PMID- 31400107 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200930 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 8 IP - 8 DP - 2019 Aug 9 TI - Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme: Protocol for a Cluster Randomized Controlled Trial. PG - e13973 LID - 10.2196/13973 [doi] LID - e13973 AB - BACKGROUND: Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE: This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. METHODS: The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. RESULTS: The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. CONCLUSIONS: This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13973. CI - (c)Sarah Dineen-Griffin, Victoria Garcia-Cardenas, Kris Rogers, Kylie Williams, Shalom Isaac Benrimoj. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.08.2019. FAU - Dineen-Griffin, Sarah AU - Dineen-Griffin S AUID- ORCID: 0000-0001-7080-0108 AD - Graduate School of Health, University of Technology Sydney, Ultimo, Australia. FAU - Garcia-Cardenas, Victoria AU - Garcia-Cardenas V AUID- ORCID: 0000-0003-3770-4557 AD - Graduate School of Health, University of Technology Sydney, Ultimo, Australia. FAU - Rogers, Kris AU - Rogers K AUID- ORCID: 0000-0001-5497-4298 AD - Graduate School of Health, University of Technology Sydney, Ultimo, Australia. FAU - Williams, Kylie AU - Williams K AUID- ORCID: 0000-0002-5094-243X AD - Graduate School of Health, University of Technology Sydney, Ultimo, Australia. FAU - Benrimoj, Shalom Isaac AU - Benrimoj SI AUID- ORCID: 0000-0001-9768-7838 AD - Emeritus Professor, The University of Sydney, Camperdown, Australia. LA - eng PT - Journal Article DEP - 20190809 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC6709938 OTO - NOTNLM OT - Australia OT - community pharmacy services OT - general practitioners OT - nonprescription drugs OT - pharmacists OT - pharmacy OT - primary health care OT - randomized controlled trial OT - self care OT - self medication COIS- Conflicts of Interest: None declared. EDAT- 2019/08/11 06:00 MHDA- 2019/08/11 06:01 PMCR- 2019/08/09 CRDT- 2019/08/11 06:00 PHST- 2019/03/11 00:00 [received] PHST- 2019/06/27 00:00 [accepted] PHST- 2019/06/21 00:00 [revised] PHST- 2019/08/11 06:00 [entrez] PHST- 2019/08/11 06:00 [pubmed] PHST- 2019/08/11 06:01 [medline] PHST- 2019/08/09 00:00 [pmc-release] AID - v8i8e13973 [pii] AID - 10.2196/13973 [doi] PST - epublish SO - JMIR Res Protoc. 2019 Aug 9;8(8):e13973. doi: 10.2196/13973.