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Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic
Public health orders were introduced in many countries, including Australia, during the COVID-19 pandemic to reduce the spread of the virus. However, for many people this led to an exacerbation of mental health symptoms, particularly those living with severe or persistent mental illness (SPMI). Addi...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10225334/ https://www.ncbi.nlm.nih.gov/pubmed/37257726 http://dx.doi.org/10.1016/j.cct.2023.107246 |
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author | O'Reilly, Claire L. McMillan, Sara S. El-Den, Sarira Collins, Jack C. Hu, Jie Ng, Ricki Stewart, Victoria Pham, Lily Webb, Fleur Roennfeldt, Helena Segrott, Rebecca Loller, Hannah Wheeler, Amanda J. |
author_facet | O'Reilly, Claire L. McMillan, Sara S. El-Den, Sarira Collins, Jack C. Hu, Jie Ng, Ricki Stewart, Victoria Pham, Lily Webb, Fleur Roennfeldt, Helena Segrott, Rebecca Loller, Hannah Wheeler, Amanda J. |
author_sort | O'Reilly, Claire L. |
collection | PubMed |
description | Public health orders were introduced in many countries, including Australia, during the COVID-19 pandemic to reduce the spread of the virus. However, for many people this led to an exacerbation of mental health symptoms, particularly those living with severe or persistent mental illness (SPMI). Additionally, the conduct of clinical research was severely impacted during the pandemic, with many difficulties encountered in the conduct of clinical trials. This paper describes the COVID-related impacts experienced during the implementation of a randomised controlled trial (RCT) testing the effectiveness of a community pharmacist-led support service for people living with SPMI in Australia (the PharMIbridge RCT), and the strategies used to successfully implement the RCT. Australian public health orders led to interstate border closures, stay-at-home orders and work-from-home requirements, resulting in necessary changes to allow for the continuation of the RCT including; changes to trial regions, transferring some training materials online while delaying face-to-face (F2F) training components, delays in pharmacy and consumer recruitment, encouraging telehealth service delivery and extensions to timelines with existing funding. Having a solution-focussed and flexible approach, while still ensuring critical trial protocol elements were adhered to, such as providing opportunities for F2F skills-based training for pharmacists, as well as F2F site visits from researchers and mentors to support trial implementation, resulted in high pharmacy and consumer participant retention through to trial conclusion. Future planning for RCTs should consider possible pandemic-related risks and rapid responses from approval bodies to ensure researchers can be agile and adapt to ensure successful trial completion. |
format | Online Article Text |
id | pubmed-10225334 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-102253342023-05-30 Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic O'Reilly, Claire L. McMillan, Sara S. El-Den, Sarira Collins, Jack C. Hu, Jie Ng, Ricki Stewart, Victoria Pham, Lily Webb, Fleur Roennfeldt, Helena Segrott, Rebecca Loller, Hannah Wheeler, Amanda J. Contemp Clin Trials Short Communication Public health orders were introduced in many countries, including Australia, during the COVID-19 pandemic to reduce the spread of the virus. However, for many people this led to an exacerbation of mental health symptoms, particularly those living with severe or persistent mental illness (SPMI). Additionally, the conduct of clinical research was severely impacted during the pandemic, with many difficulties encountered in the conduct of clinical trials. This paper describes the COVID-related impacts experienced during the implementation of a randomised controlled trial (RCT) testing the effectiveness of a community pharmacist-led support service for people living with SPMI in Australia (the PharMIbridge RCT), and the strategies used to successfully implement the RCT. Australian public health orders led to interstate border closures, stay-at-home orders and work-from-home requirements, resulting in necessary changes to allow for the continuation of the RCT including; changes to trial regions, transferring some training materials online while delaying face-to-face (F2F) training components, delays in pharmacy and consumer recruitment, encouraging telehealth service delivery and extensions to timelines with existing funding. Having a solution-focussed and flexible approach, while still ensuring critical trial protocol elements were adhered to, such as providing opportunities for F2F skills-based training for pharmacists, as well as F2F site visits from researchers and mentors to support trial implementation, resulted in high pharmacy and consumer participant retention through to trial conclusion. Future planning for RCTs should consider possible pandemic-related risks and rapid responses from approval bodies to ensure researchers can be agile and adapt to ensure successful trial completion. Elsevier Inc. 2023-08 2023-05-29 /pmc/articles/PMC10225334/ /pubmed/37257726 http://dx.doi.org/10.1016/j.cct.2023.107246 Text en © 2023 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Short Communication O'Reilly, Claire L. McMillan, Sara S. El-Den, Sarira Collins, Jack C. Hu, Jie Ng, Ricki Stewart, Victoria Pham, Lily Webb, Fleur Roennfeldt, Helena Segrott, Rebecca Loller, Hannah Wheeler, Amanda J. Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic |
title | Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic |
title_full | Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic |
title_fullStr | Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic |
title_full_unstemmed | Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic |
title_short | Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic |
title_sort | implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: lessons learnt during the covid-19 pandemic |
topic | Short Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10225334/ https://www.ncbi.nlm.nih.gov/pubmed/37257726 http://dx.doi.org/10.1016/j.cct.2023.107246 |
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