Bridging the gap between physical and mental illness in community pharmacy (PharMIbridge): protocol for an Australian cluster randomised controlled trial

INTRODUCTION: There is a significant life expectancy gap attributable to physical comorbidities for people living with severe and persistent mental illness (SPMI) compared with the general population. Medications are a major treatment for SPMI management and physical illnesses, hence pharmacists are well positioned to support mental healthcare and comorbidities. The randomised controlled trial (RCT) aim is to evaluate effectiveness of an individualised, pharmacist led, support service for people experiencing SPMI focusing on medication adherence and physical comorbidity management, compared with standard care (a medication-management service; MedsCheck). METHODS AND ANALYSIS: PharMIbridge is a cluster RCT, whereby community pharmacies in four Australian regions will be randomised (1:1 ratio), to either Intervention Group (IG) or Comparator Group (CG). All IG and CG pharmacy staff will receive Blended-Mental Health First Aid training. Additionally, IG pharmacists will receive further training on medication adherence, goal setting, motivational interviewing, managing physical health concerns and complex issues relating to psychotropic medication. CG pharmacists will not receive additional training, and will provide standard care (MedsCheck). The primary outcome will be change in participants medication adherence for psychotropic medication over 6-months. Using mixed-effects logistic regression model and a cluster size of 48 pharmacies, a total of 190 participants will need to be recruited to each arm to find a statistically significant difference in medication adherence. Secondary outcomes will be changes in factors associated with cardiometabolic risk and quality of life, emphasising physical and psychological well-being; medication-related problems; adherence to other prescribed medication; pharmacists knowledge, confidence and ability to support people experiencing SPMI; and effects on healthcare utilisation. A within RCT-based economic evaluation comparing the intervention with standard care will be undertaken. ETHICS AND DISSEMINATION: The protocol and pharmacist training programme received Griffith University Human Research Ethics Committee approval (HREC/2019/473 and HREC/2019/493 respectively). Results will be published in peer-reviewed journals and available at the Sixth Community Pharmacy Agreement website (http://6cpa.com.au/about-6cpa/). TRIAL REGISTRATION NUMBER: ANZCTR12620000577910.