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BRITIBRITISHSH JOURNAJOURNALL OOFF PP SYCHIATRYSYCHIATRY (( 22 00 00 6),6), 11 88 9,9, 33 33 00 ^^ 33 33 66

doi:do i : 11 00 .119.11 9 22 // bjp.bjp. bp.1bp.1 00 5.5. 01501 5 44 1212

UseUse ofof standardisedstandardised outcomeoutcome measuresmeasures inin adultadult mentalmental healthhealth servicesservices

RandomisedRandomised controlledcontrolled trialtrial

MIKEMIKE SLADE,SLADE, PAULPAUL McCRONE,McCRONE, ELIZABETHELIZABETH KUIPERS,KUIPERS, MORVENMORVEN LEESE,LEESE, SHARONSHARON CAHILL,CAHILL, ALBERTOALBERTO PARABIAGHI,PARABIAGHI, STEFANSTEFAN PRIEBEPRIEBE andand GRAHAMGRAHAM THORNICROFTHORNICROFTT

BackgroundBackground

standardisedstandardised outcomeoutcome measuresismeasuresis notnot universal.universal.

RoutineRoutine useuse ofof

AimsAims

standardisedstandardised outcomeoutcome assessment.assessment.

TToo evaluateevaluate thethe effectivenesseffectiveness ofof

AA randomisedrandomised controlledcontrolled trial,trial,

involving160involving160 representativerepresentative adultadult mentalmental healthhealth patientspatients andand pairedpaired staffstaff

(ISRCTN(ISRCTN16971059).Theintervention16971059).Theintervention

groupgroup ((nn¼101101)) (a)(a) completedcompleted monthlymonthly postalpostal questionnairesquestionnaires assessingassessing needs,needs, qualityquality ofof life,life, mentalmental healthhealth problemproblem severityseverity andand therapeutictherapeutic alliance,alliance, andand (b(b)) receivedreceived 3-monthly3-monthly feedback.Thefeedback.The controlcontrol groupgroup ((nn¼59)59) receivedreceived treatmenttreatment asas usual.usual.

MethodMethod

ResultsResults

improveimprove primaryprimary outcomesoutcomes ofof patient-patient- ratedrated unmetunmet needneed andand ofof qualityquality ofof life.life. OtherOther subjectivesubjective secondarysecondary outcomeoutcome measuresmeasures werewere alsoalso notimproved.Thenotimproved.The interventionintervention reducedreduced psychiatricpsychiatric in-in-

patientpatient daysdays (3.5(3.5 vv

bootstrappedbootstrapped 95%95% CI1CI1.6^25.7),.6^25.7), andhenceand hence serviceservice useuse costscosts werewere »2586»2586 (95%(95% CICI 102^5391102^5391)) lessless forintervention-groupforintervention-group patients.Netpatients.Net benefitbenefit analysisindicatedanalysisindicated thattheinterventionthattheintervention waswas costcost-effective.-effective.

TheinterventionTheintervention diddid notnot

16.416.4

meanmean days,days,

ConclusionsConclusions

measuresmeasures asimplementedinasimplementedin thisthis studystudy diddid notimprovenotimprove subjectivesubjective outcomes,outcomes, butbut waswas associatedassociated withwith reducedreduced psychiatricpsychiatric in-in- patientpatient admissions.admissions.

RoutineRoutine useuse ofof outcomeoutcome

DeclarationDeclaration ofof interestinterest

FundingFunding byby thethe MedicalMedical ResearchResearch Council.Council.

None.None.

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ThereThere isis internationalinternational consensusconsensus thatthat out-out- comecome shouldshould bebe routinelyroutinely measuredmeasured inin clin-clin- icalical workwork (Health(Health ResearchResearch CouncilCouncil ofof NewNew Zealand,Zealand, 2003;2003; Trauer,Trauer, 2003).2003). However,However, psychiatristspsychiatrists dodo notnot useuse standardisedstandardised out-out- comecome measuresmeasures routinelyroutinely (Gilbody(Gilbody etet alal,, 20022002aa),), preferringpreferring theirtheir carecare toto bebe judgedjudged byby otherother criteriacriteria (Valenstein(Valenstein etet alal,, 2004).2004). TheThe overalloverall evidenceevidence fromfrom systematicsystematic re-re- viewsviews (Gilbody(Gilbody etet alal,, 2001,2001, 20022002bb)) andand higher-qualityhigher-quality trialstrials (Ashaye(Ashaye etet alal,, 2003;2003; MarshallMarshall etet alal,, 2004)2004) isis negative,negative, soso clini-clini- cianscians remainremain unconvincedunconvinced aboutabout thethe effec-effec- tivenesstiveness ofof routineroutine outcomeoutcome measurementmeasurement (Bilsker(Bilsker && Goldner,Goldner, 2002).2002). WeWe previouslypreviously appliedapplied thethe MedicalMedical ResearchResearch CouncilCouncil (MRC)(MRC) frameworkframework forfor complexcomplex healthhealth in-in- terventionsterventions (Campbell(Campbell etet alal,, 2000)2000) toto thethe useuse ofof outcomeoutcome measuresmeasures inin adultadult mentalmental healthhealth services,services, byby reviewingreviewing relevantrelevant theo-theo- ryry (Slade,(Slade, 20022002aa)) andand developingdeveloping aa testabletestable modelmodel linkinglinking routineroutine useuse ofof outcomeoutcome mea-mea- suressures withwith improvedimproved patientpatient outcomesoutcomes (Slade,(Slade, 20022002bb).). TheThe aimaim ofof thethe presentpresent ex-ex- ploratoryploratory randomisedrandomised controlledcontrolled trialtrial waswas toto testtest thethe model.model.

METHODMETHOD

DesignDesign

TheThe trialtrial waswas intendedintended toto extendextend previousprevious workwork inin threethree ways.ways. First,First, samplesample represen-represen- tativenesstativeness waswas maximisedmaximised byby choosingchoosing patientspatients fromfrom aa sitesite whichwhich waswas demo-demo- graphicallygraphically representative,representative, andand thenthen select-select- inging thethe samplesample usingusing stratifiedstratified randomrandom samplingsampling onon knownknown prognosticprognostic factors.factors. Second,Second, outcomeoutcome measuresmeasures werewere appliedapplied longitudinally,longitudinally, i.e.i.e. withwith moremore thanthan oneone (as(as inin previousprevious studies)studies) oror twotwo administrations,administrations, toto allowallow cumulativecumulative effectseffects toto bebe investi-investi- gated.gated. Third,Third, eacheach elementelement ofof thethe pre-pre- specifiedspecified modelmodel ofof thethe interventionintervention effectseffects waswas evaluatedevaluated (Slade,(Slade, 20022002bb).). InIn summary,summary, thethe interventionintervention involvedinvolved askingasking staffstaff andand patientpatient pairspairs toto separatelyseparately completecomplete stand-stand- ardisedardised measures,measures, andand thenthen providingproviding bothboth withwith identicalidentical feedback.feedback. InIn thethe model,model, itit

waswas hypothesisedhypothesised thatthat bothboth completingcompleting thethe assessmentsassessments andand receivingreceiving thethe feedbackfeedback wouldwould createcreate cognitivecognitive dissonancedissonance (an(an awarenessawareness ofof discrepancydiscrepancy betweenbetween actualactual andand idealideal states)states) regardingregarding thethe contentcontent andand processprocess ofof care,care, whichwhich inin turnturn wouldwould leadlead toto behaviouralbehavioural changechange inin contentcontent andand pro-pro- cesscess ofof care,care, andand consequentconsequent improvementimprovement inin outcome.outcome. ThereforeTherefore thethe twotwo activeactive ingredientsingredients werewere completioncompletion ofof outcomeoutcome measuresmeasures andand receiptreceipt ofof feedback,feedback, andand thethe interventionintervention mightmight havehave hadhad anan impactimpact onon patientspatients asas wellwell asas staff.staff. Hence,Hence, inin contrastcontrast toto previousprevious studiesstudies inin whichwhich staffstaff receivedreceived feedbackfeedback onon patient-completedpatient-completed assessmentsassessments (Ashaye(Ashaye etet alal,, 2003;2003; MarshallMarshall etet alal,, 2004;2004; vanvan OsOs etet alal,, 2004),2004), inin thisthis modelmodel bothboth staffstaff andand patientspatients completedcompleted assessmentsassessments andand re-re- ceivedceived feedback.feedback. TheThe modelmodel hadhad thethe advan-advan- tagetage ofof beingbeing explicitexplicit aboutabout thethe anticipatedanticipated effectseffects ofof thethe intervention,intervention, andand thereforetherefore testabletestable andand falsifiablefalsifiable atat eacheach stage.stage.

ParticipantsParticipants

TheThe inclusioninclusion criteriacriteria forfor patientspatients werewere thatthat theythey hadhad beenbeen onon thethe case-loadcase-load ofof anyany ofof thethe eighteight communitycommunity mentalmental healthhealth teamsteams inin Croydon,Croydon, SouthSouth London,London, onon 11 MayMay 2001,2001, forfor atat leastleast 33 months;months; andand thatthat theythey werewere agedaged betweenbetween 1818 andand 6464 years.years. CroydonCroydon hashas aa nationallynationally representativerepresentative populationpopulation ofof 319319 000,000, withwith 35003500 patientspatients usingusing eighteight communitycommunity mentalmental healthhealth teams.teams. ToTo ensureensure epidemiologicalepidemiological representativeness,representativeness, samplesample selectionselection involvedinvolved stratifiedstratified randomrandom sam-sam- plingpling onon knownknown prognosticprognostic factors:factors: ageage (tertiles),(tertiles), gender,gender, ethnicityethnicity (White(White v.v. BlackBlack andand minorityminority ethnic),ethnic), diagnosisdiagnosis (psychosis(psychosis v.v. other)other) andand communitycommunity mentalmental healthhealth team.team. OneOne membermember ofof staffstaff waswas thenthen identi-identi- fiedfied whowho waswas workingworking mostmost closelyclosely withwith eacheach selectedselected patient.patient.

MeasuresMeasures

TheThe rationalerationale forfor thethe choicechoice ofof measuresmeasures isis reportedreported elsewhereelsewhere (Slade,(Slade, 20022002aa).). StaffStaff completedcompleted threethree measuresmeasures inin thethe postalpostal questionnaire.questionnaire. TheThe ThresholdThreshold AssessmentAssessment GridGrid (TAG)(TAG) isis aa 7-item7-item assessmentassessment ofof thethe se-se- verityverity ofof aa person’sperson’s mentalmental healthhealth problemsproblems (range(range 0–24,0–24, thethe lowerlower thethe score,score, thethe better)better) (Slade(Slade etet alal,, 2000).2000). TheThe CamberwellCamberwell Assess-Assess- mentment ofof NeedNeed ShortShort AppraisalAppraisal ScheduleSchedule staffstaff versionversion (CANSAS–S)(CANSAS–S) isis aa 22-item22-item as-as- sessmentsessment ofof unmetunmet needsneeds (current(current seriousserious problems,problems, regardlessregardless ofof anyany helphelp received)received) andand metmet needsneeds (no(no oror moderatemoderate problemproblem be-be- causecause ofof helphelp given)given) (range(range forfor bothboth 0–22,0–22, thethe lowerlower thethe score,score, thethe better)better) (Slade(Slade etet

USUS EE OFOF SS TANDARDTANDARDISIS EDED OUTCOMEOUTCOME MEASUREME A SURE SS ININ ADULTADULT MENTALMENTAL HEALTHHE ALTH SS ERVE RVICEICE SS

alal,, 1999).1999). TheThe HelpingHelping AllianceAlliance ScaleScale staffstaff versionversion (HAS–S)(HAS–S) isis aa 5-item5-item assessmentassessment ofof therapeutictherapeutic alliancealliance (range(range 0–10,0–10, thethe higherhigher thethe score,score, thethe better)better) (McCabe(McCabe etet alal,, 1999).1999). PatientsPatients completedcompleted threethree measuresmeasures inin thethe postalpostal questionnaire.questionnaire. TheThe CANSAS–PCANSAS–P isis aa patient’spatient’s 22-item22-item assessmentassessment ofof metmet andand unmetunmet needsneeds (scores(scores asas forfor CANSAS–CANSAS– S)S) (Slade(Slade etet alal,, 1999).1999). TheThe ManchesterManchester ShortShort AssessmentAssessment (MANSA)(MANSA) isis aa 12-item12-item assessmentassessment ofof qualityquality ofof lifelife (range(range 1–7,1–7, thethe higherhigher thethe score,score, thethe better)better) (Priebe(Priebe etet alal,, 1999).1999). TheThe HAS–PHAS–P isis aa 6-item6-item patient’spatient’s assessmentassessment ofof therapeutictherapeutic alliancealliance (score(score asas forfor HAS–S)HAS–S) (McCabe(McCabe etet alal,, 1999).1999). ThreeThree measuresmeasures werewere assessedassessed atat base-base- lineline andand follow-upfollow-up only.only. TheThe BriefBrief Psychi-Psychi- atricatric RatingRating ScaleScale (BPRS)(BPRS) isis anan 18-item18-item interviewer-ratedinterviewer-rated assessmentassessment ofof symptomssymptoms (range(range 0–126,0–126, thethe lowerlower thethe score,score, thethe better)better) (Overall(Overall && Gorham,Gorham, 1988).1988). TheThe HealthHealth ofof thethe NationNation OutcomeOutcome ScaleScale (HoNOS)(HoNOS) isis aa 12-item12-item staff-ratedstaff-rated assessmentassessment ofof clinicalclinical problemsproblems andand socialsocial functioningfunctioning (range(range 0–0– 48,48, thethe lowerlower thethe score,score, thethe better)better) (Wing(Wing etet alal,, 1998).1998). TheThe patient-ratedpatient-rated ClientClient Ser-Ser- vicevice ReceiptReceipt InventoryInventory (CSRI)(CSRI) waswas usedused toto assessassess serviceservice useuse duringduring thethe previousprevious 66 monthsmonths (Beecham(Beecham && Knapp,Knapp, 2001).2001).

SampleSample sizesize

TheThe CANSAS–PCANSAS–P andand MANSAMANSA werewere thethe pri-pri- marymary outcomeoutcome measures,measures, andand aa reductionreduction ofof 1.01.0 unmetunmet needsneeds onon thethe CANSAS–PCANSAS–P oror anan increaseincrease ofof 0.250.25 onon thethe MANSAMANSA werewere defineddefined inin advanceadvance asas thethe criteriacriteria forfor im-im- provedproved effectiveness.effectiveness. SecondarySecondary outcomeoutcome measuresmeasures werewere thethe TAG,TAG, BPRS,BPRS, HoNOSHoNOS andand hospitalhospital admissionadmission rates.rates. TheThe samplesample sizesize requiredrequired forfor thethe twotwo armsarms differeddiffered sincesince thethe studystudy alsoalso testedtested anotheranother hypoth-hypoth- esisesis withinwithin thethe interventionintervention groupgroup armarm only,only, forfor whichwhich 8585 patientspatients neededneeded toto re-re- ceiveceive thethe interventionintervention (Slade(Slade etet alal,, 2005).2005). TheThe CANSAS–PCANSAS–P unmetunmet needsneeds hashas aa stand-stand- ardard deviationdeviation ofof 1.71.7 (Thornicroft(Thornicroft etet alal,, 1998)1998) andand aa pre–postpre–post correlationcorrelation afterafter 2424 monthsmonths ofof 0.32.0.32. AssumingAssuming anan alphaalpha levellevel ofof 0.050.05 andand thatthat analysisanalysis ofof covariancecovariance isis usedused toto comparecompare tt22 valuesvalues whilewhile adjustingadjusting forfor tt11 levels,levels, aa controlcontrol groupgroup ofof 5050 wouldwould detectdetect aa changechange ofof 1.01.0 patient-ratedpatient-rated unmetunmet needneed withwith aa powerpower ofof 0.94.0.94. TheThe MANSAMANSA hashas aa standardstandard deviationdeviation ofof 0.50.5 andand aa pre–postpre–post correlationcorrelation ofof 0.50.5 (Thornicroft(Thornicroft etet alal,, 1998)1998) so,so, withwith thethe samesame assumptions,assumptions, thisthis samplesample sizesize wouldwould detectdetect aa changechange ofof 0.250.25 inin quality-of-lifequality-of-life ratingrating withwith aa powerpower ofof 0.9.0.9. ToTo allowallow forfor droppingdropping out,out, 160160 patientspatients werewere recruited.recruited.

ProceduresProcedures

EthicalEthical approvalapproval andand writtenwritten informedinformed consentconsent fromfrom allall staffstaff andand patientpatient parti-parti- cipantscipants werewere obtained.obtained. AA trialtrial steeringsteering committeecommittee metmet throughoutthroughout thethe studystudy andand requiredrequired interiminterim analysisanalysis ofof adverseadverse events.events. AllAll researchersresearchers werewere trainedtrained inin standardisedstandardised assessmentsassessments throughthrough role-play,role-play, vignettevignette ratingrating andand observedobserved assessments.assessments. Assess-Assess- mentment qualityquality waswas monitoredmonitored byby double-double- ratingrating 1313 patientpatient assessments,assessments, showingshowing acceptableacceptable concordance:concordance: 88 (2.8%)(2.8%) ofof 286286 CANCAN ratingsratings differed,differed, andand therethere waswas aa meanmean differencedifference ofof 0.140.14 inin 216216 BPRSBPRS ratings.ratings. ForFor eacheach pair,pair, baselinebaseline staffstaff andand patientpatient assessmentsassessments byby researchersresearchers composedcomposed thethe postalpostal questionnairequestionnaire plusplus trialtrial measures.measures. FollowingFollowing baselinebaseline assessment,assessment, patientspatients werewere allocatedallocated byby anan independentindependent statisti-statisti- ciancian whowho waswas maskedmasked toto thethe resultsresults ofof thethe baselinebaseline assessment.assessment. TheThe statisticianstatistician usedused aa purpose-writtenpurpose-written StataStata program,program, toto ensureensure randomrandom allocationallocation andand balancebalance onon prognos-prognos- tictic factorsfactors ofof ageage (tertiles),(tertiles), gender,gender, ethnicityethnicity (White(White v.v. BlackBlack andand minorityminority ethnic),ethnic), diag-diag- nosisnosis (psychosis(psychosis v.v. other)other) andand communitycommunity mentalmental healthhealth team.team. AllocationAllocation waswas con-con- cealedcealed untiluntil thethe interventionintervention waswas assigned.assigned. StaffStaff andand patientspatients werewere awareaware ofof theirtheir allo-allo- cationcation status.status. TheThe controlcontrol groupgroup receivedreceived treatmenttreatment asas usual,usual, involvinginvolving mentalmental healthcarehealthcare fromfrom thethe multidisciplinarymultidisciplinary communitycommunity mentalmental healthhealth teamteam focusedfocused onon mentalmental healthhealth andand socialsocial carecare needs,needs, togethertogether withwith carecare fromfrom thethe generalgeneral practitionerpractitioner forfor physicalphysical healthcarehealthcare needs.needs. TheThe interventionintervention groupgroup receivedreceived treat-treat- mentment asas usualusual and,and, inin addition,addition, staff–patientstaff–patient pairspairs werewere separatelyseparately askedasked toto completecomplete aa monthlymonthly postalpostal questionnairequestionnaire andand werewere pro-pro- videdvided byby thethe researchresearch teamteam withwith identicalidentical feedbackfeedback byby postpost atat 3-monthly3-monthly intervals.intervals. FeedbackFeedback waswas sentsent 22 weeksweeks afterafter roundround 33 andand roundround 66 postalpostal questionnaires,questionnaires, andand comprisedcomprised colour-codedcolour-coded graphicsgraphics andand text,text, showingshowing changechange overover timetime andand highlightinghighlighting areasareas ofof disagreement.disagreement. PatientsPatients werewere paidpaid £5£5 forfor eacheach roundround ofof assessments.assessments. Follow-upFollow-up assessmentsassessments werewere mademade atat 77 months.months. AtAt follow-up,follow-up, patientspatients werewere askedasked notnot toto disclosedisclose theirtheir status,status, andand assignmentassignment waswas guessedguessed byby thethe researcherresearcher afterafter thethe postalpostal questionnairequestionnaire element.element. StaffStaff andand pa-pa- tienttient self-reportself-report datadata werewere collectedcollected onon thethe cognitivecognitive andand behaviouralbehavioural impactimpact ofof thethe in-in- tervention.tervention. WrittenWritten carecare plansplans werewere auditedaudited atat baselinebaseline andand follow-up.follow-up.

AnalysisAnalysis

DifferencesDifferences inin administrationadministration timetime werewere testedtested usingusing pairedpaired samplesample tt-tests,-tests, andand be-be- tweentween patientspatients withwith andand withoutwithout follow-upfollow-up datadata usingusing chi-squaredchi-squared andand independent-independent- samplessamples tt-tests.-tests. DataData analysisanalysis waswas under-under- takentaken onon anan intention-to-treatintention-to-treat basis,basis, forfor allall participantsparticipants withwith follow-upfollow-up data.data. Effective-Effective- nessness waswas investigatedinvestigated usingusing independent-independent- samplessamples tt-tests-tests toto comparecompare thethe outcomeoutcome atat follow-upfollow-up forfor intervention-intervention- andand control-control- groupgroup patients.patients. SensitivitySensitivity analysesanalyses included:included:

(a)(a) analysisanalysis ofof covariancecovariance toto adjustadjust forfor thethe baselinebaseline level;level;

b)b) analysisanalysis ofof covariancecovariance includingincluding randomrandom effectseffects forfor staffstaff membermember andand communitycommunity mentalmental healthhealth teamteam (to(to checkcheck forfor anyany clusteringclustering effects);effects);

(c)(c) tt-test-test onon thethe outcomes,outcomes, withwith missingmissing valuesvalues imputedimputed fromfrom baselinebaseline data;data;

(d)(d) Mann–WhitneyMann–Whitney tests.tests.

AA broadbroad costingcosting perspectiveperspective waswas used.used. ProductionProduction costscosts werewere notnot included.included. Service-costService-cost datadata werewere obtainedobtained byby combin-combin- inging CSRICSRI datadata withwith unit-costunit-cost informationinformation toto generategenerate serviceservice costs.costs. MoreMore unitunit costscosts werewere takentaken fromfrom aa publishedpublished sourcesource (Netten(Netten && Curtis,Curtis, 2002).2002). SomeSome criminal-justicecriminal-justice unitunit costscosts werewere estimatedestimated specificallyspecifically forfor thethe study:study: £100£100 perper courtcourt attendanceattendance andand £50£50 perper solicitorsolicitor contact.contact. BasedBased onon assessmentassessment processingprocessing time,time, thethe averageaverage costcost ofof provid-provid- inging thethe interventionintervention waswas £400£400 perper patient.patient. ThisThis assumedassumed thatthat thethe twotwo researchersresearchers em-em- ployedployed onon thethe studystudy forfor 22 yearsyears providedprovided twotwo roundsrounds ofof thethe interventionintervention toto 100100 patients,patients, plusplus twotwo assessmentsassessments forfor 160160 patients.patients. ItIt waswas furtherfurther assumedassumed thatthat thethe assessmentsassessments entailedentailed thethe samesame administra-administra- tivetive timetime asas thethe intervention.intervention. PerPer year,year, therefore,therefore, eacheach researchresearch workerworker couldcould pro-pro- videvide 130130 assessmentsassessments oror interventions,interventions, andand thethe salarysalary costcost ofof thisthis waswas aboutabout £200£200 (i.e.(i.e. £400£400 forfor bothboth roundsrounds ofof thethe intervention).intervention). MeanMean numbernumber ofof serviceservice contactscontacts (bed-(bed- daysdays forfor in-patientin-patient care)care) andand costscosts atat follow-upfollow-up werewere comparedcompared usingusing regressionregression analysis,analysis, withwith thethe allocationallocation statusstatus andand baselinebaseline serviceservice useuse oror costcost enteredentered asas inde-inde- pendentpendent variables.variables. ResourceResource useuse datadata areare typicallytypically skewed,skewed, soso bootstrappingbootstrapping withwith 10001000 repetitionsrepetitions waswas usedused toto produceproduce confidenceconfidence intervalsintervals forfor costcost differencesdifferences (Netten(Netten && Curtis,Curtis, 2002).2002). AA sensitivitysensitivity analysisanalysis waswas performedperformed byby assessingassessing thethe significancesignificance ofof thethe differencedifference inin totaltotal costscosts afterafter excludingexcluding in-patientin-patient care.care.

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SLADESLADE ETET ALAL

Cost-effectivenessCost-effectiveness waswas investigatedinvestigated usingusing thethe net-benefitnet-benefit analysisanalysis andand cost-cost- effectivenesseffectiveness acceptabilityacceptability curvescurves (not(not shown).shown). Net-benefitNet-benefit analysisanalysis usesuses thethe equa-equa- tiontion netnet benefitbenefit¼llOO77SCSC wherewhere OO isis out-out- come,come, SCSC isis serviceservice costcost andand ll isis thethe valuevalue placedplaced onon oneone unitunit ofof outcomeoutcome (Briggs,(Briggs, 2001);2001); ll isis aa hypotheticalhypothetical amountamount thatthat wouldwould bebe problematicproblematic toto determine,determine, butbut netnet benefitsbenefits cancan bebe comparedcompared forfor differentdifferent valuesvalues ofof ll ThisThis involvedinvolved regressionregression analy-analy- sissis (controlling(controlling forfor baselinebaseline costs),costs), withwith thethe netnet benefitsbenefits associatedassociated withwith llss betweenbetween £0£0 andand £90£90 asas thethe dependentdependent variables,variables, andand al-al- locationlocation statusstatus asas thethe mainmain independentindependent variable.variable. ForFor eacheach regression,regression, 10001000 boot-boot- strapstrap resamplesresamples werewere produced,produced, andand forfor eacheach ofof thesethese thethe proportionproportion ofof regressionregression coefficientscoefficients thatthat werewere aboveabove zerozero indicatedindicated thethe probabilityprobability thatthat thethe interventionintervention waswas moremore cost-effectivecost-effective thanthan thethe controlcontrol condition.condition.

RESULTSRESULTS

ParticipantsParticipants

BetweenBetween MayMay 20012001 andand DecemberDecember 2002,2002,

160160 patientspatients werewere recruited,recruited, withwith follow-upfollow-up

completedcompleted byby JulyJuly 2003.2003. Socio-demographicSocio-demographic andand baselinebaseline clinicalclinical assessmentsassessments forfor patientspatients areare shownshown inin TableTable 1.1. AmongAmong thethe 7474 staffstaff whowho participatedparticipated inin

baselinebaseline assessmentsassessments werewere 4343 psychiatricpsychiatric nurses,nurses, 1414 socialsocial workersworkers andand 1111 psychia-psychia- trists.trists. PostalPostal questionnairequestionnaire completioncompletion ratesrates forfor staffstaff forfor roundsrounds 22 toto 66 werewere 78%,78%, 71%,71%, 67%,67%, 59%59% andand 58%58% respectively;respectively; 486486 staffstaff postalpostal questionnairesquestionnaires werewere sentsent andand 325325 (67%)(67%) returned.returned. ForFor patients,patients, thethe comple-comple- tiontion ratesrates forfor roundsrounds 2–62–6 werewere 85%,85%, 84%,84%, 76%,76%, 76%76% andand 76%76% respectively;respectively; 487487 postalpostal questionnairesquestionnaires werewere sentsent andand

386386 (79%)(79%) returned.returned. Three-monthlyThree-monthly sum-sum-

marymary feedbackfeedback waswas sentsent afterafter roundround 33 toto

9696 (95%)(95%) staff–patientstaff–patient pairs,pairs, andand afterafter

roundround 66 toto 9393 (92%)(92%) staff–patientstaff–patient pairs.pairs. TheThe trialtrial flowflow diagramdiagram isis shownshown inin Fig.Fig. 1.1. NoNo demographicdemographic oror baselinebaseline clinicalclinical variablesvariables differeddiffered betweenbetween thethe 142142 patientspatients withwith andand thethe 1818 patientspatients withoutwithout fullfull

follow-upfollow-up datadata (Fig.(Fig. 1).1). ThereThere waswas aa significantsignificant reductionreduction inin completioncompletion timetime byby thethe 129129 patientspatients forfor whomwhom completion-timecompletion-time datadata werewere availableavailable

(14.9(14.9 toto 8.78.7 min,min, PP550.001),0.001), butbut notnot forfor thethe

130130 staffstaff withwith thesethese datadata (7.8(7.8 toto 7.47.4 min).min). SomeSome researcherresearcher maskingmasking toto allocationallocation

statusstatus waswas retained.retained. InIn 8181 (57%)(57%) ofof thethe

143143 staffstaff interviewsinterviews andand inin 4141 (29%)(29%) ofof

332332

TTableable 11

SocialSocial andand baselinebaseline clinicalclinical characteristicscharacteristics ofof patientspatients ((nn¼160)160)

CharacteristicCharacteristic

AllAll

InterventionIntervention groupgroup

ControlControl groupgroup

((nn¼160)160)

((nn¼101)101)

((nn¼59)59)

Age,Age, years:years: meanmean (s.d.)(s.d.) Men,Men, nn (%)(%) Ethnicity,Ethnicity, nn (%)(%) WhiteWhite BlackBlack African^CaribbeanAfrican^Caribbean IndianIndian OtherOther HighestHighest educationaleducational level,level, nn (%)(%) NoNo formalformal qualificationqualification GCSEGCSE oror GCEGCE 11 AA levelslevels 22 HigherHigher diplomadiploma oror degreedegree NotNot knownknown PrimaryPrimary clinicalclinical diagnosis,diagnosis, nn (%)(%)

SchizophreniaSchizophrenia BipolarBipolar affectiveaffective disorderdisorder OtherOther psychosespsychoses AffectiveAffective disorderdisorder PersonalityPersonality disorderdisorder OtherOther ContactContact withwith mentalmental healthhealth services,services, meanmean (s.d.)(s.d.) YYearsears sincesince firstfirst contactcontact YYearsears inin thisthis episodeepisode ofof carecare MeasureMeasure CANSAS^SCANSAS^S unmetunmet score,score, meanmean (s.d.)(s.d.) CANSAS^SCANSAS^S metmet score,score, meanmean (s.d.)(s.d.) TAGTAG score,score, meanmean (s.d.)(s.d.) HAS^SHAS^S score,score, meanmean (s.d.)(s.d.) HoNOSHoNOS score,score, meanmean (s.d.)(s.d.) CANSAS^PCANSAS^P unmetunmet score,score, meanmean (s.d.)(s.d.) CANSAS^PCANSAS^P metmet score,score, meanmean (s.d.)(s.d.) HAS^PHAS^P score,score, meanmean (s.d.)(s.d.) MANSAMANSA score,score, meanmean (s.d.)(s.d.)

41.241.2 (11.2)(11.2)

41.841.8 (11.4)(11.4)

40.240.2 (10.8)(10.8)

7878 (49)(49)

4848 (48)(48)

3030 (51)(51)

122122 (76)(76)

7777 (76)(76)

4545 (76)(76)

2020 (13)(13)

1616 (16)(16)

99 (15)(15)

66

(4)(4)

44

(4)(4)

22

(3)(3)

1212

(8)(8)

44

(4)(4)

33

(5)(5)

6161 (38)(38)

3838 (38)(38)

2323 (39)(39)

4545 (28)(28)

2828 (28)(28)

1919 (32)(32)

1414

(9)(9)

1010 (10)(10)

33

(5)(5)

1616 (10)(10)

1111 (11)(11)

44

(7)(7)

2424 (15)(15)

1313 (13)(13)

1010 (17)(17)

6060 (38)(38)

4040 (40)(40)

2020 (34)(34)

1717 (11)(11)

88

(8)(8)

99 (15)(15)

2121 (13)(13)

1212 (12)(12)

77 (12)(12)

4343 (27)(27)

2727 (27)(27)

1616 (27)(27)

1111

(7)(7)

77

(7)(7)

44

(7)(7)

88

(5)(5)

77

(7)(7)

33

(5)(5)

13.113.1 (11.8)(11.8)

14.214.2 (12.6)(12.6)

11.111.1 (9.8)(9.8)

4.14.1 (4.2)(4.2)

4.34.3 (4.7)(4.7)

3.93.9 (3.3)(3.3)

2.982.98 (3.19)(3.19)

3.243.24 (3.31)(3.31)

2.542.54 (2.94)(2.94)

5.045.04 (3.43)(3.43)

5.065.06 (3.29)(3.29)

5.025.02 (3.69)(3.69)

5.215.21 (3.64)(3.64)

5.445.44 (3.58)(3.58)

4.814.81 (3.73)(3.73)

7.347.34 (1.61)(1.61)

7.457.45 (1.59)(1.59)

7.147.14 (1.64)(1.64)

8.878.87 (6.43)(6.43)

9.159.15 (6.63)(6.63)

8.408.40 (6.10)(6.10)

4.594.59 (3.62)(3.62)

4.364.36 (3.36)(3.36)

4.984.98 (4.05)(4.05)

4.214.21 (2.88)(2.88)

4.234.23 (2.81)(2.81)

4.174.17 (3.04)(3.04)

7.957.95 (1.94)(1.94)

8.198.19 (1.79)(1.79)

7.547.54 (2.12)(2.12)

4.254.25 (1.01)(1.01)

4.254.25 (0.99)(0.99)

4.254.25 (1.05)(1.05)

BPRSBPRS score,score, meanmean (s.d.)(s.d.)

33.5133.51 (9.29)(9.29)

33.3533.35 (9.04)(9.04)

33.7933.79 (9.78)(9.78)

CANSAS,CANSAS, CamberwellCamberwell AssessmentAssessment ofof NeedNeed ShortShort AppraisalAppraisal Schedule,Schedule, ^S,^S, staffstaff version,version, ^P,^P, patientpatient version;version; TTAG,AG, ThresholdThreshold AssessmentAssessment Grid;Grid; HoNOS,HoNOS, HealthHealth ofof thethe NationNation OutcomeOutcome Scale;Scale; HAS,HAS, HelpingHelping AllianceAlliance Scale,Scale, ^S,^S, staffstaff version,version, ^P,^P, patientpatient version;version; MANSA,MANSA, ManchesterManchester ShortShort Assessment;Assessment; BPRS,BPRS, BriefBrief PsychiatricPsychiatric RatingRating Scale.Scale.

1.1. NormallyNormally takentaken atat 1616 yearsyears ofof age.age.

2.2. NormallyNormally takentaken atat 1818 yearsyears ofof age.age.

thethe 140140 patientpatient interviews,interviews, thethe researchersresearchers werewere unableunable toto guessguess allocationallocation status.status. WhereWhere theythey diddid raterate allocationallocation status,status, theythey werewere correctcorrect forfor 9797 (92%)(92%) ofof theirtheir 105105 intervention-groupintervention-group ratings,ratings, andand forfor 5353 (95%)(95%) ofof theirtheir 5656 control-groupcontrol-group ratings.ratings. TwoTwo adverseadverse eventsevents occurred.occurred. OneOne intervention-groupintervention-group patientpatient withdrewwithdrew consentconsent duringduring thethe study,study, statingstating thatthat thethe questionsquestions werewere ‘too‘too disturbingdisturbing andand intru-intru- sive’.sive’. OneOne intervention-groupintervention-group patientpatient waswas sentsent toto prisonprison onon remandremand duringduring thethe inter-inter- vention,vention, followingfollowing aa seriousserious assault.assault. ThereThere

waswas nono evidenceevidence linkinglinking thethe assaultassault withwith involvementinvolvement inin thethe study.study.

PrimaryPrimary outcomesoutcomes

Follow-upFollow-up assessmentsassessments ofof thethe twotwo primaryprimary outcomesoutcomes areare shownshown inin TableTable 2.2. ForFor thethe 142142 patientspatients withwith baselinebaseline andand follow-upfollow-up patient-ratedpatient-rated unmet-needunmet-need data,data, 7979 (56%)(56%) hadhad atat leastleast 11 fewerfewer unmetunmet needsneeds atat follow-up,follow-up, comprisingcomprising 5151 (55%)(55%) outout ofof 9393 inin thethe interventionintervention groupgroup andand 2828 (57%)(57%) outout ofof 4949 inin thethe controlcontrol group.group. ThereThere

USUS EE OFOF SS TANDARDTANDARDISIS EDED OUTCOMEOUTCOME MEASUREME A SURE SS ININ

ADULTADULT MENTALMENTAL HEALTHHE ALTH SS ERVE RVICEICE SS

ADULTADULT MENTALMENTAL HEALTHHE ALTH SS ERVE RVICEICE SS Fig.Fig. 11 CONSORTCONSORT diagram.diagram.

Fig.Fig. 11

CONSORTCONSORT diagram.diagram.

TTableable 22

Follow-upFollow-up measuresmeasures

MeasureMeasure

Score,Score, meanmean (s.d.)(s.d.)

DifferenceDifference

95%95% CICI

InterventionIntervention groupgroup

ControlControl groupgroup

 

((nn¼93)93)

((nn¼49)49)

 

CANSAS^SCANSAS^S unmetunmet needsneeds

2.932.93 (3.56)(3.56)

2.022.02 (2.57)(2.57)

770.910.91

772.02.0 toto 0.10.1 770.10.1 toto 2.42.4 771.81.8 toto 0.70.7 770.80.8 toto 0.40.4 772.72.7 toto 2.02.0 771.21.2 toto 1.51.5 771.11.1 toto 1.61.6 771.01.0 toto 0.50.5 770.40.4 toto 0.30.3 772.22.2 toto 4.84.8

CANSAS^SCANSAS^S

metmet needsneeds

4.064.06

(2.89)(2.89)

5.235.23

(3.86)(3.86)

1.171.17

TAGTAG

5.145.14 (3.58)(3.58)

4.584.58

(3.34)(3.34)

770.550.55

HAS^SHAS^S

7.547.54 (1.62)(1.62)

7.337.33

(1.88)(1.88)

770.210.21

HoNOSHoNOS

9.239.23 (6.55)(6.55)

8.888.88

(6.53)(6.53)

770.360.36

CANSAS^PCANSAS^P

unmetunmet needsneeds

3.963.96

(3.58)(3.58)

4.104.10

(4.31)(4.31)

0.150.15

CANSAS^PCANSAS^P metmet needsneeds HAS^PHAS^P MANSAMANSA BPRSBPRS

4.394.39 (3.32)(3.32)

4.634.63

(4.71)(4.71)

0.250.25

7.377.37 (2.15)(2.15)

7.127.12 (2.38)(2.38)

770.250.25

4.274.27 (1.04)(1.04)

4.204.20 (1.14)(1.14)

770.070.07

31.3931.39 (9.27)(9.27)

32.7132.71 (11.39)(11.39)

1.31.3

CANSAS,CANSAS, CamberwellCamberwell AssessmentAssessment ofof NeedNeed ShortShort AppraisalAppraisal Schedule,Schedule, ^S,^S, staffstaff version,version, ^P,^P, patientpatient version;version; TTAG,AG, ThresholdThreshold AssessmentAssessment Grid;Grid; HAS,HAS, HelpingHelping AllianceAlliance Scale,Scale, ^S,^S, staffstaff version,version, ^P,^P, patientpatient version;version; HoNOS,HoNOS, HealthHealth ofof thethe NationNation OutcomeOutcome Scale;Scale; MANSA,MANSA, ManchesterManchester ShortShort Assessment;Assessment; BPRS,BPRS, BriefBrief PsychiatricPsychiatric RatingRating Scale.Scale.

waswas nono evidenceevidence forfor differencesdifferences betweenbetween groupsgroups inin meanmean follow-upfollow-up patient-ratedpatient-rated unmetunmet needneed (mean(mean differencedifference 0.15,0.15, 95%95% CICI 771.201.20 toto 1.49,1.49, PP¼0.83).0.83). TheThe sensitivitysensitivity analysesanalyses allall confirmedconfirmed thisthis conclusion.conclusion.

ThereThere waswas nono evidenceevidence forfor clusteringclustering becausebecause ofof staffstaff (intraclass(intraclass correlationcorrelation 0.0)0.0) andand aa minimalminimal impactimpact forfor communitycommunity mentalmental healthhealth teamteam (intraclass(intraclass correlationcorrelation

0.01).0.01).

ForFor thethe 141141 patientspatients withwith baselinebaseline andand follow-upfollow-up quality-of-lifequality-of-life data,data, 5656 (40%)(40%) hadhad aa MANSAMANSA ratingrating atat leastleast 0.250.25 higherhigher atat follow-up,follow-up, comprisingcomprising 3939 (42%)(42%) outout ofof 9292 inin thethe interventionintervention groupgroup andand 1717 (35%)(35%) outout ofof 4949 inin thethe controlcontrol group.group. ThereThere waswas nono evidenceevidence forfor differencesdifferences betweenbetween groupsgroups inin meanmean follow-upfollow-up qualityquality ofof lifelife (mean(mean differencedifference 770.07,0.07, 95%95% CICI 770.440.44 toto 0.31,0.31, PP¼0.72).0.72). TheThe sensitivitysensitivity analysesanalyses allall confirmedconfirmed thisthis conclusion.conclusion. IntraclassIntraclass correlationscorrelations werewere 0.0780.078 forfor patientspatients withwith thethe samesame staffstaff membermember andand 0.0050.005 forfor patientspatients belongingbelonging toto thethe samesame communitycommunity mentalmental healthhealth team.team.

SecondarySecondary outcomesoutcomes

ThereThere waswas nono evidenceevidence forfor differencesdifferences be-be- tweentween groupsgroups forfor thethe threethree subjectivesubjective sec-sec- ondaryondary outcomes:outcomes: mentalmental healthhealth problemproblem severityseverity (mean(mean differencedifference 770.55,0.55, 95%95% CICI 771.81.8 toto 0.7,0.7, PP¼0.38),0.38), symptomssymptoms (mean(mean differencedifference 1.3,1.3, 95%95% CICI 772.22.2 toto 4.8,4.8, PP¼0.46)0.46) oror socialsocial disabilitydisability (mean(mean differ-differ- enceence 770.4,0.4, 95%95% CICI 772.72.7 toto 2.0,2.0, PP¼0.46).0.46). ServiceService useuse isis shownshown inin TableTable 3.3. Intervention-groupIntervention-group patientspatients hadhad re-re-

ducedduced hospitalhospital admissions,admissions, withwith admissionsadmissions inin thethe 66 monthsmonths beforebefore follow-upfollow-up beingbeing

0.33,0.33, boot-boot-

strappedstrapped 95%95% CICI 770.460.46 toto 770.04)0.04) andand tendingtending toto bebe shortershorter (mean(mean 3.53.5 daysdays v.v. 10.010.0 days,days, bootstrappedbootstrapped 95%95% CICI 7716.416.4 toto 1.5).1.5). Criminal-justiceCriminal-justice serviceservice differencesdifferences werewere owingowing toto 121121 daysdays spentspent inin prisonprison byby oneone intervention-groupintervention-group patient.patient. TableTable 44 showsshows thethe costcost ofof servicesservices used.used. TotalTotal costscosts increasedincreased byby anan averageaverage ofof £1109£1109 inin thethe controlcontrol groupgroup andand fellfell byby anan averageaverage ofof £1928£1928 inin thethe interventionintervention group.group. Follow-upFollow-up costscosts werewere £2586£2586 lessless forfor thethe in-in- terventiontervention group.group. MostMost ofof thethe differencedifference waswas owingowing toto reducedreduced in-patientin-patient costscosts and,and, afterafter excludingexcluding these,these, thethe meanmean totaltotal costcost differencedifference waswas £338£338 lessless forfor thethe inter-inter- ventionvention group,group, whichwhich waswas notnot statisticallystatistically significantsignificant (95%(95% CICI 77£1500£1500 toto £731).£731). Net-benefitNet-benefit analysisanalysis indicatedindicated thatthat ifif nono valuevalue waswas placedplaced onon improvedimproved qualityquality ofof life,life, thethe probabilityprobability thatthat thethe interventionintervention waswas cost-effectivecost-effective wouldwould bebe approximatelyapproximately 0.98,0.98, andand anyany positivepositive valuevalue wouldwould raiseraise thisthis probabilityprobability stillstill higher.higher. AA positivepositive valuevalue placedplaced onon aa clinicallyclinically significantsignificant reductionreduction inin unmetunmet needsneeds wouldwould reducereduce thethe probabil-probabil- ityity ofof thethe interventionintervention beingbeing cost-effective,cost-effective, asas unmetunmet needsneeds werewere marginallymarginally lessless fre-fre- quentquent inin thethe controlcontrol group.group. However,However, thethe valuevalue wouldwould needneed toto approachapproach £1£1 millionmillion

bothboth fewerfewer (means(means 0.130.13 vv

333333

SLADESLADE ETET ALAL

TTableable 33

NumberNumber ofof serviceservice contactscontacts inin 66 -month-month periodsperiods beforebefore baselinebaseline andand follow-upfollow-up interviewsinterviews

ContactContact

BaselineBaseline 11

ControlControl groupgroup

InterventionIntervention groupgroup

Follow-upFollow-up 11

ControlControl groupgroup

InterventionIntervention groupgroup

95%95% CICI ofof follow-upfollow-up differencedifference 22

 

((nn¼59)59)

((nn¼101)101)

((nn¼49)49)

((nn¼93)93)

 

PsychiatricPsychiatric in-patientin-patient GeneralGeneral in-patientin-patient AccidentAccident andand emergencyemergency GeneralGeneral out-patientout-patient DayDay carecare CommunityCommunity mentalmental healthhealth nursenurse SocialSocial workerworker GeneralGeneral practitionerpractitioner PsychiatristPsychiatrist PsychologistPsychologist OccupationalOccupational therapytherapy CriminalCriminal justicejustice servicesservices ResidentialResidential carecare

10.310.3 (31.4)(31.4)

15.615.6 (37.4)(37.4)

16.416.4 (45.8)(45.8)

3.53.5 (16.1)(16.1)

7725.725.7 toto 771.61.6 772.22.2 toto 0.20.2 770.40.4 toto 0.30.3 770.70.7 toto 0.70.7 775.25.2 toto 10.510.5 776.56.5 toto 1.61.6 771.31.3 toto 3.53.5 771.71.7 toto 1.21.2 773.43.4 toto 1.01.0 772.72.7 toto 1.61.6 779.29.2 toto 2.12.1 0.30.3 toto 5.85.8 774.74.7 toto 0.90.9

1.91.9 (13.9)(13.9)

0.50.5 (2.9)(2.9)

0.80.8 (4.4)(4.4)

0.70.7

(5.1)(5.1)

0.40.4 (1.1)(1.1)

0.70.7 (2.1)(2.1)

0.40.4 (1.0)(1.0)

0.40.4

(1.4)(1.4)

1.01.0 (3.6)(3.6)

0.60.6 (1.5)(1.5)

0.60.6 (1.6)(1.6)

0.60.6

(2.3)(2.3)

14.214.2 (28.3)(28.3)

14.114.1 (30.2)(30.2)

7.17.1 (17.7)(17.7)

9.59.5

(30.4)(30.4)

6.26.2

(7.4)(7.4)

9.39.3 (11.1)(11.1)

9.69.6 (12.9)(12.9)

9.69.6

(13.0)(13.0)

2.52.5 (5.5)(5.5)

3.93.9

(9.4)(9.4)

2.42.4

(5.3)(5.3)

3.83.8 (10.5)(10.5)

2.52.5 (4.2)(4.2)

2.12.1

(3.2)(3.2)

2.82.8 (5.2)(5.2)

2.32.3

(4.5)(4.5)

3.93.9 (4.5)(4.5)

3.73.7 (4.7)(4.7)

3.83.8 (7.6)(7.6)

2.72.7

(4.0)(4.0)

1.01.0 (3.5)(3.5)

1.51.5 (5.2)(5.2)

1.51.5

(7.6)(7.6)

1.31.3

(4.6)(4.6)

4.14.1 (12.6)(12.6)

1.21.2

(4.3)(4.3)

4.74.7 (26.2)(26.2)

1.31.3 (10.8)(10.8)

0.70.7

(1.9)(1.9)

0.70.7 (2.9)(2.9)

0.00.0 (0.0)(0.0)

2.02.0 (14.0)(14.0)

3.33.3 (8.2)(8.2)

3.23.2

(8.1)(8.1)

5.25.2 (10.2)(10.2)

3.33.3 (8.4)(8.4)

1.1. FiguresFigures areare meanmean (s.d.)(s.d.) numbernumber ofof contacts,contacts, withwith thethe exceptionexception ofof in-patientin-patient carecare wherewhere thethe numbernumber ofof daysdays areare recorded.recorded.

2.2. BootstrappedBootstrapped confidenceconfidence intervalinterval usingusing percentilepercentile methodmethod andand controllingcontrolling forfor baselinebaseline serviceservice use.use.

TTableable 44

CostCost ofof servicesservices usedused inin 66 -month-month periodsperiods beforebefore baselinebaseline andand follow-upfollow-up interviewsinterviews (2001^2002)(2001^2002)

ServiceService

BaselineBaseline 11

ControlControl groupgroup

InterventionIntervention groupgroup

Follow-upFollow-up 11

ControlControl groupgroup

InterventionIntervention groupgroup

95%95% CICI ofof follow-upfollow-up differencedifference 22

 

((nn¼59)59)

((nn¼101)101)

((nn¼49)49)

((nn¼93)93)

 

PsychiatricPsychiatric in-patientin-patient GeneralGeneral in-patientin-patient AccidentAccident andand emergencyemergency GeneralGeneral out-patientout-patient DayDay carecare CommunityCommunity mentalmental healthhealth nursenurse SocialSocial workerworker GeneralGeneral practitionerpractitioner PsychiatristPsychiatrist PsychologistPsychologist OccupationalOccupational therapytherapy CriminalCriminal justicejustice servicesservices ResidentialResidential carecare TotalTotal (all(all services)services)

18241824 (5558)(5558)

27622762 (6624)(6624)

28932893 (8100)(8100)

626626 (2847)(2847)

7745424542 toto 77287287 77596596 toto 4242 773131 toto 2626 775555 toto 6060 77106106 toto 275275 77397397 toto 5050 773030 toto 285285 771717 toto 2424 77390390 toto 9595 774949 toto 9595 77256256 toto 167167 44 toto 467467 7718411841 toto 9696 7753915391 toto 77102102

514514 (3803)(3803)

132132

(789)(789)

206206 (1(1196)196)

176176 (1396)(1396)

3232

(79)(79)

5353 (155)(155)

2828

(76)(76)

3333

(101)(101)

8181

(297)(297)

4747 (127)(127)

5252 (128)(128)

4848

(187)(187)

562562 (1324)(1324)

476476 (1114)(1114)

177177

(443)(443)

246246

(763)(763)

251251

(395)(395)

367367 (653)(653)

437437

(751)(751)

325325

(553)(553)

173173 (480)(480)

284284

(957)(957)

9898

(224)(224)

219219

(699)(699)

7777 (143)(143)

3939

(46)(46)

5959

(97)(97)

4545

(82)(82)

533533 (1342)(1342)

412412 (902)(902)

423423

(787)(787)

296296

(504)(504)

5757 (216)(216)

8888 (333)(333)

4949 (194)(194)

7878

(282)(282)

154154 (683)(683)

3333 (130)(130)

105105

(551)(551)

7474

(679)(679)

1414

(45)(45)

2121

(101)(101)

00

(0)(0)

152152 (1296)(1296)

825825 (2077)(2077)

833833 (2144)(2144)

16781678 (3523)(3523)

900900

(2334)(2334)

50975097 (7863)(7863)

55485548 (7431)(7431)

62066206

(9994)(9994)

36203620

(4095)(4095)

1.1. FiguresFigures areare meanmean (s.d.)(s.d.) costscosts inin poundspounds sterling.sterling.

2.2. BootstrappedBootstrapped confidenceconfidence intervalinterval usingusing percentilepercentile methodmethod andand controllingcontrolling forfor baselinebaseline serviceservice use.use.

beforebefore therethere wouldwould bebe eveneven aa 60%60% chancechance thatthat thethe controlcontrol conditioncondition waswas moremore cost-cost- effective.effective. TheThe cognitivecognitive andand behaviouralbehavioural impactsimpacts ofof thethe interventionintervention werewere investigatedinvestigated atat follow-up,follow-up, andand areare shownshown inin TableTable 5.5. CareCare planplan auditaudit indicatedindicated nono differencedifference betweenbetween baselinebaseline andand follow-upfollow-up forfor directdirect carecare (possible(possible rangerange 0–10,0–10, interventionintervention changechange 0,0, controlcontrol changechange 0.7,0.7, differencedifference inin

334334

changechange 0.7,0.7, 95%95% CICI 770.10.1 toto 1.5),1.5), plannedplanned assessmentsassessments (range(range 0–4,0–4, interventionintervention changechange 0.2,0.2, controlcontrol changechange 0.2,0.2, differencedifference 770.1,0.1, 95%95% CICI 770.40.4 toto 0.3),0.3), referralsreferrals (range(range 0–3,0–3, interventionintervention changechange 0.0,0.0, controlcontrol changechange 0.1,0.1, differencedifference inin changechange 0.1,0.1, 95%95% CICI 770.30.3 toto 0.5)0.5) andand carercarer supportsupport (range(range 0–6,0–6, interventionintervention changechange 0.5,0.5, controlcontrol changechange 0.5,0.5, differencedifference 0.0,0.0, 95%95% CICI 770.60.6 toto 0.6).0.6).

DISCUSSIONDISCUSSION

ThisThis randomisedrandomised controlledcontrolled trialtrial evaluatedevaluated thethe impactimpact overover 77 monthsmonths ofof monthlymonthly as-as- sessmentsessment ofof importantimportant outcomesoutcomes byby staffstaff andand patients,patients, plusplus feedbackfeedback toto bothboth everyevery 33 months.months. RoutineRoutine outcomeoutcome assessmentassessment waswas notnot shownshown toto bebe effective,effective, sincesince meansmeans ofof thethe subjectivesubjective outcomesoutcomes werewere similarsimilar

USUS EE OFOF SS TANDARDTANDARDISIS EDED OUTCOMEOUTCOME MEASUREME A SURE SS ININ ADULTADULT MENTALMENTAL HEALTHHE ALTH SS ERVE RVICEICE SS

TTableable 55

Intervention-groupIntervention-group staffstaff ((nn¼81)81) andand patientpatient ((nn¼85)85) assessmentassessment ofof validityvalidity ofof thethe modelmodel

QuestionQuestion 11

NumberNumber (%)(%) replyingreplying ‘Y‘Yes’es’

 

StaffStaff

PatientPatient

DidDid fillingfilling inin thethe postalpostal questionnairesquestionnaires makemake youyou thinkthink aboutabout thethe carecare thethe serviceservice useruser gets?gets? DidDid fillingfillinginin thethe postalpostal questionnairesquestionnaires makemake youyou thinkthink aboutabout youryour relationshiprelationship withwith thethe serviceservice user?user? DidDid youyou receivereceive thethe feedback?feedback? DidDid youyou readread thethe feedback?feedback? DidDid youyou understandunderstand thethe feedback?feedback? DidDid receivingreceiving thethe feedbackfeedback makemake youyou thinkthink aboutabout thethe carecare thethe serviceservice useruser isis receiving?receiving? DidDid receivingreceiving thethe feedbackfeedback makemake youyou thinkthink aboutabout youryour relationshiprelationship withwith thethe serviceservice user?user? DidDid receivingreceiving thethe feedbackfeedback leadlead youyou toto discussdiscuss thethe contentcontent ofof theirtheir carecare withwith thethe serviceservice user?user? DidDid receivingreceiving thethe feedbackfeedback leadlead youyou toto changechange youryour behaviourbehaviour withwith thethe serviceservice user?user?

7272 (94)(94)

6969 (81)(81)

7171 (92)(92)

6060 (71)(71)

7070 (88)(88)

8080 (94)(94)

6969 (96)(96)

7070 (85)(85)

6161 (88)(88)

6969 (84)(84)

5959 (82)(82)

5252 (64)(64)

6060 (85)(85)

5353 (65)(65)

3636 (51)(51)

2626 (31)(31)

3030 (41)(41)

1313 (16)(16)

1.1. InIn thethe patientpatient version,version, wordingwording waswas alteredaltered toto referrefer toto staffstaff givinggiving care.care.

acrossacross thethe twotwo groups;groups; itit was,was, however,however, associatedassociated withwith costcost savings,savings, sincesince patientspatients receivingreceiving thethe interventionintervention hadhad fewerfewer psychiatricpsychiatric admissions.admissions. SubjectiveSubjective out-out- comescomes appearedappeared notnot toto havehave changed,changed, be-be- causecause thethe interventionintervention waswas unsuccessfulunsuccessful inin promotingpromoting behaviourbehaviour change.change.

UnchangedUnchanged subjectivesubjective outcomesoutcomes

SubjectiveSubjective outcomesoutcomes diddid notnot significantlysignificantly improve,improve, soso thethe modelmodel diddid notnot accuratelyaccurately predictpredict thethe impactimpact ofof thethe intervention.intervention. OnOn thethe basisbasis ofof theirtheir self-reportself-report atat follow-up,follow-up, mostmost staffstaff andand patientspatients werewere promptedprompted toto considerconsider thethe processprocess andand contentcontent ofof carecare bothboth byby completingcompleting thethe assessmentsassessments andand consideringconsidering thethe feedback.feedback. However,However, self-self- reportreport andand carecare planplan auditsaudits indicateindicate thatthat behaviourbehaviour diddid notnot changechange asas aa result.result. TheThe interventionintervention waswas notnot entirelyentirely im-im- plementedplemented asas planned,planned, sincesince thethe turnoverturnover ofof staffstaff waswas high:high: 4141 (26%)(26%) patientspatients hadhad aa differentdifferent membermember ofof staffstaff atat 7-month7-month follow-up,follow-up, includingincluding 2929 (29%)(29%) fromfrom thethe interventionintervention group.group. ThisThis maymay havehave invali-invali- dateddated somesome ofof thethe intendedintended process-relatedprocess-related mechanismsmechanisms ofof action.action. Similarly,Similarly, therethere waswas aa progressiveprogressive reductionreduction inin staffstaff returnreturn rates,rates, whichwhich maymay indicateindicate aa growinggrowing lacklack ofof en-en- thusiasmthusiasm ifif thethe feedbackfeedback waswas notnot perceivedperceived asas useful.useful. MoreMore generally,generally, improvementimprovement inin subjec-subjec- tivetive outcomesoutcomes maymay requirerequire greatergreater attentionattention

toto thethe contextcontext ofof thethe interventionintervention (Iles(Iles && Sutherland,Sutherland, 2001).2001). ServiceService staffstaff whosewhose sharedshared beliefsbeliefs areare congruentcongruent withwith thethe useuse ofof outcomeoutcome measuresmeasures areare necessarynecessary ifif thethe in-in- terventiontervention isis notnot toto bebe swimmingswimming againstagainst thethe tide.tide. ThisThis willwill involveinvolve changingchanging organi-organi- sationalsational beliefsbeliefs andand workingworking practices,practices, set-set- tingting upup researchresearch programmesprogrammes ratherrather thanthan isolatedisolated researchresearch studies,studies, andand demon-demon- strationstration sitessites (Nutley(Nutley etet alal,, 2003).2003). AA demonstrationdemonstration sitesite inin thisthis contextcontext wouldwould bebe aa serviceservice whichwhich usesuses outcomeoutcome measuresmeasures asas aa routineroutine elementelement ofof carecare onon anan ongoingongoing basis.basis. WhatWhat wouldwould suchsuch aa serviceservice looklook like?like? TheThe characteristicscharacteristics ofof suchsuch aa serviceservice wouldwould bebe aa focusfocus onon thethe patient’spatient’s perspectiveperspective inin assessment,assessment, thethe systematicsystematic identificationidentification ofof thethe fullfull rangerange ofof healthhealth andand socialsocial carecare needsneeds ofof thethe patient,patient, thethe developmentdevelopment ofof innovativeinnovative servicesservices toto addressaddress thesethese needs,needs, andand thethe evaluationevaluation ofof thethe successsuccess ofof thethe serviceservice inin termsterms ofof impactimpact onon qualityquality ofof life.life. TheThe interventionintervention alsoalso needsneeds toto bebe moremore tailoredtailored toto fosteringfostering behaviourbehaviour changechange –– identifyingidentifying topicstopics whichwhich thethe patientpatient wouldwould likelike toto discussdiscuss withwith staffstaff (van(van OsOs etet alal,, 2004),2004), oror providingproviding (and(and auditingauditing forfor levellevel ofof implementation)implementation) moremore prescriptiveprescriptive adviceadvice forfor staffstaff actionaction (Lambert(Lambert etet alal,, 2001).2001). TheThe feedbackfeedback waswas providedprovided everyevery 33 months,months, whichwhich maymay havehave beenbeen tootoo longlong aa gapgap –– feedbackfeedback maymay needneed toto bebe moremore promptprompt (Bickman(Bickman etet alal,, 2000;2000; LambertLambert etet alal,, 2001;2001; HodgesHodges && Wotring,Wotring, 2004).2004). However,However,

thethe objectiveobjective criterioncriterion ofof admissionadmission ratesrates diddid improve,improve, andand soso somesome aspectsaspects ofof behaviourbehaviour diddid change.change. ThisThis isis consideredconsidered below.below.

ReducedReduced admissionsadmissions

WhyWhy werewere admissionsadmissions reduced?reduced? ReductionsReductions inin in-patientin-patient useuse andand costscosts maymay bebe causedcaused byby earlierearlier oror differentdifferent action.action. StaffStaff receivedreceived regularregular clinicalclinical informationinformation aboutabout interven-interven- tiontion patients,patients, possiblypossibly triggeringtriggering earlierearlier supportsupport andand hencehence avoidingavoiding thethe needneed forfor admission.admission. ThisThis couldcould bebe investigatedinvestigated byby assessingassessing whetherwhether thethe timetime betweenbetween prodro-prodro- malmal indicationsindications ofof relapserelapse andand keyworkerkeyworker awarenessawareness ofof thethe needneed forfor increasedincreased supportsupport isis reducedreduced whenwhen outcomeoutcome informationinformation isis routinelyroutinely collectedcollected andand availableavailable toto staff.staff. Furthermore,Furthermore, staffstaff hadhad moremore informationinformation aboutabout intervention-groupintervention-group thanthan control-groupcontrol-group patients.patients. SinceSince decisionsdecisions toto admitadmit patientspatients areare mademade usingusing thethe bestbest clinicalclinical informationinformation available,available, therethere maymay havehave beenbeen aa marginalmarginal raisingraising ofof thethe admissionadmission thresholdthreshold forfor inter-inter- ventionvention patients.patients. FurtherFurther attentionattention needsneeds toto bebe givengiven toto thethe influencesinfluences whichwhich alteralter thresh-thresh- oldsolds forfor in-patientin-patient admission.admission. Finally,Finally, thethe wayway inin whichwhich thethe feedbackfeedback isis usedused byby patientspatients andand staffstaff needsneeds toto bebe in-in- vestigated,vestigated, forfor exampleexample usingusing qualitativequalitative methodsmethods suchsuch asas conversationconversation analysisanalysis (McCabe(McCabe etet alal,, 2002).2002).

LimitationsLimitations

ServiceService useuse datadata werewere obtainedobtained viavia patientpatient self-report,self-report, whichwhich maymay bebe unreliable.unreliable. How-How- ever,ever, aa numbernumber ofof studiesstudies havehave foundfound ade-ade- quatequate correlationcorrelation betweenbetween self-reportself-report datadata andand informationinformation collectedcollected byby serviceservice provi-provi- dersders (Caslyn(Caslyn etet alal,, 1993;1993; GoldbergGoldberg etet al,al,

2002).2002).

NeitherNeither patientspatients nornor staffstaff werewere maskedmasked toto allocationallocation status.status. ResearchersResearchers conductingconducting thethe follow-upfollow-up interviewsinterviews werewere partiallypartially maskedmasked –– theythey guessedguessed allocationallocation statusstatus correctlycorrectly forfor 38%38% ofof staffstaff andand forfor 68%68% ofof patients.patients. InIn thethe controlcontrol group,group, 4646 (78%)(78%) ofof thethe 5959 patientspatients hadhad aa membermember ofof staffstaff whowho alsoalso hadhad anan intervention-groupintervention-group patient,patient, indicat-indicat- inging thatthat contaminationcontamination waswas possiblepossible be-be- tweentween thethe twotwo groups.groups. AA solutionsolution toto contaminationcontamination problemsproblems wouldwould havehave beenbeen clustercluster randomisationrandomisation byby thethe communitycommunity mentalmental healthhealth team.team. ClusterCluster randomisedrandomised controlledcontrolled trialstrials overcomeovercome somesome ofof thethe theoretical,theoretical, ethicalethical andand practicalpractical problemsproblems ofof investigatinginvestigating mentalmental healthhealth servicesservices (Gil-(Gil- bodybody && Whitty,Whitty, 2002),2002), althoughalthough theythey areare moremore complexcomplex toto designdesign andand requirerequire largerlarger samplessamples andand moremore complexcomplex analysisanalysis (Camp-(Camp- bellbell etet alal,, 2004).2004). OnOn thethe basisbasis ofof intraclassintraclass

335335

SLADESLADE ETET ALAL

correlationscorrelations inin thisthis study,study, aa clustercluster trialtrial ran-ran- domisingdomising byby communitycommunity mentalmental healthhealth teamteam wouldwould requirerequire anan increaseincrease ofof 20%20% inin thethe samplesample size.size. RandomisationRandomisation byby staffstaff membermember wouldwould entailentail anan increaseincrease ofof 10%.10%. Finally,Finally, thethe follow-upfollow-up periodperiod ofof 77 monthsmonths maymay notnot havehave beenbeen longlong enoughenough toto capturecapture allall potentialpotential serviceservice useuse changeschanges broughtbrought aboutabout byby thethe intervention.intervention.

ImplicationsImplications forfor cliniciansclinicians andand policypolicy makersmakers

ThisThis studystudy demonstratesdemonstrates thatthat itit isis feasiblefeasible toto implementimplement aa carefullycarefully developeddeveloped approachapproach toto routineroutine outcomeoutcome assessmentassessment inin mentalmental healthhealth services.services. TheThe staffstaff responseresponse raterate overover thethe 77 roundsrounds ofof assessmentassessment waswas 67%,67%, thethe patientpatient responseresponse raterate waswas 79%,79%, andand 92%92% ofof thethe in-in- terventiontervention groupgroup receivedreceived twotwo roundsrounds ofof feed-feed- back.back. Furthermore,Furthermore, 84%84% ofof staffstaff andand patientspatients received,received, readread andand understoodunderstood thethe feedback.feedback. TheThe interventionintervention costcost aboutabout £400£400 perper personperson which,which, forfor aa primaryprimary carecare trusttrust withwith aa case-loadcase-load ofof 35003500 people,people, wouldwould equateequate toto aboutabout £1.4£1.4 million.million. However,However, thethe resultsresults ofof thisthis studystudy suggestsuggest thatthat thisthis costcost couldcould bebe moremore thanthan offsetoffset byby savingssavings inin serviceservice use.use. ThisThis studystudy isis thethe firstfirst investigationinvestigation ofof thethe useuse ofof standardisedstandardised outcomeoutcome measuresmeasures overover timetime inin aa representativerepresentative adultadult mentalmental healthhealth sample.sample. AsAs withwith previousprevious studiesstudies (Ashaye(Ashaye etet alal,, 2003;2003; MarshallMarshall etet alal,, 2004),2004), subjectivesubjective outcomesoutcomes diddid notnot improve.improve. How-How- ever,ever, aa carefullycarefully developeddeveloped andand implementedimplemented approachapproach toto routinelyroutinely collectingcollecting andand usingusing outcomeoutcome datadata hashas beenbeen shownshown toto reducereduce admissionsadmissions andand consequentlyconsequently savesave money.money.

ACKNOWLEDGEMENTACKNOWLEDGEMENT

WWee thankthank IanIanWhite,White, thethe trialtrial statistician.statistician.

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