ROWTATE feasibility study

  • Research type

    Research Study

  • Full title

    Multicentre Research Programme to Enhance Return to Work after Trauma (ROWTATE) – Feasibility of helping patients return to work during the Covid-19 pandemic.

  • IRAS ID

    265431

  • Contact name

    Katherine Radford

  • Contact email

    kathryn.radford@nottingham.ac.uk

  • Sponsor organisation

    Nottingham University Hospitals NHS Trust

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    Summary of Research
    Trauma of at least moderate severity (Injury Severity Score (ISS) >8) is a major cause of death, disability and NHS\nresource use. Many survivors experience physical and psychological problems, reduced quality of life (QoL) and\ndifficulty returning to work, with psychological and occupational needs frequently left unmet. The detrimental effects of being out of work on patient health, NHS costs and society are well documented. Our recent study found one third of patients with ISS>8 have not returned to work one year later with many suffering significant physical and psychological problems.\n\nSystematic reviews demonstrate vocational rehabilitation (VR) improves return-to-work in some conditions. However, evidence is lacking for intervention supporting return to work amongst trauma survivors who often suffer multiple injuries, affecting several body regions, with psychological and/or cognitive problems impacting on work ability. We have developed VR interventions for traumatic brain injury and stroke. Our proposal adapts these for a much wider range of injuries, potentially enabling wide-scale NHS roll-out.\n\nWe aim to develop, evaluate and assess the implementation of an intervention to enhance return-to-work and improve quality of life and wellbeing in people with at least moderate trauma. This study is the second of four work packages within a larger programme. This work package will be a feasibility study. The specific objectives of the feasibility study are to:\n1. Assess data collection tools, processes, data completeness and follow-up rates\n2. Evaluate intervention usage and acceptability\n3. Evaluate therapist and psychologist training\n4. Assess intervention fidelity checklist\n5. Identify factors that may affect running of a larger definitive trial, including barriers and facilitators to recruitment and retention\n

    Summary of Results
    : Work package 2 (WP2) was the second of the four work packages in the ROWTATE programme or research. WP2 comprised a study (called a feasibility study) to assess how feasible it is to deliver a vocational rehabilitation treatment, which we have called the ROWTATE Intervention. Learning from WP2 will be used to make sure we can deliver a larger study to assess if the intervention is effective. This larger study is a ‘randomised controlled trial’, where participants are allocated at random to the ROWTATE intervention or to continue to receive standard NHS care. Full details of the feasibility study can be found in our first publication, which outlines all the details and aims of the study (Kendrick et al, 2021). The study took place during the COVID-19 pandemic. As a result, the intervention was adapted to be delivered and evaluated remotely to ensure it was deliverable during the pandemic and beyond, as we anticipated that health services would continue to use digital interventions post-pandemic.

    The original feasibility study objectives were therefore adapted due to the pandemic. The new objectives were to 1) evaluate the occupational therapist (OT) and clinical psychologist (CP) training to deliver the intervention, 2) adapt the OT and CP training to make it suitable for re-mote delivery, 3) adapt the ROWTATE intervention to make it suitable for remote delivery 4) de-liver the adapted ROWTATE intervention and assess how feasible it is to deliver and how likely OTs and CPs are to follow the steps required in the intervention and 5) to assess how acceptable it is to patients, OTs and CPs, and what can hinder or help the remote delivery of the ROWTATE intervention.

    Objective 1: Evaluate the occupational therapist (OT) and clinical psychology (CP) training

    We recruited six therapists (4 OTs and 2 CPs) and asked them to take part in a two day face to face training workshop which took place in January 2020. OTs and CPs also completed a number of individual and group tasks and surveys at the start and end of the training which helped us evaluate the training.
    OTs and CPs found the training useful and reported that they learnt new knowledge which fitted well with their previous knowledge. They reported a positive attitude and high confidence in evidence-based practice, including confidence in delivering the ROWTATE intervention. Competency assessments were conducted for the six OTs and CPs who took part in the January 2020 training. Competency was assessed using three bespoke structured tasks: reviewing patient data and collecting additional injury, health and work information through face-to-face interaction with an actor who played a ‘patient’ (task 1), writing a management plan (task 2) and writing a letter to employers about ‘the patient’ (task 3). Fifty percent of OTs and CPs were judged to be competent for task 1, 100% for task 2 and 83% for task 3. OTs and CPs assessed as needing additional support were provided with this through mentoring and additional training.

    Objectives 2, 3 and 5: Adapting the training and intervention in response to the pandemic so that it can be delivered remotely and assessing how acceptable it is to patients, OTs and CPs, and what can hinder (barriers) or help (facilitators) the remote delivery of the ROWTATE inter-vention

    There were four stages that helped us to achieve these objectives:
    • Literature review
    The qualitative tele-rehabilitation literature was reviewed to identify barriers and facilitators to remote delivery of these type of interventions. Eight articles provided relevant information on barriers (e.g. technological issues, poor infrastructure, lack of knowledge, and patient character-istics) and facilitators (e.g. patient preference, training, organisational support and having the appropriate organisational and technological structures in place) to remote delivery which was used to inform the adapted training and intervention.

    • Questionnaires administered before and after the adapted training was delivered.

    All therapists completed a questionnaire collecting information on 14 determinants of health and professional behaviour that may influence intervention delivery before the adapted training was delivered. The results showed that one barrier was found to influence remote delivery: OTs’ and CPs’ intentions to use remote vocational rehabilitation and two facilitators helped with de-livery: social influences and knowledge. Three OTs and 1 CP completed additional question-naires one month after the adapted training. The results showed that 13 facilitators were identi-fied, with those scoring most highly being social/professional role or identity, knowledge and social influences. The only factor not scoring as a facilitator was memory, attention and decision processing. No barriers were identified after training. Full details of these analyses can be found in our second publication (Kettlewell et al, 2021).

    • Interviews with therapists before the start of the intervention
    All therapists, participated in interviews before the intervention started to help identify any fac-tors that can hinder or help the remote delivery of the ROWTATE intervention. The analysis of the interviews identified a number of barriers to remote delivery which included: access to tech-nologies, reduced ability to assess an individual’s environment remotely, challenges with con-ducting functional, cognitive or workplace assessments remotely, patients’ lack of ability or con-fidence in using technology, change in professional role and identity given the new form of de-livery, and difficulty building therapeutic rapport online. Full details of these analyses can be found in our second publication (Kettlewell et al, 2021).

    • Interviews with therapists after the start of the intervention
    Three months after starting the intervention, further interviews were conducted with OTs (n=4) and CPs (n=2) delivering the ROWTATE intervention.

    Interviews covered how well the training prepared OTs and CPs for remote intervention delivery, and the needs for improvements to training and suitability of remote training. They also covered topics around acceptability of the VR intervention, and barriers and facilitators to remote delivery. All OTs and CPs found the training useful and felt it sufficiently prepared them to deliver the ROWTATE intervention remotely, but preferred face to face training. All OTs and CPs felt that a blended approach to training (remote and face to face) would be preferable for the full-scale randomised controlled trial, hence a blended approach will be used.

    a) Adapting the training and intervention
    Therapist training and the intervention were adapted for remote delivery in a series of meetings using findings from the literature review, questionnaires completed before taking part in the adapted training and interviews completed before the intervention started. The adapted training was delivered remotely in September 2020 via MS teams across two half-days. The training was adapted to increase OT and CP confidence in delivering the remote intervention and identifying ways to overcome barriers. We found that remote delivery of the adapted training is feasible, and we have adapted the training for the main trial to use a blended approach of face-face and remote training. We identified a range of IT issues that need addressing for main trial training, including rapidly changing NHS Trust-specific remote working policies and the need to keep up to date with these.

    b) Adapted intervention

    Adapting the intervention did not change the content, only the delivery method to be predominantly by video-call/telephone. We collaborated with Australian colleagues who have successfully pioneered vocational telerehabilitation to adapt intervention components and to develop the required documentations and assessments.

    c. Acceptability of the intervention
    Analysis of the interviews showed that OTs, CPs and patients found the intervention acceptable despite the challenges of delivery. OTs, CPs and patients found benefits in terms of time and costs saved. OTs, CPs and patients also had a good understanding of the intervention and felt the intervention did what they believed it would.

    d. Barriers and facilitators to remote delivery
    Barriers identified included lack of familiarity with technology and access to reliable internet connection, and difficulties concentrating on the screen, especially amongst those with brain injuries. For OTs and CPs, remote delivery made it more difficult to understand the patient’s wider living and working context, and more difficult to obtain feedback from a third party (e.g. carer). In addition it was difficult to conduct certain types of assessment. Facilitators reflected those identified in the pre-intervention interviews such as reduced travel time and effort for patients and therapists. There were also newly identified facilitators such as improved patient engagement especially among those that felt confident using technology and wider geographical access to services for patients. An initial face-to-face appointment was felt to help address some of the concerns around building rapport remotely. (More details on acceptability and barrier and facilitators can be found in our second published paper, Kettlewell, et al 2021)

    Objective 4: Deliver the adapted ROWTATE intervention and assess feasibility and fidelity of remote delivery

    (a) Recruitment and participant characteristics

    We recruited the required sample of patients (n=10) to the feasibility study from two different NHS sites. We recruited a diverse range of patients in terms of time since injury, age, gender, education, ethnic group, injury characteristics and employment background. Sixty percent met the definition for either anxiety, depression or post-traumatic stress disorder, indicating a high prevalence of mental health problems in study participants.

    (b) Intervention delivery

    Nine (90%) participants commenced the intervention within 12-weeks of injury, and all participants were seen by the OT within 2-weeks of recruitment to the study.
    In terms of number of sessions received, a total of 136 OT sessions were delivered to the 10 participants across the 12 month period. Most sessions were delivered early in the intervention, with the highest frequency of sessions per participant in month two. Seven participants remained on the OTs’ caseload for more than 6-months. Only one participant remained on the OT caseload for 12 months. Participants received the OT intervention for an average of 35 weeks.
    Seven participants (70%) were referred by the OT to the CP and received a total of 37 CP sessions across the 12-month period. Most sessions were delivered early in the intervention, with the highest frequency of sessions per participant in month one (out of 12). Three participants remained on the CP caseload for more than 6 months. Only one participant remained on the CPs’ caseload for 12 months. Participants received the CP intervention for an average of 8 weeks.
    Attendance and use of remote delivery
    Virtually all OT sessions were attended by patients (average of 97%). All CP sessions were attended by patients. In total, 98% of OT sessions and 100% of CP sessions were delivered remotely.

    Withdrawal from the intervention
    None of the participants withdrew from the intervention before the agreed intervention end date.
    Intervention content
    For OTs, most time was spent dealing with current issues (e.g. medical, social, financial, family issues), work preparation, return to work without direct contact with employer or education provider, fatigue/pain management and dealing with medical issues (e.g. appointment issues, healthcare problems).

    For CPs, most time was spent on interrogative thinking and return to work without direct contact with employer/education provider.

    Mentoring
    Twenty seven OT and 19 CP mentoring sessions were conducted. The total time to deliver OT mentoring was 22 hours. The total time to deliver CP mentoring was 13 hours.

    Fidelity (the extent to which the intervention was delivered as planed) Fidelity of intervention delivery was high in terms of intervention components which were delivered as planned (85% for OTs and 93% for CPs).

    Adverse events
    No adverse events were reported during the study.
    Factors influencing intervention delivery Mentoring records showed that early in the study there were common issues across both sites that affected the ease of remote delivery of the intervention. These included a range of IT issues for patients, OTs and CPs, the need for flexibility to enable face-to-face delivery where necessary, the need for strategies to enhance privacy and minimise disruptions during remote contacts between OTs, CPs and patients and the need for strategies to increase employer engagement.

    Summary of main findings
    This feasibility study has shown that OTs and CPs found the training to deliver the intervention useful and at the end of training they had positive attitudes to and high levels of confidence in delivering evidence based practice and the ROWTATE intervention. Half the therapists were judged to need some additional support in the competency assessment and were provided with this via mentoring or additional training. We identified a range of barriers and facilitators to delivering the remote intervention and used this information to adapt the intervention and training for remote delivery. Barriers identified by therapists before the adapted training transformed into being facilitators or ceased to be barriers after training. Nearly all intervention sessions were delivered remotely with very high attendance rates. The intervention was delivered with high levels of fidelity to intervention components. The intervention was acceptable to patients, OTs and CPs.

    References
    1. Kendrick D, das Nair R, Kellezi B, Morriss R, Kettlewell J, Holmes J, Timmons S, Bridger K, Patel P, Brooks A, Hoffman K, Radford K. Vocational rehabilitation to enhance return to work after trauma (ROWTATE): protocol for a non-randomised single-arm mixed-methods feasibility study. Pilot Feasibility Stud 7, 29 (2021). https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbdFELGNEN9gmUgjOT6gsimi-2Bxtn7l5wzPlpuBA0-2FJ5u40ee85t2fXnQiLWQwgPhNTw-3D-3DgZu-_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLaHofwOZKduA-2FJ9uGkIQCUbdfYQtZJrxh85Tm4Jw2Q9AzUb-2BjzNd-2FLUFP4G4Vp9-2FWF1elfG8Rzq8qdW4ycV12-2B1c1YHzlsFXJBKrQzQqBKg3YLMONy2FGWh9PUg9KufsQlBNnLsTQFcv9Fa6RoCIcwEIwBi-2F4KRxjSBYexue0FkQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C5d4691c5274e4a10890208daff755310%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638103176612788005%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=EjAU2JlG20FSZDiZY%2BGTIcyXDThVSlQVeZH9cQ8Wpkc%3D&reserved=0

    2. Kettlewell J, Lindley R, Radford K, Patel P, Bridger K, Kellezi B, et al. Factors Affecting the Delivery and Acceptability of the ROWTATE Telehealth Vocational Rehabilitation Intervention for Traumatic Injury Survivors: A Mixed-Methods Study. Int J Environ Res Public Health. 2021;18(18)..

    3. Kettlewell, J, Radford K, Kendrick D, Bridger K, Patel P, Kellezi B, Timmons S. Factors affecting the implementation of a vocational rehabilitation intervention following major trauma: understanding the context for delivery. Disability and Rehabilitation.

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference

    19/NS/0130

  • Date of REC Opinion

    29 Jul 2019

  • REC opinion

    Favourable Opinion