阿片类药物逐渐减少的临床决策支持评价
The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the risk of withdrawal symptoms, overdose, and to promote tolerance of the tapering. This project will examine the state of tapering in primary care across the system as well as conduct stakeholder interviews to understand the resources available across the system to support providers in tapering and identify opportunities for clinical decision support to be implemented to support guideline concordant tapering. Utilization of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering will be examined. The rate of opioid tapering in line with CDC guidelines will be examined as well as long term patient outcomes of opioid overdose of poisoning using existing patient health records. The study period will be approximately 8 months.
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Heather Tolle, PhD
- 电话号码：303-724-9924
- 邮箱：heather.tolle@cuanschutz.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system receiving long-term opioid treatment.
描述
Inclusion Criteria: Primary care patients being tapered from an opioid. Tapering patients:
- Have an active opioid prescription for more than 3 months and
- Prescribed more than 90 morphine milligram equivalents (MME) per day or
- Co-prescribed an opioid and benzodiazepine or
- Received a reduction in opioid dosage by more than 5% MME per day
Exclusion Criteria:
- Patients <12 and >89
- Patients with active cancer diagnosis in last 1 year
- Patients with hospice care/palliative care order
- Patients with sickle cell disease diagnosis
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Usual Care
Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. |
observational study without a prospective intervention |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of potential taper-benefit patients
大体时间：8 months
|
The percentage of chronic opioid primary care patients for which EHR risk indicates tapering may be beneficial |
8 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Observed tapering
大体时间：8 months
|
The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly as an indication of tapering |
8 months
|
|
Taper magnitude
大体时间：8 months
|
The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly at a rate in line with guideline recommendations |
8 months
|
合作者和调查者
调查人员
- 首席研究员：Jason Hoppe, DO、University of Colorado, Denver
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 24-1193
- R61DA057610 (美国 NIH 拨款/合同)
- 24-1193 (其他标识符：COMIRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
De-identified data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) repository after final study results have been published.
IPD 共享时间框架
Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
IPD 共享访问标准
Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.