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临床试验/NCT03536065
NCT03536065已完成不适用

Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES): A Quality Improvement Study of Prescribing Habits and Patient Education

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 443 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
443
试验地点
2
主要终点
Opioid Use

研究概览

简要总结

ORIOLES is a non-randomized, pre-post intervention study designed to improve quality of opioid prescribing and use after discharge for patients undergoing urologic surgery. The study will initially focus on a pre-defined cohort of patients undergoing radical prostatectomy. After the predefined study period for the pre-intervention arm, a three-part intervention is employed to assess the effect on opioid prescribing and use in the post-intervention arm. Pending results, the intervention may be applied to all surgeries in the department for routine clinical care.

详细描述

The goal of the study is to reduce the amount of opioid analgesia prescribed after urologic surgery in the Department of Urology at Johns Hopkins. The initiative focuses on patients undergoing surgery for prostate cancer with radical prostatectomy including patients enrolled in IRB00123618/NCT03006562. The pre-intervention arm will consist of patients enrolled August 2017 to January 2018. The intervention arm will consist of patient enrolled January 2018 to completion of the study.

The intervention consists of a information discharge sheet, a standardized prescribing guideline at discharge, and nurses providing improved education for patients at discharge about appropriate use of opioid medication, routes for disposal, and potential side effects. Data on prescriptions written (amount and type of mediation) and use of opioid and other pain medication after surgery will be compared before and after the quality improvement initiative is started. Outcomes are assessed via 30-day phone call follow-up with data on perioperative outcomes, postoperative medication use, and symptoms already assessed in IRB00123618/NCT03006562. At the completion of the pre-intervention arm, providers in the urology department are informed about the average and distribution of usage of post-discharge opioids. Education and standardized prescribing (allowing for provider judgment) may help reduce/personalize the amount of opioids prescribed at discharge to reduce wasted medication entering circulation. The initiative may then be expanded to encompass all surgeries in the department to reduce opioid prescribing and use for routine clinical care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients diagnosed with prostate cancer and enrolled in NCT03006562

排除标准

  • Patients not undergoing radical prostatectomy (for the primary pre-post ORIOLES study)

结局指标

主要结局

Opioid Use

时间窗: 30 days

The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital

次要结局

  • Opioid Prescription(Discharge date)
  • Opioid Disposal(30 days)
  • Need for Refill or Additional Opioid Medication(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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