Daniel D. Matlock|Erica S. Spatz
Design and Testing of Tools for Shared Decision Making
Outcomes Research Consortium|Yale New Haven Hospital|Yale University|Outcomes Research Consortium|Yale New Haven Hospital|Yale University
homecirculation cardiovascular quality outcomesvol 7 3design testing tools shared decision making free accessresearch articlepdfepubaboutview pdfview epubsections toolsadd favoritesdownload citationstrack citationspermissions shareshare onfacebooktwitterlinked inmendeleyreddit jump tofree accessresearch articlepdfepubdesign testing tools shared decision making daniel matlock md mph erica spatz md mhs daniel matlockdaniel matlock university colorado school medicine aurora co ddm colorado cardiovascular outcomes research consortium denver co ddm section cardiovascular medicine center outcomes research evaluation yalenew hospitalyale university school medicine new ct ess erica spatzerica spatz university colorado school medicine aurora co ddm colorado cardiovascular outcomes research consortium denver co ddm section cardiovascular medicine center outcomes research evaluation yalenew hospitalyale university school medicine new ct ess originally published8 apr 2014httpsdoiorg101161circoutcomes113000289circulation cardiovascular quality outcomes 20147487492other versions articleyou viewing recent version article previous versions january 1 2014 previous version 1 shared decision making sdm grounded compelling theoretical framework ideally helps patients make decisions informed concordant goals values12 yet operationalizing sdm within routine clinical care remains important challenge several approaches studied improve sdm strategies include educating clinicians communication techniques using multidisciplinary medical team incorporating trained decision coaches using tools support patients decision making tools commonly referred patient decision aids ptdas garnered interest operationalizing sdm3 accordingly article focus specifically development testing ptdas highlighting important key points see boxkey points article decision tool developmentptdas used conjunction conversation clinicianhelping patients consider clarify values around decision makes ptda different information pamphletdevelopment iterative key tasks make sure information understandable accurate unbiased tool fits needs workflow enduserstrials designed test effectiveness decision aid need consider patients clinicians experience tooldecision aids living documents require updating new information arisesextensive work undertaken international patient decision aid standards ipdas collaboration provide guidance arena founded 2003 ipdas aims enhance quality effectiveness ptdas establishing evidenceinformed framework improving content development implementation evaluation45 article draw extensive work ipdas collaboration describe 4step development process interested developing ptdas includes step 1 understanding decision step 2 drafting first version decision aid step 3 iteratively modifying tools step 4 testing decision aid realworld setting additionally discuss potential opportunities expand work ipdas collaboration improve uptake ptda clinical settingdevelopment design decision aidsseveral theoretical frameworks used development ptdas67 common theories used developers include behavioral decision framework8 expected utility theory9 prospect theory10 decision conflict theory11 differentiation consolidation12 fuzzy trace theory13 image theory14 although complete discussion decisionmaking theory beyond scope article excellent summary major decision theories implications decision aid design recently summarized ipdas collaboration7 one commonly used ptda development framework based several theories ottawa decision support framework615 framework states participants decisional needs eg knowledge values support affect decisional quality informed values concordant decisions ultimately impacts subsequent outcomes emotions regret blame behavior appropriate use health services recently developers argued development include active iterative process using endusers phases development16 developers used participatory action research framework patients clinicians participate tool development realworld clinical encounters embedded researchers making modifications based observations tool ultimately usedregardless approach developers ptdas aim 3 main attributes 1 correct accurate content 2 readability usability 3 acceptability lack bias table 1 outlines typical ptda development process fourth attribute ensuring ptda effective improving quality decisions effectiveness ptdas topic separate article series throughout development process developers draw expertise multidisciplinary team team might consist limited patients clinicians experts evidence synthesis information technology health literacy graphic designtable 1 steps decision aid developmentstep 1 understand decisionliterature review aggregate appropriate data effectiveness risks surrounding given intervention summarize formal document needs assessment determine patients clinicians think important attributes decision process often done qualitative interviews written surveysstep 2 develop initial draft decision aid based user input step 1 determine type tool would useful feasible given decision situation video article webbased etc consider introduce ptda clinical encounter may influence type tool developed use ipdas criteria guide include decision aid minimum tool shoulda identify decision needs madeb describe risks benefits optionsc assist people clarifying values either explicitly implicitlyd empower person regarding next steps decisionmaking processstep 3 iteratively modify tools endusers test tool endusers including patients clinicians potential participants eg caregivers relevant role decision making determined needs assessment modify tool goal improving accuracy understandability balancestep 4 pilot test andor implement tool realworld setting researchers choose several study designs including randomized controlled trial patients clustered randomized trial clinicians clinician groups study comparisons study design advantages disadvantagesipdas indicates international patient decision aid standards ptda patient decision aidstep 1 understand decision data suggest risks benefits decision options context decision ptda developedstep one gather information decision ptda developed ptdas aim present information patients actively making decisions deceptively complex question data belong decision aid little information wrong information help decision maker much information may overwhelming17 embarking fullscale development process one check determine whether ptda already developed useful resource university ottawa az inventory patient decision aids httpdecisionaidohricaazinventphp developers register decision aids evaluated using ipdas scoring criteria18 determine relevant content ptda developers review literature regarding risks benefits possible choices information summarized background evidence document systematic review18 background evidence document becomes important users begin reviewing decision aid data presented often source contention also medical literature frequently contains articles divergent results developers need decide data present ptda case implantable cardioverterdefibrillators many conflicting studies risks related different definitions risk different time frames followup19 furthermore data originate randomized controlled trials rcts data originate observational studies general benefit therapy easily derived rct whereas one argue realworld risks may accurately derived observational study20 however decisions complicated stakeholders often disagree data presented ptda regardless source information ptda need routinely reviewed updated ensure consistent current evidencein addition comprehensive literature review ptda developers gain deeper understanding decisionmaking needs experiences participants involved accomplished strategies ranging surveys indepth interviews observed encounters process essential allow developer gain deeper understanding context ptda ultimately implemented case implantable cardioverterdefibrillators many issues learned qualitative needs assessment would never understood literature review alone eg importance guidelines influence device recalls lack understanding deactivation importance discussing inappropriate shocks driving car21step 2 developing first draft ptdaat point informationgathering process developer need draft first version ptda initial approach needs consider 2 key questions tandem 1 inform 1 type tool develop 2 introduce ptda clinical pathway current ptdas come many forms including article videos websites even scripted telenovelas322 forms shown helpful supporting decision making little guidance precisely format best3 type tool informed needs assessment target population context decision resources available development videos websites markedly expensive develop developers additionally need consider decisionmaking process introduce ptda clinical encounter implementation ptda may based feasibility cost ultimately guide type tool developed example intention ptda viewed clinical encounter webbased tool may less ideal depending target populations access comfort computers table 2 lists advantages several common types tools developedtable 2 advantages disadvantages different patient decision aid formatsformatadvantagesdisadvantagesshort article decision aidsexamples option grids wwwoptiongridorg33 statin choice article decision aid mayo clinic34 short article decision aids may success implementation within clinical encounter easy modify update inexpensive develop tools tend comprehensive thus unable meet ipdas criteria however whether ipdas criteria necessary achieve decision quality topic debate5 often require higher literacy levelslonger article decision aidsexamples ahrq booklets35 ottawa decision aids36 easy modify update inexpensive develop comprehensive difficult implement clinical encounter ideally tools would delivered patient discussion clinician often require higher literacy levelsvideo decision aidsexamples health dialog tools37 acp decisions38 may useful populations lower health literacy39 include patient vignettes costly develop visual images may influence decisions ways intended developer40webbased decision aidsexamples healthwise tools41 bresdexcom42 interactive linked electronic medical records tailored patient characteristics record data participant uses decision aid development modification require technical expertise costly patients must access internetacp indicates advance care planning ahrq agency healthcare research quality ipdas international patient decision aid standardsthe next question faced decision aid developer put ptda ipdas collaboration provides guidance although decision different actual content ptda ultimately determined literature review needs assessment iterative participant testing ipdas checklist serves useful guideline drafting initial ptda4 ipdas includes following 4 main domains 1 decision 2 risksbenefits 3 important values consider making decision 4 next steps4 cochrane review decision aids recently demonstrated detailed decision aids improved knowledge additional 5 compared simpler ptdas3step 3 iteratively modify tools potential participantsafter initial prototype developed tool tested modified iteratively endusers including patients clinicians potential participants eg caregivers relevant role decision making determined needs assessment throughout testing tool modified based input participants ensure tool accurate understandable balanced possible4 achieving balance difficult particularly opinions vary patients cliniciansstep 4 testing tool realworld settingonce tool developed consideration must given study design setting implementation ptda table 3 outlines potential study designs strengths weakness applied decision aids randomized controlled trials traditionally perceived rigorous study design minimize bias potential confounders however dyadic multidisciplinary nature shared decision making creates inherent limitations randomized trials randomization occurs patient level clinicians engaging patients decision aid usual care arms increasing probability spillover spillover clinicians may adopt language processes decision aid routine practice thereby diluting differences intervention usual care groups2324 majority trials cochrane review decision aids patientlevel randomized trials3table 3 strengths weaknesses different study designs test patient decision aid formatsstrengthsweaknessesrct patient levelminimization bias confoundingspillover regardless randomization patient clinician level disruptive workflowclustered randomized trialcontemporaneous control group ease workflow minimizes spillovercostly requires collaborations oversight confounding differences study groups unmeasured variablesquasiexperimental prepoststable population setting minimal confounding less costly ease workflowsecular trends eg new data changes attitude influence ptda outcomes primingptda indicates patient decision aid rct randomized controlled trialclustered randomized trials particularly important decision aids designed used within clinical encounter25 clustered randomized trial design offers attractive alternative avoid effects spillover seen patientlevel trials clustered randomized trials clinicians entire clinician group randomized either use decision aid control idea patients seen clinician clinician group receive care randomizing clinician level may completely avoid spillover clinician styles often influenced colleagues cultural norms may evolve intervention implemented2627 reason may preferable cluster clinician group trials decision aids clinician downsides clustered randomized trials primarily relate resources logistics outcomes assessed level group hence sample size considerably lower randomization occurred level patient may reduce statistical power draw conclusions alternative approach assess outcomes patient level however patients similar characteristics tend cluster around clinicians clinician groups may overestimate differences groupsbecause limitations challenges involved performing randomized controlled trials several researchers used quasiexperimental prepoststudy designs whereby historical control period followed compared period ptda implementation evaluation design efficient less costly characteristics patient population tend stable one limitation prepoststudy design concurrent control group thus vulnerable secular trends example changes attitude toward intervention new data may influence outcomes additionally priming may occur whereby responses survey items influenced experience topic question example assessment clinician behavior control usual care study period may show clinicians perceive always including patients decisionmaking process however implementation ptda clinicians may newly recognize report regularly engage patients type shared decisionmaking process despite adoption ptda practice recent example evaluation patient refined expectations deciding invasive cardiac treatments predict tool patients considering percutaneous coronary intervention options28researchers must also decide appropriate setting introduce decision aid presumably sweet spot period patient presented choice point decision needs made29 ideal time decision aid ptdas require patients contemplate values consider alternatives often make complex decisions important identify clinical milestoneswindows opportunities decision making easily occur30 ideal clinical milestone always obvious ptda introduced acute change health status eg acute myocardial infarction heart failure exacerbation patient may prepared engage decisionmaking process contrary decision needs timely relevant patient carry import consider example ptda left ventricular assist device lvad implantation patients advanced heart failure ptda introduced time hospitalization acute exacerbation decision implant lvad difference life death patients may sick engage shared decisionmaking process may experience decisional regret allowed emotional state opposed values influence decision31 outpatient setting patients stable yet endstage heart failure may ideal kind balance must learned early investigator performing needs assessmentrelated setting researchers must determine ideally needs assessment appropriate clinician introduce ptda practitioner longstanding relationship patient surgeon performing surgery example clear whether interventionalist referring clinician best position help patients considering bare metal stent versus drug eluting stent percutaneous coronary intervention purposes research may impractical disseminate ptdas referring providers moreover clear interventionalists would accept carry decisions involved contrary referring clinicians rapport patient may better able assess patients values reflect preferences may prepared discuss risks benefits bare metal stent versus drug eluting stentunique challenges future directionsshared decision making general ptdas particular emerging science many unanswered questions significant need future research highlight selection challenges controversies among development communityshould information ptda tailored individual patientthe type magnitude risks benefits associated decisional option may vary based characteristics patient example older patient competing morbidities likely smaller benefit larger risks many aforementioned therapies argue patients presented tailored statistics accurately reflect clinical situation28 cumbersome often requires mathematical model host assumptions determine tailored statistics provide given patient whether individual patient decisions sensitive tailoring unknowncan emotion affect addressed ptdamuch work decision aid development focused cognitive transfer information however many major decisions largely driven emotion particularly decisions involving tradeoffs around quality versus quantity affect heuristic shown influence many cognitive aspects decision making32 example found many patients hospitalized intensive care unit dying heart failure unable cognitively weigh risks benefits lvad overwhelming fear dying31 ptdas setting designed address emotions like fear help patients make cognitive decisionsare ptdas useful chronic disease models patients make multiple decisions timetraditionally ptdas conceived developed assist discrete decisions however vast majority medical decisions made patients chronic illness often make multiple repeating decisions long period time example patients heart failure may frequently need recalibrate decisions activity salt intake medications ptdas developed help patients recurring decisions ptdas used periodically patients chronic illness means reassessing goals care ongoing management present majority ptdas focus discrete decisions rather multiple decisions made time area ripe research innovationconclusionthe aim discussion provide framework potential developers consider developing ptdas however field ripe innovation particularly areas decisions difficult present ptdas stymied research setting whether lack adoption routine clinical practice stems poor development reluctance part clinicians use prohibitive workflow maligned incentives inaccessibility time needed clear certainly 1 essential step toward solution problem invite potential stakeholders patients clinicians clinical staff administrators etc aspects development increasing interest among healthcare leaders policymakers funders bring ptdas fold may opportunities study development uptake impact ptdas investigation critical informing best practices developing ptdas policies support usesources fundingdr matlock supported career development award national institute aging 1k23ag040696disclosuresnonefootnotescorrespondence daniel matlock md mph division general internal medicine university colorado school medicine academic office 1 12631 e 17th ave campus box b180 aurora co 80045 email email protectedreferences1 makoul g clayman ml integrative model shared decision making medical 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