Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics (IGNITE)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Florida
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Archer、Florida、アメリカ、32618
- Archer Family Health Care
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Gainesville、Florida、アメリカ、32606
- UF Health Spring Hill Pain Management
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Gainesville、Florida、アメリカ、32607
- UF Health Family Medicine: Hampton Oaks
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Gainesville、Florida、アメリカ、32607
- UF Health Internal Medicine - Tower Hill
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Gainesville、Florida、アメリカ、32608
- UF Health Family Medicine: Haile Plantation
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Gainesville、Florida、アメリカ、32609'
- UF Health Family Medicine: Main Street
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Gainesville、Florida、アメリカ、32610
- UF Health Internal Medicine-Medical Plaza
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Gainesville、Florida、アメリカ、32641
- UF Health Family Medicine: Eastside
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Old Town、Florida、アメリカ、32680
- UF Health Family Medicine - Old Town
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Oviedo、Florida、アメリカ、32765
- Oviedo Family Health Center
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Saint Cloud、Florida、アメリカ、34769
- ProHealth Family Physicians
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
他の名前：
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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.
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A pain assessment questionnaire will be administered at baseline and 3 months.
他の名前：
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pain medication
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Larisa Cavallari, PharmD、University of Florida
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB201400501 - N
- U01HG007269-02 (米国 NIH グラント/契約)
- OCR14741 (その他の識別子：Universiy of Florida)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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