Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics (IGNITE)
5 de junio de 2019 actualizado por: University of Florida
This study will examine the effect of having genotype information on pain management and pain control for patients treated in family medicine clinics.
This study will also examine physician-perceived usefulness of genotype information.
Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites.
Patients from implementation sites will undergo genotyping, while those from control sites will not by genotyped.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
505
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Florida
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Archer, Florida, Estados Unidos, 32618
- Archer Family Health Care
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Gainesville, Florida, Estados Unidos, 32606
- UF Health Spring Hill Pain Management
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Gainesville, Florida, Estados Unidos, 32607
- UF Health Family Medicine: Hampton Oaks
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Gainesville, Florida, Estados Unidos, 32607
- UF Health Internal Medicine - Tower Hill
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Gainesville, Florida, Estados Unidos, 32608
- UF Health Family Medicine: Haile Plantation
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Gainesville, Florida, Estados Unidos, 32609'
- UF Health Family Medicine: Main Street
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Gainesville, Florida, Estados Unidos, 32610
- UF Health Internal Medicine-Medical Plaza
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Gainesville, Florida, Estados Unidos, 32641
- UF Health Family Medicine: Eastside
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Old Town, Florida, Estados Unidos, 32680
- UF Health Family Medicine - Old Town
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Oviedo, Florida, Estados Unidos, 32765
- Oviedo Family Health Center
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Saint Cloud, Florida, Estados Unidos, 34769
- ProHealth Family Physicians
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites for pain mangement.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
Otros nombres:
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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.
Otros nombres:
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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pain medication
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Larisa Cavallari, PharmD, University of Florida
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2015
Finalización primaria (Actual)
12 de junio de 2017
Finalización del estudio (Actual)
25 de octubre de 2017
Fechas de registro del estudio
Enviado por primera vez
7 de enero de 2015
Primero enviado que cumplió con los criterios de control de calidad
8 de enero de 2015
Publicado por primera vez (Estimar)
9 de enero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
5 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IRB201400501 - N
- U01HG007269-02 (Subvención/contrato del NIH de EE. UU.)
- OCR14741 (Otro identificador: Universiy of Florida)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The consent form has an addendum for NIH dbGaP.
Participants who agree will have their deidentified results shared to dbGaP.
Those who do not agree will not have their results shared.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .