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Optimum Health and Quality of Life for Individuals with Multiple Chronic Conditions
Contents
Foreword . . . . . 1 Background . . . . . 2 HHS Vision and Strategic Framework on Multiple Chronic Conditions . . . . . 6 Next Steps and Future Direction . . . . . 16
Citation U.S. Department of Health and Human Services. . Multiple Chronic Co ConditionsA Strategic Framework: Optimum Health and Quality of Life for Individuals with Multiple Chronic Conditions. Wa Washington, DC. December 2010.
Foreword
WearepleasedtopresentastrategicframeworkfortheU.S.DepartmentofHealthand HumanServices(HHS)toimprovethehealthstatusofindividualswithmultiplechronic conditions.Thisframeworkcontainsavisionstatement,goals,objectives,anddiscrete strategiestoguidethedepartmentincoordinatingitseffortsinternallyand collaboratingwithstakeholdersexternally.Theframeworkisdesignedtoaddressthe spectrumofallpopulationgroupswithmultiplechronicconditions. Acornerstoneofournationsapproachtochronicdiseasesmustbetopreventtheir occurrence.Anenhancedfocusonpreventionandpublichealthisessentialtoensuring optimumhealthandqualityoflifeforallpeople.Inaddition,however,preventionisan importantconsiderationforpersonswhoalreadyhaveoneormorechronicconditions. Thisframeworksfocusisonimprovingthehealthandfunctionofpeoplewhocurrently havemultiplechronicconditions. Theintentionforthisframeworkistocatalyzechangewithinthecontextofhowchronic illnessesareaddressedintheUnitedStatesfromanapproachfocusedonindividual chronicdiseasestoonethatusesamultiplechronicconditionsapproach.Itisthis culturechange,orparadigmshift,andthesubsequentimplementationofthese strategiesthatwillprovideafoundationforrealizingthevisionofoptimumhealthand qualityoflifeforindividualswithmultiplechronicconditions.
Background
MorethanoneinfourAmericanshavemultiple(twoormore)concurrentchronic conditions(MCC), 1 including,forexample,arthritis,asthma,chronicrespiratory conditions,diabetes,heartdisease,humanimmunodeficiencyvirusinfection,and hypertension.Chronicillnessesareconditionsthatlastayearormoreandrequire ongoingmedicalattentionand/orlimitactivitiesofdailyliving. 2 Inadditionto comprisingphysicalmedicalconditions,chronicconditionsalsoincludeproblemssuch assubstanceuseandaddictiondisorders,mentalillnesses,dementiaandother cognitiveimpairmentdisorders,anddevelopmentaldisabilities. Theprevalenceofmultiplechronicconditionsamongindividualsincreaseswithageand issubstantialamongolderadults,eventhoughmanyAmericanswithMCCareunderthe ageof65years.Asthenumberofchronicconditionsinanindividualincreases,therisks ofthefollowingoutcomesalsoincrease:mortality,poorfunctionalstatus,unnecessary hospitalizations,adversedrugevents,duplicativetests,andconflictingmedical advice.1,2, 3 , 4 , 5 Thispictureisevenmorecomplexassomecombinationsofconditions,or clusters,havesynergisticinteractions,butothersdonot.5Forexample,thepoorhealth outcomesofindividualswithseriousmentalillnessesandotherbehavioralhealth problemswarrantsspecialattentionbecauseofthecooccurrencesofthoseconditions withotherchronicconditions. Theresourceimplicationsforaddressingmultiplechronicconditionsareimmense:66% oftotalhealthcarespendingisdirectedtowardcarefortheapproximately27%of AmericanswithMCC.1IncreasedspendingonchronicdiseasesamongMedicare beneficiariesisakeyfactordrivingtheoverallgrowthinspendinginthetraditional Medicareprogram. 6 IndividualswithMCChavefacedsubstantialchallengesrelatedto theoutofpocketcostsoftheircare,includinghighercostsforprescriptiondrugsand totaloutofpockethealthcare.1
AndersonG.ChronicCare:MakingtheCaseforOngoingCare.Princeton,NJ:RobertWoodJohnson Foundation,2010.Availableathttp://www.rwjf.org/files/research/50968chronic.care.chartbook.pdf. LastaccessedDecember2,2010. 2 WarshawG.Introduction:advancesandchallengesincareofolderpeoplewithchronicillness. Generation2006;30(3):510.(seealso:HwangW,WellerW,IreysH,AndersonG.Outofpocket medicalspendingforcareofchronicconditions.HealthAffairs2001;20:267278) 3 LeeTA,ShieldsAE,VogeliC,GibsonTB,WoongSohnM,MarderWD,BlumenthalD,WeissKB. Mortalityrateinveteranswithmultiplechronicconditions.JGenInternMed2007;22(Suppl3):403 407. 4 VogeliC,ShieldsAE,LeeTA,GibsonTB,MarderWD,WeissKB,BlumenthalD.Multiplechronic conditions:prevalence,healthconsequences,andimplicationsforquality,caremanagement,and costs.JGenInternMed2007;22(Suppl3):391395. 5 WolffJL,StarfieldB,AndersonG.Prevalence,expenditures,andcomplicationsofmultiplechronic conditionsintheelderly.ArchInternMed2002;162(20):22692276. 6 ThorpeKE,OgdenLL,GalactionovaK.ChronicconditionsaccountforriseinMedicarespendingfrom 1987to2006.HealthAffairs.2010;29(4):17.
Multiplechronicconditionscancontributetofrailtyanddisability;conversely,most olderpersonswhoarefrailordisabledhaveMCC.TheconfluenceofMCCandfunctional limitations,especiallytheneedforassistancewithactivitiesofdailyliving,produces highlevelsofspending.Functionallimitationscanoftencomplicateaccesstohealth care,interferewithselfmanagement,andnecessitaterelianceoncaregivers. 7 AreportbytheInstituteofMedicinein2001highlightedthecomplexitiesofandthe needforcarecoordinationforindividualswithmultipleconditions. 8 Notingthatthereis evidencethatpatientsreceivingcareforonechronicconditionmaynotreceivecarefor other,unrelatedconditions,theIOMarticulatedthatachallengeofdesigningcare aroundspecificconditionsistoavoiddefiningpatientssolelybytheirdiseaseor condition.8,9 TheChronicCareModelfurtherelucidatestheelementsrequiredto improvechronicillnesscare,includingsystemsrequirementsforhealthcare organization,communityresources,selfmanagementsupport,deliverydesign,decision support,andclinicalinformation. 10 Thisseminalmodelrepresentsaconceptual foundationforinnovativeapproachestoaddressingMCC. Overall,theMCCpopulationischaracterizedbytremendousclinicalheterogeneity,and substantiallyvariesinthenumberofchronicconditions,theseverityofillnessand functionallimitations,andtheclusteringofconditions.Indeed,developingmeansfor determininghomogeneoussubgroupsamongthisheterogeneouspopulationisviewed asanimportantstepintheefforttoimprovethehealthstatusofthetotalpopulation andonlyrecentlyisbeginningtobeaddressedbyresearchers. 11 Identifyingsuch subgroupswillassistinmoreeffectivelydevelopingandtargetinginterventions.A relatedconsiderationisdisparitiesinaccesstohealthcare,publichealth,andother services,whichmaypresentimplicationsforthepopulationofpersonswithMCC. Thecombinedeffectsofincreasinglifeexpectancyandtheagingofthepopulationwill dramaticallyincreasethechallengesofmanagingmultiplechronicconditionsamongthe burgeoningpopulationofolderpersons.Althoughtherehasbeentacitappreciationof thequalityofcareandcostimplicationspromptedbytheincreasingMCCpopulation, thedeliveryofcommunityhealthandhealthcareservicesgenerallycontinuestobe centeredaroundindividualchronicdiseases.Inaddition,insufficientattentionhasbeen
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AlecxihL,ShenS,ChanI,TaylorD,DrabekJ.IndividualsLivingintheCommunitywithChronic ConditionsandFunctionalLimitations:ACloserLook.OfficeoftheAssistantSecretaryforPlanning& Evaluation,U.S.DepartmentofHealthandHumanServices.January2010.Availableat http://aspe.hhs.gov/daltcp/reports/2010/closerlook.htmLastaccessedDecember2,2010. 8 CommitteeonQualityofHealthCareinAmerica,InstituteofMedicine.CrossingtheQualityChasm:A NewHealthSystemforthe21stcentury.WashingtonD.C.:NationalAcademiesPress;2001. 9 Redelmeier,DonaldA.,SiewH.Tan,andGillianL.Booth.Thetreatmentofunrelateddisordersin patientswithchronicmedicaldiseases.NEngIJMed1998;338(21):15161520. 10 WagnerE.Chronicdiseasemanagement:whatwillittaketoimprovecareforchronicillness?Effective ClinicalPractice1998;1:24. 11 KronickRG,BellaM,GilmerTP,SomersSA.TheFacesofMedicaidII:RecognizingtheCareNeedsof PeoplewithMultipleChronicConditions.CenterforHealthCareStrategies,Inc.,October2007.
paidtotheservicesandsupportrequiredtomeetlongertermneedsofthosewithMCC toenablethemtoliveaswellaspossibleincommunitysettings.
Role of the U.S. Department of Health and Human Services
TheU.S.DepartmentofHealthandHumanServicesadministersalargenumberof federalprogramsdirectedtowardpreventingandmanagingchronicconditions, including,forexample,financinghealthcareservices(CentersforMedicareand MedicaidServices);deliveringcareandservicestopersonswithchronicconditions (AdministrationonAging,HealthResourcesandServicesAdministration,andIndian HealthService);conductingbasic,interventional,andsystemsresearch(Agencyfor HealthcareResearchandQuality,NationalInstitutesofHealth);implementingprograms topreventandmanagechronicdisease(CentersforDiseaseControlandPrevention, andSubstanceAbuseandMentalHealthServicesAdministration);promotingthe economicandsocialwellbeingoffamilies,children,individuals,andcommunities (AdministrationforChildrenandFamilies);andoverseeingdevelopmentofsafeand effectivedrugtherapies(FoodandDrugAdministration). BecauseoftheleadingroleHHSplaysinhealthresearch,andpaymentforanddelivery ofhealthcareservices,HHSalsomustprovideleadershipinimprovinghealthoutcomes amongindividualswithMCC.Moreover,increasesinthecostsoftreating,poor outcomesamong,andcomplexityofmanagingthosewithMCCnecessitatethatHHS develop,implement,andcoordinateprogramsandpoliciesthatimprovethecare providedtoindividualsandtheirhealth.Toachievethisgoal,HHSwillneedtoengage stakeholdersinimplementingeffectivestrategiestoaddress,improve,andbetter managethehealthstatusofindividualswithMCC. ThehealthreformlawthePatientProtectionandAffordableCareActprovidesHHS withnewopportunitiesforaddressingthepreventionofchronicconditions,aswellas enhancingtheclinicalmanagementandimprovingthehealthstatusofindividualswith MCC.Thislawwillfacilitatetheseadvancesthroughdevelopingandtestingofnew approachestocoordinatedcareandmanagement,patientcenteredbenefits,and qualitymeasures.Newinitiativesalsowillbeaimedatenhancingtheunderstanding amongpatientsandcaregiversabouttheappropriateuseofmedications.Stateswill havetheoptionofprovidinghealthhomesforMedicaidenrolleeswithchronic conditions.Importantly,thecreationofanewCenterforMedicareandMedicaid InnovationwithinCMSpresentsunprecedentedopportunitiestoexamineandtestthe mostpromisingapproachestocarecoordinationandhealthimprovement. TwootherimportantnewinitiativesmandatedinthePatientProtectionandAffordable CareActalsohaveimplicationsforpreventingandmitigatingchronicconditions:(1)the NationalStrategyforQualityImprovementinHealthCare,whichwillincludepriorities toimprovethedeliveryofhealthcare;and(2)theNationalPreventionandHealth PromotionStrategy,whichaimstobringpreventionandwellnesstotheforefrontof nationalpolicybyidentifyingandprioritizingactionsacrossmanysectorstoreducethe 4
ToidentifyHHSoptionsforimprovingthehealthofthisheterogeneouspopulation,the HHSAssistantSecretaryforHealthconvenedadepartmentalworkgrouponindividuals withmultiplechronicconditions.NearlyallHHSoperatingdivisionsareparticipating. TheworkgroupsinitialmajoreffortwastoproduceacollationofHHSprograms, activities,andinitiativesfocusedonimprovingthehealthofindividualswithMCC.This inventory, 12 releasedinMarch2009andslatedforupdate,containsmorethan50 effortsacrossHHSdirectedprimarilytothehealthcareneedsofpeoplewithtwoor morechronichealthconditions.Inaddition,multipleinteragencyworkgroupmeetings havebeenheldontopicssuchasreducingrehospitalizationsandadversedrugeventsin thispopulation.TheworkgroupalsohasassistedHHSinbothhealthreformand comparativeeffectivenessresearcheffortsrelatedtoMCC.Manyothereffortsthat focusonthispopulationareunderwayacrossthedepartment. Theworkgroupbelievesthat,amongotherbeneficialeffects,astrategicHHSframework thatprovidesaroadmapforimprovingthehealthstatusofpersonswithMCCwillhelp ensureamorecoordinatedandcomprehensiveapproachtoimplementingthe considerableworkalreadydirectedtowardthisneed.Accordingly,theworkgroup developedadraftofthisstrategicframeworkthatwasannouncedintheFederal RegisteronMay19,2010.BecauseHHSrecognizesthatstakeholderandcommunity involvementisessentialtosuccessfulimplementationoftheframework,theFederal Registernoticeinvitedinterestedpartiestoreviewandcommentonthedraftstrategic frameworkandtoprovidefeedbacktothedepartment.Theworkgroupreviewed commentsfromthepublicandstakeholderorganizationsandthenusedthemin developingthisfinalversionofthestrategicframework.
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Availableathttp://www.hhs.gov/ophs/initiatives/mcc/mcc_inventory.pdf.
forservicemedicalcareoffersfewfinancialincentivestocoordinatecare.Inaddition, traditionaldiseasemanagementprogramswithoutastronglinktoprimarycareand thatarefocusedondiscreteconditionshavenotbeenoptimallyeffective. 13,14 Changes tothedeliveryandproviderpaymentsystem,developmentofaccompanyingquality andperformancemetrics,andincreasedinvolvementofthepublichealthsystemcan complementeffortstoachievewellcoordinatedcareforthosewithMCC. ObjectiveA:Identifyevidencesupportedmodelsforpersonswithmultiplechronic conditionstoimprovecarecoordinationToaddressgapsincarecoordination,several modelsthathaveemergedinrecentyearsemphasizepatientcenteredmultidisciplinary care,providercommunicationandcooperationtosmoothtransitionsacrosssettings, andincorporationofpublichealthandcommunityresources.Thesemodelsinclude patientcenteredmedicalhomes,communityhealthteams,accountablecare organizations,primarycareandbehavioralhealthintegrationmodels, 15 palliativecare, andmodelsthatdeliverhealthcareservicesinthehomeandcommunitysettings.Those modelsmayhaveanoverarchingeffectofenhancinghealthstatusamongindividuals withMCC.Importantelementsforsuccessfulcarecoordinationincludepersoncentered carethatempowerstheaffectedindividualincaremanagement,teambasedcare,and alignedpaymentincentives.
Strategy1.A.1.DefineandidentifypopulationswithMCCbroadly,andMCC
subgroupswithspecificclustersofconditions,andexplorefocusingcaremodelson thesubgroupsathighriskofpoorhealthoutcomes.(SeealsoStrategy4.B.3.) Strategy1.A.2.Developandexpandpilotstudiesanddemonstrationprojectsfor innovative,multidisciplinary,longitudinalpersoncenteredcaremodelsthat improvehealthoutcomesandqualityoflifewhilemaintainingordecreasingnet costs,andimplementevidencesupportedmodels. ObjectiveB:Defineappropriatehealthcareoutcomesforindividualswithmultiple chronicconditionsImprovedhealthcareoutcomesforindividualswithMCCcomprise abroadspectrum,suchasmaintainingfunction,palliatingsymptoms,preventing adversedrugevents,avoidingunnecessaryemergencydepartmentvisits,andreducing hospitalizationsandrehospitalizations.Theseoutcomesarenotdifferentinkindfrom relevantoutcomemeasuresforotherpersons,buttheydodifferinimportancebecause oftheincreasedriskofnegativeoutcomesamongpersonswithMCC;forexample,as
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thenumberofchronicconditionsincreasesinanindividual,sodoestheriskof rehospitalization. 16
Strategy1.B.1.Definedesiredhealthcareoutcomesappropriateforindividualswith
MCC. Strategy1.B.2.EnsurethattestingofcaremodelsincludesevaluationofMCC relevantoutcomes. ObjectiveC:DeveloppaymentreformandincentivesHealthcareprofessionalshave fewincentivestoprovidecarecoordinationforindividualswithMCC,approachesthat mayavoidpooroutcomessuchashospitalizationandrehospitalization.Moreover, limitationsonreimbursementformanynonphysicianprovidersfurtherconstrain multidisciplinarycaredeliverytoindividualswithMCC.Financialincentiveswould encourageuseofcaremodelsthat,inturn,encouragerelevantcategoriesofproviders tospendtheadditionaltimeneededtoaddressthecarecomplexitiesforthis population.
Strategy1.C.1.Workwithstakeholderstoidentify,develop,andtestincentivesand
paymentapproaches(e.g.,episodebasedpaymentsacrosscaresettings)that promoteeffectivecarecoordinationforindividualswithMCC. Strategy1.C.2.Disseminateinformationaboutandimplementtheuseofincentives thatpromotecosteffectivecarecoordinationbyproviderswhocareforindividuals withMCC. ObjectiveD:ImplementandeffectivelyusehealthinformationtechnologyBy facilitatingcoordinatedcareandprovidinguniforminformationtoallproviderscaring foranindividualwithMCC,interoperablehealthinformationtechnologyhasgreat potentialtohelpclinicians,healthcaredeliverysystems,families,andindividuals improvethequalityandsafetyofcareforthosewithMCC.
Strategy1.D.1.Encouragethemeaningfuluseofelectronichealthrecords,personal
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FriedmanB,JiangHJ,ElixhauserA.Costlyhospitalreadmissionsandcomplexchronicillness.Inquiry. 2008;45:408421.
approachesthatincreaseeffectivenessinthepreventionofnewchronicconditions amongpersonswithMCC,includingconditionspotentiallyarisingfrominteractions betweenexistingchronicconditionsortherapiesforthoseconditions,andthe progressionandexacerbationofexistingchronicconditions. Strategy1.E.2.Adoptpublichealthpolicies(e.g.,targetingunhealthyandrisky behaviors,environments,andfoodsassociatedwithincreasedriskofchronic disease)topreventexacerbationsoroccurrenceofnewchronicconditionsin personswithexistingchronicconditions. Strategy1.E.3.Exploreincentivestoimproveindividualsparticipationinchronic diseaseriskbehaviorandotherpreventionprograms. ObjectiveF.Performpurposefulevaluationofmodelsofcare,incentives,andother healthsysteminterventionsMonitoringandprovidingongoingfeedbackabout interventionscanassistinimprovingboththeuseandimpactofinterventionsforMCC.
Strategy1.F.1.Conductongoingsurveillancethroughprovidersandindividuals
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GreenhalghT.Chronicillness:beyondtheexpertpatient.BMJ2009;338:629631.
managementactivitiesandprograms,anddevelopsystemstopromotemodels thataddresscommonriskfactorsandchallengesthatareassociatedwithmany chronicconditions. Strategy2.A.2.Enhancesustainabilityofevidencebased,selfmanagement activitiesandprograms. Strategy2.A.3.Improvetheefficiency,quality,andcosteffectivenessofevidence based,selfcaremanagementactivitiesandprograms. ObjectiveB:FacilitatehomeandcommunitybasedservicesHomeandcommunity basedservices(HCBS)oftenplayacriticalroleinenablingindividualswithMCCtolive andworksuccessfullyintheircommunities.Evidencebasedprogramsandserviceshave beendevelopedinrecentyearstoassisttheMCCpopulationinattaininghealthierand moreindependentlives.ExamplesofsuchprogramsarethosethatretrainMedicaid homehealthaidestoprovideappropriatehomebasedphysicalactivitytrainingto beneficiaries;deliverHCBSthatpreventfalls;andprovidepeersupporttoreducethe severityofdepressivesymptoms.Otherinnovationsincludehomebasedinformation technologyandcommunitybasedorganizationsthatprovidecaretransitionservices.
Strategy2.B.1.ImproveaccesstoeffectiveHCBSfortheMCCpopulationthrough
informationandreferral,optionscounseling,andsmoothcaretransitions. Strategy2.B.2.Improveinfrastructure(e.g.,telemonitoringandsharedinformation services)tosupportHCBS,andpromoteeducationalandtechnologicalinnovations thatpermitindividualswithMCCtoremainmaximallyfunctionalandindependent, understandandbettermanagetheirconditions,andresidesafelyintheirhomesor othersettings. Strategy2.B.3.Providetrainingandinformationonevidencebasedselfcare managementto,andimprovesupportsfor,familycaregivers. ObjectiveC:ProvidetoolsformedicationmanagementAsthenumberofchronic conditionsincrease,sodothenumberofmedicationsprescribedandthedegreeof nonadherencetoregimens. 20 Inadditiontoreducingadversedrugeventsand medicationerrors,toolstoimproveknowledgeableuseofmedicationsmayreduce chronicdiseaseprogression.
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Strategy2.C.1.Developanddisseminateshareddecisionmakingandothertools
Healthcare,publichealth,andsocialservicesprofessionalsandfamilycaregivers practiceinavacuumofpublisheddataregardingcareforthosewithmultiplechronic conditions.Providingtheseprofessionalsandfamilycaregiverswiththetoolsand informationtheyneedtocareforindividualswithMCCiscriticaltoimprovecare provision.Moreover,becausemostmanagementofchronicconditionsoccursoutside themedicalcaresetting,attentionmustbefocusedacrossthecarecontinuumbothto sustainandimproveadherencewithpreventionandtreatmentstrategiesforimproved healthoutcomes. ObjectiveA:IdentifybestpracticesandtoolsTheMCCpopulationisclinically heterogeneous.Irrespectiveofthespecificcombinationsofchronicconditions,there likelyaregeneralapproachesthatfacilitateimproved,optimizedcare.Thegoalof identifyingindividualbestpracticesistopromoteasystematicapproachtothe assessmentandmanagementofthiscomplexpopulation,includingthepreventionof additionalcomorbidities.
Strategy3.A.1.Identify,develop,disseminate,andfosterintegrationofbest
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Strategy3.A.4.Developanddisseminatetoolsforusebyandacrossdifferent
organizations,providers,andfamilycaregiversthatimprovetheuseand managementofmedications,includingpromotionofknowledgeableuseof medications,reductionofprescriptionofinappropriatemedications,andreduction ofpatientrisksassociatedwithpolypharmacy. ObjectiveB:EnhancehealthprofessionalstrainingHealthcare,publichealth,and socialservicesprofessionalsaredependentonandinfluencedbytrainingprogramsthat preparethemfortheenvironmentsinwhichtheywillpractice.Evidencesuggeststhat manyhealthcareprofessionaltraineesfeeluncomfortablewithkeychroniccare competencies. 22 Addressingthesegaps,aswellastheneedforimprovingproviders culturalcompetencies,willensurethatthecurrentandnextgenerationsofproviders areproficientincaringforindividualswithMCCandininteractingwithfamily caregivers.
Strategy3.B.1.Identifyordevelopinformationrelevanttothegeneralcareof
individualswithMCCforuseinhealthandsocialserviceprofessionaltraining programs. Strategy3.B.2.Disseminateinformationrelevanttothegeneralcareofindividuals withMCCtoallHHSfundedorsupportedhealthandsocialserviceprofessional trainingprogramsforinclusioninrequiredcurricula,asappropriate. Strategy3.B.3.Ensurethathealthcare,publichealth,andsocialservices professionalsreceivetrainingonmonitoringthehealthandwellbeingoffamily caregiversforindividualswithMCC. Strategy3.B.4.Developandfostertrainingwithinbothtraditionaland nontraditionalprofessionalsettings(e.g.,medicine,nursing,socialwork, psychology/counseling,clinicalpharmacy,chaplaincy,vocationalrehabilitation, communityhealthworkers)thatemphasizesincreasedcompetencyinpalliative andpatientcenteredapproaches. ObjectiveC:AddressmultiplechronicconditionsinguidelinesEvidencebased, personcenteredclinicalguidelinesassisthealthcareprovidersinprovidinghighquality caretoindividuals.Moreoftenthannot,guidelinesonspecificchronicconditionsdonot takeintoaccountthepresenceofMCCand,importantly,howthesecomorbiditiesmay affectthetreatmentplan. 23 Moreover,guidelinesforpersonswithmentalillnessand substanceabuserarelyaddressthecooccurrenceofotherchronicconditions.Asthe evidencebasegrowstofacilitategreaterspecificityinguidelines(seealsoGoal4.C.),
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SignificantgapsexistintheapproachtocareforindividualswithMCC.Bolstering researcheffortswillenableimprovedcharacterizationoftheMCCpopulation,support healthcareandotherprovidersincoordinatingandmanagingcareforthispopulation, andassistintrackingprogressinimprovinghealthforindividualswithMCC.Thisgoal encompassesabroadspectrumofresearchconsiderations,including,forexample,basic investigationofmedicaltherapies,epidemiologicstudyoftheimpactofcomorbidities ondiseasetrajectories,efficacyandeffectivenessofpromisinginterventionsforhealth promotionandselfmanagement(asdescribedinGoal2),andhealthsystemcare managementstrategies(asdescribedinGoal1). ObjectiveA:IncreasetheexternalvalidityoftrialsAsthenumberofindividualswith MCCgrows,ensuringthattreatmentinterventions(e.g.,drugs,devices,lifestyle modifications,alternativemedicine)fortheseconditionsaresafeandeffectivebecomes moreimportant.Toachievethisend,effortstoimproveunderstandingofinteractions betweencomorbiditiesandtolimitexclusionsofthisincreasinglylargepopulationin clinicaltrialsmayassistinpreventingadverseeventsandpooroutcomesthatotherwise mighthaveoccurredifthispopulationwerenotincludedinthestudydesign.
Strategy4.A.1.DevelopmethodstoassesstheinclusionofindividualswithMCCin
clinicaltrials.Suchmethodsshouldincludedetermining1)optimaltrialdesignsfor includingMCCpatients;2)optimalapproachesforrecruitingMCCpatients;3)the potentialrisksofexposingsomeMCCpatientstonewinterventions;and4)the appropriateanalysisofoutcomesdatafromclinicaltrialsthatincludeindividuals withMCC. Strategy4.A.2.ImprovetheexternalvalidityofHHSfundedcommunityandclinical interventiontrialsbyensuringthatindividualswithMCCarenotunnecessarily excluded(asdeterminedbyscientificexpertsandexternalstakeholders). Strategy4.A.3.Ensure,throughguidanceorregulation,thatindividualswithMCC arenotunnecessarilyexcludedfromclinicaltrialsfortheapprovalofprospective drugsanddevices. 13
Strategy4.A.4.Assessandstrengthenpostmarketingsurveillanceforpotential
dyadsandtriadsofMCC. Strategy4.B.2.DeterminethedistributionofMCCforMedicareandMedicaid beneficiaries,aswellasclientsofHRSAfundedcommunityhealthcentersand IndianHealthServicehospitalsandclinics,andusethisinformationtoplan interventionsandmonitortheireffectiveness. Strategy4.B.3.Developtoolstoidentifyandtargetpopulationsubgroupsof individualswithMCCwhoareathighriskforpoorhealthoutcomes.(Seealso Strategy1.A.1.) ObjectiveC:Increaseclinical,community,andpatientcenteredhealthresearch Neitherthetreatmentofcomorbiditiesnortheimpactofcomorbiditiesonpatients healthstatusovertimehavebeenwellcharacterizedintheliterature.Therefore, researchthatelucidatestheevidencebasefortheprevention,management,and treatmentofindividualswithMCCisurgentlyneeded.Researchthatexpandsthe capacityofclinicianstodirectcaretowardoutcomesofhighestimportanceto individualswithMCCwillbeessential,aswillbeexaminationofthepoliciesthatcreate disincentivesforproviderstoadequatelyaddresstheneedsofindividualswithMCC. Feedbackonresearchprogressshouldbeprovidedtothepublicandtokeygroups includingindividuals,providers,researchers,andpolicymakersonapproachesfor reducingbarrierstoandimprovinginterventionsforMCC.
Strategy4.C.1.Expandresearchontheoptimalclinical,selfcare,andcommunity
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Strategy4.C.3.Improveknowledgeaboutpatienttrajectoriestemporallyinrelation
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