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Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation

BACKGROUND: Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity fo...

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Autores principales: Allan, Stephanie, Mcleod, Hamish, Bradstreet, Simon, Beedie, Sara, Moir, Bethany, Gleeson, John, Farhall, John, Morton, Emma, Gumley, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6930509/
https://www.ncbi.nlm.nih.gov/pubmed/31821154
http://dx.doi.org/10.2196/15634
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author Allan, Stephanie
Mcleod, Hamish
Bradstreet, Simon
Beedie, Sara
Moir, Bethany
Gleeson, John
Farhall, John
Morton, Emma
Gumley, Andrew
author_facet Allan, Stephanie
Mcleod, Hamish
Bradstreet, Simon
Beedie, Sara
Moir, Bethany
Gleeson, John
Farhall, John
Morton, Emma
Gumley, Andrew
author_sort Allan, Stephanie
collection PubMed
description BACKGROUND: Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. OBJECTIVE: This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. METHODS: The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. RESULTS: The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. CONCLUSIONS: The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. TRIAL REGISTRATION: ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15634
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spelling pubmed-69305092020-01-06 Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation Allan, Stephanie Mcleod, Hamish Bradstreet, Simon Beedie, Sara Moir, Bethany Gleeson, John Farhall, John Morton, Emma Gumley, Andrew JMIR Res Protoc Protocol BACKGROUND: Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. OBJECTIVE: This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. METHODS: The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. RESULTS: The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. CONCLUSIONS: The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. TRIAL REGISTRATION: ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15634 JMIR Publications 2019-12-10 /pmc/articles/PMC6930509/ /pubmed/31821154 http://dx.doi.org/10.2196/15634 Text en ©Stephanie Allan, Hamish Mcleod, Simon Bradstreet, Sara Beedie, Bethany Moir, John Gleeson, John Farhall, Emma Morton, Andrew Gumley. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.12.2019. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Allan, Stephanie
Mcleod, Hamish
Bradstreet, Simon
Beedie, Sara
Moir, Bethany
Gleeson, John
Farhall, John
Morton, Emma
Gumley, Andrew
Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation
title Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation
title_full Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation
title_fullStr Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation
title_full_unstemmed Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation
title_short Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation
title_sort understanding implementation of a digital self-monitoring intervention for relapse prevention in psychosis: protocol for a mixed method process evaluation
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6930509/
https://www.ncbi.nlm.nih.gov/pubmed/31821154
http://dx.doi.org/10.2196/15634
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