Pharmacy Trial Program (PTP)- Getting asthma under control using the skills of the community Pharmacist

Pharmacy Trial Program (PTP) - Getting asthma under control using the skills of the community Pharmacist. The proposed project addresses the need to improve clinical outcomes for the population at risk of uncontrolled asthma, by extending the role of pharmacists in the delivery of primary health care services through a community pharmacy. The trial will use a cluster randomised design to test the clinical and cost effectiveness of a pharmacy based service for asthma patients in the community. The cluster will be the community pharmacy and the unit of analysis the patient. It will comprise two groups (A & B). Group A: Intervention Arm - The proposed intervention involves an evidence-based pharmacist-delivered service for patients with uncontrolled asthma, which can easily be integrated into pharmacists’ workflow. To deliver the intervention, the pharmacist will undertake three private consultations with the patient over a period of 12 months (at baseline, one month and 12 months), with a six-month telephone check-up mid-program. The consultations will focus on addressing three key factors associated with uncontrolled asthma: 1) Poor adherence characterised by underuse of preventer medication and/or over use of reliever medication, 2) Sub-optimal inhaler technique and/or 3) Uncontrolled allergic rhinitis. The service will be delivered in 40 pharmacies in NSW, WA or TAS, each delivering the service to 7 patients. (280 participants in total) *Group B: Low intervention - Pharmacy screening for uncontrolled asthma and referral to GP. The low intervention service will be delivered in 40 pharmacies in NSW, WA or TAS, each delivering the service to 7 patients. (280 participants in total) Outcomes will be measured using the following validated tools: *Asthma Control - Asthma Control Questionnaire (ACQ) *The Impact of Asthma on Quality of Life Questionnaire (IAQLQ) *Visual analogue scale to assess medication adherence. *Inhaler technique score *Rhinitis Control Assessment Test (RCAT) *Short Form 12 (SF-12) a generic quality of life survey In the intervention arm at the initial/ baseline visit (20 minutes) the pharmacist will: *Assess Asthma related Quality of Life using IAQLQ *Review short acting beta agonist (SABA) use. *Assess asthma medication adherence with a visual analogue scale and using the dispensed medication history from the previous 12 months, then address any issues identified. *Assess and correct inhaler technique. *Assess allergic rhinitis control using the RCAT and recommend appropriate therapy/refer to the General Practitioner (GP) as appropriate. *Use the SF-12 for economic evaluation *Ask about Action Plan ownership and prompt to obtain an asthma action plan from their GP (if the individual does not already have one) *Download preventer medication dispensing over the previous 12 months. At the 1 month follow-up (15 minutes) the pharmacist will: *Reassess asthma control using the ACQ. *Remeasure Asthma related quality of life using IAQLQ *Reassess Inhaler technique *Review SABA use *Assess allergic rhinitis control if appropriate using RCAT At 6 months the pharmacist will contact the patient by phone (10 minutes) and will: *Reassess asthma control using the ACQ *Ask if there are any issues to address At the 12 month (15 minutes) follow-up the pharmacist will: *Reassess asthma control using the ACQ *Reassess asthma medication adherence (VAS + dispensing history) *Assess asthma-related quality of life using IAQLQ *Reassess Inhaler technique *Record action plan ownership *Assess allergic rhinitis control if appropriate *Use the SF-12 for economic evaluation *Review short acing beta agonist use (SABA) *Download preventer dispensing over the previous 12 months. Pharmacists who take part in the trial will be required to undertake a continuing professional development (CPD) accredited online training course created by The Pharmaceutical Society of Australia and the National Asthma Council to enable consistent delivery of the intervention. The modules must be completed by each participating pharmacist prior to taking part in the trial and recruiting their first patient. As many pharmacies are located in rural and remote areas of Australia, this is the most appropriate way to deliver training to the trial participants (pharmacists). Trial participants will receive online accreditation once they demonstrate an understanding of their requirements under the trial. This online training course will familiarise the trial pharmacists with the materials and resources developed to facilitate the delivery of the service, including promotional material, training and management processes and templates. It will consist of 4 modules, each taking approximately 1-2 hours to complete. The training will include: *Service protocol *Pharmacy eligibility and requirements *Patient eligibility *Clinical Pathway *How to implement the service in the community pharmacy *How to identify and recruit patients *How to approach and engage with local GPs A promotional resources kit will be distributed to all 40 participating pharmacies, and will include: *Posters to promote the service *Patient materials, including approved asthma resources and flyers/brochures about the service *Local area marketing templates and process guides The study materials pack will include: *Patient invitation letters *Patient referral letters for group B patients *Patient follow-up material *All participant plus patient information and consent documents, instruments and data recording materials Pharmacies will be randomised to pharmacy asthma intervention (Group A) or screening and referral (Group B). Randomisation will be stratified by metro/urban/rural residential areas, matched to the distribution of the Australian population. This project utilises evidence-based methods of utilising trained pharmacists to improve asthma patient’s inhaler use and medication adherence. These methods have been shown to improve asthma control in patients and improve their quality of life. The benefit to the health system is cost saving (better asthma control implies lower health care utilisation) and maximising asthma care capacity (using the privately funded infrastructure of pharmacy). Some of the costs of sub-optimally controlled asthma may stem from undermanaged rhinitis. By checking for rhinitis and providing treatment recommendations the quality of life of people with asthma may be incrementally improved as well. Pharmacists will be audited by the research team after they complete the first 2 patients. Adherence to the trial protocol and data collected will be reviewed at this stage and help will be given if there are any problems. Variations in service delivery will be minimised by: *The inherent design of the intervention software which will provide structured support and data documentation for pharmacists. *The training program for pharmacists will assess protocol competence prior to implementing the program in a given pharmacy. *A project hotline will be maintained and will allow pharmacists to access project research staff at the lead site.