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BACKGROUND: Integrating complex interventions within healthcare settings can be challenging. Mentoring can be embedded within a randomised controlled trial (RCT) to upskill and support those delivering the intervention. This study aimed to understand, from a realist perspective, how mentoring worked to support implementation fidelity for occupational therapists (OTs) delivering a vocational rehabilitation (VR) intervention within the context of an RCT. METHODS: A realist evaluation using secondary data (emails, mentoring record forms, interviews) collected as part of an RCT. Three researchers coded the data following content analysis, focused on refining or refuting an initial programme theory by exploring the interactions between context, mechanisms, and outcomes. The research team met to further refine the programme theories. RESULTS: Data from 584 emails, 184 mentoring record forms, and 25 interviews were analysed following a realist approach. We developed a programme theory consisting of two contexts (trial set-up, ongoing mentoring), nine mechanisms (collective understanding, monitoring, timely support, positive reinforcement, reflective practice, support data completeness, facilitation strategy, shared learning experience, management of research and clinical duties), and three outcomes (improved confidence, improved fidelity, reduced contamination). CONCLUSIONS: Offering mentoring support to OTs delivering a VR intervention as part of an RCT improves intervention fidelity and reduces the risk of contamination. It improves OTs' understanding of the differences between their clinical and research roles and increases their confidence and competence in trial paperwork completion and identification of potential contamination issues.
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Tutoria , Terapeutas Ocupacionais , Humanos , Tutoria/métodos , Terapeutas Ocupacionais/educação , Terapia Ocupacional/métodos , Terapia Ocupacional/educação , Mentores , Reabilitação Vocacional/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Feminino , MasculinoRESUMO
OBJECTIVE: To explore rehabilitation professionals' experiences and perspectives of barriers and facilitators to implementing the Rehabilitation Treatment Specification System (RTSS) in research, education, and clinical care. DESIGN: A cross-sectional survey with free text and binary responses was completed by rehabilitation professionals. Survey data were analyzed with a deductive approach of directed content analysis using 2 implementation science frameworks: Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC). SETTING: Rehabilitation professionals across research, educational, and clinical settings. PARTICIPANTS: One hundred and eleven rehabilitation professionals-including speech-language pathologists, occupational therapists, physical therapists, physicians, psychologists, researchers, and clinic directors-who explored possible uses or applications of the RTSS for clinical care, education, or research (N=111). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Frequency of reported CFIR barriers and facilitators, as well as keywords related to CFIR and ERIC constructs. RESULTS: The barriers and facilitating strategies differed according to the end-users' intended use, that is, research, education, or clinical. Overall, the 4 most frequently encountered CFIR barriers were the RTSS's complexity, a lack of available RTSS resources, reduced access to knowledge and information about the RTSS, and limited knowledge and beliefs about the RTSS. The ERIC-CFIR matching tool identified 7 ERIC strategies to address these barriers, which include conducting educational meetings, developing and distributing educational materials, accessing new funding, capturing and sharing local knowledge, identifying and preparing champions, and promoting adaptability. CONCLUSIONS: When attempting to use the RTSS, rehabilitation professionals commonly encountered barriers to understanding and skillfully using the framework. Theory-driven implementation strategies have been identified that have potential for addressing the RTSS's complexity and lack of educational and skill-building resources. Future work can develop the identified implementation strategies and evaluate their effects on RTSS implementation.
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Reabilitação , Humanos , Estudos Transversais , Reabilitação/educação , Pessoal de Saúde , Planejamento de Assistência ao PacienteRESUMO
BACKGROUND: Little guidance exists regarding how best to upskill and support those delivering complex healthcare interventions to ensure robust trial outcomes and implementation fidelity. Mentoring was provided to occupational therapists (OTs) delivering a complex vocational rehabilitation (VR) intervention to stroke survivors. This study aimed to explore mentors' roles in supporting OTs with intervention delivery and fidelity, and to describe factors affecting the mentoring process and intervention delivery. METHODS: Quantitative data (duration, mode and total time of mentoring support) was extracted from mentoring records and emails between mentors and OTs, alongside qualitative data on barriers and facilitators to intervention delivery. Semi-structured interviews with mentors (n = 6) and OTs (n = 19) explored experiences and perceptions of intervention training, delivery and the mentoring process. Mean total and monthly time spent mentoring were calculated per trial site. Qualitative data were analysed thematically. RESULTS: Forty-one OTs across 16 sites were mentored between March 2018 and April 2020. Most mentoring was provided by phone or Microsoft Teams (range: 88.6-100%), with the remainder via email and SMS (Short Message Service) text messages. Mentors suggested strategies to enhance trial recruitment, improved OTs' understanding of- and adherence to trial processes, intervention delivery and fidelity, and facilitated independent problem-solving. Barriers to mentoring included OT non-attendance at mentoring sessions and mentors struggling to balance mentoring with clinical roles. Facilitators included support from the trial team and mentors having protected time for mentoring. CONCLUSIONS: Mentoring supported mentee OTs in various ways, but it remains unclear to what extent the OTS would have been able to deliver the intervention without mentoring support, or how this might have impacted fidelity. Successful implementation of mentoring alongside new complex interventions may increase the likelihood of intervention effectiveness being observed and sustained in real-life contexts. Further research is needed to investigate how mentors could be selected, upskilled, funded and mentoring provided to maximise impact. The clinical- and cost-effectiveness of mentoring as an implementation strategy and its impact on fidelity also requires testing in a future trial. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275 . Registered on 13th March 2018.
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Tutoria , Acidente Vascular Cerebral , Humanos , Mentores , Reabilitação Vocacional , SobreviventesRESUMO
OBJECTIVE: To identify where and how trauma survivors' rehabilitation needs are met after trauma, to map rehabilitation across five UK major trauma networks, and to compare with recommended pathways. DESIGN: Qualitative study (interviews, focus groups, workshops) using soft-systems methodology to map usual care across trauma networks and explore service gaps. Publicly available documents were consulted. CATWOE (Customers, Actors, Transformation, Worldview, Owners, Environment) was used as an analytic framework to explore the relationship between stakeholders in the pathway. SETTING: Five major trauma networks across the UK. SUBJECTS: 106 key rehabilitation stakeholders (service providers, trauma survivors) were recruited to interviews (n = 46), focus groups (n = 4 groups, 17 participants) and workshops (n = 5 workshops, 43 participants). INTERVENTIONS: None. RESULTS: Mapping of rehabilitation pathways identified several issues: (1) lack of vocational/psychological support particularly for musculoskeletal injuries; (2) inconsistent service provision in areas located further from major trauma centres; (3) lack of communication between acute and community care; (4) long waiting lists (up to 12 months) for community rehabilitation; (5) most well-established pathways were neurologically focused. CONCLUSIONS: The trauma rehabilitation pathway is complex and varies across the UK with few, if any patients following the recommended pathway. Services have developed piecemeal to address specific issues, but rarely meet the needs of individuals with multiple impairments post-trauma, with a lack of vocational rehabilitation and psychological support for this population.
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Procedimentos Clínicos , Necessidades e Demandas de Serviços de Saúde , Reabilitação Vocacional , Apoio Social , Ferimentos e Lesões/psicologia , Ferimentos e Lesões/reabilitação , Grupos Focais , Humanos , Pesquisa Qualitativa , Centros de Traumatologia , Reino UnidoRESUMO
BACKGROUND: People with acquired brain injuries (ABIs) often experience residual limitations and co-morbid mental illnesses that restrict work participation. Employers are key in enabling successful return-to-work and job retention. OBJECTIVE: This review aimed to explore employers' perspectives of factors influencing their support for people with ABIs and/or mental illness to return to- and stay in work. Review questions focused on barriers and facilitators to their support, and contextual characteristics present at the time. METHODS: Five databases were searched from October 2010 until November 2023 for relevant qualitative studies published in English. Findings from included studies (Nâ=â25) were synthesised using thematic synthesis. RESULTS: Included studies focused on employees with ABI or mental illness, rather than dually diagnosed ABI and mental illness. Employers' support was influenced by their awareness/knowledge of- and attitudes towards the employee's condition/illness; their skills and experience in supportive strategies; factors related to provision of work accommodations; and stakeholder influence. Similarities and differences in influential factors were observed across the ABI and mental illness literature. Contextual characteristics related to organisational characteristics, cultural taboo, and involvement of certain stakeholders. CONCLUSIONS: ABI survivors (with and without co-morbid mental illness) and their employers may benefit from specialist support and resources to guide them through the return-to-work process. Further research is needed to investigate employers' knowledge of ABI and mental illness and supportive strategies. Exploration of the influence of other stakeholders, socio-demographic characteristics, and contextual factors on employers' return-to-work and retention support for ABI survivors with co-morbid mental illness is warranted.
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Few previous studies have considered the experiences of people with long covid returning to work beyond symptoms in terms of employer and other support factors. The aim of this research was to understand the experience of returning to work for those with long covid symptoms in contrast to the non-long covid group who had not experienced COVID-19 during the time restrictions were imposed to limit the spread of COVID-19 infection. Twenty-one participants with long covid and 13 participants who had not had COVID-19 were interviewed. Themes were identified from transcripts using framework analysis. Participants with long covid experienced difficulties returning to work, particularly from fatigue, cognitive symptoms and breathlessness. Symptoms were heterogeneous and fluctuated in severity over time. A lack of understanding from colleagues and managers sometimes led to a premature return to work without adequate support, associated with further long covid relapse. Outside-of-work, support was salient for a successful return to work. The standard phased return offered by employers may be too short and rigid for some people with long covid. They may benefit from a tailored intervention to support a return to work that targets symptom management, and engages with work colleagues, managers, and family members.
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COVID-19 , Pesquisa Qualitativa , Retorno ao Trabalho , SARS-CoV-2 , Humanos , COVID-19/epidemiologia , COVID-19/psicologia , Retorno ao Trabalho/psicologia , Feminino , Masculino , Reino Unido/epidemiologia , Pessoa de Meia-Idade , Adulto , FadigaRESUMO
BACKGROUND: Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to work/education in some injuries (e.g. traumatic brain and spinal cord injury), but evidence is lacking for other moderately severe or major trauma. METHODS: ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants' self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere. DISCUSSION: This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS. TRIAL REGISTRATION: ISRCTN: 43115471. Registered 27/07/2021.
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Reabilitação Vocacional , Retorno ao Trabalho , Ferimentos e Lesões , Humanos , Análise Custo-Benefício , Inglaterra , Custos de Cuidados de Saúde , Estudos Multicêntricos como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Qualidade de Vida , Reabilitação Vocacional/métodos , Reabilitação Vocacional/economia , Fatores de Tempo , Resultado do Tratamento , Ferimentos e Lesões/psicologia , Ferimentos e Lesões/reabilitação , Ferimentos e Lesões/economiaRESUMO
BACKGROUND: Chronic or persistent pain affects one's ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain. OBJECTIVE: We aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes' feasibility and test research processes for a definitive trial. METHODS: This is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation-Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention. RESULTS: Ethics approval was obtained in March 2023. Trial recruitment began in June 2023. CONCLUSIONS: The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes' selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51474.
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BACKGROUND: Determining whether complex rehabilitation interventions are delivered with fidelity is important. Implementation fidelity can differ between sites, therapists delivering interventions and, over time, threatening trial outcomes and increasing the risk of type II and III errors. This study aimed to develop a method of assessing occupational therapists' fidelity to deliver a complex, individually tailored vocational rehabilitation (VR) intervention to people with traumatic brain injury (TBI) and assess the feasibility of its use in a randomised controlled trial. METHODS: Using mixed methods and drawing on the intervention logic model, we developed data collection tools to measure fidelity to early specialist TBI VR (ESTVR). Fidelity was measured quantitatively using intervention case report forms (CRF), fidelity checklists and clinical records. Qualitative data from mentoring records, interviews with intervention therapists, participants with TBI, employers and NHS staff at trial sites explored moderators of implementation fidelity. The conceptual framework of implementation fidelity (CFIF) guided measurement and analysis of and factors affecting fidelity. Data were triangulated and benchmarked against an earlier cohort study. RESULTS: Fidelity to a complex individually tailored VR intervention could be measured. Overall, OTs delivered ESTVR with fidelity. Different fidelity measures answered different questions, offering unique insights into fidelity. Fidelity was best assessed using a fidelity checklist, intervention CRFs and clinical notes. The OT clinical notes and mentoring records were best at identifying fidelity moderating factors. Interviews added little insight into fidelity moderating factors over and above mentoring or clinical records. Data triangulation offered a comprehensive assessment of fidelity, highlighting limitations of measurement methods and learning for future trials but was resource intensive. Interviews, fidelity visits and analysing clinical notes were also resource intense. Comparing fidelity data to a benchmark and using CFIF as a framework for organising the fidelity assessment helped. CONCLUSIONS: OTs delivered the VR intervention with fidelity. A fidelity checklist and benchmark plus mentoring may offer a practical and effective way of measuring fidelity and identifying fidelity moderating factors in trials of complex individually-tailored rehabilitation interventions. Mentoring provided real-time indicators of and reasons for fidelity deviations. These methods require further evaluation. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN38581822 (Registered: 02/01/2014).
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BACKGROUND: Despite growing numbers of studies reporting the efficacy of complex interventions and their implementation, many studies fail to report information on implementation fidelity or describe how fidelity measures used within the study were developed. This study aimed to develop a fidelity checklist for measuring the implementation fidelity of an early, stroke-specialist vocational rehabilitation intervention (ESSVR) in the RETAKE trial. METHODS: To develop the fidelity measure, previous checklists were reviewed to inform the assessment structure, and core intervention components were extracted from intervention descriptions into a checklist, which was ratified by eight experts in fidelity measurement and complex interventions. Guidance notes were generated to assist with checklist completion. To test the measure, two researchers independently applied the checklist to fifteen stroke survivor intervention case notes using retrospective observational case review. The scoring was assessed for interrater reliability. RESULTS: A fidelity checklist containing 21 core components and 6 desirable components across 4 stages of intervention delivery was developed with corresponding guidance notes. Interrater reliability of each checklist item ranged from moderate to perfect (Cohen's kappa 0.69-1). CONCLUSIONS: The resulting checklist to assess implementation fidelity is fit for assessing the delivery of vocational rehabilitation for stroke survivors using retrospective observational case review. The checklist proved its utility as a measure of fidelity and may be used to inform the design of future implementation strategies. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275. Registered on 13 March 2018.
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OBJECTIVES: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. SETTING: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. PARTICIPANTS AND OUTCOME MEASURES: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists' attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings. ETHICS AND DISSEMINATION: Approval obtained through the East Midlands-Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads. TRIAL REGISTRATION NUMBER: ISRCTN12464275.
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Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Cuidadores , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Retorno ao Trabalho , Acidente Vascular Cerebral/terapia , Inquéritos e Questionários , SobreviventesRESUMO
BACKGROUND: Returning to work after traumatic injury can be problematic. We developed a vocational telerehabilitation (VR) intervention for trauma survivors, delivered by trained occupational therapists (OTs) and clinical psychologists (CPs), and explored factors affecting delivery and acceptability in a feasibility study. METHODS: Surveys pre- (5 OTs, 2 CPs) and post-training (3 OTs, 1 CP); interviews pre- (5 OTs, 2 CPs) and post-intervention (4 trauma survivors, 4 OTs, 2 CPs). Mean survey scores for 14 theoretical domains identified telerehabilitation barriers (score ≤ 3.5) and facilitators (score ≥ 5). Interviews were transcribed and thematically analysed. RESULTS: Surveys: pre-training, the only barrier was therapists' intentions to use telerehabilitation (mean = 3.40 ± 0.23), post-training, 13/14 domains were facilitators. Interviews: barriers/facilitators included environmental context/resources (e.g., technology, patient engagement, privacy/disruptions, travel and access); beliefs about capabilities (e.g., building rapport, complex assessments, knowledge/confidence, third-party feedback and communication style); optimism (e.g., impossible assessments, novel working methods, perceived importance and patient/therapist reluctance) and social/professional role/identity (e.g., therapeutic methods). Training and experience of intervention delivery addressed some barriers and increased facilitators. The intervention was acceptable to trauma survivors and therapists. CONCLUSION: Despite training and experience in intervention delivery, some barriers remained. Providing some face-to-face delivery where necessary may address certain barriers, but strategies are required to address other barriers.
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Reabilitação Vocacional , Telerreabilitação , Humanos , Terapeutas Ocupacionais , Inquéritos e Questionários , SobreviventesRESUMO
BACKGROUND: Traumatic injuries are common amongst working-age adults. Survivors often experience physical and psychological problems, reduced quality of life and difficulty returning to work. Vocational rehabilitation improves work outcomes for a range of conditions but evidence of effectiveness for those with traumatic injuries is lacking. This study assesses feasibility of delivering a vocational rehabilitation intervention to enhance return to work and improve quality of life and wellbeing in people with at least moderate trauma to inform design of a definitive randomised controlled trial (RCT). METHODS: Non-randomised, single-arm, multi-centre mixed-methods feasibility study with nested case studies and qualitative study. The case studies comprise interviews, observations of clinical contacts and review of clinical records. The qualitative study comprises interviews and/or focus groups. Participants will be recruited from two UK major trauma centres. Participants will comprise 40 patients aged 16-69 with an injury severity score of > 8 who will receive the intervention and complete questionnaires. Interviews will be conducted with 10 patients and their occupational therapists (OTs), clinical psychologists (CPs), employers and commissioners of rehabilitation services. Fidelity will be assessed in up to six patients by observations of OT and CP-patient contacts, review of patient records and intervention case report forms. OT and CP training will be evaluated using questionnaires and competence to deliver the intervention assessed using a team objective structured clinical examination and written task. Patients participating in and those declining participation in the study will be invited to take part in interviews/focus groups to explore barriers and facilitators to recruitment and retention. Outcomes include recruitment and retention rates, intervention fidelity, OT and CP competence to deliver the intervention, experiences of delivering or receiving the intervention and factors likely to influence definitive trial delivery. DISCUSSION: Effective vocational rehabilitation interventions to enhance return to work amongst trauma patients are urgently needed because return to work is often delayed, with detrimental effects on health, financial stability, healthcare resource use and wider society. This protocol describes a feasibility study delivering a complex intervention to enhance return to work in those with at least moderate trauma. TRIAL REGISTRATION: ISRCTN: 74668529 . Prospectively registered on 23 January 20.
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BACKGROUND: Rehabilitation research does not always improve patient outcomes because of difficulties implementing complex health interventions. Identifying barriers and facilitators to implementation fidelity is critical. Not reporting implementation issues wastes research resources and risks erroneously attributing effectiveness when interventions are not implemented as planned, particularly progressing from single to multicentre trials. The Consolidated Framework for Implementation Research (CFIR) and Conceptual Framework for Implementation Fidelity (CFIF) facilitate identification of barriers and facilitators. This review sought to identify barriers and facilitators (determinants) affecting implementation in trials of complex rehabilitation interventions for adults with long-term neurological conditions (LTNC) and describe implementation issues. METHODS: Implementation, complex health interventions and LTNC search terms were developed. Studies of all designs were eligible. Searches involved 11 databases, trial registries and citations. After screening titles and abstracts, two reviewers independently shortlisted studies. A third resolved discrepancies. One reviewer extracted data in two stages; 1) descriptive study data, 2) units of text describing determinants. Data were synthesised by (1) mapping determinants to CFIF and CFIR and (2) thematic analysis. RESULTS: Forty-three studies, from 7434 records, reported implementation determinants; 41 reported both barriers and facilitators. Most implied determinants but five used implementation theory to inform recording. More barriers than facilitators were mapped onto CFIF and CFIR constructs. "Patient needs and resources", "readiness for implementation", "knowledge and beliefs about the intervention", "facilitation strategies", "participant responsiveness" were the most frequently mapped constructs. Constructs relating to the quality of intervention delivery, organisational/contextual aspects and trial-related issues were rarely tapped. Thematic analysis revealed the most frequently reported determinants related to adherence, intervention perceptions and attrition. CONCLUSIONS: This review has described the barriers and facilitators identified in studies implementing complex interventions for people with LTNCs. Early adoption of implementation frameworks by trialists can simplify identification and reporting of factors affecting delivery of new complex rehabilitation interventions. It is vital to learn from previous experiences to prevent unnecessary repetitions of implementation failure at both trial and service provision levels. Reported facilitators can provide strategies for overcoming implementation issues. Reporting gaps may be due to the lack of standardised reporting methods, researcher ignorance and historical reporting requirements. SYSTEMIC REVIEW REGISTRATION: PROSPERO CRD42015020423.
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Pesquisa Biomédica , Doenças do Sistema Nervoso/reabilitação , Adulto , HumanosRESUMO
BACKGROUND: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) is more clinically and cost-effective for supporting post-stroke RTW, than UC alone. METHODS: Seven hundred sixty stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants' homes or workplaces, and outpatient/inpatient therapy settings, via telephone, email, or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 h/week). Secondary outcomes will include mood, function, participation, health-related quality of life, confidence, intervention compliance, health and social care resource use, and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out. DISCUSSION: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings. TRIAL REGISTRATION: ISRCTN, ISRCTN12464275 . Registered on 26 February 2018.
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Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Adulto , Cuidadores , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reabilitação Vocacional , Retorno ao Trabalho , Acidente Vascular Cerebral/diagnóstico , SobreviventesRESUMO
BACKGROUND: Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI. OBJECTIVE: To assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI. DESIGN: A multicentre, feasibility, parallel-group RCT with a feasibility economic evaluation and an embedded mixed-methods process evaluation. Randomisation was by remote computer-generated allocation. SETTING: Three NHS major trauma centres (MTCs) in England. PARTICIPANTS: Adults with TBI admitted for > 48 hours and working or studying prior to injury. INTERVENTIONS: Early specialist TBI VR delivered by occupational therapists (OTs) in the community using a case co-ordination model. MAIN OUTCOME MEASURES: Self-reported RTW 12 months post randomisation, mood, functional ability, participation, work self-efficacy, quality of life and work ability. Feasibility outcomes included recruitment and retention rates. Follow-up was by postal questionnaires in two centres and face to face in one centre. Those collecting data were blind to treatment allocation. RESULTS: Out of 102 target participants, 78 were recruited (39 randomised to each arm), representing 39% of those eligible and 5% of those screened. Approximately 2.2 patients were recruited per site per month. Of those, 56% had mild injuries, 18% had moderate injuries and 26% had severe injuries. A total of 32 out of 45 nominated carers were recruited. A total of 52 out of 78 (67%) TBI participants responded at 12 months (UC, n = 23; intervention, n = 29), completing 90% of the work questions; 21 out of 23 (91%) UC respondents and 20 out of 29 (69%) intervention participants returned to work at 12 months. Two participants disengaged from the intervention. Face-to-face follow-up was no more effective than postal follow-up. RTW was most strongly related to social participation and work self-efficacy. It is feasible to assess the cost-effectiveness of VR. Intervention was delivered as intended and valued by participants. Factors likely to affect a definitive trial include deploying experienced OTs, no clear TBI definition or TBI registers, and repatriation of more severe TBI from MTCs, affecting recruitment of those most likely to benefit/least likely to drop out. LIMITATIONS: Target recruitment was not reached, but mechanisms to achieve this in future studies were identified. Retention was lower than expected, particularly in UC, potentially biasing estimates of the 12-month RTW rate. CONCLUSIONS: This study met most feasibility objectives. The intervention was delivered with high fidelity. When objectives were not met, strategies to ensure feasibility of a full trial were identified. Future work should test two-stage recruitment and include resources to recruit from 'spokes'. A broader measure covering work ability, self-efficacy and participation may be a more sensitive outcome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38581822. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 33. See the NIHR Journals Library website for further project information.