Effect of Reminder Devices on Medication Adherence The REMIND Randomized Clinical Trial

Effect of Reminder Devices on Medication Adherence The REMIND Randomized Clinical Trial
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DOI:
10.1001/jamainternmed.2016.9627
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发表时间:
2017-05-01
影响因子:
39
通讯作者:
Franklin, Jessica M.
Franklin, Jessica M.
中科院分区:
医学1区
文献类型:
--
作者:
Choudhry, Niteesh K.;Krumme, Alexis A.;Franklin, Jessica M.

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重要性健忘是一个主要的贡献者不遵守慢性疾病药物治疗,并可以解决与药物提醒devices.DESIGN,设置,和participantsThis 4臂,块随机临床试验涉及53 480名注册CVS Caremark,药房福利经理,在美国各地的效果,3低成本的提醒设备。符合条件的参与者年龄在18至64岁之间,长期服用1至3种口服药物。参与者必须在随机化前12个月内对所有处方治疗的依从性不佳(药物拥有率为30%至80%)。参与者根据他们在随机化时使用的药物进行分层:用于心血管或其他非抑郁慢性疾病的药物(慢性疾病层)和抗抑郁药(抗抑郁药层)。在每个分层中,随机化发生在由患者的所有靶向药物是否每天给药一次定义的区组内。患者随机接受邮寄的带开关的药瓶条、数字定时器帽或标准药盒。对照组既没有收到通知,也没有收到器械。数据收集自2013年2月12日至2015年3月21日,数据分析针对意向治疗人群。主要结局和测量主要结局是在12个月的随访期间,慢性病分层患者对所有合格药物的最佳依从性(药物拥有率>= 80%),使用药房索赔数据确定。次要结果包括慢性病患者对心血管药物的最佳依从性以及对抗抑郁药物的最佳依从性。在53480名参与者中,平均(SD)年龄为45(12)岁,56%为女性。在主要分析中,慢性疾病分层中15.5%的患者分配到标准药盒组,15.1%分配到数字计时器帽组,16.3%分配到带开关的药瓶条组,15.1%分配到对照组,这些患者在随访期间对处方治疗的依从性最佳。对照组和任何器械之间的最佳依从性几率没有统计学显著差异(标准药盒:比值比[OR],1.03 [95% CI,0.95-1.13];数字计时器盖:OR,1.00 [95% CI,0.92-1.09];带开关的药瓶条:OR,0.94 [95% CI,0.85-1.04])。在直接比较中,使用标准药盒的最佳依从性几率高于使用药瓶条的最佳依从性几率(OR,1.10 [95% CI,1.00-1.21])。二次分析产生了类似的结果。结论和RELEVANCE低成本的提醒设备没有提高非遵守患者谁是服用3种药物治疗常见的慢性疾病的依从性。如果再加上干预措施以确保持续使用,或者如果针对具有更高不依从风险的个人,这些设备可能会更有效。
IMPORTANCEForgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices.OBJECTIVETo compare the effect of 3 low-cost reminder devices on medication adherence.DESIGN, SETTING, AND PARTICIPANTSThis 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.MAIN OUTCOMES AND MEASURESThe 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.RESULTSOf 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.CONCLUSIONS AND RELEVANCELow-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.