Davis Erin, Marra Carlo, Gamble John-Michael, Farrell Jamie, Lockyer Joe, FitzGerald J Mark, Abu-Ashour Waseem, Gillis Charlie, Hawboldt John
Memorial University School of Pharmacy, 300 Prince Philip Dr., St. John's, NL, A1B 3V6, Canada.
Memorial University Faculty of Medicine, Discipline of Family Medicine, 300 Prince Philip Dr., St. John's, NL, A1B 3V6, Canada.
Trials. 2016 Oct 13;17(1):502. doi: 10.1186/s13063-016-1623-7.
Patients 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/DESIGN: This 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.
A 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.
International Standard Randomized Controlled Trial Number (ISRCTN) ISRCTN78138190 , registered on 3 February 2016.
慢性阻塞性肺疾病（COPD）患者往往不坚持用药，吸入技术也较差。社区药剂师有助于改善COPD患者的健康相关生活质量和总体预后。我们旨在评估一种由药剂师主导的系统性干预措施对确诊COPD患者的有效性。
方法/设计：这项实用的平行组整群随机对照试验旨在确定多因素、由药剂师主导的干预措施对用药依从性、吸入技术、健康相关生活质量、包括COPD急性加重在内的医疗资源利用以及药物使用的有效性。加拿大纽芬兰与拉布拉多省（NL）的参与药房将被随机分配到干预组或对照组。干预组将提供强化护理，重点是COPD管理。对照组将提供常规护理和一份COPD教育手册。纳入的患者年龄在40岁及以上，有医生确诊的COPD，并且能够用英语回答问卷。主要结局是使用药物持有率（MPR）和莫氏药物依从性量表（MMAS - 8）从基线到6个月时两组在用药依从性变化方面的组间差异。次要结局也从基线到6个月进行测量，包括依从性有临床显著变化的患者比例、被定义为“依从性良好”的患者比例、两组间的平均MPR、用圣乔治呼吸问卷测量的生活质量、使用药剂师评分清单评估的药物吸入技术、医疗资源利用以及用于COPD急性加重的抗生素和口服糖皮质激素的使用情况。在控制聚类效应的同时，将在个体患者层面分析组间差异。
由药剂师主导的COPD干预措施有可能提高患者的用药依从性，从而提高生活质量，可能减少肺部急性加重并降低急性医疗资源的利用。本研究的方法和结果可用于在实际环境中加强社区药剂师对COPD的护理。这将有助于提高COPD人群的健康水平和生活质量。
国际标准随机对照试验编号（ISRCTN）ISRCTN78138190，于2016年2月3日注册。
