Background: Despite growing numbers of studies reporting the efficacy of complex interventions an... more 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 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 assessment structure, 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 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 in...
Background Determining whether complex rehabilitation interventions are delivered with fidelity i... more 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 ...
ObjectivesThis mixed-method process evaluation underpinned by normalisation process theory aims t... more ObjectivesThis 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.SettingRETurn 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 measuresIntervention 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 unders...
Objective Injuries can have a long-lasting effect on ability to return to work, but there is litt... more Objective Injuries can have a long-lasting effect on ability to return to work, but there is little research on which outcomes are most important to patients. This study aims to identify and prioritise return-to-work outcomes important to patients for evaluating vocational rehabilitation interventions. Methods Nominal group technique focus group with trauma patients. Results Focus group participants ( n = 6) included mostly traumatic brain injuries, a range of occupation types, ages and both genders. Participants identified and prioritised their eight most important outcomes which were: sense of purpose and life satisfaction, understanding the impact of injury, assessment of readiness to return to work, using SMART (specific, measurable, achievable, relevant and time-bound) goals, facilitated reintegration to work, assessing capacity to return to work, collaboration between key stakeholders and improved employer and employee knowledge. Many of these were measures of the process of, ...
Background Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising inci... more 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, pa...
Background: Despite growing numbers of studies reporting the efficacy of complex interventions an... more 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 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 assessment structure, 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 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 in...
Background Determining whether complex rehabilitation interventions are delivered with fidelity i... more 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 ...
ObjectivesThis mixed-method process evaluation underpinned by normalisation process theory aims t... more ObjectivesThis 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.SettingRETurn 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 measuresIntervention 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 unders...
Objective Injuries can have a long-lasting effect on ability to return to work, but there is litt... more Objective Injuries can have a long-lasting effect on ability to return to work, but there is little research on which outcomes are most important to patients. This study aims to identify and prioritise return-to-work outcomes important to patients for evaluating vocational rehabilitation interventions. Methods Nominal group technique focus group with trauma patients. Results Focus group participants ( n = 6) included mostly traumatic brain injuries, a range of occupation types, ages and both genders. Participants identified and prioritised their eight most important outcomes which were: sense of purpose and life satisfaction, understanding the impact of injury, assessment of readiness to return to work, using SMART (specific, measurable, achievable, relevant and time-bound) goals, facilitated reintegration to work, assessing capacity to return to work, collaboration between key stakeholders and improved employer and employee knowledge. Many of these were measures of the process of, ...
Background Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising inci... more 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, pa...
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Papers by Jain Holmes