ACTRN12618001105235.

Trial name or title	Enhanced intervention to improve medication adherence in a community pharmacy setting
Methods	Randomised controlled trial, parallel
Participants	Inclusion criteria: aged > 18 years Signed consent form Signed data linkage consent form Able to complete questionnaires Prescribed medication for hypertension, cholesterol, depression, anxiety, COPD, or a combination of these Eligibility identified via GuildCare software Medical possession ratio < 70% Exclusion criteria: collecting someone else's medication Communication limitations or any other impairment the recruiting pharmacist considers could preclude them from participating Gender: men and women
Interventions	3‐arm comparison of an enhanced tailored adherence intervention to an educational adherence programme and usual care in a community pharmacy setting: a cluster randomised controlled trial Arm 1: patient‐tailored brief complex interventions with monthly follow‐up over 12 months to improve, reinforce, and maintain adherence behaviour and their impact in clinical, economical, and humanistic outcomes. Arm 2: GuildLink software educational intervention as a guided counselling session to improve adherence behaviour and their impact in clinical, economical, and humanistic outcomes. Arm 3: The enhanced intervention is a brief complex intervention delivered once to eligible patients as identified through the GuildCare software which aims to optimise medicines use on a systematic and regular basis. Community pharmacists will be trained in 2 × 4‐hour sessions on the study process, data collection, and behavioural change theoretical framework by study investigators trained in practice change facilitation. The training will be delivered via power point with printed materials and motivational interviewing practice sessions. The face‐to‐face pharmacist‐delivered adherence service (evidenced‐based intervention adapted from interventions for enhancing medication adherence a systematic review by Cochrane) has several interacting components based on a sequence of principles that imply over an estimated 10‐minute session: the identification of non‐adherent patients; adherence assessment and the classification of the patient according to the type of non‐adherence presented (intentional or non‐intentional) based on the Morisky 4‐item questionnaire; the investigation of the specific barriers leading to the specific behaviour; the provision of a pharmacist‐intervention targeted to the barriers identified in the individual patient; the assessment of the patient's readiness to change, combined with communication and collaboration with the patient's GP; and a monthly follow‐up process to assess progress over 12 months. Pharmacists will determine barriers based on asking the patient questions based on the Moresby 4‐item questionnaire. These questions address patients' beliefs about their medication, knowledge of the medication, and if they stop or forget taking their medication ever. Additional questions based on pharmacist discretion (i.e. how often do you forget to take your medication?) will be asked to further evaluate reasons for non‐adherence. Pharmacist‐delivered interventions will include ≥ 1 of the following based on what barriers were discovered for non‐adherence: provide verbal information and medicine information pamphlet; prepare or recommend: medication list, dose administration aid, alarm, cue‐dose training; explain benefits of medication as well as risks of non‐adherence; address misunderstandings or probability of adverse effects and ways to manage; additional information or tools available under the pharmacist's discretion. Readiness to change will be based on the pharmacist's discretion, which we will address in the training sessions using the Transtheoretical Model. The participant will only be involved in short, 10‐minute monthly sessions when at the pharmacy to pick up their medications. If they so choose, they can opt into pharmacy repeat fill reminders to send an SMS or phone call monthly when their prescription is ready. Arm 2: 2 software programs: NTT and MedScreen Compliance guide an estimated 1 × 10‐minute face‐to‐face pharmacist–patient interactions to enhance adherence. The NTT program is a pharmacist intervention provided to patients who are initiating on a medication for the first time. It provides information on how to take/use the medication to achieve ultimate health outcomes as well as medication adherence guidance with an optional monthly follow‐up reminder to refill the medication. A software program guides a pharmacist and allows documentation of a patient's response and understanding, made from readily available resources already used in pharmacies subscribed to the GuildCare software. In addition, a pharmacist can document a clinical intervention, including compliance or education issues, and recommendation made. Under the Community Pharmacy Agreement Pharmacy Practice Incentive Programme, pharmacies may be eligible to receive an incentive payment for conducting clinical interventions. This is already included in standard dispensing for pharmacies prescribed to the GuildCare software. See clinical interventions listed on the Pharmaceutical Society of Australia website (www.psa.org.au/practice‐standards/pharmacists‐performing‐clinical‐interventions). The MedScreen Compliance and Compliance program creates a guided face‐to‐face pharmacist and patient interaction to target non‐adherent patients and increase medication adherence. The software calculates the patient's MedsIndex score, an already readily available resource from the dispensing data collected in the GuildCare software, which represents how much medicine the doctor intended the patient to take.
Outcomes	Primary outcomes: calculation of percentage of proportion of days covered (PDC) in all arms. These data will be collected from the GuildCare software dispensing records (prescription dispense dates). 'Days covered' are determined by the formula in PDC, adding total days dispensed over a period of time. This accounts for gaps in the dispense records if patients pick up their dispensed medication early; medication adherence: medication possession ratio (MPR) in all arms. These data will be collected from the GuildCare software dispensing records (prescription dispense dates); self‐report of adherence by Morisky 4‐item questionnaire. Secondary outcomes: number of hospital admissions will be measure with Australian Medicare data to determine the intervention effects on cost to the healthcare system; for COPD, a Clinical COPD Questionnaire (CCQ) will be asked to patients; for depression: Psychological Health Questionnaire (PHQ‐9) categorises severity; for humanistic outcomes: quality of life will be measured by the EuroQol‐5D‐5L; for hyperlipidaemia, total cholesterol will be measured using blood test with a cholesterol meter (total cholesterol levels); for hypertension, control of the disease will be done by the measurement of blood pressure levels using a digital blood pressure monitor; number of medications and their cost based on Australian Medicare data will be used to assess costs associated with non‐adherence and the intervention effects; time of training and mean time spent for the pharmacist on the interview and mean time PCF supporting interventional pharmacists will be measured by pharmacy and researcher records to measure the cost associated with the intervention.
Starting date	Not yet recruiting
Contact information	Dr Elyssa Wiecek, University of Technology Sydney Graduate School of Health, NSW, Australia Tel: +61 (02) 9514 9223 E‐mail: elyssa.wiecek@uts.edu.au
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