CongenitalCMV(cCMV)InitiativesAcrosstheUnitedStates:

APanelDiscussion

StephanieBrowningMcVicar,Au.D.KirstenCoverstone,Au.D.

GingerMullin,Au.D.

LearningObjectives1:DiscussCMVinitiativesoccurringacrosstheUnitedStateswithorwithoutlegislation.

LearningObjectives2:DescribesuccessfulstrategiesandbarrierstoincreasingCongenitalCMV(cCMV)awarenessand/orcCMVtesting.

LearningObjectives3:IdentifyresourcesavailableforuseinimplementingCongenitalCMVinitiatives.

StateEarlyHearingDetection&Intervention(EHDI)Coordinators

National EHDI Goals

CDC “1-3-6”:

Hearing screening before 1 monthDiagnostic evaluation before 3 monthsEarly intervention before 6 months

Congenital CMV and Hearing Loss

Congenital CMV is the most common cause of non-hereditary hearing loss in children.

In a large number of asymptomatic children with congenital CMV, hearing loss is the only sequelae (known abnormality).

TypesofcCMVInitiatives• Education- only• Screeningofchildrennotpassinguniversalnewbornhearingscreening(UNHS)

• UniversalScreening

• Legislativelymandated• Notlegislativelymandated

UTAH catalyst

Utah EHDI

26-10-10 UCA, “Cytomegalovirus (CMV) Public Education and Testing”

● UDOH establish and conduct a public education program to inform pregnant women and women who may become pregnant about CMV (incidence, transmission, birth defects, diagnostic methods, preventative measures)

● Provide information to: child care providers, school nurses, health educators, health care providers, religious organizations offering children’s programs as part of worship services

Utah EHDI

26-10-10 UCA, “Cytomegalovirus (CMV) Public Education and Testing”

If a newborn infant fails the newborn hearing screening test(s)……

Medical Practitioner shall:● Test the newborn infant for CMV before 21 days of

age…unless the parent objects; and● Provide to the parents information re: birth defects caused

by congenital CMV and available methods of treatment.

Illinois(catalyst)• Parentdrivenlegislation

• ThereisaneedforEHDIprogramstoprepareandbeatthetable.(evenbeforethetableisset)

Sec.2310-685ofthislegislationrequiresbirthingfacilitiestoprovidecytomegalovirus(CMV)educationalmaterialsand newborntestingoptionstoparents,asstatedbelow:

"(f)Ifanewborninfantfailsthe2initialhearingscreeningsinthehospital,thenthehospitalperformingthatscreeningshallprovidetotheparentsofthenewborninfantinformationregarding:– birthdefectscausedbycongenitalCMV;– testingopportunitiesandoptionsforCMV,includingtheopportunityto

testforCMVbeforeleavingthehospital;and– earlyinterventionservices.

HealthcareprovidersmayusethematerialsdevelopedbytheDepartmentfordistributiontoparentsofnewborninfants."

ILLINOISPublicAct099-0424

IllinoisCytomegalovirus(CMV)legislation

CMVEducationLegislation- effectiveJan2016▪ Iftestingiselected, itmustbecompletedby21days

ofageafteraninfantrefersontheirsecondhearingscreening

Goals▪ ToreducedisabilitiesassociatedwithcongenitalCMVby:▪ Raisingawarenessofwomenwhomaybecomepregnant;expectantandnewparents

▪ Educatinghealthcareproviderswhocare forexpectantmothersofinfants

MinnesotacCMVInitiative• Catalyst

– InfectiousDiseasespecialist,Dr.MarkSchleiss• additionalresearch/studiesonCMV&pastcollaborationwithMDH

– KirstenCoverstone,NewbornScreeningEHDIcoordinator• LongstandinginterestandcommitmenttoCMVasauniversalnewbornscreeningcondition

– 2014CMVconference,SaltLakeCity,Utah• MNNewbornscreeningprogramkeystaffattended

– MDHasEIPgrantrecipientfromCDC–• RecentadditionincludedaCMVprojectopportunity

MNCCMVStudy- Collaboration• ScopeofCMVwork

– Year1- Universaltesting(consented)• Methodologyandsamplecomparisons• ‘Justintime’FactSheetdevelopment(Parent/Provider)

– Year2– Expansiontoadditionalsite/s&initiationofgeneralpopulationeducationefforts

– Year3– develop/modifyguidelinesforcCMVscreening• LeadsforMN‘Universal’cCMVProject

– CDC– SheilaDollard,PhD– MDH– MaggieDreon,MS,CGC– UMN– MarkSchleiss,MD

• Fundingsource– CDCEPIgrant&newbornscreeningstaff‘inkind’

MNCCMVStudyPrimaryobjective:

Aredriedbloodspots(DBS)sufficientfordetectingcCMV?• CHIMESstudy- lowdetectionratesforcCMVonDBS

comparedtosaliva.• Salivauniversalscreeningwouldrequirestatesto

developnewmethodsforcollection. (costly&timeintensive)• Technologyhascontinuedtodevelop&detectionrates

forDBSsarebelievedtohaveimprovedtoacceptablerates.

• 30,000enrolleesareneededtoanswerthisquestion

MNCCMVStudy

Secondaryobjectives:DoparentsfinduniversalscreeningforcCMVacceptable?• Determinedbypercentageofparentswhoelectto

enroll.WhatistheparentalexperiencewhenachildisidentifiedtobepositiveforcCMVbynewbornscreening?• Assessparentalexperiencepost-diagnosis.

Funding

Wheredoesitcomefrom?

Isthereany?

DataCollectionConsiderations

• Whatinformationshouldbecollected?• Wherewillinformationbedocumented?• Isreportingmandatory?• Whoisgoingto“chase”thedata?

DataCollectionsthroughtheEHDIsystem

KEYPARTNERS

AreFamiliesKeptattheCenter?

Howdoesinfectiousdiseasedepartmentsgetinvolved?

Challenges

• Professionalconcern– Notallcolleaguessupportthisconditionbeingconsideredforuniversalscreeningatthistime

Whattypeoftestingisbest?Canthestatedictatethetypeoftestingdone?

CMV 101 http://www.infanthearing.org/resources_home/events/cmv-webinar-aug-2014.html

Staffing?

• Developmentofmaterials• Educationofhospitals,physicianandparents• Datacollection(atthestateandhospitallevel)

• Labtesting(inhouse/outsourced)• Follow-up

Howdowefitinsomethingnew?

Considerations

• IL– addressingthe21daytimeframewhenhearingscreeningcannotbecompletedpriorto21days

• IL– define“secondscreening”isthesecondscreeningpriortoorafterdischarge

•IL- willhospitalsscreenforCMVevenwhennotmandated

R398-4-3. Clarification of when a newborn fails a hearing screen.

The newborn must fail both hearing screens, the initialhearing screen routinely done at birth and the subsequentfollow-up screen

or if/when the initial failed hearing screen is obtainedafter 14 days of age before the medical practitioner isrequired to test for CMV.

R398-4-4. Special populations of newborns.

In special populations of newborns where newborn hearing screening(s) cannot be accomplished prior to 21 days of age, testing for CMV is left to the discretion of the medical practitioner(s) caring for the newborn.

Special population of newborns may include, but not limited to, premature or medically fragile newborns or newborns receiving on-going medical care.

ACCOMPLISHMENTS

• Screeningpriortodischarge

• Brochures

• Hospitalnotification

• Hospitalengagement

Accomplishments• Collaborationamongmultiplestakeholders• Increasingenrollment&#oflocations• Educationalinformationdeveloped:

– CMV101formedicalprofessionals/colleagues– CMVpositivefactsheets(Justintimeinformation)

• ParentsandProviders

Accomplishments

76%ofthoseapproachedchoosetoenroll• MajorityareacceptingofcCMVscreening

1Positive– asymptomatic,passedhearingscreening• Audiologicalmonitoring

● WearebeginningtoanswersomeofthequestionsraisedaboutcCMVuniversalscreening.

Accomplishments● HelpStopCMVUtahlogo

● Acomprehensivewebsite:health.utah.gov/CMV◦ Brochures(InSpanishandEnglish):“CMV:WhatWomenNeedtoKnow”,“CongenitalCMVand

HearingLoss”,“CMV:WhatChildcareProvidersNeedtoKnow”,“NewbornHearingScreening:WhatYouNeedtoKnowBeforeYouHaveYourBaby”,“CMVUtahTwo-SidedFlyer”

◦ CareDocuments:“CMVCoreFacts”,“CMVforPediatricCareProviders”,“CMVforObstetricalHealthCareProviders”,“CMVPCRTestinginUtahLabs”

◦ Posters:“CMVDuringPregnancyCanHarmYourBaby”– differentorientations,messagesandsizes◦ CongenitalCMVTestingReferencePosters:“CMVTestingInformationforHospitals”,“CMVTesting

InformationforMidwives”,“CMVTestingInformationforProviders”,“CMVTestingInformationforLabs”

◦ CMVTestingInformationforProviders(lettertogowithCMVTestingFaxForm)◦ CMVTestingInformationforParents(tohandattimeoftestingeligibility)◦ CMVandNBHSStatusFAXFrom◦ CMV,NBHS,PCPFlowchart◦ CMVMaterialsOrderForm◦ CMVAwarenessPromotionalMaterials(InSpanishandEnglish):HandSanitizerswithInformational

Leafletattached,LipBalms,Toothbrushes– allwithCMVAwarenessMessages,“AskMeAboutCMV”buttons&accompanyingcampaign

Accomplishments(Continued)● OnlinetrainingmoduleforChildCareProviders● OnlinetrainingmoduleforPhysicians(inprocess)● CMVMini-Documentary● CMVPublicServiceAnnouncements(30sec,1min,3mins)● CMVUtahFacebookpageandTwitterAccount– activesocialmedia

campaigns@CMVUtah● CMVAwarenessFocusGroups● CMVonlinetrainingwebinars● CMVbaselineknowledgesurveys● TablesatHealthFairs● GrandRoundsPresentations● Local,stateandnationalpresentations● Many,many,manyin-personpresentations● Transit(bus/train)awarenesscampaigns● Billboards● SportsPrograms,etc.

Advice• Patience• Beatthetable• Partnerships&collaboration• Trytounderstandany

opposition/concerns– learnwhatelementsyouneedtoaddresstogainsupport

• Learnfromotherstates- reachout• Rememberchallenges&obstaclescan

beovercome

•Thinkoutsidethebox•Utilizestudentprojectstoincreasehelpwithyourinitiative•Createasmanypartnershipsasyoucan

•Assembleamedical/scientificadvisorypanel

•Litreview,litreview,litreview– signupforalertsfornewresearch•Ifatallpossible,tryforuniversaltesting!•Haveadatabasesystemalreadycreatedbeforeyourinitiativestarts

•Haveacentralized,coordinatedtestingandreportingmechanism– directreportingfromthelab/sisbest!

•HaveadedicatedpersonforCMVandaCMVdatacoordinatorfromthestart•Justkeepswimminganddoyourbesteveninadversarialcircumstances

•Allofyourhardworkandeffortswillliterallybesavinglives•Youcandoit!!!!!

• Getinvolvedearlyon

• Educateyourself&informyourdepartmentaboutCMV

• Beproactive

Questions?smcvicar@utah.gov

kirsten.coverstone@state.mn.usginger.mullin@illinois.gov

RESOURCESNationalResources&HelpfulInformation▪ AmericanFamilyPhysician:https://www.aafp.org/afp/2003/0201/p526.html

▪ HealthyChildren,AmericanAcademyofPediatrics:https://www.healthychildren.org/English/health-issues/conditions/infections/Pages/Cytomegalovirus-CMV-Infections.aspx

▪ CentersforDiseaseControl&Prevention:http://www.cdc.gov/cmv/congenital-infection.html

▪ NationalCMVFoundationInformationhttp://www.nationalcmv.org/