IntersectionofInterest:EducationNeedsandCommercialSupport

DaleKummerle,PharmDDirector,MedicalEducation,Bristol-MyersSquibb

PamelaMasonSeniorDirector,MedicalEducationGrantsOffice,AstraZeneca

FrankSkopowskiTeamLeader,GEMSGrantOperations,MSD

Disclosures

• Theopinionsstatedduringthissessionareeachindividual’sownanddonotnecessarilyreflectourcompany’sposition.

Objectives

• Discusstheneedforalignmentbetweengaps,learningobjectives,educationalformat&outcomes…..”startwiththeendinmind”

• Describetherequirementsinagrantportalapplicationandappreciatecompanies’considerations/criteriaforsupport

• Usingacase-basedapproach,developcomponentsofaproposaltobesubmittedforconsiderationforcommercialsupport

Terminology•  Independentmedicaleducation/CME/CPD

•  Usuallyaccreditedactivities.Maybeunaccreditedinspecificcircumstances.•  Maybesupportedfinanciallythroughgrantsandsponsorshipsbypharmaceuticalanddevice

companies.

•  Industryhasnoinvolvementorinfluenceinthedevelopment.Nocontrolovercontentorselectionoffaculty.Ifaskedonalimitedbasis,industrycanassistwithgeneratingaudience/participants.

•  CongressSponsorships•  Supporttomedicalspecialtysocieties/associationswhereIndustryreceivessubstantialrecognition

and/orbenefitsbasedonthelevelofsupport.

•  Theremaybedesignateddonorlevelsandmayincludesymposiafeestocovereitherindependent(doesnotcontrolorinfluencecontentandspeakers)orcompany-directedactivities(companycontrolsorinfluencescontentandspeakers).

•  Company-directededucation•  Ownershipandaccountabilityofthepharmaceuticalcompany.

•  Industry-providedproduct-specifictrainingandIndustry-providedmedicaldiseaseeducation.

CoreConnections:AligningEducationalGaps,Measures,Competenciesand

Outcomes

PamelaMason,

SeniorDirector,MedicalEducationGrantsOffice

AstraZeneca

Considerationswhenapplyingforcommercialsupport

• AlignmentwithCompany’sareasofinterests

• Understandingthegaptobeaddressedwithaneducationalintervention

• Exploring“true”rootcauseofthegap•  Alignmentthroughouttheproposal:gap&rootcause,instructionaldesign,andoutcomemeasures

A convergence of interest model

of commercial support

Business Needs (Company’s Therapeutic Focus)

•  # disease areas (rare or common) •  Under-diagnosis •  Appropriate and safe product

use •  Mechanism(s) of Action •  New or emerging data •  Product Life Cycle Variables

Healthcare System Quality Gaps

•  National priorities •  Prevalence •  Incidence •  Guidelines •  Cost/Reimbursement/Value

Healthcare Provider Performance Gaps •  Root Cause of Gap •  Specialty •  Practice Setting •  Systems Variables •  Therapeutic options •  # of educational activities

currently available

Overlapping zones of

mutual interest

IOM (Institute of Medicine ). 2010. Redesigning Continuing Education In the Health Professions. Washington, DC: National Academy Press.

Patient Needs •  Shared Decision Making •  Effective Communication •  Adherence to Tx Plans •  Social/Cultural Barriers •  Access to care/cost

Patient Needs

TheGrantor’sDilemma

• Currentlandscape:• Whatdifferentiatesgrantsthatrisetothetop?•  Choosetheverybesteducationalactivity…..beginwiththeendinmind…

•  Isthegrantwellalignedwiththecompany’sareaofinterest?• Willthegrantbeabletodemonstratetheimportance,impactandqualityoftheeducationsupported?

• Willtheactivity(ies)beperceivedasvaluablebyallstakeholders(e.g.,HCPs,IndustrySupportersandtheirSr.Leaders,andtheHealthcareCommunity,etc.)?

•  Aretheeducationalgaps,rootcause(s),instructionalmethodsandoutcomemeasureswellaligned?

Case1:GapAnalysis&NeedsAssessmentCompanyYreceivesanapplicationforagrantinDiseaseStateX.

Theneedsassessmentincludesdetailed,current,well-referencedandscientificallyrigorousinformationonthefollowingtopics:

•  IncidenceandprevalenceofDiseaseX…

•  Thepathophysiologyofthediseaseanditsprogression

•  Theevolutionofthetreatmentparadigmandemergingtherapies

•  NewMOAsindevelopment

•  Theburdenofthediseaseonqualityoflife

•  Datafromapublishedarticleshowingthatalargenumberofpatientsdonotreceivestandardofcareanddetailsofspecificguidelinerecommendationsthatarefrequentlymissed.

•  CurrentsurveydatasupportingHCPsinterestinlearningmoreaboutrecentadvancesintreatmentofDiseaseX.

Theneedsassessmentconcludeswithastatement:thatthereisaneedtoeducateHCPsonthestandardsofcare,sotheycanincreasethenumberofpatientswhoaretreatedaccordingtotheguidelinesandimprovethequalityoflifeofpatientswiththedisease.

Considerations

Whatisthemostimportantinformationinthisneedsassessment?

TopicsinProposal•  IncidenceandprevalenceofDiseaseX…

•  Thepathophysiologyofthediseaseanditsprogression

•  Theevolutionofthetreatmentparadigmandemergingtherapies

•  NewMOAsindevelopment

•  Theburdenofthediseaseonqualityoflife

•  Datafromapublishedarticleshowingthatalargenumberofpatientsdonotreceivestandardofcareanddetailsofspecificguidelinerecommendationsthatarefrequentlymissed.

•  CurrentsurveydatasupportingHCPsinterestinlearningmoreaboutrecentadvancesintreatmentofDiseaseX.

Whatinformationortopicsaremissingthatwouldstrengthenthisneedsassessment?

•  Descriptionofhowthisgapalignswithnationalorregionalhealthcarepriorities

•  Informationonthegapitselfsuchasregional,cultural,age,genderdifferencesincare

•  Specificdiseasequalitymeasures

•  Insightintothereasonswhypatientsarenotreceivingstandardofcare(i.e.,therootcause)

Patientsarecurrentlynotreceivingoptimalcare

Case1Continues

Theapplicantreceivesthefollowingrequestformoreinformation:•  ReasonswhyphysiciansarenotprovidingstandardofcareforDiseaseX

•  Explainhowthisproposalwilltargettheunderlyingrootcause.

Theapplicantrespondsasfollows:

•  TherootcauseforthisgapisthatHealthcareprovidersarenotconfidentinapplyingtheguidelines,andtheyneedastrongerknowledgefoundationinthestandardsofcare.

•  Thisproposalwillprovideahighlyinteractive,case-basedapproachtoteachtheguidelinesandensurethatHCPSareawareofthemostcommonlymissedstepsinthemanagementofpatientswithDiseaseX.

•  WeanticipatethatHCPswillbemoreconfidentintheirabilitytomanagepatientswiththediseaseasaresultofparticipating.

Considerations

Whyisthisresponseincomplete?

• Reflectsthecommonmiss-assumptionthatlackofHCPknowledgeorknow-how/competenceistherootcauseofmosthealthcaregaps.

• Therearemanyotherpossiblerootcausesthathavenotbeenexplored–suchasnon-adherence,poorfollow-up,poorcommunicationacrossteamsandpatients,etc.

•  Iftheeducationfailstoaddressthefundamentalrootcauseitwon’tleadtothedesiredoutcomes.

RootCause:KnowledgeofGuidelinesorUnderstandingtheContinuumofCare?

Example

AcuteEpisode

InpatientCare

Discharge&TransitiontoOutpatient

OngoingCare

EducationalprogramsforphysiciansonGuidelines

Breakdowninpatientcare

•  Understandingthepatientjourneyandallthetouchpoints.

•  Multipleprofessionsinvolvedalongtheway(nurses,hospitalpharmacists,casemanagers,primarycarephysicians)

•  Exploringinterprofessionalstrategiestocreateconnectionsacrossthecontinuumofcare.

It’saKnowledgeGap•  Needsassessmentdeterminedthroughliteraturereview.•  TheproposedinterventionisdesignedtoclosethegapsincareforpatientswithDiseaseXbyprovidingclinicianswithexpertinsightsofkeytargetsfortherapyandthemechanismsofrecentlyapprovedandemergingagents.

•  Thiseducationalactivitywillbeconsideredsuccessfulwhenthefollowingoutcomesaredemonstrated:

•  ImproveknowledgeoftheunderlyingpathologyofDiseaseX

•  ImproveknowledgeofpotentialbiomarkerstoidentifypatientswithDiseaseX

•  ImproveknowledgeoftheclinicaldatasurroundingtheuseoftreatmentsforthemanagementofDiseaseXincludingmeasuresoftreatmentefficacyandtreatment-relatedadverseeffects

•  ImproveabilitytointegrateemergingtreatmentsforthemanagementofDiseaseXastheybecomeavailable

•  Programformat:twoonlineprograms(30minuteseach)•  Pre&postsurveys•  Patientcommunicationtoolsprovided

Example

Case2:AlignmentorMismatchAnothergrantapplicationforDiseaseXwasreceived.

•  Sameneedsassessmentinformationasthepreviousgrant.•  Inadditionanin-depthanalysisoftherootcauseforthesamegapwasprovided.

•  aliteraturereview

•  alargescalesurveyofphysiciansaskingwhytheybelievedthatsomanyHCPsfailedtodeliverthestandardofcareforDiseaseX.

•  Newinsightthatmanypatientsfailedtofollow-throughontreatmentrecommendationsbecausetheyfrequentlyfailedtounderstandtheimportanceofmonitoring.

•  Educationwasdesignedtoteachphysicianstocommunicatemoreeffectivelywithpatients.Contentincluded•  motivationalinterviewingtechniquesand

•  howtoimplementeffectivemonitoringandpatientfollow-up.

•  Themethodsincludedanexpertdescribingtheprinciplesofmotivationalinterviewing,avideoofanexpertusingthismethodwithapatientandalistoftipstoimprovecommunication,monitoringandfollow-up.

Considerations

Whatdoyouseeasthestrengthsandweaknessesofthisapproachtoaddressingtherootcauseforwhypatientswerereceivingsub-standardcareinthisdiseasestate?•  Skillscannotbelearnedwithoutanopportunitytopracticeandreceivefeedback

•  Amismatchbetweenthedesiredoutcomesofimprovedcommunicationskillsandtheeducationalmethodsproposed

•  DesiredoutcomereflectsaMoore’sLevel5Performancehowever,theeducationalmethodstargetLevel3B-ProceduralKnowledge

AligningGaps,GoalsandOutcomes

Gaps/RootCauses

Ø HCPsandpatientshavedifferentperceptionsongoalswithpatients’focusoncopingwithsymptomsofDiseaseXandHCPsfocusonreductionsinexacerbationsandmeasurements.

Ø HCPsandpatientshavedeficienciesincommunicationskills.

Goals

Ø EducatebothHCPsandpatientsontoolstoimproveHCPs’patient-focusedcommunicationperformanceskillsandtoenhancepatients’abilitytoengagewiththeirHCPseffectivelyandefficiently

ExpectedOutcomes

Ø  Enhancedpatientengagementinshareddecision-makingabouttreatmentoptions&ongoingdiseasemanagement

Ø  AlignedgoalsoftreatmentbetweenHCPsandpatients

Ø  ImprovementsinqualitycareasassessedbybothpatientsandHCPs

Example

Needsassessment:Inadditiontoliteraturereview,conductedpatient&caregiversurveys/interviewsandcliniciansurveys/interviews.Considerhealthcaregapversusperformancegap.

Case2Continues

Theoutcomesmeasureforthiseducationalinterventionstatedthatitwouldmeasurepatientleveloutcomesbyusingan“intenttochangesurvey”attheendoftheactivity.

Theapplicantsightedpublishedresearchthatintenttochangesurveysarepredictiveofactualchangesinpractice.

Considerations

Whatdoyouseeasthestrengthsandweaknessesoftheproposedoutcomesplan?

•  Thereisamismatchbetweentheinstructionalmethodandintendedoutcomes(i.e.educationtochangeknow-howandnotskills)

•  Knowinghowdoesnotautomaticallyleadtochangesinperformanceorpatientoutcomes

•  Intenttochangesurveyisnotaligned•  Follow-upevidencethatrealchangeshavebeenmadeinpracticewouldimprovethe

outcomesplanbutwouldnotaddressthemis-alignment

AligningMethodologyandAssessmenttoolswithExpectedOutcomes

EducationalMethods

Ø PrivatefeedbackcoursesforHCPsbasedonsurveysØ  Personalizedwrittenaction

plans

Ø Case-basedsimulations

Ø  Basedonactionplan,targetedlearningobjectives

Ø  Practice

Ø DiseaseXcaretoolkitØ  HCPpatient-focused

communicationperformanceskills

Ø  PatientstoenhanceabilitytoengagewiththeirHCPseffectivelyandefficiently.

AssessmentTools

Ø HCP&PatientSurveysØ  Questionsontestingfrequency,

treatmentgoals,agreementontreatmentplan,perceivedbarrierstoadherence,perceivedimpactofDiseaseXonqualityoflife

Ø  ComparativePatientandHCPdataforalignments&mismatches

Ø Pre&postsurveysforsimulations

Ø CourseevaluationsØ  Questionsonknowledge,

attitudes,beliefs,andcompetencerelatedtoevidence-basedtreatment&coordinatingcare

Ø 30daypostsurvey

ExpectedOutcomes

Ø  Enhancedpatientengagementinshareddecision-makingabouttreatmentoptions&ongoingdiseasemanagement

Ø  Alignedgoalsof

treatmentbetweenHCPsandpatients

Ø  ImprovementsinqualitycareasassessedbybothpatientsandHCPs

Example

InformeddesignoflargerscalePhaseIIproject.

It’sAllAboutAlignment!

Beginwiththeendinmind–definethehealthcaregaptobeclosedanditsimportance

• Whatbehaviorsarenothappeningthatshouldbe?

• Whyarethesebehaviorsnothappening?(e.g.,rootcause)

• Whathastohappentocreatenewsustainablebehaviors?

• Whatevidencewillshowthatbehaviorhaschanged?

CoreConnections:SubmittingGrantApplicationsAlignedtoaCompany’s

EducationalAreasofInterest

FrankSkopowskiTeamLeader,GEMSGrantOperations

MSD

It’sAllAboutAlignment!DoestheGrantProposalalignwiththeneedsoftheOrganizationyouare

requestingthefunds?

•  Whatarethetoptherapeuticareasordiseasestatesforeachorganizationyoumakeasubmission?(e.g.Oncology,PediatricandAdolescentVaccines,InfectiousDisease,etc.)www.msdgrants.com

•  Istheproposalforanspecificsupporttype-IndependentMedicalEducation(IME)Grant,CharitableContribution,Sponsorship,etc.?

•  Doestheapplicantapplyingfitthecriteriatoapply?Requestisfromtheproperorganizationandfortheproperactivityandlearnertypetoapply?(e.g.,non-profit,CE/CMEaccreditor,professionalmedicalsociety,etc.)

•  Doesthegrantapplicationeffectively“connectthedots”fromtheNeedsAssessmentofaSpecificLearnerto–Gaps–toLearningObjectives-toappropriateeducationaldesigntoEvaluationtoOutcome,etc.?

Whatarewelookingforinaproposal?

ImportantQuestionsthatNeedAnswers

Needs

Assessment

EducationalDesignEvalua'on

•  Isthetargetaudienceidentified?•  Aretheprimarygapsdefined?•  Isthescopeoftheneedsassessmentwelldefined?•  Arethereclearlearningobjectives(relevant/reasonable/

realizable)?•  Areadultlearningprinciplesconsideredinthedesign?

•  Isthedesignformatsupportiveofmeetingthelearningobjectives?•  Aretheexpectedlearningandbehaviouralchangeoutcomeswell

definedbasedontheneeds?•  Isthedesiredlevelstated?(e.g.,MooreModel)•  Isthepurposeoftheevaluationclearlystated?(e.g.howwouldthe

evaluationbeusedmovingforward?)

ExamplesoftheMooreModelbyLevel

ExamplesofMoore’sOutcomeLevels(1–7),includekeyoutcomesdatatosupporthowvariouslevelsweremeasured.Level1ParticipationMetricsLearnerDemographics(DataSource–ParticipationRecords;onlinetracking)

• WhatisthenumberofParticipants/LearnersforActivity?• BreakdownbyProfession/Specialty(i.e.,Physicians–Specialty[specifyspecialty],Nurses,

NursePractitioners,Pharmacists,PhysicianAssistants,OtherHealthcareProfessionals,NonHealthcareProvider)

• Practicesettingaffiliation• Yearsinpractice• Numberofpatientsseenwithconditionperweek• Numberofpatientsthelearnertreatsforthecondition• NumberofCertificatesIssued• #DownloadableSlidesSetswhenapplicable• Timespentonactivity• Numberofsurveyrespondents• LearnerDemographics-USvs.Ex-USbreakdownbyregion

Level2-SatisfactionMetrics

• Describetheobjectiveorsubjectivedatasourcetomeasure“Satisfaction”• WerethelearningObjectivesmet?Y/N• Wasthefaculty/speakereffectiveY/N• Didthecontentimpactyourpractice?• Doyouplantomakechangesinyourpractice?Y/N• Theactivityhelpedtoimprovemycompetence,performanceandpatientoutcomes• Wouldyourecommendthisactivitytoyourpeers?

Level3A&3B–Learning:3ADeclarativeKnowledge&3BProceduralKnowledge• Describetheobjectiveorsubjectivedatasourcetomeasure“Learning”• Analysisandsummarizationofinsightsonhoweachlearningobjectivewasmet

(include“N”)• Providelevelofincreasein3A-DeclarativeKnowledgeincreaseX%toY%• Providelevelofincreasein3B–ProceduralKnowledge&ImplementationincreaseX%

toY%• Whatwasthetotalnumberofquestionsaskedduringtheactivity• Includeparticipantverbatimresponsesasappropriate

Level4–Competence

• Describetheobjectiveorsubjectivedatasourcetomeasure“Competence”• Providetheaverage%oflearnerswithincreasedcompetenceand%ofincrease

ExampleofBudgetTemplate

Please enter data into yellow highlighted cells

Organization NameManagement Fees Total FeesAccount & Activity Management FeesContent Development FeesAudience Generation/Activity MarketingEducational Effectiveness MeasurementsPeer Review CostTotal -$ Meeting Logistics Total FeesMeeting Room(s)A/V Equipment - Rental & LaborTeleconference FeesOnsite Meeting SupportTotal -$ Production and Shipping - Live Total FeesPrinting and ProductionShipping and PostageTotal -$ Production and Shipping - Enduring Materials Total FeesInternet LearningSlide KitCD-ROM/DVDUSB DriveMonographJournal/NewsletterOtherInternet hosting feesPrinting and/or ProductionShipping and PostageTotal -$ Faculty/Staff Travel & Accommodations Cost Per Unit # of People TotalFaculty Airfare -$ Faculty Transportation -$ Staff Airfare -$ Staff Transportation -$ Faculty Hotel -$ Staff Hotel -$ Faculty Mileage Reimbursement -$ Staff Mileage Reimbursement -$ Ground Transportation -$ Total -$ Accreditation Fees (if applicable) Cost Per Unit TotalAccreditation Fees -$ Certificate Fees -$ Association Fees -$ Total -$ Meals Cost Per Unit # of People TotalBreakfast -$ Lunch -$ Dinner -$ Breaks/Snacks -$ Food & Beverages -$ Total -$ Faculty/Speaker Honoraria Cost Per Unit # of People TotalFaculty/Speakers -$ Faculty/Speakers -$ Total -$ Miscellaneous (add as applicable) Cost Total Applicable Taxes and Fees -$ Legal & Tax Advice costs -$ <describe> -$ <describe> -$ <describe> -$ Total -$

Management Fees -$ Meeting Logistics -$ Production and Shipping - Live -$

Comments (if applicable)

Totals

Comments (if applicable)

Comments (if applicable)

Comments (if applicable)

Comments (if applicable)

Comments (if applicable)

Comments (if applicable)

Comments (if applicable)

BUDGET

Comments (if applicable)

WhyDoWeAskSoManyQuestionsabouttheOrganizationandthePeopleResponsibleforthe

GrantFunds?

USPharmamustfollowtheseUSFederal/Statutes

•  ForeignCorruptPracticesAct(FCPA)•  AntiKickBackStatute•  TheOfficeofForeignAssetsControl(OFAC)

•  Food,DrugandCosmeticAct(FDCA)

USPharmamustevaluatetheOrganizationandthePeopleResponsiblefortheGrantSpend

ConnectingAlltheDotsOrgan

ization People

By-Laws

AnnualReport Activity

TherapeuticArea

Learners

Activitytype

Impa

ct

HistoryofQuality

ContinuousLearning

PatientImprovement

WorkshopSession:Creatinganapprovablegrantsubmission

DaleKummerle,PharmDDirector,MedicalEducation

Bristol-MyersSquibb

ExploringaCaseStudy

Afterparticipatinginthesession,learnerswillbeableto:•  IdentifytheneedsassessmentstodetermineclinicalandprofessionalcompetencygapstoalignCME/CPD/CEprogrammingwithcompanyneeds

•  DesignandmanageblendedlearningactivitiesthatincorporateamixofliveandeLearningactivitiestooptimizelearnerengagementforproviders,staffand/orpatients

•  Developeffectiveoutcomesplanstomeasurechangeinknowledge,skills,competence,confidenceand/orperformance.

ProposalScenarioReview•  Obesityisarapidly-growing,globalepidemic.ThelatestfiguresfromtheWHOdemonstrate

thatoverathirdofadultsareoverweight,and13%wereconsideredobese.

•  Inresponsetothedemandforeffectivetreatment,industryhasdevelopedanovelclassoftherapeutics:carbohydrate-dependentα-ketogenicexacerbator(orCKE).

•  Althoughefficacious,therehasbeenagreatdealofcontroversyovertheroleofCKEsinobesitymanagement.

•  ThisincludestheoptimaltimetoadministerCKEoverthecourseoftheday,whethertoindividualisethedoseofCKE,orwhethercombiningCKEwithCov-Ehasasynergisticeffect.Thishasledto

•  DifferentimplementationofCKEtherapyacrossEUcountries,withclinician-levelandsystems-levelbarriers

•  NewguidelineshavejustbeenpublishedbytheWHO.TheyprovideclearconsensusrecommendationsontheuseofCKEtotreatobesity.

•  Medicalsocietiesarelookingtocollaboratetoproduceindependentmedicaleducationthatidentifiesthespecificeducationalneedsofindividualcountries

•  Youhavedownloadeda“RequestforEducation”fromSkeletamPharmaceuticalsandplantosubmitaproposal.

*Note:CKEisfictitious.Theabovedetailsofindications,mechanismofactionandefficacywerecreatedforthisexercise;anyresemblancetoreal-worldcasesispurelycoincidental.

ProposalScenarioReview

Identifyadiscussionnotetaker

ReviewtheScenarioand:

•  Identifytheeducationaland/orpracticegaps/needsthatneedtobeaddressed~5minutes

•  DevelopaneducationalinitiativetoaddresstheidentifiedENAacrossmultipledifferentcountries~15minutes–discusswiththetable

•  Include1to2learningobjectives,andtheeducationaldesign.•  BesurethedesignalignswithyourENA,withclearlyidentifieddocumentationof

whichMoore’sleveltheactivitywillachieveandwhy

Notetakerwillpresenttheirtable’sinitiativetothefullgroup

*Note:CKEisfictitious.Theabovedetailsofindications,mechanismofactionandefficacywerecreatedforthisexercise;anyresemblancetoreal-worldcasesispurelycoincidental.

Moore’sConceptualFramework