A Randomised Controlled Trial for Pharmacist Review to Optimise Medicines in Residential Aged Care (PROMPT-RC)

For RACFs randomised to the INTERVENTION arm [**5 RACFs/334 participants (residents)], pharmacists who conduct medication reviews in that RACF site will be offered training to use the AusTAPER App/Pathway (including use of the AusTAPER electronic medicines management app and associated processes for review and management of medicines). Pharmacists will then be able to use this AusTAPER App/Pathway as part of medication reviews while the site remains in the study. INTERVENTION 1. Method of Engagement It is anticipated the pharmacist will conduct face-to-face or virtual (telehealth or other) meetings to engage with the resident during the initial interview (30-60 minutes) and subsequent reviews with the resident and/or the GP. Many RACFs, pharmacists, and GPs have adopted the use of virtual/telehealth appointments since the global pandemic. The flexibility to use this approach, or a mixture of both is expected to help with adherence to the intervention process and ‘buy-in’ with residents and GPs. 2. Pharmacist uptake of the Taper MD Tool Pharmacists providing services at a participating facility will be offered access to the AusTAPER App/Pathway. Pharmacists will be funded by the research grant to conduct reviews through the AusTAPER App/Pathway. In addition, they will be offered training and support through participation in a Community of Practice (CoP). The training will be conducted through a CoP, with facilitation by the Pharmaceutical Society of Australia (PSA), Society of Hospital Pharmacists of Australia (SHPA), and a paid external facilitator. Training through the CoP will be ongoing throughout the 3-year intervention period (from February 1, 2024, to February 1, 2027) to provide continuous support and learning opportunities for pharmacists. The training and intervention will be conducted in the first month after randomisation. During the training sessions, pharmacists will be introduced to the procedures for utilising the AusTAPER App/Pathway and will receive detailed instructions on how to implement the review process. The CoP will include four virtual teleconference meetings annually (hosted on Microsoft Teams) and an annual 1-day symposium with both online and face-to-face options. Meetings aim to facilitate interaction, including case discussions and journal clubs. This process is detailed in a separate protocol document for the Community of Practice component that will be considered independently of the RCT. 3. TAPER Tool (TAPER™) The key innovation used in this study is the Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER). The TAPER tool is enhanced with Medication Appropriateness Tool for Comorbid Health conditions in Dementia (MATCH-D). This study will also integrate the Medication Regimen Simplification Guide for Residential Aged Care (MRS GRACE) tool for medicines regimen simplification in RACFs and the (PRIME) conversation tool that stands for “PReparing people living with dementia and their carers to Initiate deprescribing conversations about Medications” into the review process. This package of applications, tools and processes is referred to as the AusTAPER App/Pathway. It is a web-based application that integrates evidence and a clinical pathway for structured assessment and follow-up by pharmacists and general physicians (GPs). Using integrated data from systematic review, qualitative research and piloting that informs patient priorities, AusTAPER App/Pathway utilises decision-support to incorporate validated algorithms consistent with international best practice for flagging Potentially Inappropriate Medicines (PIMs), and a clinical pathway to incorporate Numbers (of medicines) Needed to Treat (NNT)/Harm (NNH) and other decision support. The AusTAPER App/Pathway provides suggested withdrawal strategies including tapering schedules. Adherence to the intervention will be assessed through engagement metrics, including participants’ activity on the CoP platforms (Moodle, Facebook, WhatsApp), meeting attendance, and analysis of discussion transcripts. Additionally, participation logs from virtual meetings and symposium attendance will serve as indicators. 3.1 Review Process The AusTAPER App/Pathway helps pharmacists follow the step-by-step clinical reasoning process applied by experienced pharmacists when assessing complex medicine regimens. The app assists in this process through provision of electronic flags (electronic flags are automated alerts or notifications that signal potentially inappropriate medications (PIMs) within a resident's entire medication regimen).The Pharmacist will consider the medicine regimen, electronic flags and the (resident’s) questionnaire responses. Considering these data, the pharmacist will draft an electronic medicines management plan to optimise medicines for safe and effective use. The pharmacist will discuss the draft plan with the GP and health practitioners involved in the resident’s care and the resident and their relative/guardian (if appropriate or requested). Based on the consensus, the pharmacist will finalise the plan. 3.2 The Final TAPER Plan The final medicines management plan will outline any changes agreed for any of the resident’s medicines. There may be some, many or no changes to implement. The plan will include details of • the schedule of fortnightly monitoring reviews and the purpose of each review • any specific monitoring which may be required if a medication is changed/withdrawn (eg additional blood pressure monitoring, or other tests/measurements needed for the safe reduction/change/withdrawal of a medication • ‘red flags’ for early detection of potential adverse drug withdrawal events (ADWE) • recommendations for actions if such events occur (eg re-prescribing a ceased medication, alternative medication options/dosages or frequencies or additional medications to counter-act side effects. 3.3 The Monitoring Process The pharmacist will conduct a fortnightly review of the resident’s medications during the implementation of the plan. For those residents with communication issues (due to such things as stroke, dementia, cognitive impairment), the pharmacist will make use of the GP notes, RACF progress notes and reviews and other feedback which indicates issues with the medications being targeted (eg cues which suggest increased pain or discomfort, records of changes to sleep, bowel or eating habits, test results which might indicate the presence of UTIs or infection etc). The fortnightly monitoring reviews which will continue until 2 weeks after the final change to the last medication is made. The pharmacist intervention concludes two weeks after the final scheduled monitoring appointment. TIMEPOINTS: RACFs will remain in the study for 12 months post-randomisation. Primary and secondary outcomes will be measured at five (5) time points: baseline, 3, 6, 9 and 12 months (post-randomisation). For comparative purposes, data will also be sought for the 3 and 6-months pre-baseline time-points.