Evaluation of a community pharmacist-led minor ailments service in collaboration with general practitioners: a cluster randomised controlled trial

The study will use a community pharmacy-based cluster randomised controlled trial (c-RCT) design with an intervention and a control group. The intervention will be trialled by community pharmacists over a 6 month period, but may be extended to 12 months if required if patient numbers are not achieved. As we are aiming to evaluate the impact of an enhanced service compared to the one that is already being delivered in routine practice, we are proposing four innovative features within our study that include: 1. Clinical pathways for minor ailments agreed between general medical practitioner and community pharmacists prior to the beginning of the study. 2. A standardised consultation between the pharmacist and the patient during routine clinical practice using the above clinical pathways. 3. Real time shared clinical information, communication and feedback to the general practitioner. 4. A comprehensive educational training program for pharmacists including strategies to support and improve consumer self-care. Intervention patients will receive the minor ailments service on presentation to the pharmacy. This will involve a structured one-on-one face-to-face pharmacist-patient consultation with follow up. Pharmacists will follow eight steps in the patient encounter: –– Service offering, during which the pharmacist explains the features of the service; –– Obtain written informed consent; –– Establish the environment (i.e. take the patient to an appropriate or private consulting area); –– Conduct an appropriate detailed assessment using HealthPathways (to confirm medications; medical conditions and allergies; identify symptoms; identify red flags or other referral criteria); –– Use the agreed treatment protocols to determine if: (1) the patient would benefit from a non-prescription product; (2) the patient should be referred to a medical practitioner; (3) the patient only requires some verbal and written self-care advice. If a non-prescription product is recommended, the pharmacist will provide verbal and written self-care advice. If referral to another health care professional is indicated, the pharmacist will ensure this is done effectively by providing reasons for referral. –– Complete the study data collection form as required and patient quality of life assessment; –– Establish follow up plan (including how and when follow up will be conducted); –– Notify the patients regular general practitioner using HealthLink (secure messaging system) when a medicine is provided or referral made; The study will involve a patient follow-up 14 days after the consultation. This follow-up will be conducted by a member of the research team by telephone to assess symptom resolution and health care utilisation for the index ailment. We will ask intervention pharmacists to participate in: -- 5-10 minute pharmacist-patient consultation; -- 2 minutes to document per consultation; -- 2 minutes to provide electronic feedback to the patient’s usual GP per consultation; -- 7 hours of minor ailment service training. We will ask intervention patients to participate in: -- 5-10 minute pharmacist-patient consultation; -- 2 minutes to complete the EuroQoL EQ-5D questionnaire; -- 5 minute follow up telephone call with the research team. Training of pharmacists Pharmacists involved in delivering the service (intervention) will attend a two day training seminar at Western Sydney primary health network. The training course comprising of two 3.5-hour sessions will involve a combination of presentation of material, interactive workshops and on-site training delivered by the research team. Training will be supplemented with a pharmacy pack containing information and resources to be utilised throughout the study period. The entire service will be monitored by Practice Change Facilitators (PCFs), pharmacists who will ensure the quality of the delivery of the interventions and support pharmacists in all processes during the study period.