Blackburn David F, Evans Charity D, Eurich Dean T, Mansell Kerry D, Jorgenson Derek J, Taylor Jeff G, Semchuk William M, Shevchuk Yvonne M, Remillard Alfred J, Tran David A, Champagne Anne P
College of Pharmacy & Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
Pharmacotherapy. 2016 Oct;36(10):1055-1064. doi: 10.1002/phar.1831. Epub 2016 Sep 25.
To test a brief intervention for preventing statin nonadherence among community pharmacy patrons.
Prospective, cluster-randomized, controlled trial (the Community Pharmacists Assisting in Total Cardiovascular Health [CPATCH] trial).
Thirty community pharmacies in Saskatchewan, Canada.
Participating pharmacies were randomized to 15 intervention pharmacies where a brief statin adherence intervention was delivered by pharmacists (intervention group [907 patients]) or 15 usual care pharmacies where no statin adherence intervention was delivered (usual care group [999 patients]) to new users of statins (defined as less than 1 yr of statin therapy).
Staff (pharmacy managers, staff pharmacists, and technicians) from intervention pharmacies attended a 2.5-hour workshop on the CPATCH program that prepared pharmacists to deal with the adherence barriers most likely associated with statin use (e.g., safety, cost, patient-provider relationship, and tolerability). Intervention pharmacists screened for new statin users and assessed these adherence barriers. Pharmacists were then instructed to tailor their follow-up plan based on the individual patient's situation. Investigators contacted the intervention pharmacies monthly to assess their compliance with the protocol and to offer additional support to motivate ongoing participation.
The primary outcome was mean difference in statin adherence between the intervention and usual care groups. Adherence was measured by the proportion of days covered (PDC) between 6 and 12 months following the original prescription fill date. General estimating equations were used to evaluate the difference in mean adherence between groups. Secondary outcomes included the percentage of new statin users exhibiting optimal adherence (defined as PDC of 80% or higher) and the percentage exhibiting nonpersistence (defined as the cessation of all statin dispensations within 3 mo of the first dispensation). Among 1906 eligible patients, no significant differences in mean adherence were observed between those receiving the intervention and those receiving usual care (71.6% vs 70.9%, p=0.64), the percentage of patients achieving optimal adherence (57.3% vs 55.9%, p=0.51), or the percentage exhibiting nonpersistence (9.4% vs 8.3%, p=0.41). However, compliance to the study protocol was extremely low in several intervention pharmacies. In a post hoc analysis, a higher level of protocol compliance among intervention pharmacies was significantly associated with higher adherence (p<0.01 for trend). Pharmacies falling in the highest tertile of compliance to the study protocol exhibited higher mean adherence among their patients compared with those in the usual care group (β = 0.056, 95% confidence interval [CI] 0.010-0.101, p=0.01), and a significantly higher percentage of patients achieving optimal adherence (odds ratio 1.32, 95% CI 1.08-1.61; p<0.01); however, nonpersistence did not significantly differ between the two groups (5.5% vs 8.3%, p=0.27).
The CPATCH intervention was ineffective for improving patient adherence to statin therapy in community pharmacies. However, poor effectiveness may have resulted from a failure to deliver the protocol consistently in several intervention pharmacies.
测试一种简短干预措施，以预防社区药房顾客不坚持服用他汀类药物的情况。
前瞻性、整群随机对照试验（社区药剂师助力全面心血管健康[CPATCH]试验）。
加拿大萨斯喀彻温省的30家社区药房。
参与试验的药房被随机分为15家干预药房，药剂师在这些药房提供简短的他汀类药物依从性干预措施（干预组[907例患者]），以及15家常规护理药房，这些药房不对他汀类药物使用者提供依从性干预措施（常规护理组[999例患者]），他汀类药物新使用者（定义为他汀类药物治疗时间少于1年）。
干预药房的工作人员（药房经理、药剂师和技术人员）参加了一个为期2.5小时的关于CPATCH项目的研讨会，该研讨会使药剂师做好准备，以应对最可能与他汀类药物使用相关的依从性障碍（如安全性、成本、患者与提供者的关系以及耐受性）。干预药剂师筛选他汀类药物新使用者，并评估这些依从性障碍。然后指导药剂师根据患者的具体情况制定后续计划。研究人员每月与干预药房联系，评估其对方案的依从性，并提供额外支持以激励持续参与。
主要结局是干预组和常规护理组之间他汀类药物依从性的平均差异。依从性通过原始处方配药日期后6至12个月的覆盖天数比例（PDC）来衡量。使用一般估计方程来评估两组之间平均依从性的差异。次要结局包括表现出最佳依从性（定义为PDC为80%或更高）的他汀类药物新使用者的百分比，以及表现出不持续性（定义为首次配药后3个月内所有他汀类药物配药停止）的百分比。在1906例符合条件的患者中，接受干预的患者和接受常规护理的患者在平均依从性（71.6%对70.9%，p = 0.64）、达到最佳依从性的患者百分比（57.3%对55.9%，p = 0.51）或表现出不持续性的百分比（9.4%对8.3%，p = 0.41）方面均未观察到显著差异。然而，几家干预药房对研究方案的依从性极低。在一项事后分析中，干预药房中较高水平的方案依从性与较高的依从性显著相关（趋势p<0.01）。与常规护理组相比，研究方案依从性处于最高三分位数的药房，其患者的平均依从性更高（β = 0.056，95%置信区间[CI] 0.010 - 0.101，p = 0.01），达到最佳依从性的患者百分比显著更高（优势比1.32，95% CI 1.08 - 1.61；p<0.01）；然而，两组之间的不持续性没有显著差异（5.5%对8.3%，p = 0.27）。
CPATCH干预措施在提高社区药房患者对他汀类药物治疗的依从性方面无效。然而，效果不佳可能是由于几家干预药房未能始终如一地实施该方案。
