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BioMedCentralPage1of9(pagenumbernotforcitationpurposes)BMCHealthServicesResearchOpenAccessCorrespondenceDesigningamultifacetedqualityimprovementinterventioninprimarycareinacountrywheregeneralpracticeisseekingrecognition:thecaseofCyprusGeorgeASamoutis*1,2,ElpidoforosSSoteriades2,3,HenriEStoffers4,TheodoraZachariadou1,AnastasiosPhilalithis5andChristosLionis1Address:1ClinicofSocialandFamilyMedicine,SchoolofMedicine,UniversityofCrete,Heraklion,Crete,Greece,2DepartmentofPrimaryCare,CyprusInstituteofBiomedicalSciences(CIBS),Nicosia,Cyprus,3DepartmentofEnvironmentalHealth,EnvironmentalandOccupationalMedicineandEpidemiology(EOME),Boston,HarvardSchoolofPublicHealth,MA,USA,4DepartmentofGeneralPractice,SchoolofPrimaryCareandPublicHealth(CAPHRI),MaastrichtUniversity,Maastricht,TheNetherlandsand5HealthPlanningUnit,SchoolofMedicine,UniversityofCrete,Heraklion,Crete,GreeceEmail:GeorgeASamoutis*-george.
samoutis@gmail.
com;ElpidoforosSSoteriades-esoteria@hsph.
harvard.
edu;HenriEStoffers-Jelle.
Stoffers@hag.
unimaas.
nl;TheodoraZachariadou-andthe@cytanet.
com.
cy;AnastasiosPhilalithis-tassos@med.
uoc.
gr;ChristosLionis-lionis@med.
uoc.
gr*CorrespondingauthorAbstractBackground:QualityImprovementInterventionsrequiresignificantfinancialinvestments,andthereforedemandcarefulconsiderationintheirdesigninordertomaximizepotentialbenefits.
Inthiscorrespondencewepresentthemethodologicalapproachofamultifacetedqualityimprovementinterventionaimingtoimprovequalityofcareinprimarycare,properlytailoredforacountrysuchasCypruswheregeneralpracticeiscurrentlyseekingrecognition.
Methods:Ourmethodologicalapproachwasfocusedonthedesignofanopenlabel,community-basedinterventioncontrolledtrialusingallpatientsfromtwourbanandtworuralpublicprimarycarecentersdiagnosedwithhypertensionandtypeIIdiabetesmellitus.
ThedesignofourinterventionwasgroundedonastrongtheoreticalframeworkthatincludedtheUnifiedTheoryofAcceptanceandUseofTechnology,andtheChronicCareModel,whichsynthesizeevidence-basedsystemchangesinaccordancewiththeTheoryofPlannedBehaviorandtheTheoryofReasonedAction.
Theprimaryoutcomemeasurewasimprovementinthequalityofcarefortwochronicdiseasesevaluatedthroughspecificclinicalindicators,aswellasthepatientsatisfactionassessedbytheEUROPEPquestionnaireandadditionalpersonalinterviews.
Results:Wedesignedamultifacetedqualityimprovementinterventionmodel,supportedbyavaryingdegreeofscientificevidence,tailoredtolocalneedsandspecificcountrycharacteristics.
Overall,themaincomponentsoftheinterventionwerethedevelopmentandadoptionofanelectronicmedicalrecordandtheintroductionofclinicalguidelinesforthemanagementofthetargetedchronicdiseasesfacilitatedbythenecessarymodeloforganizationalchanges.
Conclusion:Healthplannersandpolicymakersneedtobeawareofthepotentialuseofcertaintheoreticalmodelsandappliedmethodologyaswellasinexpensivetoolsthatmaybesuitablytailoredtothelocalneeds,inordertoeffectivelydesignqualityimprovementinterventionsinprimarycaresettings.
Published:27August2008BMCHealthServicesResearch2008,8:181doi:10.
1186/1472-6963-8-181Received:17January2008Accepted:27August2008Thisarticleisavailablefrom:http://www.
biomedcentral.
com/1472-6963/8/1812008Samoutisetal;licenseeBioMedCentralLtd.
ThisisanOpenAccessarticledistributedunderthetermsoftheCreativeCommonsAttributionLicense(http://creativecommons.
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0),whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.
BMCHealthServicesResearch2008,8:181http://www.
biomedcentral.
com/1472-6963/8/181Page2of9(pagenumbernotforcitationpurposes)BackgroundThequalityofhealthcareservices,asmeasuredbystand-ardizedindicatorsandstakeholders'satisfaction,consti-tutesacornerstoneofhealthcaredeliveryinthecurrenteraofcontinuoushealthcarereform.
However,theachievementofqualityofcareremainsachallengeformanywesternsocieties,despiteacontinuouslyincreasinglevelofhealthcareexpenditure[1].
Furthermore,manyeffortsinthehospitalsettinghavebeendevotedtolimitpracticevariation,effectivelyutilizeavailableelectronicresourcesandimprovepatientsatisfaction;whereasinpri-marycareservicestheimportanceoffinancialsavingsalongwithsignificanthealthgainshasnotbeenade-quatelyexplored.
Inouropinion,highhealthcarequalityrequiresuniversalaccess,equityinservicesandcost-effec-tivecare[2].
Inparticular,improvingchronicillnessman-agementhasbeenattractingincreasinginterestbyhealthcareprovidersandgovernmentagencies,sincetheaveragechronicpatiententeringtheprimarycaresystemisnotreceivinganoptimalqualityofcare[3].
Furthermore,theageingpopulation,predominantlyinthewesternsocie-ties,constitutesanevergrowingeconomicandhealthcareburdenrequiringincreasingcommunity-basedservices[4].
Anumberofdifferentqualityimprovement(QI)interven-tionsimplementedatvariousclinicalsettingshavebeenevaluatedandpresentedinthemedicalliterature[5-8].
Suchinterventionsrangefromsingle-componentapproaches(e.
g.
electronicremindersystems)tomultifac-etedcomplexstrategiescombiningbothpatient-mediatedactivities(e.
g.
educationalleaflets)andhealthcarepro-viderservices(e.
g.
consensusbuilding,training,andaudit/feedbackprocesses)[9].
Inaddition,tailoringinter-ventionstothelocalgrouppractitioners'needs,hasalsobeenproposedasaconcertedefforttoattainsuccessfulandsustainableoutcomescomparedtointerventionsthatarefixedandlackprogrammaticflexibility[10].
Moreo-ver,interventionsforqualityimprovementinvolvesignif-icantamountsoffinancialinvestment,andthereforerequirecarefulmodelinginordertomaximizepotentialsuccesses[11].
Finally,processandoutcomemeasureevaluationofsuchattemptsisthoughttobeofparamountimportanceinordertoassistdecisionmakersindevelop-ingappropriatepoliciesforstructuralandlong-termplan-ning.
Manycountrieswithadequateresources,highcapacityinprimarycareresearchandpastexperienceinqualityimprovementefforts,havebeenactivelyinvolvedinimplementingmajormodificationsinprimaryhealthcareservicesinordertoincorporatequalityindicatorsbasedonabroadarrayofmethodologicalstrategies[12,13].
Theterm'clinicalgovernance'hasbeenintroducedtocapturearangeofactivitiesrequiredtoimprovethequalityofhealthcareservices,includingthedevelopmentofproc-essesforcontinuousmonitoringandaccountabilitysys-temsfordeliveredqualitycare[14].
However,countrieswithlittleexperienceandlimitedresources,includingCyprus,facesignificantchallengesinattemptingtodesignQIinterventionstailoredtocountry-specificcharacteris-ticsasdescribedbelow.
Cyprusiscurrentlymovingtowardstheintroductionofaprimarycaredriven,universalhealthcarecoveragesystemfortheentirepopulation,withqualityimprovementproc-essesasanimportantincorporatedcomponent.
However,forthetimebeing,Cyprusoperatesinadualsystemofhealthcaredelivery,offeringpublicly-fundedhealthcareservicestolowandmedium-incomecitizens,whiletherest,mostlywell-offpartofthesociety,utilizeservicesfromtheprivatesector,coveringtheirexpenseseitherfromprivatehealthinsuranceschemesorthroughoutofpocketcompensation[15].
Themajorityofpublicaswellasprivateprimarycaresettingsarecharacterizedbyunder-useofcontemporaryinformationtechnologies,limitedmonitoringsystems,andvariableuseofclinicalstandardsofcaresuchaschronicdiseasemanagementguidelinesandpatientsatisfactionsurveys[16].
TheCyprusMinistryofHealthisbeingstronglyinterestedininvestingsignifi-cantresourcestopromotequalityimprovementstrategiesinbothsectorsofhealthcareservices.
WithinanalreadyexistingframeworkofcollaborationbetweentheClinicofSocialandFamilyMedicineoftheUniversityofCreteandtheCyprusMinistryofHealth,apilotinterventionforqualityimprovementintwopublicprimaryhealthcarecentersinCypruswasdeveloped.
Inthiscorrespondence,adetaileddescriptionispresentedofthetheoriesandmethodologyusedtodesignacountry-specificqualityimprovementinterventioninanurbanandruralprimaryhealthcarecenterinCyprus,tailoredtolocalpracticesandprimarycareprofessionals'needs.
TheTheoreticalFrameworkOurapproachwasdesignedtofollowthestepsofcontem-porarytheoriesinordertoexploredifferentpathwaysincludingtheuseofinformationtechnologyandtheintroductionofstandardguidelinesforchronicdiseasemanagement.
Aliteraturereviewandananalysisoftheexistingorganizationalandoperationalcontextledtotheidentificationofthreemainareasthatrequiredstrongthe-oreticalbackgroundforasuccessfuldesignofourinter-vention;namely:a)anorganizationalchangeparadigm;b)theintroductionofinformationtechnology,andc)theadoptionofclinicalguidelinesintoeverydaypracticeforchronicdiseasemanagement.
OrganizationalChangeParadigmInanticipationofadvancedneedsforstructuralchangesintheprimarycarecentersduringtheintervention,aBMCHealthServicesResearch2008,8:181http://www.
biomedcentral.
com/1472-6963/8/181Page3of9(pagenumbernotforcitationpurposes)modeloforganizationalchangewasadopted,whichiden-tifiessevenstages:sensingofunsatisfieddemandsonthesystem,thesearchforpossibleresponses,evaluationofalternatives,decisiontoadoptacourseofaction,initia-tionofactionwithinthesystem,andimplementationandinstitutionalizationofachange[17].
InformationTechnologyTheintroductionofanelectronicmedicalrecord(EMR)followedthefourconstructsoftheUnifiedTheoryofAcceptanceandUseofTechnology(UTAUT),asdescribedinthecurrentliterature:performanceexpectancy,effortexpectancy,socialinfluenceandfacilitatingconditions[18,19].
TheUTAUThasbeenvalidatedempiricallyamongstfourbusinessesfromvariousindustries,andwascross-validatedusingdatafromanothertwobusinesses,enablingresearcherstoexplainupto70%oftechnologyacceptancebehavior[20].
Basedontheabove,aUTAUTmodelwasadoptedforthedesignofourinterventionduetoitscomprehensivecharacterandhighexplanatorypower.
AccordingtotheUTAUTmodel,technologyacceptancedependson:a)userdeterminants(e.
g.
age,gender,experience,andvoluntarinessofuse),b)informa-tiontechnologyexpectancy(e.
g.
performanceexpectancyandeffortexpectancy),c)implementationsettinganduserprofessionalenvironment,includingsocialinflu-ence,andd)organizationalfacilitatingconditions.
Alloftheaboveweretakenintoconsiderationduringthepre-parednessphaseoftheprojectaswellasfortheplanneddailyinteractionsoftheimprovementteam,inordertoenablephysiciansandnursestosuccessfullyadopttheuseofEMRinapreviouslycomputer-naveprofessionalenvi-ronment.
IntroducingdiseasemanagementguidelinesTheselectionofchronicillnessesthatwereusedintheinterventionwasbasedonthemostcommondiseasesencounteredinpublicprimarycarecentersofCyprus,namelyhypertension(HTN)andtypeIIdiabetes(T2DM)[21].
Theintroductionofclinicalguidelinesandcontinu-ingmedicalandnursingeducationforchronicdiseasemanagementwasbasedontheChronicCareModel(CCM)[22,23],theTheoryofPlannedBehavior(TPB),andtheThe-oryofReasonedAction(TRA)[24,25].
TheCCMmodelsyn-thesizesevidence-basedsystemchangesleadingtoimprovedoutcomes.
Itemphasizessixmaincomponents:a)theorganizationofhealthcare,b)communitylinkages,c)self-managementsupport,d)deliverysystemdesign,e)decisionsupportandf)informationsystems.
Furthermore,ourdesignwasinfluencedbytheChronicCareModelinordertoimplementdiseasemanagementguidelines,electronicremindersystems,ande-libraryresourcesaspartofthedecisionsupportsystems.
Moreo-ver,achroniccaresupportwasorganizedthroughtheimplementationofareferralscheme,anelectronicappointmentscheduling,andtheintroductionofanelec-tronicmedicalrecordsystem(EMR).
Inaddition,patienteducationactivitieswerescheduledtobedeployedthroughtrainingwitheducationalmaterialsandfacetofaceguidancefordiseaseself-management(e.
g.
bloodglucosemonitoringandfootexamination).
TheTheoryofPlannedBehaviorandTheoryofReasonedActionpro-videdthenecessarytheoreticalframeworkinordertoassistusinempiricallyidentifyingthoseQIinterventionfactorsonwhichoureffortsshouldbetargeted.
Applica-tionofTPBandTRAmodelsalsohelpedusidentify,throughtheconductionofin-depthopen-endedelicita-tioninterviews,theunderlyingbeliefsthatdeterminehealthprofessional'sattitudes,subjectivenorms,andper-ceivedbehavioralcontrol.
Thereby,suchtheoriesmaypotentiallyaffectthehealthprofessional'slikelihoodofmodifyingpreviousbehaviorsandsuccessfullyadoptingnewlyintroducedclinicalguidelines.
MethodologicalHypothesesBasedontheabove-describedtheoriesandanextensiveliteraturereview,wedevelopedspecificresearchhypothe-sesinaccordancewithourresearchmodel.
First,withregardstoEMRintroduction,wehypothesizedthat(a)performanceexpectancy,effortexpectancy,andsocialinfluencewouldpositivelyaffectPrimaryCarePhysicians'(PCPs)andnurses'attitudestowardadoptingEMRtech-nology;(b)organizationalfacilitatingconditionsshouldhaveadirecteffectonperformanceexpectancy,effortexpectancy,andhealthprofessionals'EMRutilizationbehavior;and(c)behavioralintentionwillhaveasignifi-cantpositiveinfluenceonhealthprofessionals'practice.
Inaddition,withrespecttotheadoptionofguidelines,weexpectedthat(a)PCPsandnurseswouldacceptandeffec-tivelyimplementclinicalpracticeguidelinesonchronicdiseasemanagement;(b)thequalityofprimarycareserv-icesforchronicdiseaseswouldbeimprovedfollowingtheimplementationofourintervention;and(c)theuseofCCM,TPBandTRA,wouldhelpusshapeapositiveimpactonchronicdiseasemanagement.
Finally,wehypothesizedthattheproposeddesign,accordingtogivenresourcesandotherdefactolocalchar-acteristics,suchaslimitedtechnologicaladoption,com-puter-naveenvironment,lackofpreviousexperienceswithqualityimprovementinterventions,andscarceincentivesforperformance,wouldhelpusefficientlyexaminetheeffectivenessofaQIinterventioninCyprus.
BMCHealthServicesResearch2008,8:181http://www.
biomedcentral.
com/1472-6963/8/181Page4of9(pagenumbernotforcitationpurposes)MethodsAMultifacetedQualityImprovementInterventioninCyprusThetranslationandimplementationoftheabovedescribedtheoriesandmodelsintoabusyday-to-dayclin-icalpractice,representsaformidablechallenge.
Commonexperiencewithotherqualityimprovementinterventions[26]coupledwiththeabovedescribedinsightsfromindustrialexamples,suggestthatsustainedimprovementsinchronicillnesscarerequireacomprehensive,continu-ous,andsystematicchangeapproachfollowingaspecificintervention.
Ouroperationalmodelwasbasedonamul-tifacetedinterventionthatwasfacilitatedthroughamulti-disciplinaryqualityimprovementteam.
Currentliteraturesupportstheimplementationofmulti-facetedinterventionsinthehealthcaresector,sincemanycomponentsmayinteractandreinforceeachotherinencouragingthechangeofprofessionalpracticeandpro-motingworkplacesatisfaction[27].
Ourmultifacetedinterventionwasdesignedtoinvolveseveralimplementa-tionstrategiesincludingacombinationofeducationalcomponents(educationalmaterials,workshops,localopinionleaders'presentations,academicdetailing),auditandfeedback,andanelectronicdecisionsupportsystemenabledthroughe-libraryandelectronicremindersystemtailoredtothelocalneeds.
Particulartailoringcharacteris-ticstookintoconsiderationthelackofmotivatorsinthepublicprimarycarecenters,thescarcityofuseofclinicalguidelinesindailypractice,theabsenceofreferralandappointmentsystemsaswellasotherorganizationalweaknessesandtheexistenceofacomputernaveenvi-ronment.
Thus,weincorporatedtheuseofphysicianfacil-itators,whointroducedseveralnon-monetaryincentivesforthehealthprofessionals,providedthemwithpracticaltoolssuchasfootexaminationscreeningchecklist,anddevelopedtailoredorganizationalchanges.
Wealsopro-motedastrongtheoreticalframeworkconsistingmainlyoftheUTAUTandCCMsupportingthecomputernaveenvironment,andappointedaresponsibleindividualwhohadtoidentifyspecificresourcesateachcenterincludingthesupportofanewappointmentandreferralsystem.
Finally,aninformedconsentformwasdevelopedinordertobeusedduringtheimplementationphase.
ThestudywasapprovedbytheNationalBioethicsCommittee.
OrganizationalChangesStructuralandorganizationalchangeswereemployed,asequallyimportantcomponentsindesigningaqualityimprovementinterventionforthemanagementofdiseaseco-morbidities,alongwiththeintroductionofstandardclinicalguidelines[28].
Consensusbuildingmeetingswereplannedinordertoidentifypotentialbarriersandevaluatealternativesfortheintroductionofanappointment-basedelectronicschedul-ingsystem,securecontinuityofsecretarialsupportduringandaftertheprojectended,andintroduceaneffectivespecialistreferralsystem.
Afterreachingaconsensus,theadopteddecisionalongwithnecessaryorganizationalchangescouldtakeplaceawaitingtheinstitutionalizationoftheselectedchanges.
Additionally,aspecificplanwasappliedthroughaframeworkofchangesthatwouldguidehealthprofessionalsintheireverydaypractice.
Uppermanagementsupportfromtheadministrativehealthserv-icesoftheMinistryofHealthwasactivelysought.
IntroductionofElectronicMedicalRecord(EMR)TheintroductionoftheEMRsystem,whichwasbasedontheInternationalClassificationSystemforPrimaryCare(ICPC-2),consistedoftheintroductionofawindows-basedsoftwareprogram(Transhis)describedindetailelsewhere[29].
Thesecretaries,nursesandphysiciansattheinterventionprimarycarecenterswereprovidedwithpersonalcomputers,printersandahigh-speedbroadbandinternetaccessforall.
Primarycarephysicians(PCPs)andnurseswereaskedtoserveasevaluatorsoftheEMRsystemperformance.
Inaddition,18randomlyselectedpatients,halfofwhichweremalesandhalffemales,weresched-uledtoundergopersonalinterviewsinordertoprovidedetailedfeedbackontheirexperiencewiththeEMRandidentifybarriersinitsdailyimplementation.
Amongmanyothersoftwareprograms,Transhis,awindows-basedEMRsystem,incorporatingepisodeofcareandremindersystemswasselectedtoserveasthesupportingelectronicinterfacebasedondefinedcriteriaforappropriateness,efficiency,andfeasibilityforthegeneralclinicalpractice[30].
ChronicDiseaseClinicalGuidelinesChronicdiseaseguidelinesrepresentedourdecisionsup-porttool,oneofthemaincomponentsoftheChronicCareModel.
Suchatoolwasscheduledtoprovideevi-dence-basedclinicalinformationtothehealthcarepro-fessionalsthatwerereadilyavailablethroughelectronicdatabasesfacilitatedbyEMR[31].
TypeIIdiabetesmelli-tusguidelineswerebasedontheAmericanDiabetesAsso-ciationandSt.
VincentDeclarationguidelines.
HypertensionmanagementguidelineswerebasedontheVIIReportoftheJointNationalCommittee,theEuropeanguidelinesoncardiovasculardiseasepreventionandtheEuropeanSocietyofHypertension–EuropeanSocietyofCardiologyGuidelines,whereaslipidcontrolpracticeguidelineswerebasedontheNationalCholesterolEduca-tionProgramIII.
QualityImprovementTeamSettingupamultidisciplinaryqualityimprovementteamwasthoughttobeofparamountimportanceforthesuc-cessfulfacilitationandfideimplementationofourinter-BMCHealthServicesResearch2008,8:181http://www.
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Theuseofaqualityimprovementteamhasbeendescribedlongagobyindustrialqualityexperts[32].
Ourstudyteamconsistedoftwofamilyphysiciansservingasprogramfacilitators,threeacademicexpertsinfamilymedicinewithpreviousextensiveexperienceinQIinter-ventions,andonefamilyphysicianwithexpertiseinEMR.
Bothstudyfacilitatorswerescheduledtomeetwithpro-vidersintheirpracticesettingsduringregulartimeinter-valsinordertoundertakethefollowingactions:(a)recordbaselinecharacteristicsofparticipantsinthestudyandpresentqualityindicatorsforeachselectedillness;(b)facilitateconsensusbuildingforthemanagementofselectedillnesses,accordingtogivenclinicalguidelines;(c)assistinthedevelopmentandadaptationoftoolsandstrategiesforimplementingtheintervention;(d)facilitatemeetingstoassessprogressandpotentialbarriersintheimplementationoftheinterventionwhilebeingabletomodifytheplanaccordingly;(e)conductinterviewsoftheparticipatingdoctors,nursesandpatients;and(f)developandcompleteelectronicchartaudits,monthlyreportsandoutreachvisitforms.
SettingandParticipantsPrimaryHealthCareCentersThestudywasscheduledtotakeplaceinNicosia,thecap-italofCyprus,intwourbanandtworuralpublicprimaryhealthcarecenters(PHCC),whichwereselectedbasedonpopulationservedandemployeecriteria(age,durationofmedicaleducation,numberofyearsinpractice).
Oneruralandoneurbancenterweredesignedtoserveascon-trolsbeingobservedtofollowregularpractice.
Eachcenterwasdesignedtohaveaworksiteleaderwhowouldlever-ageresourcesandbetheprimarycontactpersonincollab-orationwiththequalityimprovementteam.
AllPCPsandnursesfromtheinterventionprimarycarecenterswerescheduledtoparticipateinthestudyasevaluatorsoftheintervention.
PatientsandEligibilityCriteriaSeveralreasonssupportedthepatientselectioncriteriaincludingourobjectivetoincludearelativelysmall,how-everhomogeneouspatientpopulationthathasalsobeenidentifiedinthemedicalliteratureasafrequentlyneglectedgroupofpatients[33].
Inaddition,HTNandT2DMwerefoundtobethemostcommondiseasesintheprimarycaresystemofCyprus[21].
Thesehealthprob-lemsoftenoccurinaconcurrentfashionandleadtoseri-ouscomplicationsthatmaynotbeoptimallytreated[34,35].
Finally,despiterecommendationsformoreaggressivehypertensiontherapyinthepresenceofcoexist-ingdiabetes,itisunclearwhetherthereareanydifferencesinhowcliniciansmanagebloodpressureinhypertensivepatientswithorwithoutdiabetes[36].
StudyDesignTheproposedmodelwasplannedtobeevaluatedthroughacommunity-basedopen-labelinterventioncontroltrialcomparingregularpracticetoanEMR-enhancedpracticeaidedbychronicdiseasemanagementbasedonstandardclinicalguidelines.
Thedesignincludedthreephasesofevaluationincluding:(a)abaselineassessment,(b)anendoffollow-upcomparisonand(c)an18-monthpostinterventionevaluation.
Awindowof3monthsrun-in-phasewasplannedfortheeligiblepatientstoenterthestudy.
Duetothepossibilitythatdeviationsfromthepro-tocolduringtheinterventioncouldimpactthevalidityofthetrial,weproposedtheproperhandlingandreportingofanynon-adherencetotheprotocolevents.
Inaddition,ourstudydesignincludedprocessandoutcomeevalua-tionasdepictedinFigure1[37,38],alongwithabriefeco-nomicanalysis(accumulatedcostofthepersonnel,equipmentandtheinterventionitself).
ProcessEvaluationStructuredformsThefacilitatorswereexpectedtocompletetwostructuredforms:monthlyreports(MR)andoutreachvisitsreports(OVR),whichweredevelopedbasedonpreviousreportfromtheliterature[39].
MonthlyreportswereexpectedtoprovidedetailedinformationontherecordingofvisitstoaPrimaryCareHealthCenter(PCHC),theactivitieswithineachPCHC,theoutcomesofthoseactivities,thenumberofhoursspentforbothon-siteandoff-siteactiv-ities,theimplementationofguidelinesinclinicalpracticeandtheutilizationoftheEMRincludingproblemsandbarriersduringitsimplementation.
InterviewsandAuditApartfromtheabovereports,thefacilitatorsweresched-uledtomeetwiththePCPsandthenursesat6-monthand18-monthfollow-upvisitsinordertoconductsemi-struc-turedface-to-faceinterviewsaswellasfocusgroupses-sionsatbaselineandendoffollow-up.
Thehealthprofessionalswereexpectedtoprovideinformationontheiroverallsatisfactionwiththeintervention,theexperi-encesandpotentialbarriersintheimplementationofthestudyaswellastheirsuggestionsforimprovements.
Attheendofthe6-monthfollow-upperiod,qualityindicatorsauditwerescheduledtobeconductedintheinterventionPCHCs.
Additionally,semi-structuredinterviewsofran-domlyselectedpatientsfromtheinterventionPCHCswereexpectedtotakeplaceattheendofthe18-monthstudyperiod.
OutcomeEvaluationTheoutcomeevaluationofourinterventionincludedthequalityindicatorsfortheselectedillnessesalongwithval-idatedinstrumentsmeasuringpatients'opinion.
QualityindicatorsincludedspecificandmeasurableelementsofBMCHealthServicesResearch2008,8:181http://www.
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com/1472-6963/8/181Page6of9(pagenumbernotforcitationpurposes)practicethatcanbeusedtoassessthequalityofcare[40].
Asetofqualityindicatorswasdevelopedbycombiningexperts'opinionwithcurrentscientificevidence.
Qualityindicatorsfordiabetesincludedfastingbloodsugar,levelsofHbA1c,bloodpressure(BP),bodymassindex(BMI),lipidprofile(TC,HDL-C,LDL-C,TG),microalbuminuria,fundalandfeetexamination,andprevalenceofsmoking.
Hypertensionqualityindicatorsincluded:bloodpressuremeasurement(SBP,DBP),BMI,lipidprofileandpreva-lenceofsmoking.
Inaddition,weusedtheEUROPEPquestionnaire,distrib-utedtoallpatientsfromtheinterventionandcontrolPCHC,toevaluatepatients'opinionbeforeandaftertheintervention[41].
TheEUROPEPinstrumentisareliableandinternationallyvalidatedquestionnairethatmeasurespatients'satisfactionwithrespecttothecarereceivedandtheinterpersonalskillsofprimarycarephysicians.
TheGreekversionwasplannedtobeusedinourstudy[42]aftertheappropriateculturaladaptationofthequestion-naireasdeemedappropriateforCyprus.
StatisticalAnalysesSummarystatisticswereplannedtobegeneratedforbase-linecharacteristicsandclinicalevaluationsforeachstudyarm.
T-testandchi-squarestatisticswereplannedtobeusedtoassessthehomogeneityofstudyarmswithrespecttobaselinecharacteristics.
Theprimaryoutcomemeasurewastheimprovementinthequalityindicatorsofpatientswithhypertensionanddiabetesassessedbythreedifferentstatisticalmethods.
Thefirstwasbasedonacomparisonofpatientsfoundtobeattargetlevelsbasedonguidelinerecommendations,beforeandaftertheintervention,acomparisonofqualityimprovementmeasurementsusingGeneralLinearModelofRepeatedMeasures,andfinally,thepercentageofpatientswithmorethan10%improve-SchematicRepresentationoftheEvaluationFrameworkFigure1SchematicRepresentationoftheEvaluationFramework.
Facilitators1)Baselinephase.
2)Processevaluationphase.
PRQWKV3)OutcomeevaluationfirstphasePRQWKV'0DQG+71TXDOLW\LQGLFDWRUV4,V'DWDH[WUDFWLRQIURPSDSHUUHFRUGV3DWLHQWVRSLQLRQHYDOXDWLRQXVLQJ8523(3TXHVWLRQQDLUH'0DQG+714,V'DWDH[WUDFWLRQIURPSDSHUDQGHOHFWURQLFUHFRUGV,PSOHPHQWDWLRQRILQWHUYHQWLRQD(05LQWURGXFWLRQE*XLGHOLQHVLPSOHPHQWDWLRQRQWKO\UHSRUWV2XWUHDFKYLVLWIRUPV4,VDXGLW,QWHUYLHZ3&3VQXUVHVSDWLHQWV18PRQWKV4.
Outcomeevaluationsecondphase36months'0DQG+714,V'DWDH[WUDFWLRQIURPSDSHUDQGHOHFWURQLFUHFRUGV3DWLHQWVRSLQLRQHYDOXDWLRQXVLQJ8523(3TXHVWLRQQDLUHBMCHealthServicesResearch2008,8:181http://www.
biomedcentral.
com/1472-6963/8/181Page7of9(pagenumbernotforcitationpurposes)mentoverbaselineinselectedindicatorsattheendoffol-lowup,asbeingconsistentwithpreviousworkofMajumdar,etal[43].
Quantitativeanalysesofadditionalqualityindicatorsincludedthefollowingvariables:monthlyvisits(totalnumberofvisitsdividedbythedurationstudiedinmonths),andtimetoresponsemeasures(monthsuntilpatientachievedtargetlevelsforspecificindicators).
Repeatedmeasureswereplannedtobeanalyzedusingmixedeffectsmodels.
Correlationsamongmeasurementsmadeonthesamesubject,wereplannedtobemodeledusingrandomeffectsandrandomregressioncoefficients,andthroughthespecificationofacovariancestructure.
Alltestswereplannedtobetwo-sidedandalevelofstatisticalsignificancewassetat0.
05.
Allstudyoutcomeswereplannedtobeanalyzedonthebasisofintentiontotreat.
Dataobtainedduringtheprocessevaluationwouldbequalitativelyanalyzedusingaudiotapesfromface-to-faceinterviews.
Focusgroupsandpersonalinterviewinforma-tionwouldbetranscribedandaframeworkapproachanalysis[44,45],wasplannedtobeperformedbasedonthefive-stepapproach:familiarization,identifyingathe-maticframework,indexing,mappingandinterpretation.
DiscussionManycountriesnowadaysarefacingfinancialconstraintsforhealthcareexpenditures.
Theappropriatedesignofcost-effective,country-specificQIinterventionsbasedontranslationalresearch[46]isoneofthecornerstonesofcontemporaryhealthcarepolicy.
Inthecurrentreportwehavepresentedthedesignofamultifaceted,country-spe-cificandtailoredtolocalpracticespilotQIinterventioninprimaryhealthcarecentersofCyprus,groundedonanumberoftheoreticalframeworksincludingtheUnifiedTheoryofAcceptanceandUseofTechnology,theChronicCareModel,theTheoryofPlannedBehaviourandtheTheoryofReasonedAction.
Abroadarrayofkeyinitiativesinimprovingthequalityofprimarycareservicessuchasnationalsystemsforinspec-tionandmonitoringofperformanceandpay-for-per-formanceincentiveprogramshavebeenextensivelydescribedintherecentmedicalliteratureincountrieswithalongtraditioninqualityimprovementefforts[47].
Althoughsuchparadigmscanbeextremelyuseful,coun-trieswithoutpastexperienceinQIinterventions,aswellaslimitedresources,maybenefitsignificantlyfromexam-plesoriginatingfromcountrieswithsimilarexperiencesandcomparablehealthcaresystemparameters.
Anumberoflimitationsofourstudydesignareworthnoting.
First,duetolimitedresources,theinterventionwasplannedtobeimplementedinasmallnumberofpri-marycarecenterswithfewphysiciansandnursesservingasevaluators,thuslimitingourstudy'simpact.
Howeverourfindingscouldbeindicativeofthedirectionalityofchangesandpossibleimprovementsthatweretobeobserved.
Moreover,ourstudywasnotarandomizeddouble-blindcommunity-basedcontrolledtrial,sincethePCHCswerenotrandomlyselected.
Inaddition,therewasabroaddiversityamongthecenterswithrespecttothepopulationtheyserved.
Nevertheless,ourbeforeandafterspecificstudydesignwithconcurrentcontrolspro-videssufficientvalidity.
However,thepowercalculationsofourpilotstudyarelimitedbythenumberofprimarycarecentersparticipatingintheinterventionandcontrolgroups.
Typicallygrouprandomizedtrialslikeours,shouldincludeabout5–15practicespergrouptakingintoaccounttheintra-classcorrelationduetopracticemembership.
Finally,althoughourmultifacetedinterven-tionmayappearstobeexpensive,ampleevidencesug-geststhattheuseofEMRandtheimprovedcareofpatientswithchronicconditionshavethehighestpoten-tialforcostsavings.
[48]Furthermore,examplesinthemedicalliteraturesuggestthattheuseofphysicianfacili-tatorshavefavorablecost-benefitratioswhentargetedatcostlysystemissues.
[49,50]Ourstudyisoneofthefirstattemptstoimprovethequal-ityoftheprimarycaresystemofCyprusbasedoncontem-porarymethodologicalapproachesandadoptionofnovelcomputerizedtechnology.
Ourinvestigationwasdesignedtoexploreissuesoffeasibility,acceptabilityfrompatientsandhealthcareprofessionals,andeffectivenessofapilotqualityimprovementintervention.
Inaddition,ourstudywasexpectedtoevaluatethepotentialeffectoftheoreticalframeworksontheimplementationofmultifacetedinter-ventionprogramsintheprimarycaresystemofCyprusandtowhatextendsuchtheoreticalframeworkscanofferasafebaseforthedescribedobjectives.
OurstudydesigncouldalsoprovidethenecessarytheoreticalmodelandappliedmethodologyaswellasthepracticaltoolsforfutureeffortstowardsuniversalEMRimplementationandthemanagementofchronicdiseasesbasedonstandardguidelinesintheprimarycaresettingofCyprus.
However,thedesiredqualityimprovementwillneedtobeimple-mentedandevaluatedbeyondapilotsettinginordertoprovidefirmevidencewithrespecttoitseffectiveness.
ConclusionTheaimofourcorrespondencewasmainlytoillustratethemethodologicalapproachindesigningamultifacetedqualityimprovementinterventionbasedontranslationalresearchinacountrywhereappliedresearchislimited.
Webelievethatourdesignmayleadtotheimplementa-tionofasuccessfulqualityimprovementinterventionusingrelativelylimitedresourcesinanenvironmentlack-ingpreviousQIattempts.
TheeffectivenessevaluationofBMCHealthServicesResearch2008,8:181http://www.
biomedcentral.
com/1472-6963/8/181Page8of9(pagenumbernotforcitationpurposes)theinterventionisexpectedtoprovideastrongbasisforfutureeffortstocraftastandardizedapproachforcontin-uousqualityimprovementinterventionsintheprimarycaresettingofCyprus.
CompetinginterestsTheauthorsdeclarethattheyhavenocompetinginterests.
Authors'contributionsCLconceivedoftheideafortheproject,andsupervisedtheproject.
CL,AP,GAS,TZandHESdevelopedthemeth-odology.
GASsupervisedtheprojectimplementationanddevelopedthedatacollectiontools.
Allauthorsreviewedthemethodologicalapproach.
GASwrotethefirstdraftofthemanuscript,whileallauthorscontributedtothefinalversionofthemanuscript.
Allauthorsreadandapprovedthefinalmanuscript.
AcknowledgementsTheauthorswouldliketothanktheOfficersatthedepartmentofMedicalServicesoftheMinistryofHealthinCyprusandthedepartmentofClinicofSocialandFamilyMedicinefortheirsupportofthecurrentproject.
ThisworkwassupportedbyagrantfromtheMinistryofHealthinCyprus.
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