Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics
Condition: Pain
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): CYP2D6 genotyping; Pain assessment questionnaire; Physician assessment
Intervention type(s): Genetic; Other; Other
Intervention description(s): 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.; A pain assessment questionnaire will be administered at baseline and 3 months.; 20-item survey administered to physicians treating patients enrolled in the study
Other intervention name(s): PROMIS questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be enrolled from family medicine clinics serving as either implementation
        sites or control sites for pain mangement.
      
Biospecimen description: 
      genotype
    
Keywords: Pain; CYP2D6