place by email, phone, videoconference or in person, and involve a discussion with the participant\u0026rsquo;s employer about the RTW plan and potential adjustments to support RTW.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDevelopment and content of the training programme\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDocumented\u0026nbsp;training programmes, identified as part of the review of current best practice, focused on vocational case management, occupational health and vocational rehabilitation, relevant codes of practice and standards[68], competencies[69,70], and\u0026nbsp;recommendations for training[71]\u0026nbsp;were used to inform the VSW training programme. A draft training programme was reviewed by the EAG and PPIE groups, the teams reviewed the content and compared these across the proposed intervention content to ensure that there were no gaps in the training.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe best evidence review suggested that\u0026nbsp;common competencies required by VSWs include: 1) relevant knowledge base e.g. of medical conditions, obstacles to RTW, business and legal aspects; 2)\u0026nbsp;organisational/administrative skills; 3) assessment skills\u0026nbsp;(e.g. of health,\u0026nbsp;ergonomic and workplace factors; 4)\u0026nbsp;communication skills, including facilitating communication and agreement among stakeholders; 5)\u0026nbsp;Problem-solving skills\u0026nbsp;(e.g. health, work and social obstacles); 5)\u0026nbsp;planning for transitional duty; 6)\u0026nbsp;RTW facilitation skills; and\u0026nbsp;7)\u0026nbsp;managing the RTW process[69,70,72].\u0026nbsp;The training programme was designed to equip VSWs with the attitudes, knowledge, skills and confidence to deliver the VA intervention designed as part of the WAVE trial (detailed in figure 1). Elements of the training programme were aligned with the treatment targets, ensuring VSWs were aware of what these could be, how to identify them and what strategies might be best aligned to supporting participants to address these treatment targets. Training was also aligned to the intervention process, providing VSWs with the skills to use a range of techniques aimed at supporting behaviour change around work and to facilitate RTW including an understanding of the wider policy implications around health and work. Lastly, training included the practical skills VSWs would require to deliver and record the consultation in line with the trial protocol. The content of the training programme is detailed in the supplementary file along with details of the VSWs who provided the WAVE trial.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDelivery of the VSW training programme\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTraining was delivered online (to comply with Covid-19 restrictions that came into place at the time) by members of the WAVE trial team providing clinical expertise in occupational health, rheumatology, general practice, physiotherapy and vocational case-management. The training was delivered over three days (20 hours) with a half day\u0026nbsp;refresher session held online just prior to trial commencement. Prior to commencing training, all VSWs were asked to complete self-directed learning focused on some of the key topics and concepts to be covered. This self-directed learning included reading peer reviewed publications about RTW self-efficacy[73] and the impact of mental health difficulties on work, and completing online learning modules exploring work and health, how to support those with musculoskeletal pain to stay at or return-to-work, understanding the concept of motivational interviewing and current advice on supporting those with Long Covid. The training involved a mix of facilitated learning methods including: interactive presentations where VSWs were asked to share their thoughts and experiences and engage in problem-solving activities; case-study scenarios to demonstrate the application of learning to real-life situations. Role-play using actors brought the learning together and created opportunities for the VSWs to try out the skills and receive feedback. Training was supported with written resources to support VSWs\u0026rsquo; learning. All VSWs completed an evaluation assessing their knowledge, self-reported behaviour and confidence in delivering the intervention (full details provided in the supplementary file).\u003c/p\u003e\n\u003cp\u003eThroughout the WAVE trial, monthly, one-hour online mentoring sessions were provided to the VSWs by the training team, to ensure that all VSWs had access to a professional experienced in delivering vocational advice. Mentoring has been used successfully in trials of complex interventions, including interventions targeting work outcomes [9,74], the importance of mentoring in the development of competencies in RTW coordination has been emphasised[75]. Mentoring sessions included the VSWs delivering the intervention, members of the trial team including trial management and those with clinical experience of managing health and work. The supervision\u0026nbsp;aimed to:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eProvide the VSWs with peer learning and support, including about WAVE trial processes\u003c/li\u003e\n \u003cli\u003eSupport the VSWs to put the training into practice, supporting fidelity in delivery of the intervention. enable sharing of additional information and resources to support the VSWs to deliver the intervention (e.g. relating to Long-Covid and return to work)\u003c/li\u003e\n \u003cli\u003eConsolidate and further develop their knowledge, skills and behaviours to enable them to deliver the WAVE intervention\u003c/li\u003e\n \u003cli\u003eResolve practical challenges.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis paper describes a mixed-methods intervention and training development study for the VA intervention delivered in the WAVE trial. A review of current best practice identified treatment targets alongside intervention processes which formed the basis of the logic model underpinning the VA intervention. Additionally, the framework by which the VA intervention would be delivered was guided by current best practice with the intervention planned to be delivered by phone (with videoconferencing or face-to-face meetings where necessary and where appropriate given lockdowns due to Covid-19), using case management and stepped care. The review of current best practice also identified the topics to be included in the VSW training and mentoring programme which were aligned to the proposed VA intervention. The draft logic model, framework for intervention delivery and VSW training and mentoring programme were all taken to EAG and PPIE meetings to ensure that all content was appropriate, that no content was missing and in the PPIE meetings that participants felt comfortable with the proposed methods of delivering the intervention. These EAG and PPIE meetings allowed the logic model, content and framework of the VA intervention and the training and mentoring programme to be finalised.\u003c/p\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eComparison with wider literature\u003c/h2\u003e \u003cp\u003eThe WAVE trial intervention and training programme were developed from a review of current best practice, EAG and PPIE meetings and supported by an intervention developed for the SWAP trial[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] with modification to support people with any ill-health, not only musculoskeletal pain. The WAVE trial training was subsequently modified for the \u0026ldquo;MI NAV\u0026rdquo; trial[\u003cspan citationid=\"CR76\" class=\"CitationRef\"\u003e76\u003c/span\u003e] where it was used as part of a stratified care approach and amended to fit the Norwegian health and work context. The MI NAV trial reported that whilst there was a seven-day difference between those receiving usual care and those receiving each intervention (motivational interviewing and vocational advice) this difference was not statistically significant. The authors report that the stratified element of the trial whereby those assessed as low risk were offered one or two vocational advice sessions, and the extended duration of absence that participants had, of at least seven weeks, may have impacted on the results[\u003cspan citationid=\"CR76\" class=\"CitationRef\"\u003e76\u003c/span\u003e]. An examination of the mechanisms of the MI NAV trial demonstrated that changing a persons\u0026rsquo; expectation of RTW may have supported a reduction in absence[\u003cspan citationid=\"CR77\" class=\"CitationRef\"\u003e77\u003c/span\u003e] which is a key part of the WAVE trial intervention. The UK \u0026ldquo;ROWTATE\u0026rdquo; trial (trial results not yet reported) aims to support trauma survivors to RTW and has utilised similar methods for intervention delivery including a case management model, workplace accommodations and employer engagement[\u003cspan citationid=\"CR78\" class=\"CitationRef\"\u003e78\u003c/span\u003e]. Lastly, a recent realist literature review exploring programme theory for early intervention in vocational rehabilitation identified nine mechanisms and three outcomes that support RTW including: exploring options; optimising self-efficacy; staying connected; setting goals; engaging employers and flexing roles[\u003cspan citationid=\"CR79\" class=\"CitationRef\"\u003e79\u003c/span\u003e], all of which form the content of the WAVE intervention and give further confidence in the approach developed here.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and limitations\u003c/h2\u003e \u003cp\u003eThe development of the WAVE intervention and associated training programme has several strengths. The MRC framework for the development of complex interventions was followed[\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e], learning from a previous trial was incorporated[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] in addition to an underpinning review of current best practice, furthermore the intervention development process integrated the experiences, opinions and knowledge of our PPIE and EAG groups. The PPIE and EAG groups represented a broad range of experiences and in the PPIE group a range of health conditions and employment statuses. We were able to elicit a wide range of views enabling a good understanding of people\u0026rsquo;s needs when they are absent from work as well as those engaged in delivering vocational advice and employers. The use of underpinning behaviour change theories is a further strength ensuring that the intervention is developed in a way that is most likely to affect positive change on the key outcome of RTW. The RTW process is complex and requires people to take some responsibility for their RTW supported by the VSW and other stakeholders where relevant. Ensuring that VSWs build a rapport with people, adhere to the mechanisms of intervention delivery and use the embedded behaviour change techniques is paramount to a successful intervention. Lastly, this intervention focuses on the provision of \u003cem\u003eearly\u003c/em\u003e support for sickness absence, with the goal of preventing long-term absence. It is widely believed that intervening early before absence becomes long term (usually defined as greater than 4 weeks of absence[\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e]) is better for individuals, employers and brings economic benefits as demonstrated by both the SWAP trial[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] and the EASY study[\u003cspan citationid=\"CR80\" class=\"CitationRef\"\u003e80\u003c/span\u003e] and a recent systematic review[\u003cspan citationid=\"CR81\" class=\"CitationRef\"\u003e81\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA limitation to the intervention development was that we did not undertake intervention mapping or carry out a formal systematic review of the literature. The rationale for this was that the WAVE trial target population was mixed in terms of health condition and duration of absence, therefore the scope of intervention mapping and systematic review of the literature would not have been feasible. Whilst these formal methods were not used, we are confident that the underpinning logic model developed to support the WAVE trial vocational advice intervention includes appropriate treatment targets and anticipated mechanisms required for successful delivery of vocational advice as evidenced in other studies on the same topic[\u003cspan citationid=\"CR79\" class=\"CitationRef\"\u003e79\u003c/span\u003e, \u003cspan additionalcitationids=\"CR82 CR83\" citationid=\"CR81\" class=\"CitationRef\"\u003e81\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e]. Secondly, whilst we had a diverse group of participants in both our PPIE and EAG groups there were undoubtedly some underrepresented groups, for example those from ethnic minorities and those from lower socioeconomic groups. The relevance and acceptability of the intervention developed needs to be understood from the perspective of these groups, although the qualitative study as part of the WAVE trial will address this to some extent (Harrison \u003cem\u003eet al\u003c/em\u003e, under review). Recent publications have set out strategies to improve diversity within future research and adopting these strategies will go some way to addressing this issue in future studies[\u003cspan citationid=\"CR85\" class=\"CitationRef\"\u003e85\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis paper reports the development and content of the WAVE VA intervention and associated training programme for VSWs. The study has resulted in the creation of a logic model informed by behaviour change theory, the content of a VA intervention and the framework through which the intervention can be delivered. Lastly, an associated training and mentoring programme has been developed to equip VSWs with the attitudes, knowledge, skills and confidence to collaboratively identify and overcome obstacles to RTW. Given the high profile that sickness absence currently has, the WAVE trial[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] and its component parts such as the intervention, will have important implications for policy makers.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe WAVE trial was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR 17/94/49). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182). CCG is part funded by West Midlands Applied Research Collaboration (WM ARC). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe WAVE vocational advice intervention and the training programme for VSWs in the intervention was developed and/or influenced by all authors. Training and mentoring of VSWs was delivered and supported by GS, IM, KW-B, CC-G, GW-J, KC, SAL, GM, BS. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003einterests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGW-J holds a post with the West Midlands Regional Research Delivery Network. \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval for the WAVE trial was granted by National Research Ethics Service (NRES) Committee West of Scotland Research Ethics Committee (REC) 5, September 2020 (REC reference: 20/WS/0127).\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBlack C. Working for a healthier tomorrow. London; 2008. \u003c/li\u003e\n\u003cli\u003eNyl\u0026eacute;n L, Voss M, Floderus B. 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Tackling Musculoskeletal Problems a guide for clinic and workplace identifying obstacles using the psychosocial flags framework. Available from: www.tsoshop.co.uk/flags\u003c/li\u003e\n\u003cli\u003eBurton K, Kendall N, McCluskey S, Dibben P. Telephonic support to facilitate return to work : what works, how, and when ? 2013;142. Available from: https://www.gov.uk/government/publications/telephonic-support-to-facilitate-return-to-work-what-works-how-and-when-rr853\u003c/li\u003e\n\u003cli\u003eMacmillan Cancer Support. Work and cancer | Macmillan Cancer Support [Internet]. Available from: https://www.macmillan.org.uk/cancer-information-and-support/impacts-of-cancer/work-and-cancer\u003c/li\u003e\n\u003cli\u003eBritish Heart Foundation. Work and a heart condition - BHF [Internet]. 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Increasing diversity in research participation: A good practice guide for engaging with underrepresented groups. 2023 Feb. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Vocational advice, primary care, return-to-work, case-management, occupational health, training programme","lastPublishedDoi":"10.21203/rs.3.rs-6255102/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6255102/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e\u003c/em\u003e\u003cem\u003e:\u003c/em\u003e In the UK, people taking sickness absence have limited access to early vocational advice from independent practitioners, despite this being recommended as part of clinical care. This paper describes the development and content of a vocational advice intervention and associated training and mentoring programme.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/em\u003e\u003cem\u003e:\u003c/em\u003e\u003cstrong\u003e \u003c/strong\u003eThis was a mixed-methods intervention and training development study commencing with a review of current best practice. Expert advisory and patient group meetings were conducted to review components of the draft logic model; content and framework for delivery of the vocational advice intervention, and to inform the development and content of the training and mentoring programme for those delivering the intervention.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/em\u003e\u003cem\u003e: \u003c/em\u003eFrom the literature, and based on behaviour change theories, the derived logic model included treatment targets of: health; cognitions; behaviours; emotions; and occupational targets. Intervention processes included: problem-solving; goal setting; psychoeducation; reassurance; graded activity; RTW planning; and work modification. The framework for delivery was by telephone using case-management and stepped care. The logic model, treatment targets, intervention processes and delivery framework were discussed and approved by patients and expert advisors. The training programme was aligned to the content of the intervention and designed to be delivered online over 3 days with monthly online group mentoring.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/em\u003e\u003cem\u003e:\u003c/em\u003e\u003cstrong\u003e \u003c/strong\u003eA vocational advice intervention and associated training programme were developed and delivered for the WAVE trial, to be used with adults in receipt of a fit note for any health condition in primary care. Future work will evaluate the effectiveness of the intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegistration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eClinical Trials: NCT04543097\u003c/p\u003e","manuscriptTitle":"A mixed-methods intervention and training development study for the Work And Vocational advicE (WAVE) trial (Clinical Trials: NCT04543097)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-02 09:15:26","doi":"10.21203/rs.3.rs-6255102/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f6f69e34-2649-40cd-8556-c2a5d57847d2","owner":[],"postedDate":"April 2nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-07-29T21:38:32+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-02 09:15:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6255102","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6255102","identity":"rs-6255102","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}