Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study

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Research Paper

Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized

controlled study

^$

I.E.O. Moljord

^a,c,d,

*, M.L. Lara-Cabrera

^b,c,d

, Ø. Salvesen

^e

, M.B. Rise

^f

, D. Bjørgen

^g

,

D.Ø. Antonsen

^g

, T.M. Olsø

^h

, G.H. Evensen

^h

, C.B Gudde

^i,j

, O.M. Linaker

^c,d

, A. Steinsbekk

^e

, L. Eriksen

^a,c

aNidarosCommunityMentalHealthCentre,DivisionofPsychiatry,St.Olav’sUniversityHospital,Trondheim,Norway

bTillerCommunityMentalHealthCentre,DivisionofPsychiatry,St.Olav’sUniversityHospital,Trondheim,Norway

cDepartmentofNeuroscience,FacultyofMedicine,NorwegianUniversityofScienceandTechnology(NTNU),Trondheim,Norway

dDepartmentofResearchandDevelopment,DivisionofPsychiatry,St.OlavsUniversityHospital,Trondheim,Norway

eDepartmentofPublicHealthandGeneralPractice,FacultyofMedicine,NTNU,Trondheim,Norway

fDepartmentofAppliedSocialSciences,FacultyofHealthandSocialSciences,NorwegianUniversityofScienceandTechnology,Trondheim,Norway

gKBT,DepartmentofUserExperienceandServiceDevelopment,Trondheim,Norway

hNAPHA,NorwegianResourceCentreforCommunityMentalHealth,Trondheim,Norway

iDepartmentofBrøset,CentreforResearchandEducation,DivisionofPsychiatry,St.Olav’sUniversityHospital,Trondheim,Norway

jDepartmentofSocialWorkandHealthScience,FacultyofSocialScienceandTechnologyManagement,NTNU,Trondheim,Norway

ARTICLE INFO Articlehistory:

Received18July2016

Receivedinrevisedform8January2017 Accepted9January2017

Keywords:

Patientparticipation

Self-referraltoinpatienttreatment Patientcontrolledadmission Patientactivation

Recovery

ABSTRACT

Objective:Toinvestigatetheeffectofhavingacontractforself-referraltoinpatienttreatment(SRIT)in patientswithseverementaldisorders.

Methods:Arandomizedcontrolledtrialwith53adultpatients;26participantsreceivedaSRITcontract, whichtheycouldusetoreferthemselvesintoaCommunityMentalHealthCentreuptoﬁvedaysforeach referralwithoutcontactingadoctorinadvance.Outcomeswereassessedafter12monthswiththeself- reportquestionnairesPatientActivationMeasure(PAM-13),RecoveryAssessmentScale(RAS),andthe BehaviorandSymptomIdentiﬁcationScale(BASIS-32)andanalyzedusinglinearmixedandregression models.

Results:TherewasnosigniﬁcanteffectonPAM-13(estimatedmeandifference(emd) 0.41,95%CI(CI):- 7.49–6.67),norontheRAS(emd0.02,CI:-0.27–0.31)orBASIS-32(0.09,CI:-0.28–0.45).Anexploratory posthocanalysisshowedeffectofSRITinthosewithlowPAMbelow47(p=0.049).

Conclusion:Therewerenogroupdifferencesafter12months,butbothgroupsmaintainedtheirbaseline levels.

Practiceimplications:SRITcontractscanberecommendedasitsupportstherightstoself-determination, promoteuserparticipationindecision-makinginowntreatmentwithoutanyindicationofadverse effects.

1.Introduction

Shared decisionmaking andthe righttoself-determination are important ethical aspects in mental health services [1,2].

Such aspects are not well implemented in mental health servicesatpresent[3].Thus,thereisaneedforservicemodels offeringpatientstobeempoweredasdecision-makers[4,5],get involved as active partners [6] and participate in treatment decisions[7].

Patientactivationisdeﬁnedasknowledge,skillsandconﬁdence inmanagingone’sownhealth[8].Beingactiveandengagedhas been associated with improved health outcomes and positive experiencewithcare,andbettercopingskills andrecovery[9].

Conversely, patients with low levels of activation may be too

$Trialdesign:Clinicaltrials.govNCT01133587.

*Corresponding authorat:IngerEliseOpheimMoljord,NidarosCommunity Mental Health Centre, Division of Psychiatry, St. Olavs University Hospital, Østmarkveien21,Postboks1893Lade,N-7440Trondheim,Norway.

E-mailaddress:[email protected](I.E.O. Moljord).

http://dx.doi.org/10.1016/j.pec.2017.01.008

ContentslistsavailableatScienceDirect

Patient Education and Counseling

j o u r n al h o m e p a g e : w w w . el s e v i e r . c o m / l o c a t e / p a t ed u c o u

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overwhelmed to manage their own health, and have low conﬁdenceandinsufﬁcientproblem-solvingskills[10].Regaining authoritythroughbeingself-empoweredwithsupportisrequired for re-establishing and stabilizing the hope of recovery [11].

Participation in decisions empowers individuals and promotes theirpersonal recovery[12]. Personal recovery is deﬁned as a processof“changingone’sattitudes,values,feelings,goals,skills, and/orroles”for“livingasatisfying,hopefulandcontributinglife”, evenwhilelivingwithadisease[13].Suchrecoveryrequiresthat personswithseverementaldisordersestablishameaningfullife through taking more control over their lives in spite of their disorders[14].Inadditiontoimprovedpersonalconﬁdenceand willingness toask for help, there is focus on goal and success orientation, reliance on others and avoiding domination by symptoms[15].

People with severe mental disorders occasionally need treatment from inpatient services in phases with increased symptomsandcrises[16].Aﬂexible,safeandpredictablesupport fromtheserviceswillfacilitatethepatients’copinginthosephases [17].Self-referraltoinpatienttreatment(SRIT)mightbeonewayto obtainthat[18].SRIThasrecentlybeenimplementedinseveral CommunityMental health Centers (CMHC) in Norway[19–26].

Thisinterventionisbasedonlegislationregardingpatients’rights [27],personalizedcareplanning[28]andshareddecisionmaking [29].SRITseemstobeaﬂexiblemodeladaptedtopatients’needs [23].ArecentsystematicreviewofpublishedreportsonSRITfound only qualitative and observational studies [18]. However, two recentrandomizedcontrolledtrials,evaluatedtheeffectofSRIT.

Bothstudies and the present studyare parts of a larger study investigatingtheeffectofintroducingSRIT.Onestudyfoundno effectofSRITinre-admissions,inpatientsdays,andcoercionafter 12 months [22]. The other study found no effects on patient activationandrecoveryafter4months[21].Itwouldthereforebe important to investigate the effect of SRIT after 12 months regarding activation, recovery, mental health symptoms and functioning.Suchinformationhasnotbeenreported.

Objectives: The mainaimwastoassess theeffectof aSRIT contractontheprimaryoutcomepatientactivation(PAM-13).The secondary outcomes were recovery (RAS) and behavior and symptoms identiﬁcation (BASIS-32) after 12 months compared tothosewhoreceivedtreatmentasusual(TAU).

2.Methods

2.1.Trialdesign

Anopenparallel-grouprandomized,andcontrolledtrial(RCT) wasconductedataCMHCincentralNorway.Theinclusionperiod wasbetweenMay2010andDecember2012.

Theprojecthadone userrepresentativeinthemanagement groupandtwouserresearchersintheresearchgroup.Thetrialwas registeredatclinicaltrials.gov(NCT01133587).

2.2.Settings

ThecatchmentareafortheCMHCinCentralNorwayis94,000 inhabitants.

2.3.Participants

The main inclusion criteria were adults clinically diagnosed with schizophrenia or bipolar disorder. Some had several diagnosesandcomorbiddrugaddiction.Thedruguseshouldbe relativelyundercontrol.Theyneededtohavehadpreviouscontact withthe CMHCrehabilitation unit, and to havehad continued long-term primary and specialist healthcare outpatients

consultations.Theexclusioncriteriawereseveresubstanceabuse problemsorself-destructivebehavior,inabilitytoconsent,orbeing unabletouseSRITasintended.Aninterdisciplinary teamatthe CMHCdecidedwhowaseligibleforthestudy.

Therecruitmenttookplacebyinformingpatientsandstaffboth orally and in writing. The participants either volunteered themselves or were recommended by their therapists. All participantshadtobeapprovedbyaspecialistinpsychiatry.They couldeitherbeinpatientoroutpatientbeforetheywereincluded intothestudy,buttheyneededtobedischargedthesamedayor withinafewdays.Thirty-three(62.3%)participants(18inSRIT,15 inTAU)wereincludedandrandomizedwhiletheywereinpatients, andtheystayedforanaverageof13.6days.

2.4.Intervention

ThepurposeofaSRITcontractwastoincreaseuserparticipa- tionandtoofferpatientswithworseningsymptomseasyaccessto inpatienttreatmentwithouttheneedtocontact thedoctor.All participantsinthisstudyreceivedexempliﬁedinformationabout howtouseSRITpriortoinclusion(e.g.structureduringtheday,or experienced warning signs and worsening symptoms of their mentaldisorder).Allwereencouragedtoestablishanindividual plan,asallpatientswithseverementaldisordershavearightto have[30].Participantswereinformedthatiftheywererandom- izedtoTAU,aSRITcontractwouldbeofferedafteroneyearifthey stillfulﬁlledtheinclusioncriteria.Theguidanceinhowtousethe contractwasrepeatedtoeach SRITparticipantafterrandomiza- tion.Theparticipantswereencouraged todiscusstheirwarning signsandwhattheycoulddotoreducethemwiththeirtherapist.

SRITparticipantscouldself-refertotherehabilitationsection betweenMondaysandFridaybetween8:00a.m.and8:00p.m.for uptoﬁvedays.Iftheywantedtostayovertheweekend,theyhadto contacttheunitbefore3:30p.m.onFriday.Aminimumof14days betweeneachstaywasenforced,whichwasdonetoavoidcapacity problemsandbasedonproceduresfromtheﬁrststudyinNorway [19].Participantswereinvitedtofollowtheunits’usualrulesand structure. AllSRIT patientshada consultation witha specialist nurseinpsychiatryafterreferralwhodocumentedinthehealth recordonthebasisoftheconsultation.Consultationswithadoctor or psychologistwerenot planned,but couldbearranged.Their medicationplansshouldnormallynotbechangedduringthestay, butchangeswerepossibleunderdoctors’instruction.Allpatients couldbeadmittedtotheCMHCorhospitalsbyadoctorfollowing normalprocedures.ParticipantsrandomizedtoTAUfollowedusual proceduresiftheyneededhospitalization.

2.5.Outcomes

Theoutcomeswereassessedatbaselineandafter12months.A few participants completed the surveys at home. The rest completed the self-report questionnaires at the CMHC by themselves.Afewneededassistancetocompletethescales.

2.5.1.Primaryoutcome

TheprimaryoutcomePatientActivationMeasure(PAM-13)is themostfrequentlyusedmeasureofactivationinhealthcare[7].It measuresbothpatient’sbeliefsabouttheirabilitytoself-manage and theirconﬁdencetotakeaction[7].Thetranslated[31] and validatedNorwegianPAM-13wasused[31,32].PAM-13is a13- item, self-reportquestionnairemeasuringknowledge,skills and conﬁdenceinmanagingone’shealth,whichisscoredonafour- pointLikertscalefrom1=stronglydisagreeto4=stronglyagree, additionally0=notapplicable[8,33].ThePAM-13rawscores(sum score)wereconvertedintoatheoreticalrangeof0 100[33]and can be divided into four levels where 1=may not yet believe

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activation is important (47.0), 2=a lack of conﬁdence and knowledgeintakingaction(47.1–55.1),3=beginningtotakeaction (55.2–67.0),and4=takingaction(67.1)[34].Theselevelsmaybe usedascut-offsforstratifyingdata[34].

2.5.2.Secondaryoutcomes

Recovery(RAS)isdevelopedtomeasurepersonalperspective onrecoveryamongpatientswithseverementaldisorders[15]and isacommonlyusedmeasure[15,35].RASisvalidated[15,35]and comprises 24 itemsthat measure recovery fromsevere mental disorders on a five-point Likert scale, going from 1, which is completelydisagree,to5,whichiscompletelyagree[15].Thescale assessesfivevalidatedfactors:1, personalconfidenceand hope (nineitems; range 9–45); 2, willingness toask for help (three items;range 3–15);3,goaland successorientation(five items;

range5–25);4,relianceonothers(fouritems;range4–20);and5, nodominationbysymptoms(threeitems;range3–15)[15,36].The scalewastranslatedintoNorwegianforthisstudyusingforward and backward translation with two people conducting each translation.

Behavior and Symptoms Identification Scale (BASIS-32) is developedtomeasuresymptomandfunctioningdifficultiesthat lead to a need for mental health services [37]. BASIS-32 is a commonlyusedmeasureinmentalhealth[37].Basis-32,includes 32 items on a five-point Likert scale, where 0 indicates no difficulties and 4 indicates severe difficulties [37]. The scale measuresfivefactors:1,relationtoselfandothers(sevenitems);2, depression/anxiety(sixitems);3,everydaylifeandrolefunction- ing(nineitems);4,impulsiveandaddictivebehavior(sixitems);

and5,psychosis(fouritems)[37].Factors1,2,4and5areassessed

usingthetotal score,dividedbythenumberofitemsanswered (meanscores),whilefactor3usesthehighestrating.BASIS-32has beenvalidated[38],translatedandretranslated fromEnglishto Norwegianinaccordancewithcurrentstandards.

2.6.Samplesize

Thesamplesizecalculationwasbasedonatwosamplet-testto ﬁndadifferenceinPAM-13scoresamonggroupsof10.Withan equalstandarddeviation(SD)of11,signiﬁcancelevelof0.05and 80%power,21participantswererequiredineacharm.Toallowfor drop-outs,thesamplesizewassetto60participants.TheSDof11 wasbasedontheresultsfromtheNorwegianvalidationofPAM-13 amongpatientswithsomaticdisorders[31].

2.7.Randomization

A block randomization was completed using a web-based randomizationsystem(WebCRF,version1.3),whichwasdevel- opedandadministeredbyNorwegianUniversityofScienceand Technology, Trondheim, Norway. The randomization was bal- anced1:1,andstratiﬁedbywhetherornotpatientswereusinga special outpatient follow-up service (Psychiatric Ambulatory Rehabilitation Team), which was assumed to provide extra support.

2.8.Blinding

No ordinary blinding was done, but the statistician who analyzedthedatawasblindedtogroupallocation.

Fig.1.Flowchart.

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2.9.Ethics

ThetrialwasapprovedbytheRegionalCommitteeforMedical andHealthResearchEthicsinEast–Norway(no2009/1704).All participants signed consent forms prior to the study. No compensationforparticipationwasgiven.

2.10.Statistics

The characteristicsof theparticipants for both groups were analyzed usingtwo-tailed Mann Whitney Utests, independent samplet-tests,andChisquaretestsofdistributions.

Theeffectsoftheinterventionwereanalyzedaccordingtothe intentiontotreat principle(ITT) [39] and perprotocol,using a linear mixedmodel. This models uses allavailable data in the presence of dropouts, and there is no need for multiple imputations[40].Theper-protocolanalysisonlyincludedpartic- ipantswhocompletedtheprotocolfortheirallocatedtreatment andwhohadtheopportunitytousethecontract.Thosewhocould notusethecontract(e.g.moved,died,hadlong-termhospitaliza- tion)wereexcluded.

Patient identification was specified as a random effect, accounting for the within-subject correlation. The effect of interventionandtimewas specifiedasfixedwiththefollowing three levels: baseline, TAU after 12 months and SRIT after 12

months.A10-yearagedifference(p=0.002)betweenthegroupsat baseline was identiﬁedand age was foundto bean important predictorforPAMandRAS.Thus,anadditionallinearmixedmodel analysiswithageaddedascovariatewasperformed.

Supplementary post-hoc linear regression analyses were performed to assess the effect of the intervention for patients with PAM–1347, using the cut off points for those with the lowest activation level [34]. The dependent variable was the changeinPAM-13frombaselineto12months.Theindependent variablesweredichotomizedbaselinePAM–1347and>47and SRITvs.TAU.CorrespondinganalyseswereperformedforRASand BASIS-32usingtheir50thpercentilesfordichotomization.

Theconﬁdenceinterval(CI)wassetto95%forallstatisticsand the p-valuewas setto0.05. No interimanalysisor stopping guidelineswereused.Missingdatawasmanagedaccordingtothe guidelinesofthequestionnairesused.Thestatisticalanalyseswere carriedoutusingIBMcorp.SPSS,version22.0[41]andRversion 2.13.1[42].

3.Results

3.1.Participants

TheﬂowoftheparticipantsisshowninFig.1.Ofthe64eligible participants, a group of 10 had not completed their inpatient

Table1

ServiceusercharacteristicsatbaselineforSRITandTAU,andobservedvalueofPAM-13,BASIS-32andRASatbaselineand12months.

SRIT n=26

TAU n=27

p

AgeMean(SD) 45.7(12.6) 35.2(11.7) 0.002^a

Gendern(%) 0.50^b

Woman 12(46.1) 10(37.0)

Men 14(53.9) 17(63.0)

Diagnosis(ICD10)

Schizophreniaandbipolardisorders 0.30^b

Schizophreniadisorders 18(69.2) 22(81.5)

Bipolardisorders 8(30.8) 5(18.5)

Comorbiddiagnosis 10(38.4) 7(26.0) 0.24^b

Substancedisorder 8(30.8) 5(18.5) 0.31^b

Livingsituation

Livinginrelationwithother 4(15.4) 3(11.1)

Livingalone 22(84.6) 24(88.9)

Lifeincome

Work 1(3.8) 1(3.7)

Sicknessbeneﬁts/courses /disability/retirement/

22(84.6) 22(81.5) 0.94^c

student 3(11.5) 4(14.8)

PsychiatricAmbulatoryRehabilitationTeam(PART)n(%) 8(30.8) 10(37) 0.63^c

Observedvalue:

Baselineoutcome(mean,SD)

PAM-13 64.12(16.09) 63.89(15.29) 0.96^a

BASIS-32 1.13(0.74) 1.40(0.74) 0.20^a

RAS 3.79(0.67) 3.59(0.79) 0.32^a

12monthsoutcome(mean,SD)

PAM-13 65.64(16.78) 65.07(16.70) 0.91^a

BASIS-32 1.17(0.87) 1.21(0.81) 0.87^a

RAS 3.93(0.68) 3.81(0.71) 0.56^a

SRIT=Self-referraltoinpatienttreatment.

TAU=Treatmentasusual.

PAM 13=PatientactivationMeasure.

BASIS-32=BehaviourandSymptomIdentiﬁcationScale.

RAS=RecoveryassessmentScale.

a =Independentt-test(two-tailed).

b =Chisquares(22,two-tailed).

c =Mann-WhitneyUtest.

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treatment,didnotmeettheinclusioncriteriaordidnotwantto participate,leaving54patientstoberandomizedintothestudy.

OnepatientintheTAUgroupwithdrewafterrandomization.The ﬁnalsamplecontained53participants,with26patientsintheSRIT groupand27patientsinthecontrolgroup.Sevenpatientscould notcompletetheinterventionperiodandwereexcludedfromthe per-protocolanalyses(twodied,twomoved,twowithdrew,and onewaslong-termhospitalized).

3.2.Baselinedata

Themeanageofparticipantswas40.4(range:21–73,SD13.1), with22femalesand31males(Table1),wherethoseinSRITwere on average 10 years older than those in TAU. There were no signiﬁcantdifferencesingenderdistributionbetweenthegroups andnearlyallpatientslivedaloneandreceiveddisabilitybeneﬁts.

Complementary analyses were also done for other baseline characteristics(diagnosis, living situation and life income), but withnon-signiﬁcantresults,andarenotshown.

3.3.Implementationofintervention

Twenty-threeofthe26SRITparticipants(88%)completedthe interventionand20oftheSRITparticipants(77%)usedtheSRIT contractactively.Themedianwas1.5admissionsand5inpatient daysduringthe12-monthperiod.Moreinformationisgiveninthe recentpaperofSigrunarsonetal.[22].

3.4.Outcome

3.4.1.Intentiontotreatandperprotocolanalyses

Themeanscoresat12monthsforthemainoutcomePAM-13 were65.51inSRITand65.92inTAU(Table2),andtheywerenot signiﬁcantlydifferent.Theestimateddifferenceinmean(est.diff) was 0.41,(95%CI= 7.49–6.67,p=0.91).Therewerenosigniﬁcant differencesoneitherofthesecondaryoutcomes.Themeanscores ofRASwere3.86forSRITand3.84forTAU(est.diff0.02,95%CI:

0.27–0.31,p=0.90).TheBASIS-32scoreswereforSRIT1.27and forTAU1.18(est.diff0.09,95%CI: 0.28–0.45,p=0.63)(Table2).

Theper-protocolanalysesalsorevealednon-signiﬁcantdifferences (Table3).

3.4.2.Ageascovariate(modelbasedmixedmodeladjustedforage) No signiﬁcantdifferencesbetween theSRITand TAU groups wereseeninPAM-13(p=0.58),RAS(p=0.80)orBASIS-32(p=0.49) whenthemixedmodel was adjustedtoage40.4 (meanageat baseline)andtoage41.4attheendofthe12months(Table4).

3.4.3.PosthocanalysisofinteractionbetweenbaselinePAM-13and treatmentgrouponchangeinPAM-13

There was an interaction effect between the dichotomized baselinePAM-13andthetreatmentgroup(p=0.046),sixpatients (threeineach group).AmongthosewithPAM47,theeffectof SRIT compared to TAU was estimated at 19.53 (CI 0.03–39.04, p=0.049).ForthosewithPAM>47,theeffectofSRITcomparedto TAUwasestimatedat 2.63(CI10.51–5.25,p=0.51).

3.4.4.TheinteractionbetweenbaselineRASandtreatmentgroupon changeinRAS;andforbaselineBASIS-32andtreatmentgroupon changeinBASIS-32

Therewasnosigniﬁcantinteractionbetweenthedichotomized baselineRAS(tolowerorhigherthanthe50%percentile)andthe treatment group on change in RAS. A corresponding analysis showedthesameforBASIS-32.

3.4.5.Changeswithingroups

TherewasnosignificantdifferencewithingroupsinPAM-13 (Table2).Therecoveryfactor,“willingnesstoaskforhelp”changed significantlyfrombaselineto12monthswithintheSRITgroup, (est.diff0.38,95%CI:0.01–0.76,p=0.05)(Table5).Therewereno significantwithin-groupdifferencesintheotherfactorsofRASand BASIS-32(Table5).

4.Discussionandconclusion

4.1.Discussion

Contrarytotheexpectations,therewerenosigniﬁcantgroup differencesforPAM-13,RASandBASIS-32.However,anexplorative posthocanalysisindicatedthat patientswithlow activationin SRIThadmoreimprovementonPAM-13comparedwiththosein TAU.Therewasnoevidenceforanydeteriorationasaresultofthe intervention;Theoutcomeswerestableduringthe12months.

Twentyofthe26SRITparticipants(77%)usedtheSRITcontract actively.TherewerenosigniﬁcantgroupdifferencesbetweenSRIT and TAU in total number of inpatient days [22]. Both groups decreasedtheirtotalnumberofinpatientdaysabout40%[22].This parallelspreviousstudieswhich havereporteddecreaseintotal inpatientdaysforSRITparticipants[19,25,26],butthosereports [19,25,26]lackedacontrol-group.Sinceourcontrol-grouphadthe samereductionininpatientdays,wecannotascribethereduction tothe SRIT intervention.These studies also reportedincreased numberofadmissions,whichisinlinewithourSRITparticipants [22].

Therewasnosigniﬁcantgroupdifferenceinpatientactivation during 12 months SRIT intervention, accordingly SRIT did not

Table2

Modelbasedmixedmodel,ITTanalysesfrombaselineto12months,withinandbetweeneachgroup.

Outcome Meanatbaseline Meansat12-months Withingroups,frombaselineto12months Betweengroups,at12months

Mean 95%CI Mean 95%CI change 95%CI p diff 95%CI p

PAM-13 64.0 59.67 68.34 0.41 7.49 6.67 0.91

-SRIT 65.51 59.89 71.13 1.50 3.55 6.56 0.56

-TAU 65.92 60.01 71.83 1.91 3.46 7.29 0.49

RAS 3.69 3.50 3.88 0.02 0.27 0.31 0.90

-SRIT 3.86 3.62 4.10 0.17 0.04 0.38 0.11

-TAU 3.84 3.59 4.10 0.15 0.07 0.37 0.18

BASIS-32 1.27 1.05 1.48 0.09 0.28 0.45 0.64

-SRIT 1.27 0.99 1.55 0.00 0.26 0.26 0.99

-TAU 1.18 0.88 1.48 -0.09 0.36 0.19 0.53

PAM-13=PatientActivationMeasure(rangefrom0–100,anincreaseinscoresindicatesimprovement).BASIS-32=TheBehaviourandSymptomIdentiﬁcationScale(range0–

128,adecreaseinscoresindicatesimprovement).RAS=RecoveryAssessmentScale(range24–120,anincreaseinscoresindicatesimprovement).

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improvepatient’sactivation.Thestudyincludedmostlyinpatients ontheirwaytobedischarged,andwhohadknowledgeandskills afteryearsofexperienceinmentalhealthservices.Thismayhave contributedtohigheractivationlevelatbaseline(>64,beginningto takeaction)andthusitmightbemoredifﬁculttoobtainfurther improvementin activation. Twenty of 26 participantsused the SRIT contractforself-referralduringtheinterventionperiod,which showedthattheytookactionandresponsibilityforownhealth.

Due to lack of SRIT studies reporting patients assessed questionnaires one should be careful comparing other studies withthepresent.However,otherinterventionstudiesaimingto improvepatient activationfoundimprovement among patients withmentaldisorders[43,44],whileanotherfoundnosigniﬁcant difference[45].Allstudieshadlowerpatientactivationlevelat baselinethanthepresentstudy.

Thepost-hoctestshowingthatthethreeSRITparticipantswho hada PAM scorebelow thelowestactivationlevel47[34] at baseline,hadsigniﬁcantlyhigherPAMcomparedtothoseinTAU after12months.However,anexploratoryposthocanalysiscan onlybeusedforgenerating thehypothesisthatSRITisa better alternative for those with low activation. But the result is interestingin light of what Hibbardand Greene foundin their review regarding evidence of patients’ activation and health outcomes,(i.e.patientswithlowactivationtendtoimprovetheir Patient Activation Measure most) [46], and that effective interventionsmighthelpthose withlowestactivitytobemore

active[7].OnecanimaginethataSRITinterventioncanhelpthose patientstobecomemoreactivelyinvolvedintheirowntreatment by offering support, and possibilities which increase levels of activationandself-management[10].

RAS was stable over 12 months and no signiﬁcant group differenceswerefound.However,therewasasigniﬁcantwithin- group improvement in one of the recovery factors for SRIT:

“willingnesstoaskforhelp”.Thismayindicatethatthoseinthe intervention group developed an increased conﬁdence in obtainingmentalhealthcareontheirownduringtheinterven- tionperiod.Thisisanimportantaspectintherecovery-process [47–49].Moreover,qualitativestudiesnestedwithinthepresent RCTreportedthatSRITparticipantstalkedmoreabouthowmore active cognitive strategies were used, and expressed less resignation, hopelessnessandpowerlessnessthan TAUpatients [20],andthatSRITpatientsincreasedtheirconﬁdenceandability tocope[23].Thus,thesestudiesalongwithothers[18]givesome indicationthatSRITmayempowerandpromoteself-determination. Two other interventions among patients with mental disorders aimingtoimprove recovery likewisefoundnoeffect onrecovery[50,51].

WefoundnosigniﬁcantgroupdifferencesonBASIS-32.Both grouphadrelativelylowbaselinescores,and werestableafter the intervention period. There was no evidence for any deterioration on symptoms and functioning as measured by BASIS-32. SRIT is reported to be safe for included patients Table3

Modelbasedmixedmodel,perprotocolanalysesfrombaselineto12months,withinandbetweeneachgroup.

Out come

Mean atbaseline

Means at12-months

Withingroups,

frombaselineto12months

Betweengroups, at12months

Mean 95%CI Mean 95%CI change 95%CI p diff 95%CI p

PAM-13 62.8 58.39 67.15 1.44 5.68 8.57 0.69

SRIT 65.48 59.92 71.05 2.71 2.43 7.85 0.30

TAU 64.04 58.16 69.91 1.27 4.21 6.74 0.65

RAS 3.65 3.44 3.86 0.03 0.27 0.33 0.85

SRIT 3.82 3.56 4.07 0.17 0.05 0.38 0.13

TAU 3.79 3.52 4.05 0.14 0.09 0.37 0.23

BASIS-32 1.29 1.06 1.52 0.03 0.34 0.40 0.88

SRIT 1.27 0.98 1.56 0.02 0.29 0.24 0.87

TAU 1.24 0.93 1.55 0.05 0.34 0.23 0.72

PAM–13=PatientActivationMeasure(rangefrom0to100,anincreaseinscoresindicatesimprovement).

RAS=RecoveryAssessmentScale(range24–120,anincreaseinscoresindicatesimprovement).

BASIS–32=TheBehaviourandSymptomIdentiﬁcationScale(range0–128,adecreaseinscoresindicatesimprovement).

Table4

Linearmixedmodel,ITTanalysesfrombaselineto12months,withinandbetweeneachgroupadjustedforage*.

Outcome Mean atbaseline

Means at12-months

Withingroups,

frombaselineto12months

Betweengroups, at12months

Mean 95%CI Mean 95%CI d 95%CI p d 95%CI p

PAM-13 64.01 59.83 68.19 2.05 9.22 5.13 0.58

SRIT 64.63 59.09 70.17 0.62 4.48 5.72 0.81

TAU 66.67 60.86 72.49 2.67 2.73 8.07 0.33

RAS 3.69 3.50 3.88 0.04 0.33 0.26 0.80

SRIT 3.83 3.59 4.07 0.14 0.07 0.35 0.14

TAU 3.87 3.62 4.12 0.18 0.04 0.40 0.11

PAM–13=PatientActivationMeasure13(rangefrom0to100,anincreaseinscoresindicatesimprovement).

RAS=RecoveryAssessmentScale24(range24–120,anincreaseinscoresindicatesimprovement).

TAU=TreatmentasusualSRIT=Self-referraltoinpatienttreatment.

*Ageisestimatedwithuseofthemeanvalueatbaseline40.43andat12months41.43.

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[20,23].However,severementaldisordersarecomplex,require support to manage deteriorations, and may require more complex interventions [52]. SRIT supports the legislation on patients’ rights, and the medical ethical principles of doing good, autonomy,justice [53].

Thecurrentstudyhasstrengthsandlimitationsthatcanaffect theinterpretation of the findings. This is the first randomized controlled study measuring the long-term effects of a SRIT contract.However,ourfindingsshouldbeinterpretedwithcaution duetotherelativelysmallnumberofparticipants.Althoughthe sample size reached the predefined number, the standard deviationusedinthepowercalculation(SD=11)waslowerthan theoneinthepresentstudy(SD=16.7).

Thenon-signiﬁcantmainresultcouldbeduetothequestion- nairesused,whichmightnothavecoveredtheaspectsthatthe patientsfoundmostimportant.Allparticipantsknewtheywould haveaSRITcontractfromthedaytheycompletedthe12-months score.Theywerehappytogetacontract,whichcouldhaveaffected theirscorings.

Recoverycanbedeﬁnedinvariousways[54],andthemethod weappliedmaynothaveasufﬁcientscopetomeasureallsidesof personalizedrecovery[55].Theparticipantswerenotsystemati- callydiagnosedusingTheStructuredClinicalInterviewforDSM-IV AxisIDisorders(SCID-I)[56],butwereclinicallydiagnosedbased onatleasttwoyearsofpreviouscontact.

4.2.Conclusion

Therewerenosigniﬁcanteffectsonpatientactivation,personal recoveryorsymptomsandfunctioningforpatientshavingaSRIT contractcomparedtothosewithTAU,butbothgroupmaintained theirbaseline levels, after12 months.An exploratory posthoc analysis generated a hypothesis that SRIT may be a better alternativefor thosewithlow activation.Additionalresearchis neededtobetterunderstandtheeffectsandpotentialofSRIT.

4.3.Practiceimplication

SRIT in community mental health services represents a supplement to promote user participation in decision-making, andtomeetpatients’rights.

Authors’contributions

IEOM collected, analyzed and interpreted data, contributed withtheanalyses,wroteandﬁnishedthemanuscript.MLLChave contributed with the analyses and the manuscript. ØS have analyzed the main data and contributed in completing the manuscript. GHE, TMO, CBG, DØA, DB, MBR and AS have contributed to the design and completing of the manuscript.

OMLhavecontributedwiththemanuscript.Allauthorshaveread and acceptedtheﬁnalmanuscript. LEhascontributedwiththe Table5

ModelbasedmixedmodelITT,frombaselineto12months,withinandbetweeneachgrouponthesubscoresinRAS-24andBASIS-32.

Outcome Meansbaseline Meansat12months Withingroupsfrombaselineto12months Betweengroupsat12months

Mean 95%CI Mean 95%CI d 95%CI p d 95%CI p

RAS PCH

SRIT 3.51 3.27 3.75 3.62 3.32 3.91 0.10 0.15 0.35 0.42 0.10 0.45 0.25 0.57

TAU 3.72 3.40 4.03 0.20 0.06 0.47 0.13

WAH

SRIT 3.97 3.71 4.23 4.35 3.99 4.71 0.38 0.01 0.76 0.05 0.09 0.42 0.59 0.73

TAU 4.26 3.88 4.65 0.30 0.10 0.69 0.14

GSO

SRIT 3.99 3.76 4.21 4.18 3.89 4.47 0.19 0.07 0.46 0.16 0.07 0.30 0.45 0.70

TAU 4.11 3.80 4.41 0.12 0.16 0.40 0.41

ROO

SRIT 4.12 3.89 4.35 4.17 3.88 4.47 0.05 0.20 0.31 0.68 0.02 0.39 0.34 0.90

TAU 4.20 3.89 4.51 0.08 0.20 0.35 0.58

NDS

SRIT 2.89 2.57 3.21 3.21 2.78 3.65 0.32 0.11 0.75 0.14 0.34 0.25 0.94 0.25

TAU 2.87 2.40 3.33 0.02 0.48 0.43 0.92

BASIS-32 REL

SRIT 1.42 1.16 1.68 1.31 0.95 1.67 0.11 0.48 0.25 0.54 0.06 0.55 0.44 0.82

TAU 1.36 0.98 1.75 0.06 0.44 0.33 0.77

DEP

SRIT 1.57 1.30 1.85 1.50 1.12 1.88 0.07 0.45 0.31 0.72 0.10 0.62 0.42 0.71

TAU 1.60 1.20 2.00 0.03 0.38 0.44 0.89

DLR

SRIT 1.68 1.41 1.96 1.74 1.37 2.11 0.06 0.29 0.41 0.74 0.27 0.22 0.75 0.28

TAU 1.48 1.09 1.87 0.21 0.58 0.17 0.28

IAB

SRIT 0.58 0.42 0.75 0.58 0.37 0.79 0.01 0.19 0.17 0.93 0.13 0.12 0.38 0.32

TAU 0.45 0.23 0.67 0.14 0.33 0.05 0.16

PSY

SRIT 0.87 0.62 1.11 0.97 0.65 1.28 0.10 0.19 0.39 0.49 0.08 0.33 0.48 0.72

TAU 0.89 0.56 1.23 0.03 0.28 0.33 0.87

RAS=RecoveryAssessmentScale24(range24–120,anincreaseinscoresindicatesimprovement).PCH-personalconﬁdenceandhope,WAH-willingnesstoaskforhelp,GSO- goalandsuccessorientation,ROO-relianceonothers,NDS-nodominationbysymptoms.

BASIS–32=TheBehaviourandSymptomIdentiﬁcationScale32(range0–128,adecreaseinscoresindicatesimprovement).REL-relationtoselfandothers,DEP-depression/

anxiety,DLR-dailyliving/rolefunctioning,IAB-impulsive/addictivebehaviour,PSY-psychosis.