纳洛酮与阿片类药物联合配药：一项整群随机实用试验。
Naloxone Co-Dispensing with Opioids: a Cluster Randomized Pragmatic Trial.
作者信息
Binswanger Ingrid A, Rinehart Deborah, Mueller Shane R, Narwaney Komal J, Stowell Melanie, Wagner Nicole, Xu Stan, Hanratty Rebecca, Blum Josh, McVaney Kevin, Glanz Jason M
机构信息
Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.
Colorado Permanente Medical Group, Aurora, CO, USA.
出版信息
J Gen Intern Med. 2022 Aug;37(11):2624-2633. doi: 10.1007/s11606-021-07356-6. Epub 2022 Feb 7.
BACKGROUND
Although naloxone prevents opioid overdose deaths, few patients prescribed opioids receive naloxone, limiting its effectiveness in real-world settings. Barriers to naloxone prescribing include concerns that naloxone could increase risk behavior and limited time to provide necessary patient education.
OBJECTIVE
To determine whether pharmacy-based naloxone co-dispensing affected opioid risk behavior. Secondary objectives were to assess if co-dispensing increased naloxone acquisition, increased patient knowledge about naloxone administration, and affected opioid dose and other substance use.
DESIGN
Cluster randomized pragmatic trial of naloxone co-dispensing.
SETTING
Safety-net health system in Denver, Colorado, between 2017 and 2020.
PARTICIPANTS
Seven pharmacies were randomized. Pharmacy patients (N=768) receiving opioids were followed using automated data for 10 months. Pharmacy patients were also invited to complete surveys at baseline, 4 months, and 8 months; 325 survey participants were enrolled from November 15, 2017, to January 8, 2019.
INTERVENTION
Intervention pharmacies implemented workflows to co-dispense naloxone while usual care pharmacies provided usual services.
MAIN MEASURES
Survey instruments assessed opioid risk behavior; hazardous drinking; tobacco, cannabis, and other drug use; and knowledge. Naloxone dispensings and opioid dose were evaluated using pharmacy data among pharmacy patients and survey participants. Intention-to-treat analyses were conducted using generalized linear mixed models accounting for clustering at the pharmacy level.
KEY RESULTS
Opioid risk behavior did not differ by trial group (P=0.52; 8-month vs. baseline adjusted risk ratio [ARR] 1.07; 95% CI 0.78, 1.47). Compared with usual care pharmacies, naloxone dispensings were higher in intervention pharmacies (ARR 3.38; 95% CI 2.21, 5.15) and participant knowledge increased (P=0.02; 8-month vs. baseline adjusted mean difference 1.05; 95% CI 0.06, 2.04). There was no difference in other substance use by the trial group.
CONCLUSION
Co-dispensing naloxone with opioids effectively increased naloxone receipt and knowledge but did not increase self-reported risk behavior.
TRIAL REGISTRATION
Registered at ClinicalTrials.gov ; Identifier: NCT03337100.
背景
尽管纳洛酮可预防阿片类药物过量致死，但很少有开具阿片类药物的患者获得纳洛酮，这限制了其在实际应用中的效果。开具纳洛酮的障碍包括担心纳洛酮会增加风险行为以及提供必要患者教育的时间有限。
目的
确定基于药房的纳洛酮联合配药是否会影响阿片类药物风险行为。次要目的是评估联合配药是否增加了纳洛酮的获取、增加了患者对纳洛酮给药的知识，并影响了阿片类药物剂量和其他物质使用情况。
设计
纳洛酮联合配药的整群随机实用试验。
地点
2017年至2020年期间科罗拉多州丹佛市的安全网医疗系统。
参与者
七家药房被随机分组。使用自动化数据对接受阿片类药物的药房患者（N = 768）进行了10个月的随访。药房患者还被邀请在基线、4个月和8个月时完成调查；2017年11月15日至2019年1月8日招募了325名调查参与者。
干预措施
干预药房实施了联合配药纳洛酮的工作流程，而常规护理药房提供常规服务。
主要测量指标
调查工具评估了阿片类药物风险行为、危险饮酒、烟草、大麻和其他药物使用情况以及知识。使用药房患者和调查参与者的药房数据评估纳洛酮配药情况和阿片类药物剂量。使用考虑药房层面聚类的广义线性混合模型进行意向性分析。
关键结果
试验组之间的阿片类药物风险行为没有差异（P = 0.52；8个月与基线调整风险比[ARR]为1.07；95%置信区间0.78，1.47）。与常规护理药房相比，干预药房的纳洛酮配药量更高（ARR 3.38；95%置信区间2.21，5.15），参与者的知识有所增加（P = 0.02；8个月与基线调整平均差异1.05；95%置信区间0.06，2.04）。试验组在其他物质使用方面没有差异。
结论
纳洛酮与阿片类药物联合配药有效地增加了纳洛酮的获取和知识，但并未增加自我报告的风险行为。
试验注册
在ClinicalTrials.gov注册；标识符：NCT03337100。
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