Centre for Medicine Use and Safety, Monash University, Parkville, Victoria, Australia.
Faculté de Pharmacie, Université de Montréal, Montréal, Québec, Canada.
JAMA Netw Open. 2024 May 1;7(5):e2413698. doi: 10.1001/jamanetworkopen.2024.13698.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
直接面向消费者的教育可减少慢性镇静剂的使用。这种方法对慢性非癌症疼痛患者的处方类阿片类药物的效果尚未经过检验。
评估政府邮寄给社区居住的长期阿片类药物使用者的教育信息小册子对减少处方类阿片类药物使用的有效性，与常规护理相比。
设计、地点和参与者：这是一项从 2018 年 7 月至 2019 年 1 月在加拿大马尼托巴省进行的群组随机临床试验。所有长期服用阿片类药物的成年人都被纳入（n=4225）。通过马尼托巴药物计划信息网络识别参与者。接受姑息治疗或患有癌症或痴呆症的患者被排除在外。数据于 2019 年 7 月至 2020 年 3 月进行分析。
根据他们的初级保健诊所对参与者进行分组，并随机分配到干预组（通过邮件发送的代码设计的直接面向消费者的教育小册子）或常规护理（对照组）。
主要结局是在 6 个月后在参与者水平上停止使用阿片类药物处方，通过药房药物索赔确定。次要结局包括剂量减少（以吗啡毫克当量[MME]表示）和/或治疗转换。使用广义估计方程评估阿片类药物使用的减少，以考虑聚类的影响，同时进行了预先指定的年龄和性别亚组分析。分析为意向治疗。
在 4206 名参与者中，有 2409 名（57.3%）为男性；平均（SD）年龄为 60.0（14.4）岁。基线时两组之间的阿片类药物使用量相似（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 个群组中的 2136 名参与者中的 235 名（11.0%）不再开阿片类药物处方，而对照组 124 个群组中的 2070 名参与者中的 228 名（11.0%）（差异，0.0%；95%CI，-1.9%至 1.9%）。与对照组相比，干预组中有更多的参与者减少了剂量（1410[66.0%]vs 1307[63.1%]；差异，2.8%[95%CI，0.0%-5.7%]）。对于男性（差异，3.9%；95%CI，0.1%-7.7%）、18 至 64 岁（差异，3.7%；95%CI，0.2%-7.2%）或居住在城市地区（差异，5.9%；95%CI，1.9%-9.9%）的参与者，收到该手册后剂量减少幅度更大。
在这项群组随机临床试验中，干预组和常规护理组在 6 个月后，停止使用阿片类药物的比例没有显著差异；然而，与常规护理相比，该干预措施使更多的成年人减少了阿片类药物的剂量。
ClinicalTrials.gov 标识符：NCT03400384。
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