Medicine, Faculty of
Non UBC
Family Practice, Department of
DSpace
BMC Medicine. 2018 Oct 11;16(1):174
The Author(s).
McNab, Duncan
Freestone, John
Black, Chris
Carson-Stevens, Andrew
Bowie, Paul
Background: Ensuring effective identification and management of sepsis is a healthcare priority in many countries. Recommendations for sepsis management in primary care have been produced, but in complex healthcare systems, an in-depth understanding of current system interactions and functioning is often essential before improvement interventions can be successfully designed and implemented. A structured participatory design approach to model a primary care system was employed to hypothesise gaps between work as intended and work delivered to inform improvement and implementation priorities for sepsis management. Methods: In a Scottish regional health authority, multiple stakeholders were interviewed and the records of patients admitted from primary care to hospital with possible sepsis analysed. This identified the key work functions required to manage these patients successfully, the influence of system conditions (such as resource availability) and the resulting variability of function output. This information was used to model the system using the Functional Resonance Analysis Method (FRAM). The multiple stakeholder interviews also explored perspectives on system improvement needs which were subsequently themed. The FRAM model directed an expert group to reconcile improvement suggestions with current work systems and design an intervention to improve clinical management of sepsis. Results: Fourteen key system functions were identified, and a FRAM model was created. Variability was found in the output of all functions. The overall system purpose and improvement priorities were agreed. Improvement interventions were reconciled with the FRAM model of current work to understand how best to implement change, and a multi-component improvement intervention was designed. Conclusions: Traditional improvement approaches often focus on individual performance or a specific care process, rather than seeking to understand and improve overall performance in a complex system. The construction of the FRAM model facilitated an understanding of the complexity of interactions within the current system, how system conditions influence everyday sepsis management and how proposed interventions would work within the context of the current system. This directed the design of a multi-component improvement intervention that organisations could locally adapt and implement with the aim of improving overall system functioning and performance to improve sepsis management.
RESEARCH ARTICLE Open AccessParticipatory design of an improvementintervention for the primary caremanagement of possible sepsis using theFunctional Resonance Analysis MethodDuncan McNab1,2,3* , John Freestone2, Chris Black1,2, Andrew Carson-Stevens4,5,6 and Paul Bowie1,3AbstractBackground: Ensuring effective identification and management of sepsis is a healthcare priority in many countries.Recommendations for sepsis management in primary care have been produced, but in complex healthcare systems,an in-depth understanding of current system interactions and functioning is often essential before improvementinterventions can be successfully designed and implemented. A structured participatory design approach to modela primary care system was employed to hypothesise gaps between work as intended and work delivered to informimprovement and implementation priorities for sepsis management.Methods: In a Scottish regional health authority, multiple stakeholders were interviewed and the records of patientsadmitted from primary care to hospital with possible sepsis analysed. This identified the key work functions required tomanage these patients successfully, the influence of system conditions (such as resource availability) and the resultingvariability of function output. This information was used to model the system using the Functional Resonance AnalysisMethod (FRAM). The multiple stakeholder interviews also explored perspectives on system improvement needs whichwere subsequently themed. The FRAM model directed an expert group to reconcile improvement suggestions withcurrent work systems and design an intervention to improve clinical management of sepsis.Results: Fourteen key system functions were identified, and a FRAM model was created. Variability was found in theoutput of all functions. The overall system purpose and improvement priorities were agreed. Improvement interventionswere reconciled with the FRAM model of current work to understand how best to implement change, and amulti-component improvement intervention was designed.Conclusions: Traditional improvement approaches often focus on individual performance or a specific care process,rather than seeking to understand and improve overall performance in a complex system. The construction of the FRAMmodel facilitated an understanding of the complexity of interactions within the current system, how system conditionsinfluence everyday sepsis management and how proposed interventions would work within the context of the currentsystem.This directed the design of a multi-component improvement intervention that organisations could locally adapt andimplement with the aim of improving overall system functioning and performance to improve sepsis management.Keywords: Quality improvement, Complexity, Functional resonance analysis method, Sepsis, Primary care* Correspondence: Duncan.mcnab@nes.scot.nhs.uk1NHS Education for Scotland, 2 Central Quay, Glasgow, Scotland G3 8BW, UK2NHS Ayrshire and Arran, Ayr, UKFull list of author information is available at the end of the article© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.McNab et al. BMC Medicine (2018) 16:174 https://doi.org/10.1186/s12916-018-1164-xBackgroundSepsis is a life-threatening condition where tissue damage,organ failure and death may result due to the body’s own re-sponse to infection [1, 2]. It is thought to cause at least sixmillion deaths per annum worldwide, many of which arethought to be preventable with early recognition and treat-ment [1, 2]. There is international expert consensus that in-creased awareness, earlier presentation and detection, rapidadministration of antibiotics and treatment according tolocally developed guidelines can significantly reducesepsis-related deaths [3, 4]. In secondary care, compliancewith care protocols for patients with signs suggestive of sep-sis is believed critical to improving outcomes and minimis-ing sepsis-related deaths [5]. However, the implementationof sepsis management interventions has been problematicwith only 10–20% of patients receiving care that is fullycompliant with intervention recommendations [6, 7].While a significant amount has been reported about workundertaken within the hospital setting to improve sepsismanagement, work in primary care is at a much earlierstage but has become a national priority in Scotland [8–11]. Presentations with infective conditions in this settingare exceedingly common, with only a very small proportiondeveloping sepsis, while initial symptoms of sepsis can bevague—making early, accurate identification of patientswho have sepsis or may develop it a challenge [12]. In sev-eral high-profile cases, primary care management of pa-tients who had sepsis was thought to be inadequate [13,14]. Guidelines to aid the identification of acutely ill pa-tients who may have sepsis in primary care have been pub-lished that recommend the use of a structured set ofclinical observations to stratify the risk of sepsis includingpulse, temperature, blood pressure, respiratory rate, periph-eral oxygen saturation and consciousness level [10].Quality improvement (QI) as both a philosophy andsuite of methods [15] has underpinned the design ofmajor national preventive efforts to tackle sepsis inter-nationally [16–18]. Recent perspectives on QI argue thatin complex healthcare systems the design of improve-ment interventions risks being flawed if there is limitedfocus beforehand to gain a deep insight into how thesystem under study actually functions when things goright and wrong [19–26].Primary healthcare has been described as a complexsocio-technical system [28, 30]. Such systems consist ofmany dynamic and interacting components (e.g. clinicians,patients, tasks, information technology, protocols, equip-ment and culture) and are affected by rapid changes inconditions (such as patient deterioration, reduced staffcapacity, increased patient demand, limited informationand availability of resources) [28–31]. Often, differentparts of systems can be closely coupled resulting inchanges in one area affecting other areas in a non-linear,unpredictable manner. Rather than being purposivelydesigned, systems of work often emerge and evolve overtime due to the interactions between different compo-nents. People employ workarounds (for example, when in-formation is not available) and trade-offs (such as whenstaff have to prioritise task efficiency over thoroughness)to achieve safe care [31–34]. “Work-as-done” (WAD), in-cluding performance adjustments, represents everydaywork and is often different from “work-as-imagined”(WAI) as encapsulated in clinical guidelines and protocolsand imagined by those in other parts of the system suchas senior managers and policymakers.Healthcare improvement projects to implement rec-ommendations or clinical guidelines are often complexinterventions that include multiple interacting and inter-dependent components; for example, education, newcare protocols, new staff roles and new ways of accessingservices [19, 20]. There is a growing awareness of theimportance of understanding the complexity of currentwork and considering interactions between proposed in-terventions and the existing system in the planning anddesign stages of improvement projects to inform poten-tial success [24–26].The rationale for this study was to explore and betterunderstand how acutely ill patients who may have sepsis arecurrently identified and managed in the community, obtainmultiple perspectives on potential improvement interven-tions and determine how best these suggestions can informthe design of a system-centred improvement intervention.MethodsThe methods and results of this project have beenreported in keeping with current, best practice guide-lines advised by Tong et al. [35]. A COREQ checklist(Additional file 1) is included as Table 6 in Appendix 1.Clinical settingThe study was conducted in a primary care settingwithin a single, Scottish, regional health board, NHS(National Health Service) Ayrshire and Arran (NHSAA).The identification and management of sepsis is a prioritypatient safety improvement focus for NHSAA but thebest way to design and implement a related interventionin community settings was not clear to local clinicalleaders, management and improvement advisors. To ac-cess appropriate treatment including antibiotics andfluid management, patients may self-present at the hos-pital Emergency Department (ED) either by themselvesor through telephoning for an ambulance. Alternatively,they may be assessed in the community by a generalpractitioner (GP) or advanced nurse practitioner (ANP).During normal working hours (8:00 am to 6:00 pmMonday to Friday), clinical assessment is arranged by GPreception staff, while at other times it is arranged byNHS24 (a special national health board within NHSMcNab et al. BMC Medicine (2018) 16:174 Page 2 of 20Scotland that provides health information and facilitates pa-tient access to primary care out-of-hours services providedregionally by Ayrshire Doctors On Call (ADOC)). Otherhealthcare professionals, such as nurses who work in thecommunity and in nursing care homes, can arrangeout-of-hours clinical review directly using the single point ofcontact (SPOC—a non-clinical administrative member ofstaff who arranges ADOC appointments directly based onthe instruction from the healthcare professionals). If, afterclinical assessment, it is thought that admission is required,clinicians discuss secondary care assessment with colleaguesin the Combined Medical Assessment Unit (CMAU) andthen forward documentation summarising their findingsand presumed diagnosis and arrange transport.Study designA mixed methods approach, including semi-structuredinterviews, group interviews and documentary analysis,was used to identify system functions and their interac-tions and output variability to inform a contextuallygrounded design of a Functional Resonance AnalysisMethod (FRAM) model [36, 37]. Multiple clinical, man-agement and administrative perspectives on potentialsystem improvements were identified and themed. Aparticipatory design approach [38] using a key stake-holder workshop was then used to reflect on FRAMfindings and improvement suggestions and identify andagree improvement interventions based on a systems ap-proach to this issue.Functional Resonance Analysis Method (FRAM)The Functional Resonance Analysis Method (FRAM) isone way to begin to model and understand non-trivial,complex, socio-technical systems [36]. The FRAM in-volves exploring “work-as-done” with frontline workersto identify the “functions” that are being performed. Afunction is defined as “the activities—or set of activ-ities—that are required to produce a certain outcome”[36]. Identified system functions are entered into theFRAM Model Visualiser software (FMV). FRAM studiesthe relationships within a system by exploring potentialinteractions between functions to identify coupling be-tween different parts of the system. To achieve this, linksare created between functions by identifying six specificaspects of each function: input, output, preconditions,resources, controls and time factors (Table 1). For ex-ample, the output of a function <book appointment> is<appointment booked> which is a precondition of thefunction <perform clinical assessment>. A key compo-nent of the FRAM is to study and record the variabilityof the output of each function. Functional resonance re-fers to how variability of different functions can combineto produce amplified and unpredicted effects (bothwanted and unwanted).The FRAM is one method to facilitate the adoption of acomplex systems approach. Exploring and building amodel of work-as-done allows consideration of howpeople adapt to deal with unexpected clinical presenta-tions, system conditions (such as availability of informa-tion or time) and competing goals (such as efficiency andthoroughness). Exploring how these adaptations combinewith variability elsewhere in the system encourages a shiftfrom considering systems as linear, where event A causesoutcome B in a predictable manner, to adopting a complexsystems approach to focus on the relationships betweencomponents and how outcomes emerge from these inter-actions. FRAM has previously been used in healthcare toexplore the complexity of the system for taking bloodprior to blood transfusion [39] and to guide implementa-tion of guidelines [40] by exploring current work systemswith health care professionals to ensure proposed changeswere compatible with current ways of working. It is usedregularly in parts of Denmark to explore complex systemsin order to plan improvements [41].Real linkages can only be found by looking at the systemwith a specified set of conditions, such as an event thathas occurred or by predicting how a particular event mayoccur—these are called instantiations. The linkagespresent in any given instantiation are a subset of all thepotential linkages in the FRAM model and can be used tounderstand how historical events occurred, consider howthe system may perform in varying conditions or how sys-tem performance may be altered by change to one func-tion. The FRAM also describes variability of functionoutput. This variability, or functional resonance, reflectsthe normal, everyday variability of function output causedby altering system conditions and the adaptations peopleemploy to continue successful operations in these condi-tions. Rather than being quantified, variability is recordedTable 1 Aspects of FRAM functionsAspect Description Example for function<perform clinicalassessment>Input (I) What the function acts on orchanges and starts the functionPatient arriving atthe consulting roomOutput (O) What emerges from thefunction—this can be anoutcome or a state changeClinical assessmentcompletePrecondition (P) Some condition that must bemet before the function can startAppointmentbookedResources (R) Anything (people, information,materials) needed to carry outthe function or anything that isused up by the functionThermometer,stethoscopeControl (C) Anything that controls ormonitors the functionProtocol orguidelinesTime (T) Time constraint that mayinfluence the function10-min consultationMcNab et al. BMC Medicine (2018) 16:174 Page 3 of 20as present or not within a function and can be describedas too early, on time, too late, not at all, precise, acceptableand imprecise. Resonance (or variability) in one functioncan combine with resonance in other functions and leadto unpredicted outcomes both positive and negative.Study participantsA pragmatic, purposive sampling strategy was employedto identify appropriate healthcare professionals workingin primary, secondary and interface care settings withexperience and knowledge of their part of the NHSAASepsis identification and management system who werethen invited to participate in semi-structured interviews.Twenty-two healthcare professionals and administratorswere contacted by email and all agreed to participate.Fifteen interviews were completed (Table 2).To assess variability of functions, ADOC were askedto provide relevant out-of-hours data and a pragmatic,convenience sample of NHSAA general practices wasapproached to provide in-hours data (Table 3). Twenty(of 55 NHSAA) general practices were asked to providedata on recent admissions of which eight practicesreturned requested data (40%).Data collection and analysisThe following data collection, interpretation and analyticalmethods were applied to enable construction of a prelim-inary FRAM Model, identify and theme improvementsuggestions and design an improvement intervention.Semi-structured interviewsFifteen semi-structured, face-to-face, individual (n = 11)and group (n = 4) interviews were conducted at theparticipants’ place of work by DM. Only DM, who is a GPin the area and an experienced qualitative researcher, andthe participants were present during interviews, and norepeat interviews were conducted. The duration of inter-views was from 22 to 54 min. Study aims were explainedand a definition of sepsis was provided to participants. In-terviews were informed by an inductive approach [42] andstructured in design to ensure data collection identifiedfunctions and their aspects to construct the FRAM modeland suggestions for system improvement.GP in-hours dataParticipating GP practices (n = 8) provided data on theirlast ten admissions for adults with a presumed infectivecause (chest infection, urine infection, cellulitis or otherpresumed infective cause based on the recorded consult-ation). A worksheet was completed by either a GP withinthe practice or the practice manager to record if the fol-lowing were explicitly stated in the admission letter: pa-tient’s pulse, temperature, oxygen saturations, bloodpressure, a comment on level of consciousness and if aworking diagnosis of sepsis or possible sepsis was noted.GP out-of-hours dataAnonymised data for all acute hospital admissions wasextracted from the ADOC computer system for a fullcalendar month in 2016 and downloaded to MS ExcelSoftware [Microsoft Corporation, version 12.0 / 2007]for analysis (Table 3). Patients aged 16 or over admittedwith a suspected infective cause were identified and se-lected by the lead author (DM). The Microsoft Excelrandom number generator was used to select 50 patientcases, which the research team agreed should be suffi-cient to provide evidence of variability within this partof the system.Identification of system functions and aspectsAll individual and group interviews with participantswere audio-recorded and transcribed with consent. Asystematic and iterative approach to analysis of the inter-view data based on the constant comparative methodwas adopted [43]. Transcription text was read andre-read by DM to facilitate a deep understanding of thedata. Functions required in the current system for theidentification and management of sepsis were identifiedand treated as themes. Responses were coded withinQDA Miner [Provalis Research, Montreal, Canada,Table 2 List of interviewsProfessional role Number ofintervieweesIndividualor groupinterviewGeneral practitioners with both in-hoursand out-of-hours roles4 IndividualGP specialty trainee—who work both inand out-of-hours1 IndividualIn-hours ANPs 2 GroupOut-of-hours advanced nurse practitioners 1 IndividualNHS 24 nursing staff 5 GroupADOC administrative staff (single point ofcontact and reception staff)2 IndividualCombined assessment unit (secondary care)senior nurse1 IndividualAccident and emergency senior nurse 1 IndividualAccident and emergency consultant 1 IndividualGeneral practice receptionist 2 GroupCommunity nurses 2 GroupTable 3 Data extracted from ADOC electronic recordsDate and time seenAgeCase summary (consultation text and values)Diagnostic codes appliedPriority assigned by NHS24 (to be seen within 1, 2 or 4 h)The use of a specific sepsis template (yes/no)McNab et al. BMC Medicine (2018) 16:174 Page 4 of 20Table4FunctionsfromtheFunctionalResonanceAnalysisMethod(FRAM)modelFunctionDescriptionofinfluenceofsystemconditionsonfunctionandoutputvariabilityDatafromauditinboldQuotesfrominterviewsinitalicsa)ProcessrequestforclinicalassessmentNHS24•Capacity/demandmismatches(morerequestsfrompatientstospeaktostaffthannumberofstaffavailabletomeetthisdemand)maydelaycommencementofthisfunction.•Staffreporteddeviatingfromthealgorithm(whichmaybeconsideredacontrol)whennecessaryinanattempttoachievesuccessWehavegotthealgorithmbutquicklyyoulearnthatit'sonlyaguide.Imean,whenIwasnewIusedtosticktoitbutnowIdonotrefertoit.ImeanIknowitinmyheadanyway,butIaskotherthingsandgetthemtoholdthephonenexttothemtohearthebreathing,askthemiftheyfeelwarmandaskthemaboutconfusion.Ithinkthatismorehelpful.NHS24•Variabilityofassignedtriagetimeswasobservedwithnoassociationbetweentriagetimeandthelikelihoodofapatientsubsequentlybeingadmittedwithsuspectedsepsis.NHS24triagetime,n(%),whenadmittedwithinfectivecausefromout-of-hours○1h=12(24)○2h=18(36)○4h=20(40)NHS24triagetime,n(%),whensepsissuspectedatoutofhours○1h=7(24)○2h=10(34)○4h=12(41)b)ProcessrequestforclinicalassessmentGPsurgery•Therewasadifferencebetweenwork-as-donebyadministrativestaffandwork-as-imaginedbytheGPs.○Ingeneral,ourstaffaregoodatsayingthispersondoesn’tsoundwellandtheyareconcernedandtheydon’tcalloftenandtheyletusknowsotheywillputitontotheemergencydoctor.GP3○Idon’tknowifIwouldnecessarilyrecogniseitinapatientcominginbecausealotofitislikefeverandsickness-itcouldbeanything.Trainingorachecklistmayhelp.Receptionist2○Ithinkitiseasyforustorecognisesomeonethatcomesinwithchestpainsratherthansomeonewhocomesinwithsepsis.Receptionist1•Capacity/demandissuesinfluencedfunctionoutputresultinginstafftakinglesstimetoassesspotentialurgencyofthemedicalconditionatbusyperiods.○ItcanbequitehardonaMondaymorningwhenyouhavegotlotsofpatientswaitingforanon-the-dayappointmentandwejustgetaseaofpeopleitwouldbequitehardtosaythencouldyougivemeindicationoftheproblem.Receptionist2•Resourcessuchastraining,experienceandknowledgeofthepatientwerealsothoughttoinfluencefunctionoutput.•Therewerenoguidelinesorprotocolsinplaceforstaff.ThesemayactaspotentiallybeneficialcontrolsthathelpstafftodecideactionssuchastheurgencyofspeakingtoaGP—whentointerruptandwhentowait.○Ithinkit’sdifficultIdon’tthinktheyhavehadadequatetrainingonitIdon’tthinkyearsofpracticeorasaHealthBoardhaveaddressedtrainingforadminreceptiontypestaff.GP3c)Processrequestforclinicalassessmentbyanout-of-hoursclinicianviathesinglepointofcontact•Outputwasbasedontheinformationgivenbycommunityhealthcareworkersandwasthoughttobevariable.•Therewasnoguidancetodirecttherequiredurgencyofclinicalassessment.d)Performclinicalassessment•Resourceavailabilitytoaidclinicalassessmentwasthoughttobeadequateinbothin-hoursandout-of-hourscare.•In-hourselectronictemplateswerethoughttobemoreuseful.○Inthesurgerywehaveatemplateweusethatiseasyandhelpful.GPANP○Theout-of-hourstemplatemakesitmoredifficult–youseeitwhenyouarebackinthecarwritingupthecaseafteryouhavemadeyourdecision–it’stoolate.Ithinkifitwasquick,easyandstraightforwardyoumightgetbetterrecording(ofobservations).GP2•Cliniciansstatedthatpatientswithpossiblesepsiswouldtakemoretimetoassessandmanage.Thiswasnotthoughttoinfluenceactionswiththesepatients,butwouldcauseincreasedtimepressurewhenconsultingwithsubsequentpatients.○Timeisamajorfactoralthoughwhenyouaredealingitisnotafactorbecauseyoublankeverythingelseoutandyoudealwithit-youhavetosuckitupafter.GPANP○Ithinkoftenthesepatientsareunwellsoyoutakethetimeanyway.GPANP•ItwasfeltthatthelackofinformationavailablethroughtheKeyInformationSummary(KIS),anelectronicsummaryofimportantclinicalandsocialinformationcreatedbythepatient’sGPpracticeandavailabletoout-of-hoursGPsandsecondarycare,couldinfluenceclinicalassessmentasusualphysiologicalparameterswerenotavailableMcNab et al. BMC Medicine (2018) 16:174 Page 5 of 20Table4FunctionsfromtheFunctionalResonanceAnalysisMethod(FRAM)model(Continued)FunctionDescriptionofinfluenceofsystemconditionsonfunctionandoutputvariabilityDatafromauditinboldQuotesfrominterviewsinitalicse)CreateandmaintainKIS•TheinformationcontainedinKISwasnotedtobevariablebyGPsandbyhospitalteams.Thiswasthoughttoreflectbothalackofguidanceoncompletionandlackoftimetoperformthistaskproperlybyin-hoursclinicalteams.○Ithinkitisvariablesometimesitisexcellent(theKIS)anditmakessuchadifference-andthenothertimesitisnot-andIthinkthatisprobablyoneofthereasonswhyitisnotbeingaccessedstrategicallybecauseitisnottheeasiestorquickestthingtogetintoanditisalmostlikeitisabitlikealotteryifyougetonethatisgoingtohelpyouornot.AEcons○Iknowitishardtofindthetimeduringthedaytocompletethese(KIS)butinOOHthemostimportantthingsIhaveisbackgroundobservationandbaselineobservations.GP○Inoutofhoursandyouhaveaconfusedbuddyyoudon’thaveanybackgroundinformation.Youhavenocarertotellyouwhy,thereisnorelativeitisverytrickythereisagoodchanceyouaregoingtomisssomething.Thenasyoudon’tknowiftheyareconfusednormally-youdon’tknowanything-sothatmakesittricky.GP2f)Recordpatientobservationsinclinicalrecord•InMay2016,therewereatotalof731admissionsviaADOC,ofwhich592werepatientsaged16orover(Table5).Ofthese,270wereforapresumedinfectivecause(66.2%).Out-of-hoursAllphysiologicalparameterspresenttocalculateNEWSscore.•Thosewithinfectivecause:32of50(64%)•Thosewithpresumedsepsis:10of29(34%)•NEWSscorenevercalculated•Electronictemplateusedin5patients(10%)In-hoursAllphysiologicalparameterspresenttocalculateNEWSscore.•Thosewithinfectivecause:11of76(14.5%)•Thosewithpresumedsepsis:2of11(18.2%)•Recordingofobservationsinout-of-hourswashigherthanin-hoursandvariedbetweenpractices.Despitetheout-of-hourstemplatesbeingdescribedasalessusableresource,cliniciansdescribedfeeingmorevulnerableinanout-of-hourssettingandweremorelikelytorecordallvalues.Mostcliniciansdiscussedmeasuringandrecordingphysiologicalparameterstoaiddiagnosisandtodefendthemselvesifsomethingwentwrong,butwerenotawareifsecondarycarecolleaguesfoundthisinformationuseful.○Ifeelinoutofhoursyoudon’tknowthepatientsowellsoIamverypreciseinoutofhoursofrecordingobservationsandIthinkitwouldbeagoodideaifmorepeopledidthat.GP•Allphysiologicalparameterswererecordedlessfrequentlyforpatientsadmittedwithpresumedsepsis,asopposedtoaninfectivecausewheresepsiswasnotsuspected.OneGPreportedthatoncethedecisiontoadmitapatienthadbeenmade,furtherobservationswerenotmade.Thiswasfelttobeabeneficialtrade-offtodealwiththecompetinggoalsofefficiencyversusthoroughness.○IsawthismanonavisitandfromthemomentIwalkedinIknewIwasadmittinghim.Wehadtheinformationthathewasgettingchemoandwasabitshaky.Ididhistempandpulseandthought–rightyouaregoingin–soIdidnotdotheothervalues.GP2g)Decidetoadmitpatient•Thisfunctionwasthoughttovarydependentontheclinicalpictureandalsoclinicianexperience.○IthinkitisvariableIthinkitisprobablycliniciandependant.Experiencedependant.Possiblypatientdependantorpracticedependant.GP1•Thelackoftimetoobservethetrajectoryofthepatientconditionwasreported.○Thefactsomanyotherthingscouldbegoingonandtherapidlychangingclinicalpicturecauseyouhaveonly10–15maybe20mins,ifyouarelucky,withthepatients.GP1•Somecliniciansusedearlywarningscoringsystemstoaiddecisionmaking.Theseinvolveassigningavaluetoeachphysiologicalvalueandcalculatingacompositescoretostratifyrisk.Othersfeltsuchscoreswerenothelpfulasroutinelyrecordingearlywarningscoreswouldmakenormalworkmoredifficulttodo(throughextratimetocalculateandrecordscores).○Idoobservations-IprobablydoaversionofNEWS…andImaketheclinicaldecisionbasedonthat.GP2•Theoverallclinicalpicturewasfelttobeamoreimportantindicatoroftheseverityofillness.○Youhavegottoputittogetherwithotherobservationsandclinicalpictureandthehistoryitgivesyoumoreweight,itisallaboutpickingupthingsthathelpyoumakeyourdecision.GP4•WhenapatientcomesthroughSPOCwedonotgetKISaccess–surelythiscouldbechanged.GP1○Itwouldbegoodtohaveaccesstopreviousnotestohelpdecisionmaking.GP1McNab et al. BMC Medicine (2018) 16:174 Page 6 of 20Table4FunctionsfromtheFunctionalResonanceAnalysisMethod(FRAM)model(Continued)FunctionDescriptionofinfluenceofsystemconditionsonfunctionandoutputvariabilityDatafromauditinboldQuotesfrominterviewsinitalicsh)Transferpatienttosecondarycare•OneGPreportedthatspecialtytrainees,whohesupervised,usuallyorderedanimmediateambulanceifsepsiswasconsideredwhereas,ifthepatientwasrelativelystable,hemayorderanambulancethatwouldtransferthepatienttohospitalwithinonehour.Variabilityinthisareawasthoughttorelatetoalackofguidanceontransferurgency.○Idunno…Isupposeweshouldgetabluelightambulance..yeahthat’swhatthetraineesIsupervisedo.SometimesIhavearrangeda1hthough...Imeannotiftheyarelikeveryillbutifsomeoftheirobsareoffbuttheyarestillwellenough.GP2i)Communicatewithsecondarycare•Variabilitywasseenintheoutputofthisfunction.Secondarycarecliniciansreportedthatthenumberofphysiologicalparameterscommunicatedduringadmissionwasvariable.Inaddition,theuseofthewordsepsistoalertsecondarycarecolleaguesthatthepatientbeingadmittedmayrequireimmediateclinicalassessmentwasvariable.○InOOHthereisavariationofwhatinformationwegetalotoftimes.emsothegirlsmanningthephonewillstillaskthesamequestionsitjustthatinformationisn’talwaystohanditispersondependent.CAU•So,themostimportantthingforusisthemorewarningwehave-andclearcommunicationcomesisreallyhelpful-becauseassoonasthewordsepsisisuseditwillprecipitateacertainresponseamongstourteam.AE○Idon’tthinkIhaveeverusedthewordsepsisIamadmittingthispatientwithsepsis.GPANP○IwoulddescribethesituationratherthansaysepsismaybeIshouldsaysepsis.GP2j)Assessinsecondarycare•ItwasfeltthatthevariabilityofinformationreceivedinadmissioncommunicationandintheKIShadthepotentialtoinfluencethisfunctionandresultindelayedassessment,treatmentandpossiblepoorerpatientoutcomes.○Rightweknowthispatientiscomingweareexpectinghimassoonasthatambulancearrivestheyarestraightintoourresusbaywheretheteamarewaiting.CAU○Ithinkiftherehasbeenabnormalphysiologyitisusefultohavethatdocumented.AEk)Performassessmentofpatientbycommunityhealthcarestaff•Theoutputofthisfunctionwasinfluencedbylackofavailableresources(thermometers,oxygensaturationmonitors)andabsenceofcontrols-guidanceonhowtoassesspatients,whatinformationshouldbecommunicatedtoclinicalcolleaguesandtoguideurgencyofclinicalreview.○Idonotthinkwecouldrecordallthesescoresaswedonotcarrythermometersorsatsmonitors.IknowthatthechemofolkneedadmittedandweareabletocallthesurgerytogetaGPtoseethem.Attheweekend,wecanusetheSPOC[singlepointofcontact]todirectlyrequestaGPvisitbutIamnotsurehowquicklythat[visit]happens.Communitynursel)Makeguidelinesavailabletoclinicalstaff•NHS24hadelectronicversionsofguidelinesandtwoGPsreportedhavingandusinganelectronicsmartphoneapplicationforsepsismanagement.Otherswerenotawareofnewguidanceordidnotknowwhereitcouldbeaccessed.○Ihavenotseenthenewguidelines.GP4○Imeanifthereweresomeguidelines-getguidelinesout.GP2○Idocarrythe[sepsis]app.GP1m)Educatecliniciansonsepsismanagement•Educationalmeetingswereconsideredvaluableinraisingawarenessofguidelinesforsepsismanagementbythosethatattendedthem,butmanyhadnotattendedanylocallearningevents.Otherformsofdeliveringtargetededucationweresuggested.○Educationsessionstryingtogetpeopletoengage–differentpeoplelikedifferentthingsandmeetingsarenotsuitableforeveryonesonoteveryonehasattendedbefore.GP2n)Maintainandstockequipment•Variableaccesstoresourcessuchasthermometersandsaturationmonitorswasreportedbycommunitynurses.Forbothin-hoursandout-of-oursGPsandANPs,thiswasthoughttobeadequate.○MostofthetimeinADOCyouhavethethermometerandstuffandhavesparebatteries-Ihaveneverhadaproblemwiththat.GP1○InthesurgerythereiseverythingyouneedbutIsupposesometimesIhavetogoandfindstuff.Imeanlikeathermometerorasatsmonitor.GPANP○Wedonotcarrythermometersorsatsmonitors.DNsMcNab et al. BMC Medicine (2018) 16:174 Page 7 of 20Version 1.4.6.0, 2002] based on these themes. The datafor each theme was analysed to identify aspects of eachfunction. All data were cross checked with other authorswith any disagreements resolved by discussion untilconsensus was achieved. Finally, system functions andaspects were uploaded to FMV software [Zerprize, NewZealand, Version 0.4.1, 2016].Assessment of variability of function outputVariability of function output was assessed through ana-lysis of interview data for reported variability in functionoutput. In addition, out-of-hours and in-hours admissiondata was analysed to determine the number and percent-age of patients with each physiological parameter re-corded, the number and percentage with all parametersrecorded and the median number of physiological param-eters recorded per patient. The median was calculated asit was thought that some practices may have either veryhigh or very low levels of recording physiological parame-ters [44]. For out-of-hours admissions, the use of an elec-tronic template for recording observations and priority (1,2 or 4 h) assigned by NHS24 was recorded. This was de-termined for all patients and separately for those with apresumed diagnosis of sepsis. Variability of function out-put was entered into the FMV software.Design of improvement interventionA separate thematic analysis identified suggested areas forsystem improvement. Suggestions from interviewees werecoded in QDA Miner by DM and arranged into themesthrough discussion of codes by authors (DM, JF and CB).A workshop was held for key local stakeholders with pri-mary care management, leadership and frontline clinicalroles (n = 6) to both validate the FRAM model and gainconsensus on improvement priorities and strategies.Through discussion, the FRAM model was used to recon-cile improvement suggestions with work-as-done andconsensus was sought on the design of an improvementintervention. A Driver Diagram was constructed to linkthe overall aim of the project with the major improvementdrivers identified enabling a multi-component improve-ment intervention strategy to be designed [45]. Consensuswas deemed to have been reached when full agreementwas achieved by all attendees.ResultsFRAM modelFourteen foreground system functions were identified withdescription of the function and output variability outlinedin Tables 4 and 5 (Fig. 1). Seventeen background functionswere required to complete the FRAM model of which thekey stakeholder group felt ten were relevant to discussionson improvement intervention design. For example, thefunction <Create guidance on KIS completion> was not thefocus of the FRAM; therefore, its aspects were not ex-plored, meaning it only had an output and was thus a back-ground function. It was considered relevant in the design ofthe improvement intervention as change to this functionmay influence the function <Create and maintain KIS>. Incontrast, it was thought that an intervention would be un-likely to influence the background function <Manage staffcapacity> and so this was not included in the FRAM modelthat was discussed.Co-design of improvement interventionSix improvement intervention themes were identifiedcomprising of (1) feedback to facilitate reflective learning,(2) improving communication pathways, (3) use of earlywarning scores, (4) improving electronic template forTable 5 Recording of physiological parameters admissions dataData set MeanageNumber ofphysiologicalparametersrecorded perpatient (max 6)median(interquartile range)Temp,n (%)Pulse,n (%)BP,n (%)Saturations,n (%)Resp rate,n (%)Consciousnesslevel, n (%)All physiologicalparameterspresent tocalculate NEWSscore, n (%)Out-of-hours admissionsdiagnosed as possibleinfection (n = 50)66.2 5 (1) 50(100)50 (100) 48 (96) 45 (90) 31 (62) 38 (76) 32(64)Out-of-hours admissionsdiagnosed as sepsis orpossible sepsis (n = 29)66.1 5 (1) 29(100)28 (97) 20 (69) 26 (90) 18 (62) 22 (76) 10 (34)In hours patients diagnosedwith possible infection(n = 76)Notrecorded4 (2) 53(69.7)66 (86.8) 40 (52.6) 53 (69.7) 42 (55.2) 37 (48.7) 11 (14.5)In-hours patients wheresepsis considereddiagnosis (n = 11)Notrecorded4 (1) 10(90.9)10 (90.9) 6 (54.5) 7 (63.6) 6 (54.5) 6 (54.5) 2 (18.2)McNab et al. BMC Medicine (2018) 16:174 Page 8 of 20recording physiological parameters, (5) provision of sepsiseducation and (6) improving KIS completion.1) Feedback to facilitate reflective learningMany of the professionals interviewed stated that theywanted feedback on their own practice to facilitate learningbut this was rarely given. A system-based reflective toolwas developed to direct practice teams to reflect on theircurrent systems. This could be used to investigate eventswhen patients were diagnosed with sepsis or to prospect-ively examine their systems and share learning within teamson how they manage difficult system conditions. The toolprovided data from the FRAM to encourage individual andteam reflection on their role in the overall system and howthis influences other parts of the system. This included howwork-as-imagined and work-as-done differ in areas such asarranging clinical review, assessing patients and communi-cation across interfaces.For example, practice teams were encouraged to ana-lyse their own recording of physiological parameters andcompare this to the data collected when constructingthe FRAM. It was felt that recording, interpreting andcommunicating the individual physiological parameterswas essential to successfully recognise and manage pa-tients who may be at risk of sepsis. This is demonstratedin the FRAM model which shows that the function <rec-ord observations> links to four other functions (<decideto admit patient>, <communicate with secondary care>,<transfer patient to secondary care> and <assess insecondary care>). Variability in this function could influ-ence all of these functions (Fig. 2).Clinicians were much more likely to record physiologicalparameters in an out-of-hours setting than an in-hours set-ting. This was due to feeling that out-of-hours work was risk-ier as they did not know the patients as well as those seen intheir own practices during normal in-hours working.I feel in out of hours you don’t know the patient sowell so I am very precise in out of hours of recordingobservations and I think it would be a good idea ifmore people did that. GP1When patients were admitted and the diagnosis wasthought to be sepsis, it was less likely that all physiological pa-rameters were recorded. Clinicians recognised that this wasdue to employing an efficiency thoroughness trade off basedon making a rapid decision to quickly admit patients who ap-peared acutely ill and so did not record all parameters.I saw this man on a visit and from the moment Iwalked in I knew I was admitting him. We had theinformation that he was getting chemo and was a bitshaky. I did his temp and pulse and thought – rightyou’re going in – so I didn’t do the other values. GP2Although this is an effective trade-off from the GP perspec-tive, this physiological information is considered extremely im-portant when the patient is assessed in secondary care whichwas not fully appreciated by those in the community.Fig. 1 Functional Resonance Analysis Method (FRAM) model of system to identify and clinically manage sepsis in primary care in NHSAAMcNab et al. BMC Medicine (2018) 16:174 Page 9 of 20I think if there has been abnormal physiology it isuseful to have that documented. AETeams were asked to reflect on their own data and thepresented data to consider if changes to local systemswere required. Trade-offs and performance variabilityare needed in complex healthcare systems, but it is es-sential that we understand the potential effects at a localand wider system level through exploring and under-standing the system [34, 46].2) Communication pathwaysPhysiological parameter values were important whenthe patient is assessed in hospital (Fig. 2). The results ofthis project fed into existing work-streams on communi-cation between primary and secondary care. During tele-phone admission calls to the secondary care combinedassessment unit, all physiological parameters will rou-tinely be requested by receiving staff. This allows a de-gree of flexibility for community staff while stillencouraging communication of all parameters.3) Use of early warning scoresAlthough early warning scores have been endorsed asa way to detect acute illness due to sepsis, there weremixed opinions on the use of early warning score.There is much more of a push to do observationswhich I think gives you more of an objectivemeasurement which might push someone towards apotential sepsis rather than just an unwell diagnosisand make you act a bit more promptly. GPST3I think [a score] gives you more weight to make thedecision that this person is unwell - Even youngpeople for example could be septic and still lookalright you know. GP4I don’t think it would change what I do much itwould just be more to stimulate me to remembermore things. GP2Yeah and I think a lot of the times when you have thisscoring system we are taking away people’s commonsense it is just a scoring system, it’s just a helpful toolit shouldn’t replace your clinical judgement. CAUsenior nurseThere is less evidence for the use of a “one off” earlywarning score in the community to identify patients withpossible sepsis as opposed to repeatedly recording earlywarning scores to identify clinical deterioration of a pa-tient. It was felt that the use of an early warning scoredid not fit with the way that GPs currently worked asthey were more likely to consider the whole clinical situ-ation. They felt that the interpretation of parameters andthe communication of concern between health profes-sionals were more important than the calculation of thescore which also increased workload.You have got to put it together with other observationsand clinical picture and the history it gives you moreweight, it is all about picking up things that help youmake your decision. GP4There was concern by some clinicians that if early warn-ing scores were used as part of a QI intervention,Fig. 2 Extract from Functional Resonance Analysis Method (FRAM) model demonstrating importance of recording observations to other functionsin the systemMcNab et al. BMC Medicine (2018) 16:174 Page 10 of 20compliance would be rigidly monitored reducing scope forclinicians to adapt their behaviour to suit the patient infront of them and the work conditions experienced. In-stead, a less rigid approach was recommended focussing onthe social aspects of communicating across interfaces andproviding opportunity for feedback to encourage reflectionon when and why to record physiological parameters.But people want every box ticked. Because someonewill audit it, someone will look at it and then they willcome round and go like we have had a complaintfrom a patient who had a sore throat turned out twodays later he had quinsy you don’t seem to haverecorded saturations on him. GP1Despite this, it was agreed that the early warning scoremay be useful to communicate with professionals inother parts of the system, for example, ambulance ser-vices or community nurses. To test this, a pilot projectwas planned involving community nurses using earlywarning scores to assess patients and communicate withclinicians in an out of hours setting. Study of the FRAMallowed anticipation of potential problems whenimplementing these changes by identifying functionsthat would be influenced by the intervention (Fig. 3).Systems need to be in place to ensure availability of re-sources such as thermometers and oxygen saturationmonitors for community nurses. The output of commu-nity nurse assessment will direct the priority of clinicalreview required. Communication and escalation policieswill be required to direct this process for the single pointof contact and clinicians.4) Electronic template for recording physiologicalparametersThe existing electronic templates were non-intuitiveand did not fit with the way work was currently done. Be-cause of this mismatch, clinicians used workarounds suchas hand-writing values or typing them into the electronicrecord as free text. The template available on the in-hourssystem was considered more useful as it provided infor-mation to aid interpretation of results but it often stilltook time to find and open. Some practices had createdshortcuts to allow its use within the consultation—a code,that when typed, automatically opened the template. TheFig. 3 Extract from Functional Resonance Analysis Method (FRAM) model demonstrating extra functions (on left) that will be needed if systemis changedMcNab et al. BMC Medicine (2018) 16:174 Page 11 of 20out-of-hours template was rarely used as values had to beentered after the clinician had left the patient and so anyguidance from the template came too late.The out-of-hours template makes it more difficult –you see it when you are back in the car writing up thecase after you have made your decision – it’s too late.I think if it was quick, easy and straightforward youmight get better recording (of observations). GP2The stakeholder group recommended the design of anelectronic template that fits with the current work tomake its use as simple as hand written notes or free textentries. Work is underway to develop a template to alertclinicians in real time to abnormal physiological parame-ters that may prompt recording of all relevant parameterswith automatic calculation of an early warning score.5) Provision of sepsis trainingBy exploring multiple perspectives, the FRAM helpedidentify the conditions of work that result in divergenceof work-as-imagined by clinicians and work-as-done byadministrative staff. Clinicians generally thought thattheir administrative staff could accurately identify pa-tients who may need early assessment and knew how toarrange this. However, administrative staff felt that theyhad no training or guidance on how to identify patientswho may be at risk of sepsis and often had no clear ad-vice on how to arrange rapid review.In general, our staff are good at saying this persondoesn’t sound well and they are concerned and theydon’t call often and they let us know so they will putit onto the emergency doctor. GP3I don’t know if I would necessarily recognise it in apatient coming in because a lot of it is like fever andsickness - it could be anything. Training or a checklistmay help. Receptionist 2System conditions affected the output of the function de-scribing staff arranging clinical review and so, even withtraining, staff may not be able to successfully identify anddeal with patients who may have sepsis. This informationwas used to design educational materials that accompanythe system-based reflective tool. The aim is to allow teamsto consider how the sepsis education material can be ap-plied in their own setting to improve care. For example, ifstaff are more aware of the vague symptoms that may indi-cate risk of sepsis (such as confusion) they need a way toraise their concerns with clinical staff and the clinical staffneed a way to respond flexibility dependent on the situation(such as knowledge of patient and competing priorities).It can be quite hard on a Monday morning when youhave got lots of patients waiting for an on-the-dayappointment and we just get a sea of people it wouldbe quite hard to say then could you give me indicationof the problem. Receptionist 2I think it is easy for us to recognise someone thatcomes in with chest pains rather than someone whocomes in with sepsis. Receptionist 1I need to be able to go to someone comfortably andsay I am just raising this. To make you aware as I amconcerned. Receptionist 26) KIS completionThe importance of the Key Information Summary be-came clear when interviewing professionals in differentparts of the system and was demonstrated within theFRAM model (Fig. 4). Work was already underway locallyto improve KIS completion in terms of identifying patientsappropriate for KIS completion and recording relevant de-tails such as usual oxygen level, pulse, blood pressure, levelof confusion and wishes regarding ceilings of care. TheFRAM model was used to inform further work in thiswork-stream as well as providing evidence in thesystem-based reflective tool of the importance of this taskelsewhere in the system.I think it is variable sometimes it is excellent (the KIS)and it makes such a difference - and then other timesit isn’t - and I think that is probably one of the reasonswhy it is not being accessed strategically because it isnot the easiest or quickest thing to get into and it isalmost like it is a bit like a lottery if you get one that isgoing to help you or not. AE consultantI know it is hard to find the time during the day tocomplete these (KIS) but in OOH the most importantthings I have is background observation and base lineobservations. GPIt was also identified that the KIS was not availablewhen the SPOC was used to refer patients to primarycare out-of-hours clinicians. Information Technologysystems were altered to solve this problem.Following consideration of each improvement theme,consensus was reached on the design of a Driver Diagramand multi-component improvement intervention (Figure 5,Appendices 1 and 2). It was agreed that the overall pur-pose of the system was the identification and managementof sepsis in the community. The boundary of the systemMcNab et al. BMC Medicine (2018) 16:174 Page 12 of 20for improvement excluded NHS24 as this was a nationalorganisation over which we would have little influence.DiscussionIn this paper, we described how a FRAM model of thecomplex system to identify and manage sepsis in primarycare was constructed to understand how conditions ofwork and system interactions influenced everyday work ina regional NHS Board. This information directly allowedreconciliation between improvement suggestions fromfrontline staff and current works systems and informedthe design of a multi-component improvement interven-tion to improve overall system functioning.Despite the complex systems that exist in healthcare,many improvement projects fail to take a “systems ap-proach”, or misunderstand and misapply this concept.Many seek to introduce new procedures in a top-downmanner or implement change and improvement at the levelof individual performance through, for example, audit andfeedback strategies [24, 47]. As a result, the focus of manyinterventions has been on single-system components suchas performing a clinical assessment more reliably or effect-ively [48–51]. Improvement interventions often target theperson through education and training, protocol dissemin-ation or recommend the use of a tool or technology, suchas an IT template or early warning scores [49–51]. Educa-tional interventions alone are considered weak as theydepend on memory of training whereas introducing toolsor technology to aid recall is considered to be of intermedi-ate strength as an improvement intervention [52]. Evalu-ation of such interventions involves measuring compliance(of the component targeted) with the proposed change. It isthought that this attempt to reduce process variation willimprove health outcomes [53]. However, the evidence fre-quently demonstrates that these types of interventionsoften fail to have the sustainable impact anticipated leadingto missed opportunities to improve system performanceand reduce avoidable patient harm [28].Rather than persisting with linear, cause and effect ap-proaches, the use of a complex system lens may help tomaximise the impact of improvement interventions [26, 27].One way to do this is to engage the people in the systemwho are expert at doing the work to both understand thesystem and identify potential improvements [26]. In thisway, improvement strategies can be co-designed that con-sider important contextual factors when implementingchange and include strategies to support local adaptation tocope with the conditions faced [34, 54]. In this study, the in-terventions did not over specify work by mandating andmeasuring the use of early warning scores but encouragedrecording and communication of physiological parameterswhile allowing clinicians to adapt if needed based on theconditions they experience. The edges of systems are blurryand interact with other systems [26]. As such, treating sepsisFig. 4 Extract from Functional Resonance Analysis Method (FRAM) model demonstrating the importance of the Key Information Summary (KIS) toseveral functions in the systemMcNab et al. BMC Medicine (2018) 16:174 Page 13 of 20identification as a standalone system, and educating admin-istrative staff on its identification, is unlikely to be effectiveunless consideration is given to the other task they are doingand the other systems with which they are interacting. Webelieve that the method described in this study is one way toinvolve multiple perspectives in the co-design of change andwill add value to existing quality improvement methods.It may be argued that simply discussing implementationof the improvement suggestions with a multidisciplinaryteam would yield similar results. The benefit of using theFRAM is that it allowed the qualitative and quantitative datato be synthesised and the whole system to be conceptua-lised. By identifying the conditions and interactions that in-fluence work and cause variable function output, we believeit helped support clinical teams to consider where improve-ment efforts should be targeted. Constructing the FRAMmodel is a trade-off between showing all related functionsand ensuring that it is useable and understandable. It maybe argued that the FRAM could describe many other back-ground functions (such as <manage staff capacity>) andlinks to other systems (such as <patient obtain access to la-boratory results>). FRAM models can be constructed withdifferent levels of resolution. For example, if the function<process request for clinical assessment – GP surgery> wasthe main object of improvement, this could be broken downto include all the functions needed to complete this task,such as <answer the telephone>. This has potential to in-crease the complexity of the FRAM model by identifyingmore interrelated functions. The level of detail required isdependent on the data collected and validated by thosedoing the work. If links to other systems significantly influ-ence work in the system under study, then they should beincluded, and if variability in a specific task within a function(such as how the telephone is answered) is important, thenit should be included as a separate function [36].Consensus already exists on how improvement interven-tions should be described and reported [55, 56] and recentrecommendations to improve the design of improvementinterventions in complex systems have been published [23].These include rigorously defining the problem, co-designingimprovement interventions, use of a programme theory andconsidering the interaction between the social and the tech-nical aspects of change. We have described one way torigorously explore and understand the system to identifypotential problems by exploring local work-as-done byfrontline staff—for example, expected actions of administra-tive staff when patients present with possible sepsis and thelack of community nursing equipment. Improvement ideaswere generated and interventions co-designed with frontlinestaff. The reflective sepsis tool promoted co-design of spe-cific practice level interventions. It may be argued that thiswill produce a new work-as-imagined from which peoplewill have to vary when conditions change in an unexpectedway. However, the tool encourages repeated team reflectionon performance to understand different perspectives onhow the system functions and will support furtheradaptation to guidance to bring work-as-imagined andwork-as-done closer.Fig. 5 Preliminary driver diagram of improvement intervention for management of sepsis in primary careMcNab et al. BMC Medicine (2018) 16:174 Page 14 of 20The FRAM explored how the system worked andhow interactions, resources, controls and time influ-ence output. This allowed us to develop a programmetheory, presented in the Driver Diagram (Fig. 2), thatdefines how interventions may lead to overall systemimprovement and how each intervention could be eval-uated [57]. This will be used by local teams to learnabout and adapt local processes to maximise successand is currently being piloted. As recently recom-mended for improvement interventions in complex sys-tems, we have agreed a measurement of the finaloutcome of interest allowing for local adaptation ofprocesses to create success [46].The participatory approach we adopted helped us toexplore the social and technical aspects of change. In-creasingly, the use of risk stratification and early warningscores are being promoted in primary care but there islittle evidence of their benefit as part of a one-offpre-hospital clinical assessment [9, 10]. The key stake-holder group felt that the social “processes” that lead tothe interpretation and communication of the output ofthese tools (the actual physiological parameters and anindication of clinical condition) are what will ultimatelyinfluence the quality and safety of care [58].Many factors that should be considered to maximise im-plementation and sustainability of improvement interven-tions within complex system have been described [59].These include how the intervention fits with current work,demonstrating the benefits of the intervention and theability to adapt it to local conditions [59]. Consideringthese factors can help understand why measuring the useof early warning scores as a quality improvement processmeasure was rejected by the key stakeholder group. Thecurrent electronic templates are not simple to use and donot fit with the way work is currently done. The benefitswere not obvious to community clinicians—althoughthere may be benefits in other parts of the system. Therewas also concern that if they were used as part of a QIintervention, compliance would be rigidly monitored re-ducing scope for clinicians to adapt their behaviour to suitthe patient in front of them and the work conditions expe-rienced. Instead, a less rigid approach was recommendedfocussing on the social aspects of communicating acrossinterfaces and providing opportunity for feedback to en-courage reflection on when and why to record physio-logical parameters.This study has several limitations. First, several keystakeholders were not involved—most notably patients,home care teams and the Scottish Ambulance Service.We did not know if this approach would work andwished to initially test it with healthcare professionals.Better integrated patient participation will be sought todevelop the improvement intervention design. The studyincluded small numbers of participants in eachprofessional group. This did not present a problem inthe construction of the FRAM model and it appearedthat data saturation was achieved for improvement sug-gestions. However, with more participants, it is possibleother ideas for change may have been generated. TheFRAM model was constructed based onwork-as-disclosed by participants and observation of ac-tual work may have revealed other ways of working. In-terviewees may have been guarded in their descriptionof how they completed work as they were speaking to alocal GP; however, this made access to participants’ eas-ier and improved understanding of contextual factorssuch as the limitations of existing electronic templates.Transcripts were not returned to participants for check-ing. Data from NHS24 only included patients who re-ceived an out-of-hours clinician review, and did notinclude how often an emergency ambulance was called.It may be that NHS24 identify most patients with sepsisand arrange ambulance transport. Nevertheless, itallowed assessment of the variability of output of thefunction of arranging clinical review that may delaytransfer to hospital. Similarly, the low rate of GP practiceparticipation in data collection may mean levels of re-cording are not representative but they do demonstratevariability which was the main objective. The stake-holder meeting held to agree the improvement interven-tion did not include representation from all staff groupsbut their perspective was considered through the discus-sion of the suggested improvement interventions. Themethods used to explore and understand the system re-quire considerable experience and time investment thatwill not be available in all improvement projects. FRAMmodel construction through facilitated group discussionis successfully used elsewhere and this may be a moretime efficient method to allow wider application and in-clusion of more participants from each professionalgroup [40, 41]. This method has only been used to de-sign the intervention, and future evaluation of the inter-vention is required. Similarly, the method has only beentested in a single regional health board and furtherevaluation of its application in different settings is re-quired. A full evaluation of the impact of this approachis planned and further research on the application of thismethod in different healthcare areas is required.ConclusionWe have demonstrated the use of FRAM in a complexsystem to aid the design of a quality improvementintervention for identifying and managing sepsis in asingle regional NHS board. This allowed an explorationof how conditions and interactions influence perform-ance and output and how improvement suggestionsfrom frontline staff could be reconciled with currentwork systems.McNab et al. BMC Medicine (2018) 16:174 Page 15 of 20Appendix1Table6SystemimprovementinterventioninformedbySEIPS2.0model[60]PartofworksystemImprovementaimHowwillthisbedone?AnticipatedoutcomesEvaluationPerson1.Increaseadministrativestaffknowledgeonsepsis.2.Increaseclinicalstaffknowledgeontheidentificationandmanagementofsepsisinthecommunity.1.Developmentofsepsiscaseanalysistoolforusewithinpractices.2.Educationsessionforreceptioniststaff,productionoflearningpackdeliverableinpractices.3.Clinicaleducationalsessionsandproductionofaccessibleeducationalmaterial(e.g.webinar,onlinemodule,disseminationoflearningpack)Containingsummaryofguidelines,systemsapproach,recommendationsandtheirrationaleforstandardisingcommunicationtoincreaserecordingofphysiologicalparameters.4.Trainingforadultcommunitynursesonsepsismanagementandmeasuringandinterpretingphysiologicalvalues.1.Receptionstaffawareofhowsepsiswillpresentandpossibleredflags—promptingthemtoarrangesoonerclinicalreview.2.Increasedknowledgeofguidelines,availabletools(ITtemplatesandNEWS),appreciationbyclinicalstaffofreasonsforrecordingandcommunicatingvaluesandhowthiscanbeachieved.3.EarlierrecognitionbycommunityadultnursesofsepticpatientsandmoreeffectivecommunicationofconcernresultinginsoonerclinicalreviewbyGP.1.Evaluatesatisfactionwithtrainingandothereducationalmaterials.2.Evaluatechangeinattitudeandknowledgefollowingtraining.ToolsandTechnology1.Provideadultcommunitynurseswithrequiredresources—thermometersandsaturationmonitors.2.Facilitaterecordingofphysiologicalvalues.1.Resourcesprovidedthroughhealthboardfunding.2.ImprovedITsystemsthatareausefulresource,availablewhenneededthatmayhelppositivelyconstrainbehaviour.3.Disseminationofexistingin-hoursITtemplatestopracticemanagerswithinstructionsonhowtouseshortcutstoopen—workwithfrontlinestafftoimproveout-of-hoursITsystems1.Allnecessaryequipmentavailable.2.Easiertorecordphysiologicalvalues.3.Awarenessofguidelinethatsupportseverydaywork(positivecontrol).Patientswhoarepotentiallysepticareidentifiedearlier.1.Assessviasurvey—satisfactionwithcreatedprotocolsandtemplates.2.Surveystafftodetermineifprotocolsandtemplatesareabeneficialcontrolandrepresentwork-as-done.3.Measureuseoftemplates.Tasks1.Increaserecordingandcommunicationofphysiologicalparameters2.Improvetheabilityofpracticeadministrativestafftoidentifypatientswhomayhavesepsis.3.ImprovecompletionofKeyInformationSummarytoinclude—therecordingofriskfactorsforsepsisandnormalphysiologicalparameters1.Developmentofsepsiscaseanalysistoolforusewithinpractices.2.Througheducationaleventsthatdescribeimportanceofrecordingvaluesinotherpartsofthesystem.3.Co-designguidancewithcommunitynursesfollowingeducationonsepsis—potentiallypositivecontrol.4.Co-designprotocolforcommunicationbetweenprimary/secondarycare.5.Co-designguidancewithpracticeadministrativestafffollowingeducationalsessions—potentiallypositivecontrol.6.ImprovementinKIScompletionwillbeachievedthroughexistingprogrammeofwork—sepsisworkwillfeedintothis.1.Increaserecordingandcommunicationofphysiologicalparameters.2.MoreaccurateandusefulinformationcontainedinKIS—allowsinterpretationofphysiologytofacilitateaccuratediagnosisinout-of-hoursandsecondarycare.1.Measureuseofprotocolsandtemplatestodetermineiftheyrepresentwork-as-done.2.EvaluateinformationcontainedinKIS—throughexistingGPclusterandlocalitywork.3.Evaluatepatientsadmittedwithsepsistodetermineifallparametersrecorded—resultstobeusedforreflectionandnotasaperformanceindicator.InternalEnvironment1.Developpracticeculturewherereceptionistscaninterruptcliniciansifneeded.2.Improveculturewithinout-of-hourstoreduceconcernregardingauditingofdata.1.Developmentofsepsiscaseanalysistoolforusewithinpractices.2.Co-designofprotocolswithclinicalandadministrativestaffinpracticesfollowingreceptionandGPtraining.3.Regularreinforcementofuseofdataandincidentinvestigationforlearning—recordingof1.Receptionistsknowwhentoadaptbehaviour—whentoseekearlyreviewandhaveconfidencetoimplement—supportsstaffwellbeingandimprovesperformance.2.Feedbackfromincidentinvestigationanddatausedforlearning—supportsstaffwellbeing.1.Surveyofperceptionsofculture.McNab et al. BMC Medicine (2018) 16:174 Page 16 of 20Table6SystemimprovementinterventioninformedbySEIPS2.0model[60](Continued)PartofworksystemImprovementaimHowwillthisbedone?AnticipatedoutcomesEvaluationobservationsorearlywarningscoresshouldnotbeusedasaperformanceindicatorwithoutappreciationofthecontextwithinwhichthepatientwasassessed.Organisation1.KISavailablewhenSPOCused—resourceprovision.2.Improvecommunicationwhenout-of-hourscommunityhealth-carestaffusethesinglepointofcontact.3.Improvecommunicationbetweenprimary/secondarycare1.ChangesystemtoensureKISavailable—arrangedwithout-of-hoursleaders.2.Followingeducationsessionswithadultcommunitynursesandout-of-hoursadministrativestaff—co-designguidanceforcommunicationincludingcommunicationofphysiologicalvalues.Potentiallypositivebehaviourcontrol.3.Thesepsisworkwouldfeedintoexistingcrossinterfaceprogrammeboards—co-designprotocolforcommunicationbetweenprimary/secondarycare.1.Normalvaluesavailableforout-of-hoursandsecondarycareclinicianstofacilitateearlydiagnosisandtreatment.2.Awarenessofguidelinethathelpswork(positivecontrol).Patientswhoarepotentiallysepticareidentifiedearlier.1.Evaluationasabove.ExternalInfluences1.SepsismanagementprioritisedbyHealthboard.2.NiceGuidelineswidelydistributed3.ReflectiononmanagementofsepsispatientswithotherGPpractices1.ReportsenttohealthboardfordiscussionandapprovalatPrimaryCareLeadershipcommittee.2.Disseminationguidelinesandsepsisappaspartofeducationalintervention-—potentiallypositivebehaviourcontrol.1.Resourcesavailabletoimplementandevaluatechanges.2.Morepatientsmanagedfollowingguidance.1.Useofguidancecanbeevaluatedfollowingeducationaleventsusingasurvey.Processes1.Increasedratesofprovisionofrelevantphysiologicalvalueswhenadmissionarrangedbyprimarycareclinicians.2.Increasedratesofprovisionofrelevantphysiologicalvalueswhencommunityhealthcarestaffcontactsout-of-hoursservices.1.Workwithsecondarycaresepsisleads—foralladmissionsreceivingteamwillrequestallphysiologicalparameters—GPexpectedtoprovidevalueswhenrelevant—educationalsessionsdetailwhenitisrelevant.Thiswillincludealladmissionswithinfective,cardiacorrespiratorycause.Efficiencythoroughnesstrade-offsmayleadtoperformancevariabilityandthisshouldberecognised.2.SPOCwilluseatemplateandaskforallphysiologicalparameters.1.Improvedcommunicationofphysiologicalvaluessosecondarycareawareofadmissionsandhavevaluesfromcommunityforcomparison.Resultsinquickerassessmentandinitiationofappropriatetreatment.2.Out-of-hoursstaffwillbeawareofseverityofillnessofpatientand,ifnecessaryseesoonerandensuretreatmentinitiatedsooner,resultinginimprovedhealthcareoutcomes.1.MeasureratesofcommunicationofrelevantvalueswhenSPOCusedandatadmission.2.Survey—perceptionsofclinicalstaffinacutecarehubtonewsystemforadultcommunitynurses.Outcomes1.Reducetimefromcontactinghealthservicestoreceivingantibioticsfortenpatientswithaconfirmedadmissiondiagnosisofsepsispermonth.1.Longtermoutcomeofallabovemeasures1.Improvedmortalityandmorbidityoutcomesforpatientspresentingtoprimarycarewithsepsis.1.MeasurefortenpatientspermonthandfeedbacktoallGPsandANPs.Oncebaselinemeasureobtainedspecifictargetwillbeset.McNab et al. BMC Medicine (2018) 16:174 Page 17 of 20Additional fileAdditional file 1: Consolidated criteria for reporting qualitative studies(COREQ): 32-item checklist. (DOCX 16 kb)AbbreviationsADOC: Ayrshire Doctors on Call; ANP: Advanced nurse practitioner;CMAU: Combined Medical Assessment Unit; COREQ: Consolidated criteria forreporting qualitative research; ED: Emergency department; FMV: FRAM ModelVisualiser; FRAM: Functional Resonance Analysis Method; GP: Generalpractitioner; GPST3: General Practitioner Specialty Trainee 3; KIS: KeyInformation Summary; NHSAA: National Health Service Ayrshire and Arran;QI: Quality improvement; SPOC: Single point of contact; WAD: Work-as-done;WAI: Work-as-imaginedAcknowledgementsThe authors would like to thank all those that participated in interviews, thepractices that submitted data, the ADOC staff who collected data and thekey stakeholder group who designed the intervention and Julie Anderson,Associate Director Scottish Improvement Science Collaborating Centre forfeedback on the paper.Availability of data and materialsData is held by DM—permission for public access was not given by participants.Authors’ contributionsThe project was devised and planned by DM, PB, JF and CB. DM conductedthe interviews, coded the data and analysed the quantitative data. DM, JFand CB developed themes from the coded data. All authors contributedequally to develop the improvement intervention. DM produced the firstdraft of the manuscript and all authors reviewed, edited and revised themanuscript. All authors read and approved the final manuscript.Ethics approval and consent to participateUnder UK research governance regulations, ethical review is not required asfollowing application of the Medical Research Council “Decision tool - is itresearch?” the authors considered this project to be service evaluation.Consent for publicationWe confirm we have consent to publish this information from those involvedin the project and NHS Ayrshire and Arran.Competing interestsThe authors declare that they have no competing interests.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims in publishedmaps and institutional affiliations.Author details1NHS Education for Scotland, 2 Central Quay, Glasgow, Scotland G3 8BW, UK.2NHS Ayrshire and Arran, Ayr, UK. 3Institute of Health and Wellbeing,University of Glasgow, Glasgow, UK. 4Division of Population Medicine, Schoolof Medicine, Cardiff University, Cardiff, UK. 5Department of Family Practice,University of British Columbia, Vancouver, Canada. 6Australian Institute ofHealth Innovation, Macquarie University, Sydney, Australia.Appendix 2Fig. 6 Sepsis improvement intervention logic modelMcNab et al. 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Quality improvement
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Sepsis
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Participatory design of an improvement intervention for the primary care management of possible sepsis using the Functional Resonance Analysis Method
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