Effectiveness and Efficiency of Assertive Outreach for Schizophrenia in Germany study protocol on a pragmatic quasi-experimental controlled trial.docVIP

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Effectiveness and Efficiency of Assertive Outreach for Schizophrenia in Germany study protocol on a pragmatic quasi-experimental controlled trial.doc

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Bramesfeldetal.BMCPsychiatry2013,13:56 /1471-244X/13/56 STUDY PROTOCOL OpenAccess Effectivenessandefficiencyofassertiveoutreach forSchizophreniainGermany:studyprotocolon apragmaticquasi-experimentalcontrolledtrial AnkeBramesfeld1,2,J?rnMoock1,KirstenKopke1,DorotheaBüchtemann1,DeniseK?stner1,JeanettRadisch1 andWulfR?ssler1,3* Abstract Background:Amodelofassertiveoutreach(AO)inwhichoffice-basedpsychiatristscollaboratewithambulatory nursingservicesforprovidingintensivehome-treatmentiscurrentlybeingimplementedinruralareasofLower Saxony,Germany.Thecostsofthemodelarereimbursedbysomeofthestatutoryhealthinsurancecompanies activeinLowerSaxony.Effectivenessandefficiencyofthismodelforpatientssufferingfromschizophreniais evaluatedinapragmaticandprospectivetrial. Methods:Quasi-experimentalcontrolledtrial:patientsreceivingtheinterventionareallthosereceivingAO;controls arepatientsnoteligibleforAObasedontheirhealthinsuranceaffiliation.Eligibilitycriteria:clinicaldiagnosisof schizophrenia(ICD-10F.20),agedatleast18yearsandbeingmoderatelytoseverelyimpairedinglobalfunctioning. Primaryoutcome:admissionanddaysspentinpsychiatricinpatientcare;secondaryoutcomes:clinicaland functionalstatus;patientsatisfactionwithchroniccare;healthcarecosts.Follow-uptime:6and12months. Discussion:Thestudyfacesmanychallengestypicaltopragmatictrialssuchastherejectionofrandomisationby serviceproviders,thequalityoftreatmentasusual(TAU)towhichtheinterventionwillbecompared,andthe impairmentofthestudysubjects.Solutionsofhowtodealwiththesechallengesarepresentedanddiscussedin detail. Trialregistration:InternationalStandardRandomisedControlledTrialNumber:ISRCTGermanClinical TrialRegister:DRKKeywords:Hometreatment,Psychiatry,Integratedcare,Seriouslymentallyill,Controlledtrial Background toprovide continuityof careacross services andservice The aim of modern mental health care is to enable se- sectors[3,4]. verely mentally ill people to live integrated in the com- On