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.

Enablers and barriers to non-dispensing pharmacist integration into the primary health care teams of Aboriginal community-controlled health services.

BACKGROUND: The primary health care management of chronic disease affecting Aboriginal and Torres Strait Islander peoples requires healthcare quality and equity demands to be met, and systems that foster better team-based care. Non-dispensing pharmacists (NDPs) integrated within primary healthcare settings can enhance the quality of patient care, although factors that enable or challenge integration within these settings need to be better understood. OBJECTIVES: To investigate enabling factors and barriers influencing integration of NDPs within Aboriginal community-controlled health services delivering primary health care. This was achieved through qualitative evaluation of the Integrating Pharmacists within Aboriginal Community Controlled Health Services (IPAC) Trial exploring the perceptions of NDPs, community pharmacists, healthcare staff, managers, and Aboriginal and Torres Strait Islander patients of these services. METHODS: NDPs were employed across twenty urban, rural, and remote services in three Australian states and provided pre-defined medication-related roles to adult Aboriginal and Torres Strait Islander patients. Perceptions were elicited from online surveys, interviews, and focus groups. Transcripts were thematically analyzed using the constant comparison method to identify, compare, and refine emerging themes. RESULTS: One hundred and four participants informed the findings, including 24 NDPs, 13 general practitioners, 12 service managers, 10 community pharmacists, 17 health service staff, and 17 patients. Enablers of integration included: personal (previous experience with Aboriginal and Torres Strait Islander peoples, cultural awareness, skills, individual attributes); health service-related (induction programs, Aboriginal Health Worker support, team-building initiatives); and community-related factors (engaged community elders, leaders, cultural mentors, community pharmacy champions). Barriers to NDP integration included a lack of systems supports for patients and staff to adapt to NDP roles, health service factors, travel requirements, a lack of community linkages, and time and budget constraints. CONCLUSIONS: NDP integration within primary health care services has potential to enhance medication-related services to Aboriginal and Torres Strait Islander peoples if enabling factors are supported and health systems and adequate resources facilitate the integration of pharmacists within these settings.

Integrating pharmacists into Aboriginal Community Controlled Health Services (IPAC project): Protocol for an interventional, non-randomised study to improve chronic disease outcomes.

BACKGROUND: Aboriginal and Torres Strait Islander peoples experience a higher burden of chronic disease yet have poorer access to needed medicines than other Australians. Adverse health outcomes from these illnesses can be minimised with improved prescribing quality. This project aims to improve quality of care outcomes for Aboriginal and Torres Strait Islander adult patients with chronic disease by integrating a pharmacist within primary health care teams in Aboriginal Community Controlled Health Services (ACCHSs). METHODOLOGY: This non-randomised, prospective, pre and post quasi-experimental study, will be pragmatic, community-based and participatory, comparing outcomes and costs using paired patient data. Pharmacists will be integrated at 22 sites for approximately 15 months to conduct patient-related and practice-related activities through 10 core roles: providing medication management reviews, assessing adherence and medication appropriateness, providing medicines information and education and training, collaborating with healthcare teams, delivering preventive care, liaising with stakeholders, providing trnsitional care, and undertaking a drug utilisation review. With patients' consent, de-identified client-level data will be extracted from clinical information systems and pharmacists will record deidentified activity in an electronic logbook. Primary expected outcomes include improvements in biometric indices (glycated haemoglobin, systolic and diastolic blood pressure, lipids, cardiovascular risk, albumin-creatinine ratio) from baseline to end of study. Expected secondary outcomes include improvements in estimated glomerular filtration rate, prescribing indices (appropriateness, overuse and underuse), medication adherence, self-assessed health, and health service utilisation indices. A qualitative assessment of stakeholder and patient perceptions and a cost-effectiveness analysis will be undertaken. DISCUSSION: Numerous inquiries have recommended evaluating the impact of pharmacists integrated within primary health care settings. This study is the first to explore this impact on the health of Aboriginal and Torres Strait Islander peoples who are medically underserved. Evaluation of innovative integrated workforce models is necessary to address the challenges of delivering quality care together with this population.