Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics (IGNITE)
研究概览
详细说明
Codeine and tramadol are opioid analgesics that depend on cytochrome P450 2D6 (CYP2D6) for bioactivation to morphine and O-desmethyltramadol, respectively. Morphine and O-desmethyltramadol have much greater affinity for the opioid receptor and thus are more powerful analgesics.
Individuals with genotypes associated with low CYP2D6 activity (poor metabolizers) are unable to convert sufficient amounts of codeine or tramadol to their active metabolites and may fail to derive sufficient pain relief. At the opposite extreme, individuals with genotypes associated with increased CYP2D6 activity (ultra-rapid metabolizers) are at risk for serious toxicity with usual codeine or tramadol doses.
The CYP2D6 genotype also has implications for response to other drugs, such as tricyclic antidepressants (TCAs), which are commonly used for neuropathic pain.
Patients will be recruited from family medicine clinics, serving as either implementation sites or control sites. Patients from implementation sites will undergo CYP2D6 genotyping, with results placed in the medical record to assist with prescribing of pain medications. Pain medications prescribed from baseline to 3 months will be assessed through medical record review. A pain assessment questionnaire will be administered to patients enrolled from both sites at baseline and 3 months.
At the end of the study, a 20-item survey will be administered to physicians at the implementation sites. We will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective.
We will also assess medicines prescribed to patients enrolled from both sites over the 12-month period after enrollment from medical record review and determine the number of patients who were prescribed a medication that has genetic information in its FDA-approved label.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Florida
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Archer、Florida、美国、32618
- Archer Family Health Care
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Gainesville、Florida、美国、32606
- UF Health Spring Hill Pain Management
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Gainesville、Florida、美国、32607
- UF Health Family Medicine: Hampton Oaks
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Gainesville、Florida、美国、32607
- UF Health Internal Medicine - Tower Hill
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Gainesville、Florida、美国、32608
- UF Health Family Medicine: Haile Plantation
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Gainesville、Florida、美国、32609'
- UF Health Family Medicine: Main Street
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Gainesville、Florida、美国、32610
- UF Health Internal Medicine-Medical Plaza
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Gainesville、Florida、美国、32641
- UF Health Family Medicine: Eastside
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Old Town、Florida、美国、32680
- UF Health Family Medicine - Old Town
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Oviedo、Florida、美国、32765
- Oviedo Family Health Center
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Saint Cloud、Florida、美国、34769
- ProHealth Family Physicians
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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
描述
Inclusion Criteria:
- Treated in family medicine clinic
- History of pain for at least 3 months
- Prescribed medication for pain relief
Exclusion Criteria:
- Pain for less than 3 months
- Not currently prescribed any medication for pain
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Control
Patients will continue to receive their current pain management therapy.
In addition, a pain assessment questionnaire will be administered at baseline and 3 months.
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A pain assessment questionnaire will be administered at baseline and 3 months.
其他名称：
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Implementation
Patients will undergo CYP2D6 genotyping, with results entered into the medical record to assist the physician with prescribing pain medication.
In addition, a pain assessment questionnaire will be administered at baseline and 3 months.
|
A pain assessment questionnaire will be administered at baseline and 3 months.
其他名称：
CYP2D6 genotype results and an interpretive report will be placed in the electronic medical record to assist the physician with prescribing medication for pain management.
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Physician assessment
At the end of the study, a 20-item survey will be administered to physicians who treated patients enrolled in the study.
The survey will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective.
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20-item survey administered to physicians treating patients enrolled in the study
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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 |
|---|---|---|
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Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
大体时间：Change from baseline to 3 months
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Patient Reported Outcomes Measurement Information System (PROMIS) measures will be used to assess pain intensity, physical functioning, and emotional functioning.
There are 10 subscales on the PROMIS questionnaire that address the domains of pain, pain functioning, and emotional functioning.
At least 4 (and up to 30) items are used to derive a score for each subscale.
A computer adaptive version of the questionnaire based on item response theory will be used to administer the survey.
A score of 0 to 100 based on survey responses will be resulted for each subscale.
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Change from baseline to 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in pain medication
大体时间：Change from baseline to 3 months
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Change in pain medication will be evaluated in several manners: change in the opiate prescribed, change from an opiate to a non-opiate; and change in dose of the opiate prescribed
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Change from baseline to 3 months
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Change in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
大体时间：Change from baseline to 3 months
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Patient Reported Outcomes Measurement Information System (PROMIS) subscale for pain intensity, with the score ranging from 0 to 100 resulting.
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Change from baseline to 3 months
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Change in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
大体时间：Change from baseline to 3 months
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Patient Reported Outcomes Measurement Information System (PROMIS) subscales for physical functioning include pain function, pain interference, pain behavior, sleep disturbance, and sleep-related impairment.
A score of 0 to 100 based on survey responses will be resulted for each subscale.
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Change from baseline to 3 months
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Change in pain score of emotional functioning
大体时间：Change from baseline to 3 months
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Patient Reported Outcomes Measurement Information System (PROMIS) subscales for emotional functioning include fatigue, anxiety, depression, and anger.
A score of 0 to 100 based on survey responses will be resulted for each subscale.
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Change from baseline to 3 months
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Physician perceived usefulness of genetic information (survey)
大体时间：3 months
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Survey will be administered to physicians with patients in the study to assess the effect of having genotype information on their prescribing decisions.
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3 months
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Medications prescribed with pharmacogenetic implications (Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing)
大体时间：12 months
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Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing
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12 months
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合作者和调查者
调查人员
- 首席研究员：Larisa Cavallari, PharmD、University of Florida
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
- IRB201400501 - N
- U01HG007269-02 (美国 NIH 拨款/合同)
- OCR14741 (其他标识符：Universiy of Florida)
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
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
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