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RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory
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. SETTIN...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8928258/ https://www.ncbi.nlm.nih.gov/pubmed/35292493 http://dx.doi.org/10.1136/bmjopen-2021-053111 |
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author | Radford, Kathryn A McKevitt, Christopher Clarke, Sara Powers, Katie Phillips, Julie Craven, Kristelle Watkins, Caroline Farrin, Amanda Holmes, Jain Cripps, Rachel McLellan, Vicki Sach, Tracey Brindle, Richard Holloway, Ivana Hartley, Suzanne Bowen, Audrey O'Connor, Rory J Stevens, Judith Walker, Marion Murray, John Shone, Angela Clarke, David |
author_facet | Radford, Kathryn A McKevitt, Christopher Clarke, Sara Powers, Katie Phillips, Julie Craven, Kristelle Watkins, Caroline Farrin, Amanda Holmes, Jain Cripps, Rachel McLellan, Vicki Sach, Tracey Brindle, Richard Holloway, Ivana Hartley, Suzanne Bowen, Audrey O'Connor, Rory J Stevens, Judith Walker, Marion Murray, John Shone, Angela Clarke, David |
author_sort | Radford, Kathryn A |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8928258 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-89282582022-04-01 RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory Radford, Kathryn A McKevitt, Christopher Clarke, Sara Powers, Katie Phillips, Julie Craven, Kristelle Watkins, Caroline Farrin, Amanda Holmes, Jain Cripps, Rachel McLellan, Vicki Sach, Tracey Brindle, Richard Holloway, Ivana Hartley, Suzanne Bowen, Audrey O'Connor, Rory J Stevens, Judith Walker, Marion Murray, John Shone, Angela Clarke, David BMJ Open Cardiovascular Medicine 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. BMJ Publishing Group 2022-03-15 /pmc/articles/PMC8928258/ /pubmed/35292493 http://dx.doi.org/10.1136/bmjopen-2021-053111 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Cardiovascular Medicine Radford, Kathryn A McKevitt, Christopher Clarke, Sara Powers, Katie Phillips, Julie Craven, Kristelle Watkins, Caroline Farrin, Amanda Holmes, Jain Cripps, Rachel McLellan, Vicki Sach, Tracey Brindle, Richard Holloway, Ivana Hartley, Suzanne Bowen, Audrey O'Connor, Rory J Stevens, Judith Walker, Marion Murray, John Shone, Angela Clarke, David RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory |
title | RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory |
title_full | RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory |
title_fullStr | RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory |
title_full_unstemmed | RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory |
title_short | RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory |
title_sort | return to work after stroke (retake) trial: protocol for a mixed-methods process evaluation using normalisation process theory |
topic | Cardiovascular Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8928258/ https://www.ncbi.nlm.nih.gov/pubmed/35292493 http://dx.doi.org/10.1136/bmjopen-2021-053111 |
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