Citation
An Integrated-Delivery-of-Care Approach to Improve Patient Reported Physical Function and Mental Well-Being After Orthopaedic Trauma: Protocol for a Randomised Controlled Trial

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Title:
An Integrated-Delivery-of-Care Approach to Improve Patient Reported Physical Function and Mental Well-Being After Orthopaedic Trauma: Protocol for a Randomised Controlled Trial
Series Title:
Trials. 2018 Jan 11;19(1):32. doi: 10.1186/s13063-017-2430-5.
Creator:
Vincent, Heather
Publisher:
BioMed Central
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English
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Journal Article

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Abstract:
BACKGROUND: Orthopedic trauma injury impacts nearly 2.8 million people each year. Despite surgical improvements and excellent survivorship rates, many patients experience poor quality of life (QOL) outcomes years later. Psychological distress commonly occurs after injury. Distressed patients more frequently experience rehospitalizations, pain medication dependence, and low QOL. This study was developed to test whether an integrative care approach (IntCare; ten-step program of emotional support, education, customized resources, and medical care) was superior to usual care (UsCare). The primary aim was to assess patient functional QOL (objective and patient-reported outcomes) with secondary objectives encompassing emotional wellbeing and hospital outcomes. The primary outcome was the Lower Extremity Gain Scale score. METHODS/DESIGN: A single-blinded, single-center, repeated measures, randomized controlled study is being conducted with 112 orthopedic trauma patients aged 18-85 years. Patients randomized to the IntCare group have completed or are receiving a guided ten-step support program during acute care and at follow-up outpatient visits. The UsCare group is being provided the standard of care. Patient-reported outcomes and objective functional measures are collected at the hospital and at weeks 2, 6, and 12 and months 6 and 12 post surgery. The main study outcomes are changes in Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires of Physical Function quality of life, Satisfaction with Social Roles, and Positive-Illness Impact, Post-Traumatic Stress Disorder Check List, and the Tampa Scale of Kinesiophobia-11 from baseline to month 12. Secondary outcomes are changes in objective functional measures of the Lower Extremity Gain Scale, handgrip strength, and range of motion of major joints from week 2 to month 12 post surgery. Clinical outcomes include hospital length of stay, medical complications, rehospitalizations, psychological measures, and use of pain medications. A mixed model repeated measures approach assesses the main effects of treatment and time on outcomes, as well as their interaction (treatment × time). DISCUSSION: The results from this study will help determine whether an integrative care approach during recovery from traumatic orthopedic injury can improve the patient perceptions of physical function and emotional wellbeing compared to usual trauma care. Additionally, this study will assess the ability to reduce the incidence or severity of psychological distress and mitigate medical complications, readmissions, and reduction of QOL after injury. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02591472 . Registered on 28 October 2015.
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Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Heather Vincent.

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University of Florida
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Copyright Creator/Rights holder. Permission granted to University of Florida to digitize and display this item for non-profit research and educational purposes. Any reuse of this item in excess of fair use or other copyright exemptions requires permission of the copyright holder.

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STUDYPROTOCOLOpenAccess Anintegrated-delivery-of-careapproachto improvepatientreportedphysicalfunction andmentalwellbeingafterorthopedic trauma:studyprotocolforarandomized controlledtrialLauraZdziarski-Horodyski1,MaryBethHorodyski1,KaliaK.Sadasivan1,JenniferHagen1,TerrieVasilopoulos1,2, MatthewPatrick1,RobertGuenther3andHeatherK.Vincent1*AbstractBackground: Orthopedictraumainjuryimpactsnearly2.8million peopleeachyear.Despitesurgical improvementsandexcellentsurvivorshiprates,manypatientsexperiencepoorqualityoflife(QOL)outcomes yearslater.Psychologicaldistresscommonlyoccursafterinju ry.Distressedpatientsmorefrequentlyexperience rehospitalizations,painmedicationdependence,and lowQOL.Thisstudywasdevelopedtotestwhetheran integrativecareapproach(IntCare;ten-stepprogramofemotionalsupport,education,customizedresources, andmedicalcare)wassuperiortousualcare(UsCare).TheprimaryaimwastoassesspatientfunctionalQOL (objectiveandpatient-reportedoutcomes)withse condaryobjectivesencompassingemotionalwellbeingand hospitaloutcomes.TheprimaryoutcomewastheLowerExtremityGainScalescore. Methods/design: Asingle-blinded,single-center,repeatedmeasures,rand omizedcontrolledstudyisbeingconducted with112orthopedictraumapatientsaged18 Â… 85years.PatientsrandomizedtotheIntCaregrouphavecompletedorare receivingaguidedten-stepsupportprogramduringacutecareand atfollow-upoutpatient visits.TheUsCaregroupis beingprovidedthestandardofcare.Patient-reportedoutcomesand objectivefunctionalmeasuresarecollectedatthe hospitalandatweeks2,6,and12andmonths6and12 postsurgery.ThemainstudyoutcomesarechangesinPatientReportedOutcomesMeasurementInformationSystem(PROMIS)questionnai resofPhysicalFunction qualityoflife, SatisfactionwithSocialRoles,andPositive-IllnessImpact,Post-TraumaticStressDisorderCheckList,andtheTampaScale ofKinesiophobia-11frombase linetomonth12.Secondaryoutcomesarech angesinobjectivefunctionalmeasuresofthe LowerExtremityGainScale,handgrip strength,andrangeofmotionofmajorjointsfromweek2tomonth12post surgery.Clinicaloutcomesincludehospitallengthofstay,medicalc omplications,rehos pitalizations,psychological measures,anduseofpainmedications.Amixedmodelrepeatedmeasuresapproachassessesthemaineffectsof treatmentandtimeonoutcomes,aswellastheirinteraction(treatmenttime).(Continuedonnextpage) *Correspondence: vincehk@ortho.ufl.edu1DepartmentsofOrthopaedicsandRehabilitation,UniversityofFlorida, Gainesville,FL32608,USA Fulllistofauthorinformationisavailableattheendofthearticle TheAuthor(s).2018 OpenAccess ThisarticleisdistributedunderthetermsoftheCreativeCommonsAttribution4.0 InternationalLicense(http://creativecommons.org/licenses/by/4.0/),whichpermitsunrestricteduse,distribution,and reproductioninanymedium,providedyougiveappropriatecredittotheoriginalauthor(s)andthesource,providealinkto theCreativeCommonslicense,andindicateifchangesweremade.TheCreativeCommonsPublicDomainDedicationwaiver (http://creativecommons.org/publicdomain/zero/1.0/)appliestothedatamadeavailableinthisarticle,unlessotherwisestated.Zdziarski-Horodyski etal.Trials (2018) 19:32 DOI10.1186/s13063-017-2430-5

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(Continuedfrompreviouspage)Discussion: Theresultsfromthisstudywillhelpdeterminewhetheranintegrativecareapproachduringrecoveryfrom traumaticorthopedicinjurycanimprovethe patientperceptionsofphysicalfunction andemotionalwellbeingcompared tousualtraumacare.Additionally,thisstudywillassessthe abilitytoreducetheincidenceorse verityofpsychological distressandmitigatemedicalcomplications,re admissions,andreduc tionofQOLafterinjury. Trialregistration: ClinicalTrials.gov,NCT02591472.Registeredon28October2015. Keywords: Orthopedictrauma,Psychosocial,Physi calfunction,EmotionalwellbeingBackgroundTraumaresultinginmusculoskeletalinjuryisanunforeseen life-changingevent.Nearly2.8millionAmericanssustain traumaticorthopedicinjuriessuchasmajorfracturesor amputationeachyear[1].Severeinjuriesoftenrequireprolongedhospitalstayswithmultiplereconstructivesurgeries [2,3].Oncetheacuityoftheinjuryisover,patientsareleft withthenebuloustaskofreintegratingintotheirlives.Althoughmedicaladvanceshavedramaticallyimprovedsurvivorship,theseinjuriesneverthelessresultinpoorquality oflife(QOL)-relatedoutcomesin otherwisehealthypeople [4].Concomitantly,50 Â… 90%ofpatientsdevelopseverepsychologicaldistresssuchaspost-traumaticstressdisorder (PTSD),depression,oranxiety[5 Â… 7].Oneexacerbatingfactorforthispatternisthatpatientsaretypicallynotprovided comprehensivesupportandresourcesthatarenecessaryto successfullycopewithpsychologicaldistress[8].Thisisa seriousissuebecausehighdistresslevelspredictpoorphysicalfunction,useofpainmedicationsandlowQOL[9,10]. Traumasurvivorsoftencannotreturntowork,[11]have persistentpain[12],andexperiencesocialisolation.Distress worsenstheself-perceptionsoffunctionalgainandefficacy [13]anddecreasespersonalfulfillment.Lingeringpsychologicaldistresscontributestothedevelopmentofother healthproblems[14,15].Thelackofpsychosocialsupport contributestoinjuryreoccurrence,injuryrecidivism,[16] rehospitalizationsandlongerhospitalization,[17]and higherpersonalandsocietalhealthcarecosts[18]. Developmentofprogramsthatcanhelpreducepsychologicaldistressandprovidefocustopatientsmayhelpfully engagepatientsintherapeuticactivityandeasethetransitionfromhospitaltohome.Thereiscurrentlyalackof rigorouscomparativeefficacytrialstodeterminewhether programslikethiscanimpactfunctionalQOLandemotionalwellbeing.Currently,usualtraumacarefocuseson themedicalandanatomicalrestorationofthepatient.It doesnot,however,providethesimultaneouspsychosocial andemotionalsupportthatpatientsneedearlyinthecare processtocopewiththeirinjuries,stress,andunderstand therecoveryprocess.Thiscommunicationandsupportgap incareworsensthepsychopathologyoforthopedictrauma. Thepatient,whilereceivingthelatestmedicalcarefortheir injuries,doesnotreceivetheoverallcareneededtotreat theentireperson.Anintegrativecareapproach,which involvesafacilitator-driventen-stepsupportprogram,may helppatientsdevelopfocus,engageintherecoveryprocess, andsetupsupportivenetworksbeforeleavingthehospital. Insodoing,traumasurvivorsmaybettercopewiththe hardshipsafterhospitaldischargeandintotheirrecovery process.MethodsObjectives PrimaryobjectiveTheprimaryobjectiveistodetermineifIntCare(integrated care)improvesfunctionalQOLbetterthanUsCare(usual care)inpatientsreceivingcareforanorthopedictrauma injury.SecondaryobjectivesSecondaryobjectivesinclude:(1)determiningwhether IntCareimprovesmarkersofemotionalwellbeingmore thanUsCare;and(2)comparingtheprevalenceofmedical complications,rehospitalizations,andco-morbiddisease upto12monthsaftersurgery. First,wehypothesizethatIntCarewillimprovefunctional QOLandemotionalwellbeingafterhospitaldischarge morethanUsCare[8,19,20].Second,wehypothesizethat patientswithIntCarewillhavefewerrehospitalizations, medicalcomplications,andco-morbidpsychologicalillness comparedtopatientswithUsCare.DesignThisisasingle-center,single-blinded,repeatedmeasures, randomizedexploratorycontrolledstudywithparallel1:1 allocationinwhichtheresearchandcareteams,including thephysicians,knowwhichpatientsarereceivingtheintegratedmedicalcareorusualmedicalcare[21].Figure1 providesthestudyflowdiagramofthisongoingstudy,for whichtherearetwostudyarms:theIntCarearmand UsCarearm.WeareexecutingthisstudyundertheConsolidatedStandardsofReportingTrials(CONSORT)Statement[21]forrandomizedcontrolledtrialswiththePatientReportedOutcomesextension[22].ThisisanInvestigator InitiatedTrialthatwasregisteredwithClinicalTrials.gov (NCT02591472)on28October2015,beforepatientenrollmentwasinitiated.TheInstitutionalReviewBoardforthe ProtectionofHumanSubjectsattheUniversityofFloridaZdziarski-Horodyski etal.Trials (2018) 19:32 Page2of12

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approvedallstudyprocedures.Theprojectwas launchedinNovember2015.Thetrialisfinancially supportedinpartbytheFoundationforPhysical Medicine&Rehabilitation(internalfundingreference number00098192),theNationalAthleticTrainers  AssociationResearch&EducationFoundation(grant number15DGP012),andtheW.MartinSmithInterdisciplinaryPatientQualityandSafetyAward.The trialmeetsthecriteriadescribedintheStandard ProtocolItem:RecommendationsforInterventional Trials(SPIRIT)checklist(Additionalfile1).Patients InclusioncriteriaTheinclusioncriteriawereasfollows:aged18 … 85 years;admittedwithsevereormultipleorthopedic trauma(anymajorbonefracturesthatimpairsmobilityand/orparticipationinactivitiesofdailylivingand self-care);andhavereceivedorwillreceiveoneor moresurgicalprocedurefortheirorthopedicinjuries.ExclusioncriteriaTheexclusioncriteriawere:presenceofatraumatic braininjury;inabilitytocommunicateeffectively(e.g. atalevelwhereself-reportmeasurescouldnotbeansweredcompletelysuchasmedicatedstateormechanicallyventilated);currentlyusingpsychotropic medications;orhavepsychotic,suicidal,orhomicidal ideations.Allparticipantsprovidedwrittenconsent onaninstitutionapprovedconsentdocument.RecruitmentStudyrecruitmentbeganinNovember2015.Patients wereinitiallyapproachedbytheirorthopedictrauma physicianafteradmissiontotheOrthopedicTraumaserviceatUFHealthatShandsHospitalinconjunction withtheUniversityofFlorida(UF).Toensureadequate recruitment,thetraumaphysiciansscreenedallpersons admittedtotheircare.RegistrationandconsentPatientsweremedicallystablebeforeinitiationofrecruitmentbythephysicianand/ortheresearchteam.Thepatients  orthopedictraumaphysicianprovidedpatientsand family(asappropriate)withabriefoverviewandexplanationastowhytheywereconductingthetrial.Ifapatient expressedinterestinparticipating,studypersonnelthen metwiththepatienttocoverallstudy-relatedinformation andtoaddressquestionsthepatentortheirfamilymay haveaboutstudyparticipation.Thephysicianandstudy teammadeaconcertedefforttoexplainthevoluntarynatureofthestudyandthattheirdecisiontoparticipate wouldhavenoimpactontheirmedicalcare.Patientswere informedthatatanytimetheycouldwithdrawthemselves fromthestudyaswellasthestudystaffcouldwithdraw themifitbecameapparentcontinuedparticipationwas notintheirbestinterest. Asignedanddatedcopyoftheconsentformwasprovidedtoparticipants.Asecondsignedanddatedcopyof theconsentformwasretainedbythestudystaff.Theserecordsarestoredinalockedfilecabinetandlockedoffice withinthelablocatedintheUniversityofFloridaOrthopedicandSportsMedicineInstitute,theoutpatientfacility. Fig.1 Study flowdiagram followingtheCONSORTguidelinesforrandomizedcontrolledtrialswiththePatient-ReportedOutcomesextension Zdziarski-Horodyski etal.Trials (2018) 19:32 Page3of12

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LocationsUFHealthatShandsHospitalislocatedGainesville, Florida,USA.Thisisalevel1traumacenterwithacatchmentareaof18urbanandruralcountiescomprisingtwo millionpeople.Approximately2500patientswithtraumaticinjuriesareadmittedannually.Consentandbaseline datawerecollectedatthelevel1traumacenter.Afterdischarge,patientsarefollowedupwithattheUniversityof FloridaOrthopedicandSportsMedicineInstitute.Thisfacilityhousestheoutpatientorthopedicclinicsandiswhere allpatientsreceivetheirfollow-upcare.TrialinterventionDr.Sadasivan  spreviousworkwithadoctoralstudentin psychologyrevealedthestrongneedforpsychosocialcare inacutecareafterorthopedictrauma[8].Asubsequent pilotstudywasconductedtoevaluatefeasibilityofperformingresearchwithorthopedictraumapatientsinthe acutesettingandtheoutpatientclinic.Thepresenttrialis theresultofmanyyearsofworkingwithorthopedic traumapatientsandidentifyingtheneedformorecomprehensivecareanddevelopingworkflowpatterns.Thepilot studyoccurredoverthecourseofoneyearandwith follow-upuptothreemonthsandonlyaselectnumberof surveyinstrumentsutilized.TheState-TraitAnxietyInventory(STAI)andBeckDepressionInventory-II(BDI-II) wereusedinthepilotandwerethenusedtohelpconduct ourpoweranalysisforthepresenttrialdesign.Duringthe courseofthepilotstudy,ourresearchgroupreliedonour institutionalOrthopaedicTraumaPatientAdvisoryPanel forinputonpatientneedsandappropriatewaystomeasurebetteroutcomes.Dr.Vincentusedthepanel  sinputto createtheinteractivefolder.Dr.Zdziarski-Horodyskidevelopedaresourcemanual,suchaspetcareservices,for patients(Table1).Usualcare(UsCare)Postoperativecareisbasedonwidelyacceptedrecommendations[8]andonthecurrentunderstandingofinjury treatment.ThekeycomponentsofUsCareincludemedical stabilization,injuryrepair,dischargeplanning,andacute caretherapies.ParticipantsrandomizedtotheUsCare groupreceivemedicalcarefromastandardorthopedic medicalteamwithoutthepresenceofafacilitator.All otherroutinecarefromthephysicaltherapistanddischargeplanneroccuraswouldusuallytranspireatalllevel onetraumafacilitiesacrosstheUnitedStates.Baseline measurementsforallstudyinstruments(describedinthe nextsection)areadministeredafterconsentandatthe subsequentfollow-upappointmentsattheOrthopaedic andSportsMedicineInstitutebytheresearchteam.Atthe participant  s12-monthfollow-upvisit,alleducationalmaterialsareprovidedandasinglemeetingwithoneofthe facilitatorstogooverthe  Transform10 Ž isoffered.Integratedcare(IntCare)IntCareprovidesallUsCareprocessesasdescribedabove, pluspsychosocialsupportviaaten-steptransformative program(  Transform10 Ž ).Psychosocialcomponentsand resourcecontentareincludedtohelppatientsfocusonthe positiveandproductivepathwaysnecessarytocopewith stressandachieveahighQOL.Facilitatorshelppatients identifytheimmediateconcernsandhelpidentifysolutions toaddressthem.Commonconcern sincludelossofjob, childcare,obtainingfoodormedicine,transportationto appointments,andwheelchairaccesstothehomeenvironment.ThestepsofthisprogramareshowninFig.2[23 … 32].Keycomponentscanbeadaptedfordifferenthospital Table1 Excerptsfromthemanualcontainingresourcesthat canberecommendedtotraumapatientsbythestudy facilitators.Thecontentoftheresourcemanualshouldbe specifictothegeographiclocationofthetraumacenterJobplacementagencies Vocationalrehabilitation(FloridaDivisionofVocationalRehabilitation) OurMissionis  tohelppeoplewithdisabilitiesfindandmaintain employmentandenhancetheirindependence. Ž OurVisionis  to becomethefirstplacepeoplewithdisabilitiesturnwhenseeking employmentandatopresourceforemployersinneedofqualified employees. Ž http://www.rehabworks.org/ Contactinformation:352-9553200 … Gainesvillelocation2610NW43rdStSuite1AGainesville,FL 32606;800-451-4327 … Toll-freeStateOffice;850-245-3399 … Tallahassee StateOffice Homemodifications ChristianConcernedfortheCommunity.Ramps,showerbars;(352)-3711768; http://cccgainesville.org/ CenterforIndependentLiving.Mission  TheCILNCFisanestablished communitydisabilityresourcecenteroperatedbypeoplewith disabilitiesandservingNorthCentralFloridaforover30years.We deliverhighqualityprogramsandservicesthatenhancequalityoflife andincreaselevelsofpersonalindependence. Ž Housing/Repairs … can helpbuildramps.Contactinformation:1-800-265-5724 Transportationandfood RegionalTransitSystem(RTS).ServicestheGainesvillecitylimits;most busesareaccessibleforalldisabilities(pleaseseewebsiteforroutes andspecifics http://go-rts.com/ada/ ).Busfaresareintherangeof $0.75 … 1.50/eachway(seewebsitefordetails) EldercareofAlachuaCounty.Utilities/rentassistance,transportation assistance,foodservices(mealsonwheelsandprivatepaymealplan), homemaking,personalcare,andrespite.Contactinformation:(352)-2659040; http://eldercare.ufhealth.org/about-eldercare/contact-eldercare/ RideSolution.Palatka,FL.Canassistwithtransportationtoandfrom Palatka,FLtoGainesville,FL.Seewebsiteforbusstoplocationsand schedulinginformation. http://theridesolution.org/ #$2.00busfare MealsonWheels.InpartnershipwithElderCareofAlachuaCounty.Providing mealstotheelderlywhoareinneed. http://eldercare.ufhealth.org/services/ meals-on-wheels .Gainesville … ThelmaBoltinCenter.Contact information:(352)-334-2189,516NE2ndAvenue,Hours:10am … 1pm, Monday … Friday Petservices DaytimeDogsandFriends.Mission:  Ourgoalistodeliverconvenient, personalized,reliableservicesinacaringandtrustworthymannertoall ofourclientsandtheirbelovedpets. Ž Contactinformation:352-2194246. http://www.daytimedogs.com/ Zdziarski-Horodyski etal.Trials (2018) 19:32 Page4of12

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settings,geographicallocations,andavailableresources whenimplementedinalargersca le.Facilitatorshelppatientsdevelopproductivefocusontheshort-termgoals (e.g.acknowledgingthatthey areasurvivor,developingthe mindsettomoveforwardwithsurgeries,andrehabilitation thatwillhelpimprovetheirphysicalstatus,decrease stressors,andsetgoalsforrecovery)andlong-termgoals (e.g.bewheelchair-independentbymonth3,abletopick upchildonownbymonth4,getbacktoworkasfastas possible).Theprogramprovidesinformationandcustomizedresourcesneededtohelppatientsempowerthemselves toachievethesegoals,optimize physicalandmentalhealth, anddevelopresilience. Thefacilitatorprovidesafoldercontainingthe  Transform 10 Ž program,penandnotepad,andspacestorecordappropriateresourcesthatthepatientbelieveswouldbehelpful forthem.Aviewoftheopenedpatientfolderisshownin Fig.3.Thestudyteamcompiledalargeregional resourcelist;asampleisshowninTable1.Specific resourcesarerecommendedtopatientsdependingon theirneeds.Lastly,patientswithinthisgroupreceive astructured,physician-approvedexerciseprogramat follow-upvisitstopromotemovementandstrength beforebeginningsupervisedphysicaltherapy.While thepatientishospitalized,dailyinteractionsoccur withpatientsbyfacilitatorstopromotethe  Transform10 Ž stepsandwhenneededprovideinformation totheattendingorthopedicsurgeon.Asmanysteps aspossibleareinitiatedwitheachpatientduring acutecare.Beforebeginningnewsteps,previoussteps arereviewed.Attheoutpatientfollow-upvisits,the patientisaskedtobringtheirfoldertoreviewany stepsasneededandpresentanystepsthatwerenot presentedinacutecare.Facilitatorshelppatientsselfmanageanyconfoundingissuesorbarrierstoreachingtheirgoals. Fig.2 ThetenstepsoftheTransformativeCoachingProgram.Theorderofthestepsmaybeadjustedasneededbasedonthestatusofthepatient Zdziarski-Horodyski etal.Trials (2018) 19:32 Page5of12

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FacilitatorsAllfacilitatorsutilizedinthistrialhadatminimuma collegeleveldegreeinahealth-relatedfield.Thetwo primaryfacilitatorswereathletictrainers,onewitha EdDinKinesiologyandthesecondaPhDcinRehabilitationSciences.TheotherfacilitatorshadvaryinglevelsoftrainingfrombachelorsinSport PsychologytomastersinHealthandHumanPerformance.ThetwoprimaryfacilitatorsreceivedtrainingandoversightfromDr.Sadasivanandtheclinical psychologist(mainlyinhowtoreferpatientsindestress,see  Distressreferralprotocol Ž ),aswellas playedanintegralroleincreatingtrainingmaterials forfuturefacilitators.Allotherfacilitatorsfirstwere interviewedtoassesstheirabilitiesanddesiretowork withthispopulation.Next,facilitatorswereprovided thescientificliteratureforeachofthetensteps,had anobservationperiodwithoneofthetwoprimary facilitators,practicedscenarios,andsupervisedinterventionadministrationbeforeadministeringtheintervention ontheirown.Additionally,everyweektheentirestudy team(facilitators,researchers,andphysicians)wouldmeet anddiscussanydifficultiesencounteredearlierintheweek orprovidefeedbackonvariousobservationsoftheintervention.EveryIntCarepatientwasprogressedthroughall tensteps;however,everypatients  needsaredifferentand thereforethespecificsdiscussedundereachstepmaybe different.Theweeklymeetingsallowforcontinuous facilitatordevelopment. Thefacilitatorswerealsoresponsibleforencouragingand monitoringadherencetotheintervention.Thisisachieved throughtheinteractivefolderprovidedtothepatientswhere goalsandotherneedscanberecorded.Facilitatorsrecorded thepatient  sgoalsintheassociatedstudyfolderaswellas anyothernotesastheyfoundnecessarywhencoveringa step,sothatwhenthepatientreturnsforfollow-upvisits Fig.3 Imagesoftrifoldpatientfoldercontainingthe10-stepprogram,goalsettingspace,pre-dischargechecklist,spaceforcustomizedresources andspaceforpaperandpen Zdziarski-Horodyski etal.Trials (2018) 19:32 Page6of12

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accountabilitycanbeachieved.Allofthisinformationisrecordedondatacollectionformswithinthestudyfolders.Randomization AllocationandconcealmentAlleligibleparticipantswereconsecutivelyrandomized toeithertheIntCareorUsCaregroups.Randomization processwasconductedusingacomputer-generatedrandomnumberlistandconsecutivelynumberedopaque envelopescontainingthegroupallocation.Thesewere preparedbyaClinicalCoordinatornotinvolvedinthe testing.Everystudyparticipant  sfolderwasprefilledby theClinicalCoordinatorwithallmaterialsforthestudy, randomizationenvelope,consentforms,supplemental materials,andalldatacollectionformsregardlessof groupassignment.Thisensuredthatstudystaffwould notknowwhichgroupthepatientwouldbeassignedto beforeopeningtheenvelope.BlindingPatientswereblindedtowhichtreatmentgroupthey wererandomized.Studystaffopenedtherandomization envelopeinthestudyofficeatthehospital,outsideof thepatient  sroomafterobtainingconsent.Thepatient wasneverexplicitlytoldtowhichgrouptheyhadbeen assigned.Aftertheresearchstaffmembersopenedthe envelope,theypromptlyreturnedtothepatient  sroom withtheiPadandotherdatacollectionmaterialsto begindatacollection.DatacollectionThestudyteamisfollowingasystematicprocessfordata collectionusingelectroniccasereportforms(CRFs)that follow GoodClinicalPractice rules.ElectronicCRFsare managedusingtheResearchElectronicDataCapture (REDCap)[33].Dataarevalidatedatthetimeofinputby computerizedcontrolsthatensurevalidityandquality. REDCapcontainssystemintegritymeasurestoguarantee theintegrityofthesystemandtoprotectagainstdataloss. Onaweeklybasis,allrecordsarereviewedbythestudy team.Allparticipantdataisde-identifiedandstoredunder aconsecutivelynumberedstudycode.Consentformsare theonlydocumentthathavepatientnamesandareimmediatelyremovedfromthestudyfolderaftersigning.The consentformsarethenstoredinthestudybinderlocked inthePI  soffice;nostudycodeisassociatedwiththeconsentforms.Allstudy-relateddataandmaterialswillbe kepttheminimumnumberofyearsafterstudyclosure, pergovernmentstandards,inalockedcabinetandincineratedaftertheperiodoftime. Perseveralofthefundingmechanisms,quarterlyreportsontrialprogressaregeneratedandserveasaninternaldatamonitoringprocess.Noexternalagencywill monitorthedata,outsidetheUniversity  sIRBif necessary.Thestudyteamandphysicianswillhaveaccesstothequarterlyreportgenerated,shouldanything inthedatasuggestthatthetrialbestoppedthephysicianswillbeabletoprovidejudgement.PatienttimelineBaselinemeasurementsforallpatient-reportedoutcomes,measuresofpsychologicaldistress,andhandgripstrengthwerecollectedwhilethepatientwas receivingacutecare.Afterdischargefromacutecare, patientsreturntotheoutpatientorthopedictrauma clinicforregularfollow-ups.Thestudyteamisminimizingthepatientburdenbycollectingdataatthe normaloutpatientvisitswhichoccuratweeks2,6, and12andatmonths6and12postsurgery.Patients wereaskedforemailaddressesafterconsentingso thatsurveysmaybeemailed,ifthepatientprefers andbaseduponpatients  resources.Therefore,patientsmaycompletethesurveysathomebeforetheir follow-upvisits.Forpatientsnotusingemail,study staffmayconductthesurveysoverthephoneifthe patientindicatedthedesire.Ifsurveysarenotcompletedbeforetheirvisit,thepatientwillbemetonce theyhavecheckedinandthenprovidedaniPadto completetheelectronicsurveys.AllfunctionalmeasuresareobtainedintheHumanDynamicsLaboratory,locatedonthefirstflooroftheoutpatientclinic. Atthe12-monthfollow-up(insomespecialcases wherethepatient  sorthopediccarewascomplete,atthe six-monthfollow-up)anexitsurveyisgiven.Thissurvey aimstounderstandthepatient  sexperiencesthroughout thestudyandtheircare.Thestudyteamrecognizesthat patientresponsesmaybeinfluencedbytheirperception ofcaregiven.Additionally,thesurveywillhelpensure nocross-contaminationofstudyparticipants.Amajority oforthopedictraumapatientsarecaredforonthesame floor;therefore,patientshavethepotentialtointeract witheachotherinthecommonspaces(allpatient roomsaresingleoccupancy).Atthis12-monthtime point,theUsCaregroupisnotifiedastotheir randomization.Individualsassignedtothisgroupwillbe giventheopportunitytoreceiveallthematerialsthe IntCaregroupreceived.Thestudyscheduleoverviewis showninFig.4.OutcomemeasuresPrimaryoutcomemeasures PhysicalfunctionObjectiveclinicalmeasuresofphysicalfunctioncomplementthepatient-reportedoutcomes.Threekey measuresarebeingcollected:theLowerExtremity GainScale(LEGS);handgripstrength;andjointrange ofmotion(ROM)[34].LEGSwastheprimaryoutcomeofthisstudy.First,theLEGSassessmentZdziarski-Horodyski etal.Trials (2018) 19:32 Page7of12

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consistsofseverallowerbodymovementsthatoccur indailylife[35],includinga3-mwalk,puttingona sock,puttingonashoe,risingfromanarmlesschair, steppingupanddownstairs,gettingonandoffthe commode,andreachingfromasittingpositiontoan objectontheground.Inpeoplewithtraumaticfractures,LEGShashighinternalconsistencyandthe content,concurrent,andconstructvalidityarehigh [35].Theclinicalrelevanceofbetterphysicalfunction andambulationscoresisareducedriskofinfection, delirium,andprolongedh ospitalstay[36].Second, isometrichandgripstrengthisavalidpredictorofmobilityandQOLandisbeingmeasuredusingahandheldhydraulicdynamometer[37].Handgripstrengthis clinicallyimportantasitstronglypredictslong-termfunctioncapabilityafterorthopedictrauma[37].Theintraclass coefficient(ICC)forhandgripstrengthtestingis0.95. Third,theuseofactiveROM(AROM)asameasureof functionalityiscommonacrossmultipledisciplines, includingorthopedics,physicaltherapy,andathletictraining.EstablishingearlyandappropriateAROMwithinand atthejointsaboveandbelowtheinjurysiteinthesubacute/pre-structuredphysicaltherapyphaseissignificantly correlated[38]withincreasedfunctionaloutcomes[39]. AROMisbeingmeasuredwithagoniometerandadigital inclinometer[40].LowerextremityROMwillbecollected forhipflexion,kneeflexion/extension,andankleplantar/ dorsiflexion.UpperextremityROMjointswillinclude: shoulderflexion/extension,abduction,andinternal/externalrotation;elbowflexion/extension;andwristflexion/ extension.Secondaryoutcomemeasures Patient-reportedoutcomesPatient-reportedoutcomesaretheprimarymeasuresofthe study.Patientsarethemostimportantsourceofinformationregardingtheoutcomesofinterest,becausethisstudy Fig.4 Scheduleofstudyenrollment,interventions,andassessments Zdziarski-Horodyski etal.Trials (2018) 19:32 Page8of12

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focusesonpatientperceptionsoffunctionalQOLandemotionalwellbeing.Patient-ReportedOutcomesMeasurement InformationSystem(PROMIS ’ )assessmentsareadministeredusingcomputeradaptivetests[41].TestingofPROMIS ’ domainshasbeenperformedinpatientswithvarious upperandlowerbodyorthopedic injuries[42,43].AsindicatorsoffunctionalQOLandemotionalwellbeing,the PROMISmeasuresofPhysicalFunction,PsychosocialIllnessImpactPositive,andSatisfactionwithSocialRolesand Activitiesarebeingadministered.ClinicaloutcomesElectronicmedicalrecordsarebeingusedtoobtaininformationonpatients,includingsociodemographicand socioeconomiccharacteristics,traumainjurytypeand severity,location,andadditionalsoft-tissueinjuries.Informationaboutthenatureofthetraumaisbeingobtainedincludingissuesthatmayhaveprecipitatedtheir orthopedicinjury(e.g.drunkdriv ing,druguse,ifother individualswereinjured/killedintheaccident).The prevalenceofmedicalcomplications,rehospitalizations, andco-morbiddiseaseisalsobeingcapturedintwo ways:(1)usingdataextractionmethodsfromelectronic medicalrecords;and(2)directlyfrompatientsduring theirfollow-upvisitsintheoutpatientclinics.The numberofreadmissions(andlengthofthereadmissions),reasonsforreadmissions,thenumberandtype ofcomplicationsarebeingcollected. Theonsetofnewco-morbiddiseases,withparticularemphasisonpsychologicalillnesses,isalsobeing collectedusingthesefollowingtoolsthathavebeen validatedforuseinthetraumapopulation.TheseincludethePTSDChecklist,withhightemporalandinternalconsistencyandhighcontentvalidity[44],the BDI-II,withhighreliabilityandconsistency[45],and theSTAI,withhighinternalconsistencyintherange of0.86 … 0.95,andconstructandconcurrentvalidity [46].Kinesiophobiaisthepsychosocial,somatosensory neuronalfeedback,manifestationoffearofmovement dueabeliefitwillinducepainorinjury[47,48].To assessthepain-relatedfearinorthopedictraumathe TampaScaleofKinesiophobia-11inbeingused,with aninterclasscorrelationof0.81[48].DistressreferralprotocolWeacknowledgethatforsomepatientsthelevelofpsychologicaldistressisbeyondthecapabilityofthisprogramtoprovidethesupportnecessary.Inthesecases, wewillenactadistressreferralprotocol.Patients,who haveBDI-II,STAI,and/orPTSDscores>2standarddeviations(SD)fromthepopulationnormwillbereferred forfurtherevaluationbythePsychologyServiceviathe electronicmedicalrecord(EPIC)referralprocess.Those serviceswillincludeaformalclinicalinterview,developmentofadiagnosticconceptualization,developmentof atreatmentplan,andprovisionoftreatmentdesignedto reducethepatient  sdistressandimprovecoping.Treatmentwillusuallyconsistofcognitive-behavioralinterventionswithstrongscientificsupportfortheirefficacy. Additionally,ifthepatientanswerstheSTAIquestion aboutsuicidewithanyresponseotherthan,  Idonot haveanythoughtsofkillingmyself, Ž theirphysicianis immediatelynotifiedtofurtherassessthesituation.Analysis SamplesizeAsamplesizeof100wasdeterminedinanapriori mannerusingtheG*Powersoftwareprogram[49,50]. Anticipatingthatthestudypopulationwillbeyounger butotherwisesimilarlydistributedasthatofZimmermanetal.[35],thesamplesize,n=100,wasdeterminedtobesufficienttohaveamediumeffectsize (Cohen  sd=0.60,powerof0.80,andalphaof0.05). DatafromZimmermanetal.  s[35]studyvalidating theestablishedtheLEGSwasusedastheprimary measuretopowerforthestudy.Thisanalysisthen translatesintovariabledetectablemeandifferences dependingontheoutcome.Forexample,a6.4-point differenceintheSTAI(oneofthepsychologicalmeasuresforthestudy)canbedetectedassumingaSD of10.0;forAROM,8.3differencewitha12.0SD. Thissamplesizeisthereforeexpectedtobesufficient todetermineifdifferencesinfunctionalQOLand emotionalwellbeingoccurred.StatisticalanalysisTheStatisticalpackagefortheSocialSciences(SPSS, v24.0;Chicago,IL,USA)willbeusedforanalysis. Descriptivestatisticswillbecalculatedoncategorical studyvariablesanddemographics(meansandSDfor continuousvariables,frequenciesandpercentagesfor categoricalvariables).Chi-squareforfrequencydistributionswillbeusedforpatientsatisfactiontotest maineffectsoftimeandtreatmentandtheirinteraction.Theprimaryanalysesforallaimswillutilizea mixedmodelrepeatedmeasuresapproach.Theseanalysescanassessthemaineffectsoftreatmentand timeonoutcomes,aswellastheirinteraction(treatmenttime).Specifically,independentvariableswill includecareapproach(integratedvsstandard)and timepoint(baseline,weeks2,6,12,months6and12 postsurgery).Dependentvariableswillincludeall PROMIS ’ andfunctionalmeasures.Mixedmodelsare thepreferredapproachtoanalyzedatawithrepeated measures;thesemodelscanaccounttoforcorrelation amongrepeatedmeasurements,flexibletimeeffects,Zdziarski-Horodyski etal.Trials (2018) 19:32 Page9of12

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andcanhandlemissingdata.Significantinteractions betweentreatmentandtimewouldindicatethatthe changeintheoutcomes(i.e.slope)wasdependenton thepatient  streatmentgroup.Ifasignificantinteractionisidentified,thePreachermethodwillbeused toestimatethemagnitudeanddirectionoftheinteraction.A p valuewillbeestablishedaprioriat<0.05 forallstatisticaltests.Continuousdatathatarenot normallydistributedwillbetransformedbeforeanalysis.Appropriatemultipletestingcorrectionswillbe performedtolimitTypeIerrors.DiscussionAtpresent,thereisalackofrigorous,high-quality,comparativeeffectivenessresearchtodeterminewhetheracomprehensivecareapproachforbothphysicalandemotional healthproducesgreaterimprovementsinthekeyoutcomes functionalQOLandemotionalwellbeing.Thisstudytests thehypothesesthatIntCarecanimprovepatient-reported outcomesoffunctionalQOLandemotionalwellbeingmore thanUsCare,andthatIntCarewillresultinfewermedical complicationsandhospitalreadmissions,andalowerincidenceofpsychologicalillnessonsetinpatientsrecovering fromorthopedictrauma.Acombinationofsubjectiveand objectiveassessmentsisbeingusedtotestthesehypotheses. Whilesomepsychosocialsupportistypicallyavailable inthehospital,itisoftenreservedforpatientswith acutecrisisorifdeemedathreattothemselvesor others.Assuch,psychosocialsupportisnottypicallyaddressedatallduringacutetraumacare.Supportismore likelyobtainedbypatient  smonthsaftertheyareat hometryingtocopewiththeadjustmenttolife.The TraumaSurvivorsNetwork(TSN)andotherresearch groupshaveproposedstepstoprovideIntCaresystems inreal-lifesettings[51,52].TheTSNisapublic-health approach(consistingofpeersupport,self-management help,information,andresources)thatwasdesignedto helptraumapatientsovercomechallengesinrecovery andincreaseself-efficacy,functionaloutcomes,andwellbeing.Limitedevidencehasrevealedsignificantimprovementsinperceivedhealthandlowerratesof depressionintheTSNservicegroupcomparedto UsCare[4].EarlyIntCarecanempowerthepatientstobecomeresilient,activeparticipantsintheircare.Asmaller randomizedcontrolledtrialshowedthatanearlyfocuson patientmotivationwithaspectsofpsychosocialsupportreducesthelengthofhospitalstayandimprovesthetrajectoryofrecoveryafterhipfracture[53].Comparedto patientswithhighstress,patientswithlowstresslevels achievedgreaterfunctionalstatuslevelsandresilienceinrecovery[52].Theuseofvariouspsychosocialsupportsuch ascounseling,pastoralcare,copingskillsforpain,meditation,andmindfulnesscanreducepatientanxietyanddepressionatonemonthpostdischargeby16 … 66%[54]. Supportinterventioncomparedtousualcareimproved QOLdomainsofphysicalfunction,vitality,physicalrole limitation,andmentalhealthby34 … 95%andreducedthe needforpainmedicationsinpeoplewithhipfracture[55]. Earlyadministrationofaneducationalintervention(breathingexercise,educationonpainmanagement,relaxation techniques)reducedanxiety,improvedself-efficacy,andreducedhospitallengthofstayby20%comparedtoUsCare inpatientswithvarioustraumainjuries[56]. Theuseoffacilitatorswithnon-mentalhealthcare backgroundsisanovelmethodofprovidingpatients emotionalsupport,patienteducation,focus,anda connectiontoresourcesthatmayhelppatientsreach theirrecoverygoals.Hence,thisstudywillhelpdetermineifsupportprovidedbyfacilitatorswithallied healthtraining,non-psychologytrainedpersonnel,can positivelyimpactpatientoutcomes.Thiswilladdto thefeasibilityofdevelopingtheseinterventionmodels inotherhealthcaresystemsandwillempowerorthopediccareteamsbygivingthematoolkitthatdoes notrelyheavilyonmentalhealthcareservices.The evidencegeneratedfromthisstudywillhelpprovide futureframeworktobetterempowerpatientstoparticipatemoreeffectivelyintheircareandrecovery andachievementofpersonalgoalsforrecovery.This researchshouldassistcliniciansandhealthcaresystem managerstomakeinformeddecisionsaboutimplementationofasystemthatproducesthebestoutcomesfortheirpatients.PotentiallimitationsPotentiallimitationstothepresenttrialdesignincludeinterferencewiththecontrolgroupandastringentmonitoringpolicyforinterventionadherence. Whiletheresearchteamhastakenverycautiousmeasureswithacontrolgroup,ithasbecomeapparent thatthesimpleinteractionofaskingorthopedic traumapatientstocompletesurveysabouthowthey arefeelingandfunctionaltestsmaygivetheperceptionthattheyarereceivingadditional  care. Ž Theresearchteamrecognizesthattheinteractionstocollect datafromthecontrolgroupatpresentarenecessary andunavoidable,butmaybepositivelyinfluencing thisgroup  soutcomes.Infuturestudydesign,acontrolgroupwithlimitedtimepointsforfollow-up couldbeutilized.Patientsagreeingtoparticipatein thistrialarenotreceivingclinicalmentalhealthcare andtheirparticipationisst rictlyvoluntary.Therefore, ensuringstrictadherencetotheinterventionmaybe alimitationtothetrialdesign.Theuseoftheinteractivefolderisonemechanisminplacetoaddress adherence;however,participantsdonotreceivecompensationandthusrepercussionfornon-adherenceis notfeasible.Zdziarski-Horodyski etal.Trials (2018) 19:32 Page10of12

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DisseminationplansTheauthorsplantopublishamanuscriptfocusingon theprimaryandsecondaryobjectivesinthe Journalof OrthopaedicTrauma atthecompletionofthetrial.Furthermore,datawillbepresentedatvariousconferences inanefforttotargetallareasofhealthcare.Intheimmediatefuture,datawillbesharedandthethemes learnedfromthetrialcommunicatedwiththehouse staffwithintheuniversityhospital.TrialstatusEnrollmentofpatientswasinitiatedinNovemberof2015 anddatacollectionandanalysesareexpectedtobecompletedinNovemberof2018.Datacollectionisongoing.AdditionalfileAdditionalfile1: SPIRIT2013Checklist:Recommendeditemstoaddress inaclinicaltrialprotocolandrelateddocuments.(DOC120kb) Abbreviations AROM: Activerangeofmotion;BDI-II:BeckDepressionInventorysecond version;ICC:Intraclasscorrelationcoefficient;IntCare:Integratedcare treatmentgroup;LEGS:LowerExtremityGainScale;PhDc:Doctorateof PhilosophyCandidate(atermusedintheUnitedStateshighereducation systemtoindicatethataPhDstudenthaspassedtheirqualifyingexamsand successfullyproposedtheirdissertationtopic);PROMIS:PatientReported OutcomeMeasurementInformationSystem;PTSD:Post-traumaticstress disorder;QOL:Qualityoflife;SD:Standarddeviation;SPSS:StatisticalPackage fortheSocialSciences;STAI:StateTraitAnxietyInventory;TNS:Trauma SurvivorsNetwork;UsCare:Usualcaretreatmentgroup Acknowledgements Notapplicable. Funding ThisprojecthasreceivedsupportfromtheFoundationforPhysicalMedicine& Rehabilitation(internalfundingreferencenumber00098192),theNational AthleticTrainers  AssociationResearch&EducationFoundation(grantnumber 15DGP012),andtheW.MartinSmithInterdisciplinaryPatientQualityandSafety Award.Thesefundingmechanismsprovidedmonetarysupportonlytowards thecompletionofthisproject.Theagencieslistedhadnoinvolvementinstudy designordatacollectionandwillnothaveinputinfuturedataanalysis, interpretation,ormanuscriptwriting. Availabilityofdataandmaterials Notapplicable.Uponcompletionoftrialdatawillbemadeavailableperthe requirementsofallregisteredclinicaltrialsatclinicaltrials.gov.Programmaterials areprovidedasfiguresassociatedwiththismanuscript. Authors  contributions MBH,KKS,andHKVconceivedthestudy.LZH,MBH,KKS,TV,RG,andHKV designedthestudy.HKV,LZH,andMBHwrotethestudyprotocol.TVand LZHprovidedsamplesizeandstatisticalpoweranalysisforstudyprotocol.JE andMPcontributedtostudyprotocolamendmentsandconductedpatient recruitment,alongwithKKS.RGprovidedclinicalservicesaspartofthe distressprotocol.HKVandLZHdraftedthemanuscript.MBH,JE,TV,andMP providededitstomanuscript.Allauthorsreviewedandapprovedthefinal versionofthemanuscript. Ethicsapprovalandconsenttoparticipate Beforeanystudy-relatedproceduresoccurred,theIRBfortheprotectionof humanrightsattheUniversityofFloridaapprovedthestudyprotocol(study number201500753).Additionally,informedconsentwasobtainedfromevery participantbeforerandomizationintothestudy. Consentforpublication Notapplicable. Competinginterests Theauthorsdeclarethattheyhavenocompetinginterests.Publisher  sNoteSpringerNatureremainsneutralwithregardtojurisdictionalclaimsin publishedmapsandinstitutionalaffiliations. Authordetails1DepartmentsofOrthopaedicsandRehabilitation,UniversityofFlorida, Gainesville,FL32608,USA.2DepartmentsofAnesthesia,UniversityofFlorida, Gainesville,FL32608,USA.3DepartmentsofClinicalPsychology,Universityof Florida,Gainesville,FL32608,USA. Received:2November2017Accepted:14December2017 References1.HallMJ,DeFrancesCJ,WilliamsSN,GolosinskiyA,SchwartzmanA.National HospitalDischargeSurvey:2007summary.NatlHealthStatRep.2010;29:1 … 20.24. 2.BrownerBD,AlbertaFG,MastellaDJ.Anewerainorthopedictraumacare. SurgClinNorthAm.1999;79:1431 … 48. 3.HoppenfeldS,MurthyV.Treatmentandrehabilitationoffractures. Philadelphia,PA:Lippincott,WilliamsandWilkins;2000. 4.CastilloRC,WegenerST,NewellMZ,CarliniAR,BradfordAN,HeinsSE,etal. 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Psychologicaldistressafterorthopedictrauma:prevalenceinpatientsand implicationsforrehabilitation.PMR.2015;7:978 … 89. 55.GambatesaM,D  AmbrosioA,D  AntiniD,MirabellaL,DeCaprarisA,IusoS, etal.Counseling,qualityoflife,andacutepostoperativepaininelderly patientswithhipfracture.JMultidiscipHealthc.2013;6:335 … 46. 56.WongEM-L,ChanSW-C,ChairS-Y.Effectivenessofaneducational interventiononlevelsofpain,anxietyandself-efficacyforpatientswith musculoskeletaltrauma.JAdvNurs.2010;66:1120 … 31. € We accept pre-submission inquiries € Our selector tool helps you to “nd the most relevant journal € We provide round the clock customer support € Convenient online submission € Thorough peer review € Inclusion in PubMed and all major indexing services € Maximum visibility for your research Submit your manuscript at www.biomedcentral.com/submit Submit your next manuscript to BioMed Central and we will help you at every step: Zdziarski-Horodyski etal.Trials (2018) 19:32 Page12of12