A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT).
A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT).
复制标题
减少处方阿片类药物滥用的整群随机临床试验：提高阿片类药物治疗 (ISOT) 的安全性。
DOI：
10.1007/s11606-022-07476-7
复制
发表时间：
2022
影响因子：
5.7
通讯作者：
Dobscha,StevenK
中科院分区：
文献类型：
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作者：
Morasco,BenjaminJ;Adams,MelissaH;Hooker,ElizabethR;Maloy,PatriciaE;Krebs,ErinE;Lovejoy,TravisI;Saha,Somnath;Dobscha,StevenK
背景初级保健需要减少处方阿片类药物相关危害的干预措施。目的确定提高阿片类药物治疗安全性(ISOT)的多组分干预措施在减少处方阿片类药物危害方面是否有效。(ClinicalTrials.gov：NCT02791399)设置1个退伍军人事务部卫生保健系统的8个初级保健诊所。参与者35名初级保健临床医生和286名患者接受了长期阿片类药物治疗(LTOT)。干预所有临床医生参加了关于阿片类药物依从性监测以患者为中心的2小时教育会议，并被随机分配到单纯教育组或ISOT组。ISOT是一种多成分干预措施，包括外部临床医生对患者进行一次性会诊，并在12个月内监测并反馈给临床医生。主要结果是处方阿片类药物滥用风险(当前阿片类药物滥用衡量标准)和尿药试验结果的变化。次要结果是临床医患关系的质量、其他处方阿片类药物安全结果、临床医生阿片类药物处方特征的变化，以及对疼痛强度和功能变化的非劣势分析。关键结果ISOT不能降低处方阿片类药物滥用的风险(组间差异=−1.12，p=0.097)、尿药试验结果异常的可能性(组间差异=−0.04，p=0.401)或临床医患关系的衡量标准。被分配到ISOT的参与者更有可能停止使用处方阿片类药物(20.0%比8.1%，p=0.007)。ISOT没有恶化参与者报告的疼痛强度或功能评分。结论ISOT不影响处方阿片类药物滥用的风险，但确实导致处方阿片类药物停用的可能性增加。可能需要更密集的干预措施来影响治疗结果。
BackgroundInterventions to reduce harms related to prescription opioids are needed in primary care settings.ObjectiveTo determine whether a multicomponent intervention, Improving the safety of opioid therapy (ISOT), is efficacious in reducing prescription opioid harms.DesignClinician-level, cluster randomized clinical trial. (ClinicalTrials.gov: NCT02791399)SettingEight primary care clinics at 1 Veterans Affairs health care system.ParticipantsThirty-five primary care clinicians and 286 patients who were prescribed long-term opioid therapy (LTOT).InterventionAll clinicians participated in a 2-hour educational session on patient-centered care surrounding opioid adherence monitoring and were randomly assigned to education only or ISOT. ISOT is a multicomponent intervention that included a one-time consultation by an external clinician to the patient with monitoring and feedback to clinicians over 12 months.Main MeasuresThe primary outcomes were changes in risk for prescription opioid misuse (Current Opioid Misuse Measure) and urine drug test results. Secondary outcomes were quality of the clinician-patient relationship, other prescription opioid safety outcomes, changes in clinicians’ opioid prescribing characteristics, and a non-inferiority analysis of changes in pain intensity and functioning.Key ResultsISOT did not decrease risk for prescription opioid misuse (difference between groups = −1.12,p= 0.097), likelihood of an aberrant urine drug test result (difference between groups = −0.04,p=0.401), or measures of the clinician-patient relationship. Participants allocated to ISOT were more likely to discontinue prescription opioids (20.0% versus 8.1%,p= 0.007). ISOT did not worsen participant-reported scores of pain intensity or function.ConclusionsISOT did not impact risk for prescription opioid misuse but did lead to increased likelihood of prescription opioid discontinuation. More intensive interventions may be needed to impact treatment outcomes.