Sustainable return-to-work in large organisations: feasibility of a multi-level cluster-randomised controlled trial

Sustainable return-to-work in large organisations: feasibility of a multi-level cluster-randomised controlled trial | Research Square 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 Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Sustainable return-to-work in large organisations: feasibility of a multi-level cluster-randomised controlled trial Fehmidah Munir, Alice Sinclair, Oliver Davis, Jeremy Dawson, Lizzie Degerdon, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8702436/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 Background: Long-term sickness absence is a growing public health concern in the UK, yet few workplace-based interventions address both health and work factors needed to support sustainable return-to-work. This study assessed the feasibility of delivering and evaluating a multi-component return-to-work intervention to inform a fully powered trial. Methods: We conducted a two-arm, cluster randomised controlled feasibility trial in large organisations (≥600 employees) across NHS, public services, higher education, and private sector in Yorkshire and Humberside, UK. Nine clusters participated, including 91 senior leaders and HR professionals (intervention only), 112 workers (43 intervention, 69 control), and 83 managers (20 intervention, 63 control). Eligible workers were on long-term sick leave (15–42 days) for mental or physical health conditions. The IGLOo intervention comprised three phases: (1) e-learning for senior leaders and HR; (2) and (3) mirrored six-step online toolkits for workers and line managers during sick leave and post-return to work. Feasibility outcomes included recruitment, retention, intervention completion, acceptability, and usability assessed using predefined stop–go traffic light criteria. Secondary outcomes (collected at baseline and 3, 6, 9, and 12 months) included sick leave duration, sustained work participation, mental health, quality of life, workplace support, and communication Web analytics, qualitative interviews and an organisational survey explored engagement, implementation and contextual factors. Results Retention, acceptability, and usability met green feasibility thresholds. Intervention completion met amber thresholds. However, recruitment of workers and managers met red thresholds. Qualitative findings identified mechanisms supporting sustainable return-to-work including improved confidence, communication and job-crafting; and highlighted organisational factors (e.g. workload, restructuring, managerial capability) that shaped feasibility. Preliminary exploratory findings indicated that workers in the intervention group took longer to return to work but were more likely to return and remain in work compared with controls. Conclusions Findings indicate that the IGLOo intervention is acceptable and usable, with promising indications for supporting sustainable return-to-work. Recruitment challenges and contextual barriers suggest refinements are required before progressing to a fully powered trial. A future trial should prioritise improved recruitment strategies and consider organisational readiness to implement multi-level return-to-work support. Trial registration number ISRCTN11788559, registered on 6 th October 2022 (prospectively registered)) Feasilbity cluster randomised trial sick leave return-to-work employer manager worker Figures Figure 1 INTRODUCTION Long-term sickness absence is a major and escalating public health challenge in the UK and internationally, contributing to rising economic inactivity, lost productivity and widening health inequalities [ 1 , 2 ]. Mental health conditions, often co-occurring with other health conditions such as musculoskeletal problems, are leading drivers of long-term sickness absence [ 3 – 5 ], with many workers continuing to experience symptoms, reduced functioning and work limitations after they return to work (RTW) [ 6 , 7 ]. These challenges create substantial societal and economic burdens [ 8 ] and highlight the need for comprehensive workplace approaches that support both RTW and long-term sustainability of work participation. Evidence suggests that RTW interventions are most effective when symptom-focused strategies (e, g., cognitive behavioural approaches) are RTW when combined with work-directed components such as early, high-quality communication and structured panning led by line managers. regular manager contact during absence and structured support [ 9 – 12 ]. However, most comprehensive RTW programmes have been developed in countries with strong legislative incentives or integrated health-social care structures (e.g., parts of Scandinavia, the Netherlands, Canada) [ 13 – 15 ], limiting transferability to the UK, where employers and line managers hold primary responsibility for absence management [ 16 ], and organisational RTW practices remain variable [ 17 ], despite national guidance from UK bodies such as NICE [ 18 ]. This gap points to the need for UK-based, evidence-informed multi-component interventions that can be implemented within diverse organisational contexts. The IGLOo intervention was designed to address this gap through a multi-level, multicomponent approach grounded in the IGLOo model [ 19 ], which emphasises resources and actions at the Individual, Group, Leader, Organisation, and Outside-context levels (Supplementary File 1). IGLOo integrates principles from cognitive and-behavioural [ 20 ], communication-accommodation [ 21 ], and social cognitive-theories [ 22 ], and from job-demands-resources concepts [ 23 ], to strengthen self-management, supportive communication, managerial practice and job design for sustainable RTW. The intervention aims to facilitate initial RTW and to maintain participation over time, reflecting evidence that many workers face ongoing challenges for up to a year after returning. [ 6 , 24 ]. Policy priorities in the UK increasingly emphasise early intervention, stronger employer capability and sustained employability for people with health conditions. Government initiatives [ 25 , 26 ] highlight the urgent need for evidence-based practices to reduce long-term sickness absence and support people to return to and remain in work. This intervention directly responds to these priorities by offering a structured, theoretically informed approach that targets known barriers at individual, managerial and organisational levels. Despite strong conceptual foundations there have been no cluster-randomised feasibility evaluation of IGLOo within larger UK organisations to establish the practicality of delivery in large, real-world organisations, to understand implementation mechanisms and contextual barriers, and to inform a future effectiveness trial focusing on sustainability of RTW. This study therefore aimed to assess the feasibility of a cluster-randomised controlled trial of the IGLOo intervention, examining recruitment, retention, data collection and outcome sensitivity. It also evaluated implementation in terms of acceptability, fidelity, usability, and sustainability and explored contextual factors and mechanisms to inform a future efficacy trial. METHODS Study design, setting and population We conducted a two-arm pilot cluster-randomised controlled trial with a nested mixed methods process evaluation to assess the feasibility, acceptability and implementation of the multi-level IGLOo RTW intervention in large UK organisations. The trial was conducted over 36 months, followed the CONSORT 2010 Extension to Pilot and Feasibility Trials [ 27 ] received Health Research Authority approval from the Leicester Central Research Ethics Committee (IRAS 313499; REC 22/EM/0143), was conducted in accordance with the Declaration of Helsinki and was prospectively registered on 6th October 2022 (ISRCTN11788559). The trial protocol is published [ 28 ], and a list of amendments to the protocol is available in Supplemental File 2. A Patient and Public Involvement (PPI) group of 13 members with diverse job roles and health conditions co-designed the recruitment plan, promotional materials, and evaluation tools, helping enhance clarity and relevance. The lead PPI contributor (LD) also joined project team meetings to ensure ongoing engagement. Settings, clusters and randomisation Organisations were the unit of randomisation to minimise and reflect the organisational nature of the intervention. Organisations with ≥ 600 employees in the Yorkshire and Humber region, England, and with at least 2% of staff on long-term sick leave in past year, 29 were eligible and recruited through NHS partnerships, sector networks and direct outreach. Our recruitment target was ten organisations and at least four clusters per arm [ 29 ]. Ninety-four large organisations were approached, resulting in 24 expressions of interest. Ten organisations provided informed consent, one withdrew prior to the start, leaving nine clusters that were randomised 1:1 to intervention or usual practice, were stratified by NHS versus non-NHS status. Participants and intervention providers were unblinded due to the nature of the intervention. All participating organisations provided written consent. Participants and recruitment Participants were recruited across three phases corresponding to intervention levels. In Phase 1, HR contacts in intervention organisations only, identified and invited eligible senior leaders and HR professionals via email. Those interested contacted the research team directly and subsequently provided informed consent to participate. In Phase 2, HR teams in intervention and control organisations used sickness absence records to identify workers on long-term sick leave for 15–42 days due to any mental or physical health condition, excluding severe mental disorders (e.g. psychosis), substance misuse and cancer cases with prolonged investigation or workers under disciplinary procedures. Postal invitations were sent by HR to workers and parallel email invitations were sent to their line manager. Participants registered their interest electronically or by post directly to the research team and were subsequently provided informed consent to participate. Worker–manager dyads were encouraged but not required so that either party could participate independently. Workers and managers consenting in Phase 2 were followed in Phase 3 after the worker’s return. Intervention The IGLOo intervention was structured across three phases and targeted Individual, Group, Leader Organisation, and Outside-context levels to support both RTW and sustained participation. Phase 1 (Organisational level) delivered a five-step online programme for senior leaders and HR professionals covering mental health and RTW foundations, integrating best practice into policy and processes, stakeholder engagement and strategies for embedding the toolkits within existing systems In Phases 2 and 3 (both targeting Individual and Leader levels), workers and managers accessed mirrored online toolkits organised into six-steps: 1) managing initial sick leave, 2) maintaining communication during absence, 3) preparing to return, 4) reintegration in the first week back, 5) staying healthy at work, and 6) sustaining work participation. Each step included evidence-based guidance, action checklists, communication guides, exercises, RTW planning tools and resources to support sustained work participation. Toolkit use was flexible to reflect stage of absence and local context. Workers were additionally offered three one-hour telephone coaching sessions delivered by trained researchers to enhance engagement with the toolkits, support goal-setting and problem-solving and address barriers to returning to work [ 28 ]. Intervention components related to Group and External Support levels were not assessed. The intervention was underpinned by cognitive-behavioural theory [ 20 ], communication and accommodation theory [ 21 ], social cognitive theory [ 22 ] and job-demands resources concepts [ 23 ]. In this feasibility trial, Group and Outside-context components were not formally assessed. Control condition Control organisations continued with usual absence and RTW procedures. Prior to randomisation, organisational policies were reviewed to confirm that existing RTW processes did not duplicate or conflict with the intervention. Implementation strategies To support study implementation, multi-level strategies were used. At organisational entry, sickness-absence and return-to-work (RTW) policies were mapped to assess readiness and identify integration routes. As described in the intervention section, senior leaders and HR staff completed a structured online learning programme (Phase 1), which functioned as a leadership capacity-building strategy to secure buy-in and support embedding of RTW practices within organisational policies, consistent with ERIC guidance [ 30 ]. Each site nominated an internal HR lead who acted as an implementation champion, coordinating eligibility screening, invitations, and serving as liaison for implementation check-ins. Co-produced internal communications supported study awareness, and intervention organisations were encouraged to provide protected time for toolkit use, with alternative formats supplied where digital access was constrained. Ongoing facilitation was provided by the research team through regular meetings with HR leads to monitor progress, address contextual barriers, and adapt roll-out as required. Recruitment procedures described elsewhere also functioned as an implementation strategy, enabling systematic identification and invitation of eligible workers and managers. Participant-facing conversation guides and checklists supported consistent enactment of RTW practices. Indicators of organisational integration were documented, and proposed adaptations for future scale-up were identified through the process evaluation. Outcomes, measures and timepoints The primary objective was feasibility rather than effectiveness. Pre-specified stop-go “traffic light” criteria [ 27 , 31 ] guided progression decisions for recruitment, retention, completion, acceptability and usability (Table 1 ). Feasibility outcomes comprised organisational uptake, participant recruitment; and retention and data completion at each timepoint: Phase 1 participants completed surveys at baseline, 1 month after receiving the learning and a 6-month email follow-up regarding practice changes and use of toolkits. Phase 2 participant workers and managers completed surveys at baseline, 3, 6, 9, and 12 months. Baseline data were used to assess potential selection bias between groups. The feasibility of collecting sick-leave data via monthly text messages to participants was evaluated for completeness. Table 1 Stop-go feasibility criteria and the traffic light* grading assessment Criteria Traffic Light Assessment + Criteria met Recruitment Organisation Worker and Manager Green > 50%; amber 30–50%; red < 30% Green ≥ 50%; amber 30–49%; red < 30% 42% 6.2% &4.2% Amber Red & Red Retention Worker and Manager Green ≥ 70%; amber 40–69%; red < 40% 70.5% & 69.2% Green & Amber Phase 1 of intervention Usability Green: ≥ 75%; amber 50–74%; red < 50% 91.2% 30.8% Green Completion Green ≥ 50%; amber 25–49%; red < 25% Amber Phase 2 of intervention workers Completion Acceptability Usability Coaching attendance (x3) Green ≥ 50%; amber 25–49%; red < 25%. Green: ≥ 80%; amber: 50–79%; red: < 50% Green: ≥ 75%; amber 50–74%; red < 50% Green: ≥ 75%; amber 50–74%; red < 50% 32.6% 41.9% 76% (mean %) 100% Amber Amber Green Green Phase 2 of intervention managers Completion Acceptability Usability 30.0% 90.0% 91.7% (mean %) Amber Green Green Green ≥ 50%; amber 25–49%; red < 25%. Green: ≥ 80%; amber: 50–79%; red: < 50% Green: ≥ 75%; amber 50–74%; red < 50% Phase 3 workers Completion Behaviour Change 32.6% 79.3% Green ≥ 50%; amber 25–49%; red < 25%. Amber Green ≥ 25%; amber 10–24%; red < 10%. Green Phase 3 managers Completion Behaviour change Green ≥ 50%; amber 25–49%; red < 25%. 30.0% Amber Green ≥ 25%; amber 10–24%; red < 10%. 75% Green * Green light: main trial to go ahead; amber: main trial with adjustments; red: no main trial. Completion assessed by web analytics and does not include those who may have used a hard copy either by downloading the toolkit or by requesting a hard copy. Usability, acceptability and behaviour change are based only on those who took part in the interviews. Intervention Implementation A nested process evaluation, informed by the Implementation Outcomes Model (IOM) [ 32 ] and Integrative Process Evaluation Framework (IPEF) [ 33 ] was conducted to assess intervention fidelity (from website analytics and participant interviews), acceptability, appropriateness, usability, sustainability, self- reported behaviour changes among workers and managers, implementation costs, and context-mechanism-outcome patterns. Data sources included website analytics, worker, manager, leader interviews (with embedded Likert-rating questions) at phase-specific milestones (all participants invited to interview), recording of worker coaching sessions, monthly interviews with HR contacts to document operational barriers and facilitators and contextual influences on implementation. Organisational documents and communications (e.g. emails, posters) were analysed to assess awareness-raising strategies, and the organisation-wide survey captured work demands, policy awareness, mental health culture and climate (baseline and 18 months). Qualitative interviews also focused on how organisational conditions (e.g. workload, restructuring, strikes) influenced implementation and engagement. Exploratory outcomes Exploratory RTW outcomes were defined a priori as days from the first day of the long-term sick-leave spell to the first day of partial or full RTW, and the number of days at work without a subsequent spell of long-term sick leave during the following six months, to capture both speed and sustainability. RTW status and dates were collected via surveys and monthly text messages and were triangulated. Secondary worker-reported outcomes included depression [ 34 ], anxiety [ 35 ], quality of life [ 36 ], exhaustion/burnout [ 37 ], RTW expectations [ 38 ], readiness and confidence [ 39 ], communication quality and support [ 40 ], intention to quit [ 41 ], and job satisfaction [ 42 ]. Once a worker had returned to work, questions were asked on work performance [ 43 ], readiness to stay [ 44 ], work adjustments, job crafting [ 45 ], and colleague support [ 46 ]. Secondary manager-reported outcomes included prior training and experience in sick leave/RTW management, job demands [ 47 ], 44 autonomy [ 48 , 49 ], confidence in managing mental health [ 50 ]. Workers and managers also completed a manager competence scale [ 51 ]. Demographic data were collected. Leaders and HR professionals survey questions included policy awareness, job autonomy and demands, change readiness, communication, and demographics. See protocol for a full description [ 28 ]. Sample size and analyses As a feasibility trial, the target was to recruit 100 workers (50 per arm) from eight organisations across 18 months, to estimate design parameters [ 52 ]. No recruitment targets were set for managers or leaders and HR professionals. Analysis focused on feasibility and exploratory evaluation. Quantitative analyses summarised feasibility indicators descriptively and explored patterns in outcomes with multilevel models accounting for organisational clustering. Time to RTW was examined using multilevel Cox regression; binary outcomes (any RTW, sustained RTW) used multilevel logistic regression; and continuous measures used multilevel linear regression with baseline adjustment where available. Sensitivity analyses included demographic covariates (age, gender, ethnicity, education) and Multiple Imputation by Chained Equations for missing data. Interview transcripts were analysed using template and thematic analysis guided by context–mechanism–outcome reasoning; qualitative and quantitative findings were integrated to refine theories of change and inform design options for a subsequent evaluation RESULTS Recruitment and retention Table 2 provides details of the nine participating organisations (fur intervention, five control). Eight were public-services organisations including three NHS Trusts. Policies on sick leave and RTW were broadly comparable at baseline, with minor procedural variations (Supplementary File 3). Table 2 Summary of invites and consented participants for each organisation Group Organisation Size Total invites sent Workers consented Managers consented Intervention 1 [NHS] ~ 3,500 437 27 (6%) 13 (3%) 2 [NHS] ~ 5,640 ~ 287 12 (4%) 6 (2%) 3 [Education] ~ 2,100 33 2 (6%) 1 (3%) 4 [Transport] ~ 2,006 Unknown 2 0 Control 5 [Law Enforcement] 3,337 593 44 (8%) 36 (6%) 6 [Emergency Services] ~ 6,000 206 7 (3%) 12 (5%) 7 [Local Authority] 2,135 234 8 (3%) 7 (3%) 8 [Emergency Services] ~ 961 96 5 (5%) 4 (4%) 9 [NHS] 6,766 67 5 (7%) 4 (6%) In Phase 1, 247 senior leaders and HR professionals were invited from intervention organisations; 91 (36.8%) consented and completed baseline, 41 (45.1%) completed the one-month follow-up, 23 were interviewed, and 13 provided six-month behaviour change feedback. In Phases 2–3, organisations posted 1,953 invitations to eligible workers and emailed a corresponding number of managers. In total, 112 workers (43 intervention, 69 control) and 83 managers (20 intervention, 63 control) consented; no dyads were formed. Most intervention-arm participants were recruited from two organisations, and over half of control participants were from one site (Organisation 5, Table 2 ). Incomplete absence records prevented calculation of proportion of all eligible workers invited. Participant flow is shown in Fig. 1 and participant characteristics in Table 3 . Across arms, the modal reason for sick leave was poor mental health, followed by other conditions (e.g. surgery, cardiopulmonary, abdominal) and musculoskeletal problems. Irrespective of condition, most workers reported at least moderate depression and anxiety at baseline. Retention met or approached green feasibility thresholds (workers 70.5%; managers 69.2%). Table 3 Demographic data from Phase 1 and Phase 2/3 participants Senior leaders/ HR (Phase 1) Workers (Phase 2&3) Managers (Phase 2&3) Intervention only n = 91 Intervention n = 43 Control n = 69 Intervention n = 20 Control n = 63 Gender Male 23 (25%) 9 (21%) 24 (34%) 0 (0%) 26 (41%) Female 67 (73%) 34 (79%) 45 (64%) 19 (95%) 37 (58%) Ethnicity White 83 (88%) 41 (95%) 64 (91%) 17 (86%) 61 (95%) Asian 5 (5%) 0 (0%) 2 (3%) 0 (0%) 2 (3%) Black 0 (0%) 1 (2%) 1 (1%) 0 (0%) 0 (0%) Mixed 1 (1%) 1 (2%) 1 (1%) 0 (0%) 0 (0%) Prefer not to say 2 (2%) 0 (0%) 2 (3%) 2 (10%) 0 (0%) Mean age (years) 45 50 44 44 45 Age range (years) 25–63 28–67 21–66 28–57 26–62 Highest level of education Undergraduate degree or above 64 (70%) 20 (47%) 27 (39%) 9 40 Below degree level 27 (30%) 23 (53%) 42 (60%) 10 23 Mean years in organisation [SD] 10.7 [10.2] 12.3 [10.7] 11.5 [9.2] 16.8 [10.1] 15.1 [13.8] Mean years in role [SD] 3.5 [4.1] 6.6 [7.8] 6.2 [6.5] 4.1 [4.9] 3.4 [3.6] Occupational classification Managers, directors 43 (47%) 1 (2%) 4 (6%) 2 (10%) 18 (29%) Professionals 48 (53%) 21 (49%) 15 (22%) 9 (45%) 18 (29%) Assoc. professionals - 5 (12%) 31(45%) 7 (35%) 26 (41%) Administrative - - 6 (14%) 15 (22%) 1 (5%) 1 (2%) Skilled trades - 1 (2%) 0 (0%) - - Service occupations - 2 (5%) 2 (3%) - - Machine Operatives - 2 (5%) 2 (3%) - - Elementary/routine - 5 (12%) 0 (0%) - - Job type Office based - 14 (33%) 42 (61%) - - Manual - 10 (23%) 13 (19%) - - Mix of both - 19 (44%) 14 (20%) - - In a relationship - 30 (70%) 58 (84%) - - Main earner - 26 (60%) 31 (45%) - - Mean salary [min-max] - £28,813 [£12,000- £51,000] £31,587 [£9,000- £62,000] - - Health conditions* Mental health - 25 (58%) 28 (41%) 11 (55%) 28 (45%) Musculoskeletal - 7 (16%) 18 (26%) 4 (20%) 16 (26%) Other (e.g. surgery, heart, lung problems) - 11 (26%) 23 (33%) 5 (25%) 19 (29%) PHQ9 mean score (SD) Mental health - 15.6 (6.9) 14.3 (5.3) - - Musculoskeletal - 9.1 (4.6) 10.0 (6.0) - - Other (e.g. surgery, heart, lung problems) - 9.7 (7.7) 9.5 (6.4) - - Score of ≥ 10 on PHQ9** Mental health Musculoskeletal Other (e.g. surgery, heart, lung problems) - - - 24 (56%) 4 (9%) 5 (12%) 23 (34%) 11 (16%) 10 (15%) - - - - - - GAD-7 mean score (SD) Mental health Musculoskeletal Other (e.g. surgery, heart, lung problems) Score of ≥ 8 on GAD 7 + Mental health Musculoskeletal Other (e.g. surgery, heart, lung problems) - - - - - - 12.7 (6.1) 6.3 (4.3) 7.8 (5.9) 20 (47%) 4 (9%) 5(12%) 12.9 (5.3) 7.0 (6.8) 6.1 (5.7) 23 (33%) 5 (7%) 8 (12%) - - - - - - - - - - - - *For managers, health conditions are for those workers they were managing on sick leave. ***moderate to severe depression. + Moderate to severe anxiety. Intervention fidelity, acceptability and usability In Phase 1, website analytics were available for 57/91 leaders/HR (Supplementary File 4); 28/91 (30.8%) accessed all content and 18/23 (78%) interviewed reported full engagement. Among those who used the materials and completed follow-up; 31/34 (91.2%) found the training engaging and would recommend it. Participants reported improved understanding of mental health at work (83%), and sickness absence/RTW support (about half), with high baseline scores likely limiting change in readiness to change and communication. Most planned to embed the toolkits into policy and practice (75–83%). Qualitative analyses found participants liked the balance of video and text in the webinars and clarity, relevance and easiness of the toolkits. In Phases 2–3, worker fidelity by website analytics showed 10/43 (23.3%) accessed steps 1–5 during Phase 2, 14/43 (32.6%) accessed steps 2–5, and 13/43 (30.2%) accessed step 6 (Supplementary Files 5a). Eight workers used printed toolkits, suggesting true engagement exceeded online metrics. In interviews, 26/27 (96.3%) reported completing at least one step in Phase 2 and 14/18 (77.8%) completed step 6 at Phase 3. Among managers, 4/20 (20.0%) accessed steps 1–5 online during Phase 2 and 6/20 (30.0%) accessed step 6 (Supplementary File 5b); some used hard copies or became ineligible because workers moved teams. In interviews, 10/12 (83.3%) managers reported completing at least one step, though none completed all steps. Findings integrate content, template and inductive thematic analyses. Acceptability was high: all workers and 80% of managers who used the toolkits rated them positively. Workers frequently described the toolkits as clear, relevant and supportive during a period often characterised by emotional strain and uncertainty. “ I couldn’t even think about work, but [the toolkit] helped me to think about it and not be frightened of going back ” (organisation 2). Likert rating indicated that most workers and managers found checklists and exercises as useful or very useful (Supplementary File 6a and 6b) and the content appropriate to the realities of long-term sickness absence and RTW. Workers found the step-by-step format as being clear and applicable across different roles and health conditions; and valued having supportive content at a challenging time when HR or healthcare input felt limited. As one participant noted, “It’s made [my return] more positive… made me aware of what I can expect or what should be made available for me, and the importance of making contact with colleagues and speaking to your line manager ” (organisation 1). However, a few workers found the volume of information difficult to process early in their absence. Managers valued the structure and clarity the toolkit offered, noting that it aligned with expected RTW conversations; supporting “logical” and “ methodical” conversations; and “one of the easier things I’ve had to use.” (organisation 1). Some managers with heavier workloads found the length challenging and suggested more short videos to support engagement. Usability issues were minor and mainly related to accessing material on mobile devices or work computers with firewall restrictions. Several participants found printed copies easier to use. Behaviour changes and adoption Across interviews and coaching, 23/29 (79%) workers reported specific behaviour changes linked to toolkit use. Workers described improved communication with managers, more proactive help-seeking, structured goal-setting and wellbeing activities, journalling to externalise worries, using readiness-to-return scales to avoid premature RTW, and implementing workplace adjustments or job-crafting strategies such as taking breaks and reducing distractions. One worker described writing exercises as a way of “offloading… it reinforces what I’m thinking about.” (Worker, organisation 2). A dominant theme for workers was the toolkit helped them take ownership of their RTW journey and “check [things] off, because it’s quite easy, when you’re ill, to forget about these things, or not consider them" (worker from organisation 1), prepare for work participation, have confidence in asking for work adjustments and hold proactive communication with managers and colleagues. Workers also described improved wellbeing through greater self-compassion. Managers reported more compassionate communication as illustrated by one participant “I’d say that I’m quite an empathetic manager myself, but when there were things that surprised me, where I’d think ooh I never thought of asking about that…” ( organisation 3), more frequent wellbeing check-ins, and greater confidence in managing RTW, and offering more structure support “ right from them going off to returning and the in-between” ( manager, organisation 2). Benefits included stronger manager–worker relationships and improved mental health awareness. Less experienced managers found it especially useful for aligning practice with policy and anticipated using it in future cases. Workers and managers supported future use of the toolkits but noted that lack of time, especially for staff in patient-facing roles, could limit uptake. They also emphasised the importance of manager involvement and organisational awareness. As one worker noted, “ It’s a really positive, proactive tool… if the line manager is involved ” (Worker, organisation 1). The toolkit was seen as suitable for integration into existing policies and suggestions were made to shortening content, providing introductory training, and embedding job-crafting into supervision to support wider use. Who did the toolkits work best for Overall, the intervention appeared to work best for workers with either physical or mental health, workers whose job demands allowed time to engage with the toolkits after returning to work as one described “ work wise, patient wise, problems wise It felt like there was an avalanche of work and it wasn’t worth me putting my umbrella up " (organisation 1), whose managers supported their use during work hours and were receptive to job-crafting ideas, and for those able to implement small work adjustments independently. Workers with previous experience of long-term sick leave or established self-management strategies also valued elements that were new to them. Among managers, benefits were most evident for those who were newer or less confident in managing long-term absence, as well as for experienced managers seeking to refine existing practice; engagement was facilitated when managers had “ got enough time to look at that [toolkit]” (Organisation 1), autonomy over how they used the toolkits and organisational permission to undertake the additional actions required to support staff wellbeing. Coaching engagement and contribution Among 43 intervention workers, 25 (58%) attended at least one session and 18 (42%) completed all three. Participants rated the coaching useful (Supplementary File 7). Qualitative findings indicated that coaching was viewed as the mechanism that “ glued together” the toolkit by bridging reflective exercises with actionable RTW planning. Participants found the coaching sessions strengthened motivation, offered a confidential space for emotional containment, and supported structure and pacing of decisions during a vulnerable period. As one participant put it, “[The coach] was my structure through my whole absence” (Worker, Organisation 1). Workers with high anxiety or cognitive load particularly valued coaching to organise tasks, rehearse conversations and build confidence to request adjustments. Monthly sessions were seen as appropriate, though some suggested aligning coaching more tightly with toolkit steps. Organisational context and climate-level change Feasibility and engagement were shaped by substantial organisational pressures. Monthly interviews with HR contacts described recruitment freezes, industrial action, staff shortages and restructuring, all of which limited capacity for both managers and workers to engage. These pressures were most pronounced in large public-sector settings with high demand and change agendas. Despite these constraints, several intervention organisations made early system-level changes influenced by the intervention, including revising attendance policies, incorporating toolkit content into manager training and improving sickness absence reporting systems, suggesting nascent integration of the intervention into routine processes. Organisation wide surveys conducted at baseline and at 18-months (n = 871 responding at both points; mean age 44.9, 74% women, 97% White), provided evidence of change at the climate level: mental health stigma decreased in intervention sites relative to controls (mean difference = -0.27, 95% CI -0.49 to -0.04; p = 0.02), while perceived leadership support declined in intervention sites (mean difference = − 0.21, 95% CI − 0.39 to − 0.03, p = 0.030), likely due to restructuring and strike action reported by HR contacts. There were no differences in wellbeing, burnout, or mental health communication at the organisational level. Study awareness increased at follow-up in both arms Secondary (exploratory) outcomes Findings indicate trends only (Supplementary File 8). For primary outcome, time to RTW, the hazard ratio was 0.88 (95% CI: 0.49–1.56), indicating the control group returned slightly sooner (median days 60, IQR 34–86) than the intervention group (median 94, IQR 49–157). Sensitivity analyses adjusting for demographic covariates produced a similar result (HR 0.91, 95% CI: 0.48–1.70). However, RTW rates were slightly higher in the intervention group (79% vs 72%; OR 1.51, 95% CI: 0.51–3.26), as were rates of sustained return (70% vs 65%; OR 1.23, 95% CI: 0.41–3.58). Intervention participants also showed lower depression and anxiety scores at 3 months (mean (SD): intervention 17.4 (6.8); control 16.9 (4.7)), and intervention managers reported greater confidence and competence in managing sickness absence. Economic data were limited: mean organisational cost to implement IGLOo was £9,068 over 24 months; the mean per-user cost was £30 for workers and £64 for managers, with toolkit access provided free of charge. Stop–Go Decision for Main Trial Organisational willingness met the amber criteria (41.7–42%). Phase 1 recruitment and retention met amber thresholds, while worker and manager recruitment in Phases 2–3 were red (6.2% and 4.2%, respectively). Retention to study-end met green (workers 71%, managers 69%). Intervention engagement and completion were amber across phases, while acceptability and usability were green (> 90% positive ratings among those interviewed). Reported behaviour change (e.g., manager more supportive of worker post return) exceeded green benchmarks. Overall, findings support progression to a full trial with adjustments in the recruitment strategy and stronger organisational enablement. DISCUSSION This feasibility cluster-randomised controlled trial examined the acceptability, usability and implementation of the multi-level IGLOo intervention in large UK organisations, and the findings provided promising evidence to support progression to a fully powered trial. Our findings also offer critical information for refining both the intervention and the future trial design. Across workers, managers and senior leaders, the intervention was well received, and retention met or exceeded feasibility thresholds, demonstrating that delivery of a complex RTW intervention is possible within organisational systems facing substantial operational demands. At the same time, recruitment of workers and managers did not meet feasibility targets and fell within the predefined red range, indicating that any future trial will require revised recruitment strategies and stronger organisational enablement. The study generated new insights into how multicomponent interventions operate in real-world settings and reinforce prior evidence that multi-component workplace interventions addressing both health and work factors can influence RTW experiences in positive ways [ 9 , 12 ]. A distinctive strength of this feasibility trial is its embedded process evaluation. Few RTW intervention studies incorporate implementation science frameworks this extensively and doing so provided rich context-mechanism-outcome explanations. The trial identified clear mechanisms of change. Workers described improvements in confidence, self-efficacy and communication with managers, alongside increased ability to pace their return and negotiate adjustments. Coaching emerged as a critical mechanism for facilitating engagement with the toolkits, providing continuity during periods of uncertainty. These mechanisms align with the theoretical underpinnings of IGLOo, particularly cognitive-behavioural, communication and job demand–resources principles and provide plausible explanation for why the intervention may influence long-term outcomes. Managers also reported increased confidence and a more structured, compassionate approach to supporting workers, suggesting that IGLOo strengthens leadership capability as well as individual self-management. The results also identified who the intervention is most likely to benefit within organisations. For example, workers and managers were more able to use the toolkits when job demands were manageable and were supported in using the toolkits and implementing small changes. These insights are essential for targeting support and refining future implementation. Importantly, who benefited, and to what extent, appeared contingent on contextual conditions and the observed recruitment challenges, reinforcing the need to pair intervention delivery with realistic, system-sensitive recruitment routes. The study also highlighted significant contextual influences that shaped feasibility and engagement. Widespread industrial action, organisational restructuring and high workloads were common across several intervention sites, limiting both HR capacity to identify eligible participants and the ability of workers and managers to engage fully with intervention steps. These findings mirror well-documented system-level pressures across UK public-sector organisations and demonstrate that successful implementation of workplace RTW interventions depends not only on the quality of the intervention content but also on organisational readiness, role design, digital accessibility and the stability of local systems. The clear message is that implementation strategy, not just intervention design, will be critical for future scale-up. A key contribution of this study is the distinction between the speed and sustainability of RTW. Exploratory analyses suggested that workers in the intervention arm took longer to return to work but were more likely to return and remain in work thereafter. Although the trial was not powered to detect statistical differences, this pattern is conceptually important. Much RTW policy and practice continues to prioritise rapid return; however, emerging evidence indicates that premature RTW may increase the risk of relapse and recurrent absence [ 53 , 54 ]. By contrast, the IGLOo intervention, grounded in theory and involving both worker and manager resources, appears positioned to support sustainable RTW outcomes that align with UK policy goals to improve long-term work participation for people with complex health profiles. From a public-health perspective, these findings also have implications at policy and system levels. UK government initiatives such as Get Britain Working [ 25 ] and the Keep Britain Working Review [ 26 ] highlight the need for early intervention, improved employer support and sustained employability for people with health conditions. The present findings align with these policy goals by identifying mechanisms that support longer-term work participation, the importance of manager capability and the value of structured, evidence-based organisational support. They also suggest that large public-sector organisations, despite having existing policies, may struggle to fully engage in additional interventions during periods of organisational pressure. Smaller employers, which often lack structured sickness-management processes altogether, may therefore represent a more responsive and higher-impact setting for future implementation This study has several strengths including its mixed-methods design, theory -informed intervention high retention, rigorous process evaluation and diverse organisational settings. It also has limitations typical of feasibility studies. Worker and manager recruitment fell below predefined targets, partly due to capacity constraints within HR teams and data-system limitations in identifying eligible staff. The intervention was delivered under challenging organisational conditions that may have limited exposure, and the sample lacked diversity across ethnicity and job roles. These limitations highlight areas for adaptation before a fully powered trial. Future research should explore alternative recruitment pathways, including occupational health, healthcare services and intermediaries such as Employee Assistance Programmes. Designs such as stepped-wedge trials, naturalistic implementation studies or hybrid implementation-effectiveness designs may offer pragmatic and scalable approaches. Further intervention refinement, including versions for new versus experienced managers may improve uptake. Finally, studies involving small-and-medium sized enterprises (SMEs) are particularly warranted, given the potential for high impact in settings with fewer resources. In summary, this feasibility trial demonstrated that the IGLOo intervention is highly acceptable and has promise for improving sustainable RTW outcomes, while also highlighting significant contextual and organisational barriers that must be addressed before a larger trial. The findings advance knowledge about multilevel RTW interventions, mechanisms of change and real-world implementation challenges, and provide a strong foundation for future research aimed at improving public-health outcomes for workers on long-term sick leave. Abbreviations RTW Return–to–work IGLOo Individual, Group, Leader, Organisation, Outside–context Declarations Ethics approval and consent to participate: Ethical approval was obtained from the Leicester Central Research Ethics Committee HRA on 5 August 2022. IRAS project ID: 313499 REC reference: 22/EM/0143. All organisational contacts provided informed consent to participate on behalf of their organisation; all control and intervention participants individually informed consent to participate. All research was conducted in accordance with the Declaration of Helsinki. Consent for publication: Obtained Competing interests: None declared Funding: This project is funded by the National Institute for Health Research (NIHR) Policy Research Programme (Reference: NIHR202986). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Author Contribution Study conceptualisation FM, JY, KN; study design AS, FM, J Dawson, J Delgadilo, JY, LD, OD, UK; data collection AS, OD; analyses OD, AS, J Dawson; writing, reviewing and editing manuscript AS, FM, J Dawson, J Delgadilo, JY, LD, OD, UK. Acknowledgement We thank all participating organisations for their time and study support. We also thank all participants for their participation. We acknowledge the significant contribution of Karina Nielsen in the conception and contribution of the project, and who sadly passed away before the project end. 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