Reducing Prescription Opioid Misuse: ROPEs Pilot Trial
追踪信息 | |||
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首次提交日期 ICMJE | September 27, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | January 2019 | ||
预计主要完成日期 | August 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Methodological Feasibility: Recruitment Rate[ Time Frame: Baseline completion, approximately 2 hours ] Number of Participants Recruited Methodological Feasibility: Completion Rates[ Time Frame: Baseline completion, approximately 2 hours ] Percent of Patients Completing ROPES (or control) Methodological Feasibility: Follow-Up Completion Rates[ Time Frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) ] Percent of baseline participants completing the one-month follow-up assessment Methodological Feasibility: Time to Complete Intervention[ Time Frame: Baseline completion component, approximately 90 minutes ] Time participant takes to finish engaging with ROPES intervention or control intervention |
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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 | Reducing Prescription Opioid Misuse: ROPEs Pilot Trial | ||
正式标题 ICMJE | Reducing Prescription Opioid Misuse: Dental Provider Intervention Development | ||
简要概况 | This is a randomized controlled pilot trial to establish methodological feasibility and determine whether a web-based, continuing dental education intervention regarding opioid prescribing risk mitigation strategies - consistent with ADA guidelines - produces pre-to-post changes in knowledge, motivation, and behavioral skills pertaining to the use of risk mitigation strategies when prescribing opioids in dental practice. The current study involves completion of a self-report pre-test (dentists), randomization to complete ROPEs or attention control intervention, completion of a self-report post-test (immediately following intervention/control completion), and completion of 1-month self-report follow-up assessment. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Other |
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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 |
60 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | August 2019 | ||
预计主要完成日期 | August 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: 1. Male or female; any race or ethnicity; age 21-85 years. 2. Able to comprehend English. 3. Be either a licensed dental practitioner currently practicing or a Resident enrolled in the College of Dental Medicine at the Medical University of South Carolina or a practicing dentist in the Charleston-county area or a licensed dental practitioner currently participating in the National Dental Practice Based Research Network (NDPBRN). 4. Report having ever prescribed an opioid analgesic to a patient 5. Must have Internet access 6. Must have a valid, usable email account 7. Must agree to complete all study measurements. Exclusion Criteria: 1. Unable to provide informed consent due to mental or physical limitations. 2. Participation in ROPEs intervention development focus groups. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:85 Years | ||
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 | Yes | |
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 | Jenna McCauley,Medical University of South Carolina | ||
研究赞助商 ICMJE | Medical University of South Carolina | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Medical University of South Carolina | ||
验证日期 | October 2018 | ||
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 |