Better Outcomes For Everybody (BOFE) evaluates the effectiveness and cost-effectiveness of a pharmacist-led intervention, delivered by community pharmacists in collaboration with physicians, in improving disease control, compared with usual care, in asthma and COPD patients during and after COVID-19: study protocol for a pragmatic, parallel randomised controlled trial

Abstract

Introduction: In 2025, more than 400 million people will have asthma, and chronic obstructive pulmonary disease (COPD) will be the third leading cause of death by 2030. This trial, called better outcomes for everybody (BOFE), will evaluate the effectiveness and cost-effectiveness of a pharmacist-led intervention delivered by community pharmacists in collaboration with physicians to asthma and COPD patients to improve disease control compared with usual care.
Methods: A pragmatic parallel 2-arm randomized controlled trial will be conducted in one Italian region (Sicily). A 2:1 randomization and sample size of 900 adult patients (450 with asthma, 450 with COPD) will be sufficient to detect a difference of 15% between the intervention and control groups using a dichotomized score (controlled versus non-controlled) of the Asthma Control Test (ACT) and the Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ) with a two tails, 99% power and 5% significance level. A hundred pharmacists will recruit 9 consecutive patients each and administer either ACT or CCQ according to the patients’ disease. Patients will be followed up for 12 months, and the pharmacists will meet their patients every three months. The control group will receive usual care, the intervention a bespoke, structured, and systematic
consultation immediately after baseline and 6 months later. The primary outcomes are asthma and COPD control at baseline and 12 months. Secondary outcomes: risk of uncontrolled asthma and COPD, number of active ingredients, pharmaceutical care issues, adherence to medications, minimal clinically important differences in asthma and COPD, and a full health economic evaluation. The analysis will follow an intention-to-treat principle. Generalized estimating equations will be used to test the primary outcomes. Ethics approval was obtained.
Discussion: This is the first study conducted in Italy to assess the effectiveness and cost�effectiveness of a pharmacist-led intervention in asthma and COPD patients at the same time. This research could introduce a new model of care that can be adapted to other chronic conditions in primary care settings. The results will be disseminated to service users and their families via media, healthcare professionals via professional training and meetings, and researchers via conferences
and publications.