Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics (IGNITE)
5 de junho de 2019 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Real)
505
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites for pain mangement.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
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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.
Outros nomes:
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
Prazo: Change from baseline to 3 months
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in pain medication
Prazo: 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)
Prazo: Change from baseline to 3 months
|
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)
Prazo: Change from baseline to 3 months
|
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
Prazo: Change from baseline to 3 months
|
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)
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Larisa Cavallari, PharmD, University of Florida
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2015
Conclusão Primária (Real)
12 de junho de 2017
Conclusão do estudo (Real)
25 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
7 de janeiro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de janeiro de 2015
Primeira postagem (Estimativa)
9 de janeiro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de junho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de junho de 2019
Última verificação
1 de junho de 2019
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- IRB201400501 - N
- U01HG007269-02 (Concessão/Contrato do NIH dos EUA)
- OCR14741 (Outro identificador: Universiy of Florida)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .