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将行为科学纳入药物依从性沟通:一项随机临床试验。

Incorporating Behavioral Science in Medication Adherence Communication: A Randomized Clinical Trial.

作者信息

Keller Punam, Robertson Ted, Kao Lee-Sien, Li Yong, Merrell Brandon, Chung Linda, Boudreau Emily, James Alex, Esterly Lauren, Hanken Kaitlin, Choudhry Niteesh K

机构信息

Tuck School of Business, Dartmouth College, Hanover, New Hampshire.

ideas42, Washington, DC.

出版信息

JAMA Netw Open. 2025 May 1;8(5):e2510162. doi: 10.1001/jamanetworkopen.2025.10162.

DOI:10.1001/jamanetworkopen.2025.10162
PMID:40366654
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12079288/
Abstract

IMPORTANCE

Hypertension increases the risk of myocardial infarction and strokes, but adherence to antihypertensive medications remains suboptimal. Increasing medication adherence may help prevent hypertension-related disability and death.

OBJECTIVE

To estimate the effect of incorporating behavioral science principles in mailed communications intended to increase hypertension medication adherence.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from August 18 to December 31, 2023, at Humana, a large health insurance provider, and included Medicare Advantage beneficiaries aged 65 to 80 years who were taking hypertension medications with adherence rates of 60% to 85%. Data were extracted for the as-treated analysis on April 14, 2024.

INTERVENTION

Study participants were randomized in equal proportions to 1 of 7 groups: 6 received mailed communications that incorporated combinations of behavioral science principles, and 1 received no mailing (control, or usual care condition). The specific principles included were social norming (the mailing noted that more Humana beneficiaries each year were improving their medication adherence scores), messenger effects (the mailing signatory was a pharmacist), and processing fluency (the mailing incorporated a visual circle metaphor indicating current and complete adherence to prompt "closing the ring"). The first mailing contained the participant's baseline refill score, and a second mailing noted any changes in the participant's refill score after 60 days.

MAIN OUTCOMES AND MEASURES

The primary outcome was end-of-year hypertension medication adherence calculated from pharmacy claims data using the proportion of days covered (PDC) metric (having medication available for 1 target hypertension drug, as measured through prescription claims, counted as adherent on a given day). A secondary outcome was the proportion of study participants with end-of-year PDC of 80% or greater.

RESULTS

The study participants (n = 64 290) had a mean (SD) age of 71.4 (4.1) years, and 54.1% were female. Mean (SD) end-of-year adherence in the control group was 0.81 (0.12) and was no different in any of the intervention arms (absolute mean difference compared with control was 0.00 [95% CI, -0.01 to 0.01]). The proportion of participants with an end-of-year PDC greater than 80% also did not differ significantly between the control group (6587 of 9183 [71.7%]) and any of the intervention arms (range, 6467 of 9180 [70.4%] to 6598 of 9177 [71.9%]).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, use of social norms, messenger effects, and processing fluency in mailed communications did not significantly increase hypertension medication adherence. Further research is needed to identify tactics to effectively increase adherence.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT06066541.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccbf/12079288/e3ac8d5c1af7/jamanetwopen-e2510162-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccbf/12079288/e3ac8d5c1af7/jamanetwopen-e2510162-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccbf/12079288/e3ac8d5c1af7/jamanetwopen-e2510162-g001.jpg
摘要

重要性

高血压会增加心肌梗死和中风的风险,但对抗高血压药物的依从性仍不理想。提高药物依从性可能有助于预防与高血压相关的残疾和死亡。

目的

评估将行为科学原理纳入邮寄通信中对提高高血压药物依从性的效果。

设计、设置和参与者:这项随机临床试验于2023年8月18日至12月31日在大型健康保险提供商Humana进行,纳入了年龄在65至80岁之间、服用高血压药物且依从率为60%至85%的医疗保险优势受益人。2024年4月14日提取数据进行实际治疗分析。

干预措施

研究参与者被等比例随机分为7组中的1组:6组收到纳入行为科学原理组合的邮寄通信,1组未收到邮寄(对照组,即常规护理条件)。纳入的具体原理包括社会规范(邮件指出每年有更多Humana受益人提高了他们的药物依从性得分)、信使效应(邮件签署人为药剂师)和处理流畅性(邮件采用视觉圆圈隐喻表示当前和完全依从以促使“闭环”)。第一封邮件包含参与者的基线再填充分数,第二封邮件指出60天后参与者再填充分数的任何变化。

主要结局和测量指标

主要结局是根据药房报销数据使用覆盖天数比例(PDC)指标计算的年末高血压药物依从性(通过处方报销测量,有一种目标高血压药物有药可用在给定日期计为依从)。次要结局是年末PDC达到80%或更高的研究参与者比例。

结果

研究参与者(n = 64290)的平均(标准差)年龄为71.4(4.1)岁,54.1%为女性。对照组的平均(标准差)年末依从性为0.81(0.12),任何干预组均无差异(与对照组的绝对平均差异为0.00 [95% CI,-0.01至0.01])。对照组(9183人中的6587人[71.7%])与任何干预组(范围为9180人中的6467人[70.4%]至9177人中的6598人[71.9%])之间,年末PDC大于80%的参与者比例也无显著差异。

结论和相关性

在这项随机临床试验中,在邮寄通信中使用社会规范、信使效应和处理流畅性并未显著提高高血压药物依从性。需要进一步研究以确定有效提高依从性的策略。

试验注册

ClinicalTrials.gov标识符:NCT06066541。

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