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). 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.

A Multi-Mode Education Program to Enhance Asthma Care by Pharmacists.

Objective. To provide optimal asthma care, community pharmacists must have advanced, contemporary knowledge, and the skills to translate that knowledge into practice. The development and evaluation of an innovative multi-mode education program to enhance pharmacists' clinical knowledge and practical skills is described.Methods. The online education modules were collaboratively developed alongside asthma and pharmacy organizations. The education program was comprised of five evidence-based education modules delivered online and a skills review conducted either in-person with real-time feedback (urban pharmacists) or via video upload and scheduled video-conference feedback (regional and remote pharmacists). A mixed methods approach was used to evaluate the feedback obtained from pharmacists to assess the content, efficacy, and applicability of the education.Results. Ninety-seven pharmacists opted into the program and successfully completed all education requirements. A larger proportion of pharmacists did not pass trial protocol-based education modules on their first attempts compared to the number that passed the asthma and medication knowledge-based modules. Prior to skills review, the proportion of pharmacists demonstrating device technique competency was suboptimal. Pharmacists rated the education modules highly in both quantitative and qualitative evaluations and reported that the program adequately prepared them to better deliver care to asthma patients.Conclusion. We developed, implemented, and evaluated a novel multi-mode asthma education program for community pharmacists that supports knowledge and practical skill development in this crucial area of patient care. The education program was well received by pharmacists. This form of education could be used more broadly in international collaborative trials.

A Targeted Approach to Improve Asthma Control Using Community Pharmacists.

Background: Building on lessons learnt from evidence-based community pharmacy asthma management models, a streamlined and technology supported Pharmacy Asthma Service (PAS) was developed to promote the integration of the service into routine practice. Objective: This study investigates the efficacy of the PAS in improving asthma symptom control and other health outcomes. Methods: A two-arm pragmatic cluster randomized controlled trial was implemented in 95 pharmacies across three Australian States. Participants were adults with poorly controlled asthma as per the Asthma Control Questionnaire (ACQ), with or without allergic rhinitis. Patients within the PAS arm engaged in four consultations with the pharmacist over a 12-month period. An evidence-based algorithm guided pharmacies, via a trial specific software, to deliver a series of interventions targeting three issues underpinning uncontrolled asthma (medication use and adherence, inhaler technique, and allergic rhinitis management) to patient clinical asthma status and patient need. Comparator arm patients received a minimal intervention likened to usual practice involving referral of eligible patients to the GP and two follow-up consultations with their pharmacist to collect comparative data. Results: In total, 143 of 221 PAS patients (65%) and 111 of 160 comparator patients (69%) completed the trial. Improvements in asthma control were achieved in both the PAS (mean difference (MD) in ACQ from baseline = -1.10, p <.0001) and comparator (MD in ACQ from baseline = -0.94, p <.0001) arms at the trial end; however, there were no significant differences between the two arms (MD = -0.16, 95% CI -0.41 to 0.08, p = 0.19). Patients' quality of life in the PAS arm improved significantly when compared with the comparator arm (MD in Impact of Asthma on Quality-of-Life Questionnaire (IAQLQ) = -0.52, 95% CI -0.89 to -0.14, p = 0.0079). Conclusion: Despite the PAS achieving a greater improvement in patients' quality of life, the pharmacist-led service and usual practice arm produced comparable improvements in asthma control. These results ask us to reflect on current standards of usual care, as it appears the standard of asthma care in usual practice has evolved beyond what is reported in the literature.