SITE: University Of Maryland GENE/DRUG: CYP2C19/clopidogrel TYPE: Research

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SITE: University of Maryland GENE/DRUG: CYP2C19/clopidogrel TYPE: ResearchPatientClinicalTeamAlternative therapy considered;Cardiology Fellow orders drug of choiceAgree to studyinclusionIf Poor Metabolizer or IntermediateMetabolizer, Critical Alert Call fromPath Lab to msLabsFinal therapychoice providedLHCindicatedCath Prep andRecovery Unit ordersCYP2C19 test inPowerChart6 cc bloodcollected in CathLabBlood sampleaccessionedGenotype result enteredinto PowerchartTGL: h Eligibility confirmedCoordinatorConsent obtainedDeliver CDS to Cardiology teamDeliver results to patient

SITE: Ohio State University GENE/DRUG: CYP2C19/clopidogrel TYPE: ResearchPatientPatient eligible forCoriell PersonalizedMedicine studyPatient informed byemail that genotypeavailable in portalPhysician informed byemail that genotypeavailable in nt counseled inperson by OSU GC ifrandomized to active armGenotype available inEMRCoriell uploads genotypeto patient portal andemails genotype to RCCoriell genotypessaliva samplePhysician receives OSUGC summary report forpatients in active armGenotype available inpatient portalCoriell randomizes patientsto active (OSU GC) orcontrol arm (no OSU riell GC is available byphone for questions frompatients in control armRC obtains patient consentand saliva sample andsends to CoriellRC entersgenotype intoEMROSU GC contacts andthen counsels in personfor patients in active armOSU GC writes summaryreport and sends tophysician

SITE: University of Florida GENE/DRUG: CYP2C19/clopidogrel TYPE: criberordersCYP2C19 testPatient andprescriber discusstreatment decisionPhlebotomist/nurseobtains sample andsends to labIn-basket EMRmessage sent toclinical lopidogrelClinical lab performsCYP2C19 genotypetestIf genotype available, CDSalerts indicating genotype therapy recommendationClinical lab addsresult to EpicPharmacist reviewspatient chart forneeded follow upPharmacist reviewsalternative therapies withinterventionalist team

SITE: University of Florida GENE/DRUG: CYP2C19/clopidogrel TYPE: ResearchPatientPatient has clinicalCYP2C19 test enetic data movedinto Integrated DataRepositoryClinical lab performsCYP2C19 genotypetest on broad array*allele translationsoftware checks forconsent rRC obtainselectronicpatient consentRC providesBiorepository staff list ofconsented patientsLeftover sample is pickedup to be stored inBiorepository

PreImplementationTechnicalDevelopmentPGx Evidence Synthesis andInternal Feasibility AssessmentDevelopment of Inpatientand Outpatient Rx CDSConfiguration ofEHR and PHRLaboratoryOperationsPatientGenotyped for184 variantsUsersEHR and PHROperationsPREDICT order –entry supportPrognostic Modelrisk scorecalculatedVanderbilt (PREDICT)Review andApproval by P&TCommitteesPrognosticidentification orIndication warrantsPREDICT testingSequestration ofnon-actionablegene variantsSequestered genotypeinformation maintainedfor future useActionablevariants deliveredto EHRGenotype informationdelivered to PersonalHealth RecordRx order of targetmedicationtriggers Rx CDSProviderDecision SupportService tailorsCDS to genotypeand drugPatientPeterson JF et al. Genet Med. 2013 Oct;15(10):833-841.

PREDICT Result Reporting ArchitectureVanderbilt (PREDICT)Peterson JF et al. Genet Med. 2013 Oct;15(10):833-841.

St. JudeAll PGen Results InterpretedReceiveresultQCPlace resultinto EMRFlowsheetAdd genotypespecificinterpretation toEMR, with pt-specificnotes as neededPriorityresult?YesPt onhigh-riskdrug now?Add PGproblem toproblem listYesMedicationreconciliationdiscussion with theclinicians on service“PG problemadded” email toattending MD,NP, and fellowNoPt agreed toreceive resultsin letter tohome address?YesSend resultletter USPSNoPt EMRportal

St. JudePre-test: drug order attempt, no genetic tests; general caseHigh-riskdrug orderattempted InPt/OutPt/Clinic Order,Modify,Refill,VerifyAny relatedgenetic testordered?YesAny relatedgenetic testresulted?YesContinue withdrug orderNo“Test isrecommended”alert to clinicianOverride,documentreason“Drug orderattempted”email to PGPharmDsOrder genetictestPost-test: drug order attempt, genetic results available;general caseHigh-riskdrug orderattempted InPt/OutPt/Clinic Order,Modify,Refill,VerifyProblem listentry frompriority resultpresent?NoContinue withdrug orderYes“Changesrecommended”alert to userRecommend Changing dose Changing drug MonitoringOverride,documentreasonAdvertised lines of support information Contact PG PharmD; phone, email www.stjude.org/pg4kds;www.pharmgkb.org PG Formulary (linked from hospitalformulary) Contact PK research nurses; phone,email

In-basket EMR message sent to clinical pharmacy Phlebotomist/nurse obtains sample and sends to lab Patient and prescriber discuss treatment decision . Prescriber orders clopidogrel . If genotype available, CDS alerts indicating genotype therapy recommendation Pharmacist reviews patient chart for needed follow up . Clinical lab adds result to Epic