Supporting employers and their employees with mental hEalth conditions to remain eNgaged and producTive at wORk (MENTOR):A feasibility randomised controlled trial

Employees with mental health conditions often struggle to remain in employment. During the COVID-19 pandemic, these employees faced additional stressors, including worsening mental health and work productivity. In 2020, as part of a larger programme of work called the Mental Health and Productivity Pilot (MHPP), we developed a new early intervention (MENTOR) that jointly involved employees, managers, and a new professional (Mental Health Employment Liaison Worker (MHELW). The intervention involved trained MHELWs delivering ten sessions to employees with existing mental health conditions and managers (three individual sessions and four joint sessions) over twelve weeks. These sessions aimed to improve psychological flexibility, interpersonal relationships, and engagement of employees. This feasibility randomised controlled trial aimed to examine the feasibility and acceptability of the intervention from the perspective of employees and managers using a mixed methods approach. The intervention was largely considered feasible and acceptable. Initial findings suggest there may be benefits for employee's productivity, mental health, and managers mental health knowledge. Logistical challenges acted as a barrier to the participation and retention of participants in the trial. The major strengths of this study were the co-design and inter-disciplinary approach taken. Overall, findings suggest that this novel intervention has potential but needs some adjustments and testing in a larger sample

Patient journey following lumbar spinal fusion surgery (FuJourn): A multicentre exploration of the immediate post-operative period using qualitative patient diaries.

The aim of this study was to capture and understand the immediate recovery journey of patients following lumbar spinal fusion surgery and explore the interacting constructs that shape their journey. A qualitative study using Interpretive Phenomenological Analysis (IPA) approach. A purposive sample of 43 adult patients (≥16 years) undergoing ≤4 level instrumented fusion for back and/or leg pain of degenerative cause, were recruited pre-surgery from 4 UK spinal surgery centres. Patients completed a weekly diary expressed in their own words for the first 4 weeks following surgery to capture their life as lived. Diary content was based on previous research findings and recorded progress, recovery, motivation, symptoms, medications, healthcare appointments, rehabilitation, positive/negative thoughts, and significant moments; comparing to the previous week. To maximise completion and data quality, diaries could be completed in paper form, word document, as online survey or as audio recording. Strategies to enhance diary adherence included a weekly prompt. A framework analysis for individual diaries and then across participants (deductive and inductive components) captured emergent themes. Trustworthiness was enhanced by strategies including reflexivity, attention to negative cases and use of critical co-investigators. Twenty-eight participants (15 female; n = 18 (64.3%) aged 45-64) contributed weekly diaries (12 withdrew post-surgery, 3 did not follow through with surgery). Adherence with diaries was 89.8%. Participants provided diverse and vivid descriptions of recovery experiences. Three distinct recovery trajectories were identified: meaningful recovery (engagement in physical and functional activities to return to functionality/mobility); progressive recovery (small but meaningful improvement in physical ability with increasing confidence); and disruptive recovery (limited purpose for meaningful recovery). Important interacting constructs shaped participants' recovery including their pain experience and self-efficacy. This is the first account of immediate recovery trajectories from patients' perspectives. Recognition of a patient's trajectory may inform patient-centred recovery, follow-up and rehabilitation to improve patient outcomes

Immediate patient perceptions following lumbar spinal fusion surgery: semi-structured multi-centre interviews exploring the patient journey and experiences of lumbar fusion surgery (FuJourn).

PURPOSE To understand the patient journey to Lumbar Spinal Fusion Surgery (LSFS) and patients' experiences of surgery. METHODS Qualitative study using interpretive phenomenological analysis. Adult participants following LSFS were recruited from 4 UK clinical sites using purposive sampling to ensure representation of key features (e.g. age). Semi-structured interviews informed by a piloted topic guide developed from the literature were audio-recorded and transcribed verbatim. Framework analysis for individual interviews and then across participants (deductive and inductive) identified emerging themes. Trustworthiness of data analyses was enhanced using multiple strategies (e.g. attention to negative cases). RESULTS Four emerging themes from n = 31 patients' narratives were identified: decision for surgery, coping strategies, barriers to recovery and recovery after surgery. Decision for surgery and recovery after surgery themes are distinguished by the point of surgery. However, barriers to recovery and coping strategies are key to the whole patient journey encompassing long journeys to surgery and their initial journey after surgery. The themes of coping strategies and barriers to recovery were inter-related and perceived by participants as parallel concepts. The 4 multifactorial themes interacted with each other and shaped the process of an individual patient's recovery. Factors such as sporadic interventions prior to surgery, time-consuming wait for diagnosis and surgery and lack of information regarding recovery strongly influenced perceptions of outcome. CONCLUSION Patient driven data enables insights to inform research regarding surgery/rehabilitation through depth of understanding of the patient journey. Awareness of factors important to patients is important; ensuring that patient-driven data informs research and patient care

Supporting employers and their employees with Mental hEalth problems to remain eNgaged and producTive at wORk (MENTOR): A feasibility randomised controlled trial protocol.

Employees with mental health problems often struggle to remain in employment. During the COVID-19 pandemic, these employees face multiple additional stressors, which are likely to worsen their mental health and work productivity. Currently, it is unclear how to best support employees with mental health problems (and their managers) to improve wellbeing and productivity. We aim to develop a new intervention (MENTOR) that will jointly involve employees, managers, and a new professional (mental health employment liaison worker, MHELW), to help employees who are still at work with a mental health condition and currently receiving professional support for their mental health. A feasibility pilot study will then be undertaken to examine the feasibility and acceptability of the intervention from the perspective of employees and line managers. The study involves a feasibility randomised controlled study comparing outcomes of participants randomised to receive the intervention (MENTOR) with wait-list controls. Participants allocated to the waitlist control group will receive the intervention after three months. We aim to randomise 56 employee-manager pairs recruited from multiple organisations in the Midlands region of England. An intervention including 10 sessions for employees and managers (3 individual sessions and 4 joint sessions) will be delivered over 12 weeks by trained MHELWs. Primary outcomes include measures of feasibility and acceptability of the intervention and work productivity. Secondary outcomes include mental health outcomes. Qualitative interviews will be undertaken with a purposively selected sub-sample of employees and line managers at three-month post-intervention assessment. To our knowledge, this will be the first trial with a joint employee-manager intervention delivered by MHELWs. Anticipated challenges are dual-level consent (employees and managers), participants' attrition, and recruitment strategies. If the intervention and trial processes are shown to be feasible and acceptable, the outcomes from this study will inform future randomised controlled trials. Trial registration: This trial is pre-registered with the ISRCTN registry, registration number: ISRCTN79256498. Protocol version: 3.0_March_2023. https://www.isrctn.com/ISRCTN79256498

Predictors of poor outcome following lumbar spinal fusion surgery: a prospective observational study to derive two clinical prediction rules using British Spine Registry data

Purpose: Lumbar spinal fusion surgery (LSFS) is common for lumbar degenerative disorders. The objective was to develop clinical prediction rules to identify which patients are likely to have a favourable outcome to inform decisions regarding surgery and rehabilitation. Methods: A prospective observational study recruited 600 (derivation) and 600 (internal validation) consecutive adult patients undergoing LSFS for degenerative lumbar disorder through the British Spine Registry. Definition of good outcome (6 weeks, 12 months) was reduction in pain intensity (Numerical Rating Scale, 0–10) and disability (Oswestry Disability Index, ODI 0–50) > 1.7 and 14.3, respectively. Linear and logistic regression models were fitted and regression coefficients, Odds ratios and 95% CIs reported. Results: Lower BMI, higher ODI and higher leg pain pre-operatively were predictive of good disability outcome, higher back pain was predictive of good back pain outcome, and no previous surgery and higher leg pain were predictive of good leg pain outcome; all at 6 weeks. Working and higher leg pain were predictive of good ODI and leg pain outcomes, higher back pain was predictive of good back pain outcome, and higher leg pain was predictive of good leg pain outcome at 12 months. Model performance demonstrated reasonable to good calibration and adequate/very good discrimination. Conclusions: BMI, ODI, leg and back pain and previous surgery are important considerations pre-operatively to inform decisions for surgery. Pre-operative leg and back pain and work status are important considerations to inform decisions for management following surgery. Findings may inform clinical decision making regarding LSFS and associated rehabilitation

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents.

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents.</p

Consent form given to employees and managers to take part in MENTOR.

Consent form given to employees and managers to take part in MENTOR.</p

Data collection process and time-points.

Employees with mental health problems often struggle to remain in employment. During the COVID-19 pandemic, these employees face multiple additional stressors, which are likely to worsen their mental health and work productivity. Currently, it is unclear how to best support employees with mental health problems (and their managers) to improve wellbeing and productivity. We aim to develop a new intervention (MENTOR) that will jointly involve employees, managers, and a new professional (mental health employment liaison worker, MHELW), to help employees who are still at work with a mental health condition and currently receiving professional support for their mental health. A feasibility pilot study will then be undertaken to examine the feasibility and acceptability of the intervention from the perspective of employees and line managers. The study involves a feasibility randomised controlled study comparing outcomes of participants randomised to receive the intervention (MENTOR) with wait-list controls. Participants allocated to the waitlist control group will receive the intervention after three months. We aim to randomise 56 employee-manager pairs recruited from multiple organisations in the Midlands region of England. An intervention including 10 sessions for employees and managers (3 individual sessions and 4 joint sessions) will be delivered over 12 weeks by trained MHELWs. Primary outcomes include measures of feasibility and acceptability of the intervention and work productivity. Secondary outcomes include mental health outcomes. Qualitative interviews will be undertaken with a purposively selected sub-sample of employees and line managers at three-month post-intervention assessment. To our knowledge, this will be the first trial with a joint employee-manager intervention delivered by MHELWs. Anticipated challenges are dual-level consent (employees and managers), participants’ attrition, and recruitment strategies. If the intervention and trial processes are shown to be feasible and acceptable, the outcomes from this study will inform future randomised controlled trials. Trial registration: This trial is pre-registered with the ISRCTN registry, registration number: ISRCTN79256498. Protocol version: 3.0_March_2023. https://www.isrctn.com/ISRCTN79256498.</div

Recommended content for the schedule of enrolment, interventions, and assessments.

Recommended content for the schedule of enrolment, interventions, and assessments.</p

Principles of MENTOR.

Employees with mental health problems often struggle to remain in employment. During the COVID-19 pandemic, these employees face multiple additional stressors, which are likely to worsen their mental health and work productivity. Currently, it is unclear how to best support employees with mental health problems (and their managers) to improve wellbeing and productivity. We aim to develop a new intervention (MENTOR) that will jointly involve employees, managers, and a new professional (mental health employment liaison worker, MHELW), to help employees who are still at work with a mental health condition and currently receiving professional support for their mental health. A feasibility pilot study will then be undertaken to examine the feasibility and acceptability of the intervention from the perspective of employees and line managers. The study involves a feasibility randomised controlled study comparing outcomes of participants randomised to receive the intervention (MENTOR) with wait-list controls. Participants allocated to the waitlist control group will receive the intervention after three months. We aim to randomise 56 employee-manager pairs recruited from multiple organisations in the Midlands region of England. An intervention including 10 sessions for employees and managers (3 individual sessions and 4 joint sessions) will be delivered over 12 weeks by trained MHELWs. Primary outcomes include measures of feasibility and acceptability of the intervention and work productivity. Secondary outcomes include mental health outcomes. Qualitative interviews will be undertaken with a purposively selected sub-sample of employees and line managers at three-month post-intervention assessment. To our knowledge, this will be the first trial with a joint employee-manager intervention delivered by MHELWs. Anticipated challenges are dual-level consent (employees and managers), participants’ attrition, and recruitment strategies. If the intervention and trial processes are shown to be feasible and acceptable, the outcomes from this study will inform future randomised controlled trials. Trial registration: This trial is pre-registered with the ISRCTN registry, registration number: ISRCTN79256498. Protocol version: 3.0_March_2023. https://www.isrctn.com/ISRCTN79256498.</div