PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Pharmacogenomics Education & Implementation Program for Pharmacists

A pharmacogenomics (PGx) education and implementation program will be developed and tested on pharmacists participating in the PRECISION-ITS multisite interrupted time series tele-trial. The PGx education/implementation program will run concurrently with the primary PGx trial. In the primary trial, pharmacogenomics pharmacists at the primary site are responsible for all PGx consenting and follow up, whereas these activities may be delegated to pharmacists at regional tele-sites in Time Series 2 who have completed the PRECISION-ITS Pharmacogenomics Education/Implementation program. Pharmacists recruited to PRECISION-ITS will be enrolled in the PGx education/implementation program to acquire PGx knowledge and to discuss PGx service implementation plans, successes and barriers. The program will focus on PGx in the context of adults receiving systemic anticancer therapies, establishing a framework which may then be applied to other settings (such as paediatric oncology) and healthcare disciplines. Development of the PGx education/implementation program will occur in Time Series 1 (over 10-12 months). Delivery of the PGx education/implementation program will occur within 6 months before Time Series 2 participant accrual in the primary PGx trial (to allow for credentialed pharmacists at regional tele-sites to conduct primary PGx trial follow up assessments). Time Series 2 in the Primary PGx trial will commence 3-4 months after Time Series 1 participant accrual is completed. 1. Education Program The PGx education program will feature up to 9 online education modules on a learning management system written and developed by the PRECISION-ITS Education working group. The education working group consists of pharmacists, clinical educators, consumer representatives, clinical geneticists, genetic counsellors, and experts in pharmacogenomics and implementation science, who will meet weekly to biweekly to create/review module content. Program development will occur in Time Series 1 across 10-12 months, and will be informed by internationally recognized web content accessibility guidelines standards. The program will incorporate key program elements of flipped classroom, clinical case vignettes, self-test multiple choice/short answer questions, reflective (v)logs, expert pharmacist/ clinician-moderated discussion boards that will connect participants in a learning community, and three virtual educational outreach sessions to facilitate local PGx service implementation at regional Teletrial sites using guided reflection. Knowledge, Attitudes and Practices (KAP) surveys regarding PGx for consumers and healthcare professionals practicing in oncology within Australia (designed specifically for this study) will also be undertaken to provide a needs assessment to inform program design. Separate surveys will be developed for the adult and paediatric oncology settings. One set of surveys will be targeted at consumers/carers (who have had or cared for someone who was treated for cancer in the Australian healthcare system). The other set of surveys will be targeted at health care professionals working in cancer care (e.g. oncologist, haematologists, pharmacists & nurses). KAP surveys will be distributed at Month 6 and are to be completed/evaluated at Month 9 in preparation for program finalisation. The Theoretical Domains Framework (TDF) and Bradshaw’s model of needs were used to develop a holistic, stakeholder-centred needs assessment that will elicit the needs of health care professionals and consumers. These behaviour change frameworks for a targeted education program will be embedded within PRECISION-ITS’s learning health system to provide value by addressing pharmacists’ unmet information needs, and extending their scope of practice. Content will be hosted on a globally recognised Learning Management System that supports creating and deploying custom role-specific courses to craft groups. Modules will be developed from established US/UK competencies for pharmacists and other health professionals; reviewed/assessed for appropriateness in the context of adults receiving anticancer treatment; and designed with implementation science theory to ensure successful integration/sustainability of PGx-guided medicines optimization within and beyond the trial, Although the modules are targeted at pharmacists, modules have been written such that other healthcare professionals may undertake these modules beyond the trial. The modules will undergo two rounds of user testing during Time Series 1 by 5-9 pharmacists at the primary site, with an aim to deliver the final program to 1-2 pharmacists per PRECISION-ITS site. Each education module will take approximately 30 minutes to complete, with an aim for trainees to complete all modules within 2-3 months. The education program will incorporate key program elements of flipped classroom, clinical case vignettes, self-test multiple choice/short answer questions, reflective (v)logs and expert pharmacist/clinician-moderated discussion boards. 2. Implementation program The PGx implementation program will feature 3 educational outreach sessions on facilitation of local PGx service implementation at regional teletrial sites. Outreach sessions will be delivered to pharmacists enrolled in the PRECISION-ITS program by pharmacists within the PRECISION-ITS working group with established experience in clinical education and PGx service implementation. This will consist of three 1-hour virtual sessions occurring before program participation, during program participation, and after implementation of a local PGx service at the regional tele-trial sites.