Institute of Neuroscience and Public Policy, INECO Foundation, Buenos Aires, Argentina.
Institute of Cognitive and Translational Neuroscience, CONICET, Ineco Foundation, Favaloro University, Buenos Aires, Argentina.
JAMA Netw Open. 2020 Dec 1;3(12):e2027082. doi: 10.1001/jamanetworkopen.2020.27082.
Nimodipine is a highly prescribed drug for the treatment of cognitive impairment and dementia in Argentina. There is little evidence to support the use of nimodipine for cognitive impairment and dementia.
To test the effectiveness of a behavioral intervention based on social norm feedback to reduce prescription of nimodipine for cognitive impairment in Argentina.
DESIGN, SETTING, AND PARTICIPANTS: This pragmatic parallel-group randomized clinical trial included 2 arms with a 1:1 allocation ratio. General practitioner physicians in the national health care system for older adults in Argentina (INSSJP-PAMI) with history of high nimodipine prescription rate were enrolled. The study was conducted from May 2019 to October 2019, and data were analyzed from November 2019 to February 2020.
The treatment group received 2 emails with evidence-based information about nimodipine plus the individual's level of nimodipine prescription compared with their peers. The control group received 2 emails with general information about the risks of overprescription in older adults.
The primary outcome was the cumulative number of nimodipine prescriptions per 1000 prescriptions of all drugs made by the targeted physicians during the 6 months of the study. Secondary outcomes included annual monetary savings attributable to the intervention and physicians' qualitative perceptions of the acceptability of the procedure.
Of 1811 physicians enrolled, 906 physicians (354 [39.1%] women; mean [SD] age, 57.10 [10.73] years) were randomized to treatment and 905 participants (331 [36.6%] women; mean [SD] age, 56.49 [10.47] years) to the control group. Physicians in the treatment group wrote a mean of 93.25 (95% CI, 89.27 to 97.24) prescriptions of nimodipine, compared with 98.99 (95% CI, 95.00 to 102.98) prescriptions among practitioners in the control group during the half-year of the intervention (mean difference, -5.73 [95% CI, -11.38 to -0.10] prescriptions; P = .046), which meant a 5.79% reduction. Regression analysis revealed a significant association of the group condition with number of prescriptions per 1000 total prescriptions when controlling for baseline prescriptions (B = -0.312 [95% CI, -0.465 to -0.160]; P < .001). The observed difference corresponds to a 4.48% reduction in nimodipine prescriptions per 1000 prescriptions of all drugs made by physicians in the treated group compared with the control group. Physicians who effectively opened the email in the treatment group (427 physicians [47.1%]) prescribed the drug 11.3% less compared with the control group (426 physicians) (mean difference, -10.78 [95% CI, -18.53 to -3.03] prescriptions; P = .006). Expenditures were 7.18% lower in the treatment group, resulting in an estimated annual net cost benefit of US $234 893.35 (95% CI, $225 565.35 to $237 112.30).
In this randomized clinical trial, the social norm email feedback program showed an effect on curbing the nonrecommended prescription of nimodipine. It was highly cost-effective and well accepted by participants.
ISRCTN.org identifier: ISRCTN17823729.
重要性:尼莫地平是阿根廷治疗认知障碍和痴呆的高处方药物。目前几乎没有证据支持尼莫地平治疗认知障碍和痴呆。
目的:测试基于社会规范反馈的行为干预措施减少阿根廷认知障碍尼莫地平处方的有效性。
设计、地点和参与者:这是一项具有 1:1 分配比例的实用平行组随机临床试验。阿根廷全国老年人保健系统(INSSJP-PAMI)的全科医生,具有高尼莫地平处方率的历史,被纳入研究。研究于 2019 年 5 月至 2019 年 10 月进行,数据于 2019 年 11 月至 2020 年 2 月进行分析。
干预措施:治疗组收到了两封电子邮件,一封是关于尼莫地平的循证信息,另一封是关于他们与同龄人相比尼莫地平处方的个人水平。对照组收到了两封关于老年人过度处方风险的一般信息的电子邮件。
主要结果和措施:主要结果是在研究的 6 个月内,目标医生开具的所有药物中尼莫地平的累积处方数每 1000 处方。次要结果包括归因于干预措施的年度节省金额和医生对该程序的可接受性的定性看法。
结果:在 1811 名登记的医生中,906 名医生(354 名女性[39.1%];平均[SD]年龄,57.10 [10.73]岁)被随机分配到治疗组,905 名参与者(331 名女性[36.6%];平均[SD]年龄,56.49 [10.47]岁)被分配到对照组。治疗组的医生平均开具 93.25 份(95%CI,89.27 至 97.24)尼莫地平处方,而对照组医生在干预的半年内开具 98.99 份(95%CI,95.00 至 102.98)尼莫地平处方(平均差异,-5.73 [95%CI,-11.38 至-0.10];P = .046),这意味着处方减少了 5.79%。回归分析显示,在控制基线处方的情况下,组条件与每 1000 份总处方的处方数量存在显著关联(B = -0.312 [95%CI,-0.465 至-0.160];P < .001)。观察到的差异相当于治疗组与对照组相比,尼莫地平每 1000 份处方的处方减少了 4.48%。在治疗组中,有效打开电子邮件的医生(427 名医生[47.1%])与对照组(426 名医生)相比,处方减少了 11.3%(平均差异,-10.78 [95%CI,-18.53 至-3.03];P = .006)。治疗组的支出降低了 7.18%,估计每年的净成本效益为 234893.35 美元(95%CI,225565.35 美元至 237112.30 美元)。
结论和相关性:在这项随机临床试验中,社会规范电子邮件反馈方案对抑制不推荐的尼莫地平处方有一定效果。它具有很高的成本效益,并且受到参与者的高度认可。
试验注册:ISRCTN.org 标识符:ISRCTN84465414。