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

Claire L O'Reilly; Sara S McMillan; Sarira El-Den; Jack C Collins; Jie Hu; Ricki Ng; Victoria Stewart; Lily Pham; Fleur Webb; Helena Roennfeldt; Rebecca Segrott; Hannah Loller; Amanda J Wheeler

doi:10.1016/j.cct.2023.107246

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

Contemp Clin Trials. 2023 Aug:131:107246. doi: 10.1016/j.cct.2023.107246. Epub 2023 May 29.

Authors

Affiliations

¹ The University of Sydney, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia. Electronic address: claire.oreilly@sydney.edu.au.
² Menzies Health Institute Queensland, Griffith University, Brisbane, QLD, Australia; Centre for Mental Health, Griffith University, Brisbane, QLD, Australia; School of Pharmacy and Medical Sciences, Griffith Health, Griffith University, Gold Coast, QLD, Australia.
³ The University of Sydney, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
⁴ Menzies Health Institute Queensland, Griffith University, Brisbane, QLD, Australia.
⁵ Menzies Health Institute Queensland, Griffith University, Brisbane, QLD, Australia; Centre for Mental Health, Griffith University, Brisbane, QLD, Australia; Centre for Psychiatric Nursing, University of Melbourne, Melbourne, VIC, Australia.
⁶ National Secretariat, The Pharmacy Guild of Australia, Barton, ACT, Australia.
⁷ The Pharmaceutical Society of Australia, Deakin, ACT, Australia.
⁸ Menzies Health Institute Queensland, Griffith University, Brisbane, QLD, Australia; Centre for Mental Health, Griffith University, Brisbane, QLD, Australia; Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.

Abstract

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.

Keywords: COVID-19; Clinical trials; Mental health; Pharmacists.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Australia
COVID-19* / prevention & control
Humans
Mental Disorders* / epidemiology
Mental Disorders* / therapy
Mental Health
Pharmacies*