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

INTERVENTION: 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. CONDITION: Asthma Chronic Obstructive Pulmonary Disease Hypertension PRIMARY OUTCOME: Adherence to medications: Self‐Report and Proportion of Days Covered INCLUSION CRITERIA: 1) Age>18 years, 2) Having signed informed consent; 3) Able to complete questionnairesEuroQol‐5D, Morisky 4 items, ACQ (Asthma Control Questionnaire), COPD assessment test; SECONDARY OUTCOME: Clinical Outcome: Asthma control assessed using the Asthma Control Questionnaire (ACQ) Clinical Outcome: Blood Pressure Levels assessed measuring blood pressure levels with OMROM or similar Clinical Outcome: COPD control assessed using the COPD Questionnaire (CCQ) Economic outcome: Patient use of health resources (hospital admissions) assessed by patient self report during the interviews and calculated using costs from the public system for diagnosis‐related groups. Economic outcome: Patient use of health resources (number of emergency department visits, hospital admissions, visits to general practitioner) assessed by patient self report during the interviews and cost calculated using prices from the public system. Economic outcome: Patient use of health resources (number of medications used) assessed by patient report during the interviews. Cost calculated from the official list of drug prices. Economic outcome: Patient use of health resources pharmacist's time) assessed measuring the pharmacist time, in minutes, during the interview with the patient. Humanistic Outcome: Health‐related quality of life assessed using EuroQol‐SD‐5L 4) Being prescribed either a blood pressure medication (medicines included in groups CO2, CO3, C07, C08, C09, according to Anatomical Therapeutical Chemical ATC classification system), an asthma medication (medicines included in group R03), or an COPD medication (medicines included in group R03).