政府减少处方阿片类药物使用的直接面向消费者的教育:集群随机临床试验。
Government Direct-to-Consumer Education to Reduce Prescription Opioid Use: A Cluster Randomized Clinical Trial.
发表日期:2024 May 01
作者:
Justin P Turner, Alex S Halme, Patricia Caetano, Aili Langford, Cara Tannenbaum
来源:
JAMA Network Open
摘要:
直接面向消费者的教育减少了镇静剂的长期使用。这种方法对慢性非癌性疼痛患者中处方阿片类药物的有效性尚未经过测试。旨在评估政府主导的向社区居住的长期阿片类药物消费者邮寄的教育信息手册的有效性,以减少与常规护理相比处方阿片类药物的使用。这项整群随机临床试验于2018年7月至2019年1月在加拿大马尼托巴省进行。所有长期服用阿片类药物处方的成年人均被纳入研究(n = 4225)。参与者是通过马尼托巴药物计划信息网络确定的。接受姑息治疗或诊断患有癌症或痴呆症的个人被排除在外。数据分析时间为 2019 年 7 月至 2020 年 3 月。参与者根据其初级保健诊所进行分组,并随机接受干预措施(通过邮寄发送的共同设计的直接面向消费者的教育手册)或常规护理(比较组)。主要结果是6 个月后,根据药房药品声明确定,参与者停止服用阿片类药物处方。次要结局包括剂量减少(以吗啡毫克当量[MME]为单位)和/或治疗转换。使用广义估计方程来评估阿片类药物使用的减少,以解释聚类,并按年龄和性别进行预先指定的亚组分析。分析是意向性治疗。4206 名参与者中,2409 名(57.3%)为男性;平均 (SD) 年龄为 60.0 (14.4) 岁。组间平均 (SD) 基线阿片类药物使用量相当(干预组,157.7 [179.7] MME/d;对照组,153.4 [181.8] MME/d)。 6 个月后,干预组 127 个集群中的 2136 名参与者中有 235 名 (11.0%) 不再服用阿片类药物处方,而对照组 124 个集群中的 2070 名参与者中有 228 名 (11.0%) 不再服用阿片类药物(差异为 0.0%;95% CI, -1.9% 至 1.9%)。干预组中减少剂量的参与者多于对照组(1410 [66.0%] vs 1307 [63.1%];差异,2.8% [95% CI, 0.0%-5.7%])。收到该手册后,年龄为 18 至 64 岁的男性参与者(差异为 3.9%;95% CI,0.1%-7.7%)(差异为 3.7%;95% CI,0.2%-7.2)剂量减少幅度更大。 %),或生活在城市地区(差异,5.9%;95% CI,1.9%-9.9%)与常规护理相比。在这项集群随机临床试验中,6 个月后观察到阿片类药物戒断发生率没有显着差异干预组和常规护理组之间;然而,与常规护理相比,干预导致更多成年人减少阿片类药物剂量。ClinicalTrials.gov 标识符:NCT03400384。
Direct-to-consumer education reduces chronic sedative use. The effectiveness of this approach for prescription opioids among patients with chronic noncancer pain remains untested.To evaluate the effectiveness of a government-led educational information brochure mailed to community-dwelling, long-term opioid consumers to reduce prescription opioid use compared with usual care.This cluster randomized clinical trial was conducted from July 2018 to January 2019 in Manitoba, Canada. All adults with long-term opioid prescriptions were enrolled (n = 4225). Participants were identified via the Manitoba Drug Program Information Network. Individuals receiving palliative care or with a diagnosis of cancer or dementia were excluded. Data were analyzed from July 2019 to March 2020.Participants were clustered according to their primary care clinic and randomized to the intervention (a codesigned direct-to-consumer educational brochure sent by mail) or usual care (comparator group).The main outcome was discontinuation of opioid prescriptions at the participant level after 6 months, ascertained by pharmacy drug claims. Secondary outcomes included dose reduction (in morphine milligram equivalents [MME]) and/or therapeutic switch. Reduction in opioid use was assessed using generalized estimating equations to account for clustering, with prespecified subgroup analyses by age and sex. Analysis was intention to treat.Of 4206 participants, 2409 (57.3%) were male; mean (SD) age was 60.0 (14.4) years. Mean (SD) baseline opioid use was comparable between groups (intervention, 157.7 [179.7] MME/d; control, 153.4 [181.8] MME/d). After 6 months, 235 of 2136 participants (11.0%) in 127 clusters in the intervention group no longer filled opioid prescriptions compared with 228 of 2070 (11.0%) in 124 clusters in the comparator group (difference, 0.0%; 95% CI, -1.9% to 1.9%). More participants in the intervention group than in the control group reduced their dose (1410 [66.0%] vs 1307 [63.1%]; difference, 2.8% [95% CI, 0.0%-5.7%]). Receipt of the brochure led to greater dose reductions for participants who were male (difference, 3.9%; 95% CI, 0.1%-7.7%), aged 18 to 64 years (difference, 3.7%; 95% CI, 0.2%-7.2%), or living in urban areas (difference, 5.9%; 95% CI, 1.9%-9.9%) compared with usual care.In this cluster randomized clinical trial, no significant difference in the prevalence of opioid cessation was observed after 6 months between the intervention and usual care groups; however, the intervention resulted in more adults reducing their opioid dose compared with usual care.ClinicalTrials.gov Identifier: NCT03400384.