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临床试验/NCT04758637
NCT04758637已完成不适用

Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 2 (AESOPS-2): Availability of Opioid Harm

University of Southern California1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2023年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Change in Daily Average Number of 5 MME Pill Counts

研究概览

简要总结

The opioid epidemic is the largest man-made public health crisis the United States has faced. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) study, is to discourage unnecessary opioid prescribing by increasing the salience of negative patient outcomes associated with opioid use.

详细描述

In AESOPS-2, a multi-site study, 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). The AESOPS-2 trial will take place in 3 diverse health systems in the U.S. - Northwestern Medicine, AltaMed Health Services, and The Children's Clinic. At Northwestern Medicine, clinicians in the intervention group receive a letter notifying them of their patient's fatal or nonfatal ED overdose. At AltaMed Health Services, and The Children's Clinic, clinicians in the intervention group receive a letter notifying them of their patient's nonfatal ED overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) dose prescribed in 6-month periods before and after receiving the letter. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. 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 weekly dose. 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 unnecessary population exposure to these drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •1) The clinician prescribed a qualifying scheduled drug to a patient in the 12 months prior to their non-fatal or fatal overdose 2) the patient is 18 years old or older at the time of the overdose, 3) the provider practices within a health system enrolled in the study, and 4) the overdose occurs during the 12-month observation period. Qualifying prescriptions include those for one of the following scheduled drugs: opioids, benzodiazepines, muscle relaxants or sedative-hypnotics.

排除标准

  • •Prescriptions to patients in hospice or with active cancer

研究组 & 干预措施

Control Group

No Intervention

Physicians in the control group will receive no notification of their patient's fatal or nonfatal overdose.

Overdose Notification Group

Experimental

The overdose notifications will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses.

干预措施: Overdose Notification (Behavioral)

结局指标

主要结局

Change in Daily Average Number of 5 MME Pill Counts

时间窗: 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)

The primary outcome is the change in daily average number of 5 morphine milligram equivalent (MME) pill counts ordered by clinicians during the last week of baseline (week 26) and the last week of the intervention period (week 53) letter intervention.

次要结局

  • Change in Clinician-level, Pre-to-post Mean Proportion of High Dose (=> 50 MME) Patient Visits(13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Doctor

Professor

University of Southern California

研究点 (1)

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