Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics (IGNITE)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Florida
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Archer, Florida, États-Unis, 32618
- Archer Family Health Care
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Gainesville, Florida, États-Unis, 32606
- UF Health Spring Hill Pain Management
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Gainesville, Florida, États-Unis, 32607
- UF Health Family Medicine: Hampton Oaks
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Gainesville, Florida, États-Unis, 32607
- UF Health Internal Medicine - Tower Hill
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Gainesville, Florida, États-Unis, 32608
- UF Health Family Medicine: Haile Plantation
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Gainesville, Florida, États-Unis, 32609'
- UF Health Family Medicine: Main Street
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Gainesville, Florida, États-Unis, 32610
- UF Health Internal Medicine-Medical Plaza
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Gainesville, Florida, États-Unis, 32641
- UF Health Family Medicine: Eastside
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Old Town, Florida, États-Unis, 32680
- UF Health Family Medicine - Old Town
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Oviedo, Florida, États-Unis, 32765
- Oviedo Family Health Center
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Saint Cloud, Florida, États-Unis, 34769
- ProHealth Family Physicians
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
Autres noms:
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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.
Autres noms:
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in pain medication
Délai: Change from baseline to 3 months
|
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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Larisa Cavallari, PharmD, University of Florida
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB201400501 - N
- U01HG007269-02 (Subvention/contrat des NIH des États-Unis)
- OCR14741 (Autre identifiant: Universiy of Florida)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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