Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, OR, USA.
Department of Psychiatry, Oregon Health & Science University, Portland, USA.
J Gen Intern Med. 2022 Nov;37(15):3805-3813. doi: 10.1007/s11606-022-07476-7. Epub 2022 Mar 16.
Interventions to reduce harms related to prescription opioids are needed in primary care settings.
To determine whether a multicomponent intervention, Improving the safety of opioid therapy (ISOT), is efficacious in reducing prescription opioid harms.
Clinician-level, cluster randomized clinical trial. ( ClinicalTrials.gov : NCT02791399) SETTING: Eight primary care clinics at 1 Veterans Affairs health care system.
Thirty-five primary care clinicians and 286 patients who were prescribed long-term opioid therapy (LTOT).
All 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.
The 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.
ISOT 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.
ISOT 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.
初级保健环境中需要采取干预措施减少与处方类阿片相关的危害。
确定多组分干预措施（改善阿片类药物治疗安全性）是否能有效减少处方类阿片类药物的危害。
临床医生层面、集群随机临床试验。（ClinicalTrials.gov：NCT02791399）
1 个退伍军人事务医疗保健系统的 8 个初级保健诊所。
35 名初级保健临床医生和 286 名接受长期阿片类药物治疗（LTOT）的患者。
所有临床医生都参加了 2 小时的关于以患者为中心的阿片类药物依从性监测的教育课程，并被随机分配到仅接受教育或接受 ISOT。ISOT 是一种多组分干预措施，包括为患者提供一次外部临床医生咨询，以及在 12 个月内为临床医生提供监测和反馈。
主要结局是处方类阿片类药物滥用风险的变化（当前阿片类药物滥用量表）和尿液药物检测结果。次要结局包括临床医生-患者关系的质量、其他处方类阿片类药物安全结局、临床医生阿片类药物处方特征的变化以及疼痛强度和功能变化的非劣效性分析。
ISOT 并未降低处方类阿片类药物滥用的风险（组间差异=-1.12，p=0.097）、尿液药物检测结果异常的可能性（组间差异=-0.04，p=0.401）或临床医生-患者关系的衡量标准。分配到 ISOT 的参与者更有可能停止处方类阿片类药物（20.0%比 8.1%，p=0.007）。ISOT 并未使参与者报告的疼痛强度或功能评分恶化。
ISOT 并未影响处方类阿片类药物滥用的风险，但确实增加了停止处方类阿片类药物的可能性。可能需要更强化的干预措施来影响治疗结果。
