Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; School of Pharmacy, University of Southern California, Los Angeles, CA, United States of America.
Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.
Contemp Clin Trials. 2022 Jan;112:106650. doi: 10.1016/j.cct.2021.106650. Epub 2021 Dec 8.
High levels of opioid prescribing in the United States has resulted in an alarming trend in opioid-related harms. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) is to dampen the intensity and frequency of opioid prescribing in accordance with the Centers for Disease Control and Prevention recommendation to "go low and slow". We aim to accomplish this by notifying clinicians of harmful patient outcomes, which we expect to increase the mental availability of risks associated with opioid use.
The trial is multi-site. Random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual care (control). Clinicians in the intervention group receive a letter notifying them of their patient's overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) prescribed in a 6-month period before and after receiving the letter. Additional outcomes are the change in the proportion of patients prescribed at least 50 daily MME and in the proportion of patients referred to medication assisted treatment. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME.
The AESOPS-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering population exposure to these drugs.
ClinicalTrials.gov: NCT04758637.
美国阿片类药物处方水平较高，导致阿片类药物相关危害呈惊人趋势。应用经济学和社会心理学改善阿片类药物处方安全（AESOPS-2）试验 2 的目的是根据疾病控制和预防中心的建议“降低剂量，缓慢增加”，减少阿片类药物的开具强度和频率。我们希望通过通知临床医生患者发生有害后果，来实现这一目标，这预计会增加与阿片类药物使用相关风险的心理可及性。
该试验是多地点的。随机分组决定遭受阿片类药物过量（致命或非致命）的患者的处方医生是否了解这一事件（干预组）或接受常规护理（对照组）。干预组的临床医生会收到一封信，通知他们的患者发生了阿片类药物过量。主要结果是在收到信前后 6 个月内临床医生每周开具的毫克吗啡当量（MME）的变化。其他结果是至少开具 50 每日 MME 的患者比例和接受药物辅助治疗的患者比例的变化。使用意向治疗差异-差异框架和混合效应回归模型比较这些结果的组间差异，以估计临床医生的 MME。
AESOPS-2 试验将提供新的知识，即增加临床医生对患者阿片类药物相关过量的认识是否会导致阿片类药物处方减少。此外，通过降低人群对这些药物的接触，该试验可能更好地告知如何减少阿片类药物使用障碍和阿片类药物过量。
ClinicalTrials.gov：NCT04758637。
