Medication adherence management in a community pharmacy setting (AdherenciaMED): a cluster randomized controlled trial

• Register: ANZCTR
• Last refreshed on: 11 June 2018
• Main ID: ACTRN12618000410257
• Date of registration: 21/03/2018
• Prospective Registration: No
• Primary sponsor: Consejo General de Colegios Oficiales de Farmaceuticos
• Public title: Medication adherence management in a community pharmacy setting (AdherenciaMED): a cluster randomized controlled trial
• Scientific title: The effect of a medication adherence management service in a community pharmacy setting on patient's adherence to medications: a cluster randomized controlled trial
• Date of first enrolment: 29/09/2017
• Target sample size: 1230
• Recruitment status: Active, not recruiting
• URL: http://www.anzctr.org.au/ACTRN12618000410257.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Hypertension

Chronic Obstructive Pulmonary Disease

Asthma

Intervention(s)

Patient tailored brief complex interventions to improve, reinforce and maintain adherence behaviour and their impact in clinical, economical and humanistic outcomes.

The intervention will be delivered by pharmacists, in community pharmacies distributed in 6 provinces in Spain to patients with medications for treating asthma, COPD and hypertension. A total of six monthly face to face interviews will be agreed between the pharmacist and the patient in a consultation hold on a counselling area. All the data will be recorded in an electronic data collection form specifically developed for the study.

Before patient recruitment, pharmacists allocated to the Intervention group will be trained on the study protocol and service delivery, The training will be provided by the members of the research team, and will involve theoretical and practical (role play) approaches. It will be focused on clinical aspects of the conditions, adherence management, including the application of several frameworks for changing patient behaviour (motivational interviewing, health belief model, necessity and concerns model, information-motivation-strategy model and transtheoretical model).

During each interview a review of the patient's current medications will be undertaken. The dispensing dates of each medication will also be recorded, based on the pharmacy refill data. These variables will be used for the further calculation proportion of days covered.
All the new medications and clinical conditions will be recorded.

The pharmacist then will assess (1) medication adherence (through the Morisky-4 self report questionnaire) and (2) inhaler technique (through a specific inhaler device checklist). This step will only be undertaken in patients with COPD or asthma.
Based on these responses the patient will be identified in one of the four categories of non-adherence (intentional, non-intentional, combined, erratic). The concepts of Motivational Interviewing will be applied throughout the whole pharmacist-patient interaction and specific models will be used based on the patient's classification of non-adherence. For all the non-adherent patients, the health belief model, Necessity and Concerns, Information-Motivation-Strategy and Transtheoretical model will be applied.

A list of barriers and strategies has been defined based on defined determinants of non-adherence according to the World Health Organization; and also strategies to maintain and reinforce adherence in adherent patients. Strategies will cover educational (e.g. written or oral information), social (e.g. family support), healthcare communication (e.g. regimen simplification or change) or medication aids (e.g. dose taking aids, phone messages, alarms) amongst others.

The project will be monitored by Practice Change Facilitators (PCF), who will ensure the quality of the service delivery and will support the participant pharmacists through monthly visits.