The Excess Opioid Disposal Study
赞助:
Dartmouth-Hitchcock Medical Center
合作者:
信息的提供 (责任方):
Richard J. Barth,Jr.，Dartmouth-Hitchcock Medical Center
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 15, 2018 | ||
| 预计主要完成日期 | July 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
opioid disposal rate[ Time Frame: 1 year ] % of patients that dispose of excess opioids in an FDA compliant manner |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | The Excess Opioid Disposal Study | ||
| 正式标题 ICMJE | The Excess Opioid Disposal Study | ||
| 简要概况 | This study is designed to test the hypothesis that providing information to patients about excess opioid disposal, calling patients prior to their outpatient post-operative surgical appointment and providing a convenient drop box for opioid disposal will increase rates of FDA compliant disposal. |
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| 详细说明 | It is hypothesized that: 1. By providing pre-operative patient education, a drop-box in a convenient location (the hospital pharmacy near the surgical outpatient clinic) and a reminder phone call prior to the post-operative clinic appointment, an increase in FDA-compliant unused opioid disposal rates to at least 40% will be seen. 2. The investigator's guideline for opioid prescribing after operations that require an inpatient admission which the investigator established for general surgical procedures will satisfy the opioid requirements of at least 85% of patients undergoing a variety of operations from differing specialties. 3. The utilization of guideline opioid prescribing and FDA-compliant unused opioid disposal will decrease the percentage of patients who are taking opioids at 6 months and 1 year after their surgery to less than 1%. The primary objective is to determine the effect of pre-operative patient education, a drop-box in the hospital pharmacy and a reminder phone call on the proportion of patients who dispose of unused opioids using a FDA-compliant method. Secondary objectives include: 1. Determine in a prospective study whether our guideline for opioid prescribing after surgery which requires inpatient admission fulfills the opioid requirements of at least 85% of patients undergoing a variety of operations. 2. Determining the effect of guideline opioid prescribing and FDA-compliant unused opioid disposal on the proportion of patients who are on opioids 6 months and 1 year after their surgery. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
300 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 1, 2021 | ||
| 预计主要完成日期 | July 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Having surgery with expected duration of admission of 2 days or more Exclusion Criteria: - Allergies to opioids - Allergy or contra-indication to short term acetaminophen or ibuprofen - Chronic opioid use - History of opioid abuse | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Richard J. Barth,Jr.，Dartmouth-Hitchcock Medical Center | ||
| 研究赞助商 ICMJE | Dartmouth-Hitchcock Medical Center | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Dartmouth-Hitchcock Medical Center | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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