Choudhry Niteesh K, Krumme Alexis A, Ercole Patrick M, Girdish Charmaine, Tong Angela Y, Khan Nazleen F, Brennan Troyen A, Matlin Olga S, Shrank William H, Franklin Jessica M
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts2Center for Healthcare Delivery Science, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
CVS Health, Woonsocket, Rhode Island.
JAMA Intern Med. 2017 May 1;177(5):624-631. doi: 10.1001/jamainternmed.2016.9627.
Forgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices.
To compare the effect of 3 low-cost reminder devices on medication adherence.
DESIGN, SETTING, AND PARTICIPANTS: This 4-arm, block-randomized clinical trial involved 53 480 enrollees of CVS Caremark, a pharmacy benefit manager, across the United States. Eligible participants were aged 18 to 64 years and taking 1 to 3 oral medications for long-term use. Participants had to be suboptimally adherent to all of their prescribed therapies (with a medication possession ratio of 30% to 80%) in the 12 months before randomization. Participants were stratified on the basis of the medications they were using at randomization: medications for cardiovascular or other nondepression chronic conditions (the chronic disease stratum) and antidepressants (the antidepressant stratum). In each stratum, randomization occurred within blocks defined by whether all of the patient's targeted medications were dosed once daily. Patients were randomized to receive in the mail a pill bottle strip with toggles, digital timer cap, or standard pillbox. The control group received neither notification nor a device. Data were collected from February 12, 2013, through March 21, 2015, and data analyses were on the intention-to-treat population.
The primary outcome was optimal adherence (medication possession ratio ≥80%) to all eligible medications among patients in the chronic disease stratum during 12 months of follow-up, ascertained using pharmacy claims data. Secondary outcomes included optimal adherence to cardiovascular medications among patients in the chronic disease stratum as well as optimal adherence to antidepressants.
Of the 53 480 participants, mean (SD) age was 45 (12) years and 56% were female. In the primary analysis, 15.5% of patients in the chronic disease stratum assigned to the standard pillbox, 15.1% assigned to the digital timer cap, 16.3% assigned to the pill bottle strip with toggles, and 15.1% assigned to the control arm were optimally adherent to their prescribed treatments during follow-up. There was no statistically significant difference in the odds of optimal adherence between the control and any of the devices (standard pillbox: odds ratio [OR], 1.03 [95% CI, 0.95-1.13]; digital timer cap: OR, 1.00 [95% CI, 0.92-1.09]; and pill bottle strip with toggles: OR, 0.94 [95% CI, 0.85-1.04]). In direct comparisons, the odds of optimal adherence were higher with a standard pillbox than with the pill bottle strip (OR, 1.10 [95% CI, 1.00-1.21]). Secondary analyses yielded similar results.
Low-cost reminder devices did not improve adherence among nonadherent patients who were taking up to 3 medications to treat common chronic conditions. The devices may have been more effective if coupled with interventions to ensure consistent use or if targeted to individuals with an even higher risk of nonadherence.
clinicaltrials.gov Identifier: NCT02015806.
健忘是导致慢性病患者不坚持服药的主要原因，可通过药物提醒装置加以解决。
比较三种低成本提醒装置对药物依从性的影响。
设计、设置和参与者：这项四组、区组随机临床试验纳入了美国一家药房福利管理机构CVS Caremark的53480名参保者。符合条件的参与者年龄在18至64岁之间，正在服用1至3种口服药物进行长期治疗。参与者在随机分组前的12个月内，对所有规定治疗的依从性欠佳（药物持有率为30%至80%）。参与者根据随机分组时正在使用的药物进行分层：用于心血管疾病或其他非抑郁症慢性病的药物（慢性病层）和抗抑郁药（抗抑郁药层）。在每个层中，根据患者所有目标药物是否每日服用一次来定义区组进行随机分组。患者被随机分组，通过邮件接收带扣的药瓶条、数字定时器瓶盖或标准药盒。对照组既未收到通知也未收到装置。数据收集时间为2013年2月12日至2015年3月21日，数据分析针对意向性分析人群。
主要结局是在12个月的随访期间，慢性病层患者对所有符合条件药物的最佳依从性（药物持有率≥80%），通过药房报销数据确定。次要结局包括慢性病层患者对心血管药物的最佳依从性以及对抗抑郁药的最佳依从性。
53480名参与者的平均（标准差）年龄为45（12）岁，56%为女性。在初步分析中，慢性病层中分配到标准药盒的患者有15.5%、分配到数字定时器瓶盖的患者有15.1%、分配到带扣药瓶条的患者有16.3%、分配到对照组的患者有15.1%在随访期间对规定治疗达到最佳依从性。对照组与任何一种装置之间的最佳依从性几率无统计学显著差异（标准药盒：优势比[OR]，1.03[95%置信区间，0.95 - 1.13]；数字定时器瓶盖：OR，1.00[95%置信区间，0.92 - 1.09]；带扣药瓶条：OR，0.94[95%置信区间，0.85 - 1.04]）。在直接比较中，标准药盒的最佳依从性几率高于带扣药瓶条（OR，1.10[95%置信区间，1.00 - 1.21]）。次要分析得出类似结果。
低成本提醒装置并未提高正在服用多达3种药物治疗常见慢性病的不依从患者的依从性。如果这些装置与确保持续使用的干预措施相结合，或者针对不依从风险更高的个体，可能会更有效。
clinicaltrials.gov标识符：NCT02015806。
