Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial

Abstract

BackgroundPatients with chronic obstructive pulmonary disease (COPD) are often nonadherent with medications and have poor inhaler technique. Community pharmacists can help to improve health-related quality of life and overall outcomes in patients with COPD. We aim to measure the effectiveness of a systematic, pharmacist-driven intervention on patients with diagnosed COPD.Methods/designThis pragmatic, parallel-group, cluster randomized controlled trial is designed to determine the effectiveness of a multifactorial, pharmacist-led intervention on medication adherence, inhaler technique, health-related quality of life, health care resource utilization including COPD exacerbations, and use of medications. Participating pharmacies in Newfoundland and Labrador (NL), Canada will be randomly assigned to either the intervention or the control group. The intervention group will deliver an enhanced form of care that emphasizes COPD management. The control group will provide usual care and a COPD education pamphlet. Included patients will be aged 40 years or older, have a physician-confirmed diagnosis of COPD, and be able to answer questionnaires in English. The primary outcomes are the between-group difference in the change from baseline to 6 months in medication adherence using the Medication Possession Ratio (MPR) and the Morisky Medication Adherence Scale (MMAS-8). The secondary outcomes are also measured from baseline to 6 months, and include the proportion of patients with a clinically significant change in adherence, the proportion of patients defined as having “good adherence,” the mean MPR between groups, quality of life as measured by the St. George’s Respiratory Questionnaire, medication inhalation technique using a pharmacist-scored checklist, health care resource utilization and antibiotic and orally administered corticosteroid use for COPD exacerbations. Differences between groups will be analyzed at the individual patient level while controlling for clustering effect.DiscussionA pharmacist-led COPD intervention has the potential to improve patient medication adherence, thus increasing quality of life, possibly decreasing pulmonary exacerbations and reducing utilization of acute health care resources. Methods and results taken from this study could be used to enhance the delivery of COPD care by community pharmacists in a real-world setting. This would serve to enhance COPD population health and quality of life.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN) ISRCTN78138190, registered on 3 February 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1623-7) contains supplementary material, which is available to authorized users.

Assessment of Medication Adherence Barriers in COPD Patients in A Secondary Care Teaching Hospital

“…Illiterate patients displayed less priority to self-care and being part of a minority group and having low income resulted in lesser ability to understand medical information and label instructions which lead to decreased adherence compared to literate patients. (11,12,13,14) Furthermore, our results suggests that socioeconomic status was significantly associated with adherence where lower socioeconomic group showed highest non adherence than other groups. In our study most patients were in the older population and required complex medications for various comorbid conditions which led to frustration and confusion and resulted in unintentional non adherence.…”

Knowledge, Attitude and Practice of Lebanese Community Pharmacists toward Chronic Obstructive Pulmonary Disease

“…Previous studies have recognized the pharmacists' responsibility and role in education, counseling, prevention, and management of COPD [13,[16][17][18]. Interventions led by community pharmacists have been found to be beneficial on treatment outcomes in COPD patients according to international studies [37,38].…”

“…Inclusion of a pharmacist to the formula has been tested in several countries (India, Canada, and Jordan). In fact, three randomized controlled trials [16][17][18] showed that pharmacy-led patient education can positively impact treatment outcome, COPD knowledge, medication adherence, quality of life, significant reduction in hospital admission rates, and emergency department visits [19].…”

How to design an education programme for patients with chronic obstructive disease?

“…A Canadian patient education project [27] covered adherence, inhalation techniques, health-related quality of life, and the use of health resources such as drug therapy and COPD exacerbations. Content included explanation of the current therapy, dosage, administration, patient expectations, duration of therapy, and potential outcomes, and follow-ups and improved inhaler use.…”