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Valenti, Pietro (2013) Introduzione della cartella clinica elettronica nell'ULSS 9 di Treviso - Approccio Metodologico -. [Ph.D. thesis]

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Abstract (english)

Summary

Introduction

We are now witnessing an increasing interest of Public Health Institutions towards the introduction of ICT. However, although several data/information are available, each Aziende Sanitaria and clinical units often employ individual digital systems that are not connected to each other.
With the start of the ESCAPE project the Azienda ULSS 9 in Treviso developed a model for the management of digital signed documents that could be shared between the different clinical units of the Hospitals (Treviso and Oderzo) and the citizens. This first experience of clinical response dematerialization allowed putting the basis for the extension of the process to all the documents associated with hospitalization. In fact, the main objective of this project, named OSCAR (Ospedale Senza CARta), is to extend the digital processes to all the clinical records of patients during his hospital admission, thus helping to move from the Medical Paper (MP), towards the Electronic Health Record (EHR).

Objective

Only few data are available in the literature about the use of ICT in the Health System. In particular, no methodological approaches have been developed to test the introduction in the clinical use of the Electronic Medical Record (EMR). In particular we need to identify tools for the estimation of risk/benefit ratio, and learn how to manage changes within the organization. The scope is to minimize unfavourable responses associated with CCE introduction. How to develop this new approach is the main object of the present study.

Materials and methods

We studied the introduction of EMR in the Cardiology Unit. Analysis of the process furnished valuable data about the presence of criticisms that could limit the diffusion of EMR to all the others clinics.
The methodological approach was based on the following points which in several cases are connected with “Project Management”:
- Study of economic feasibility based on benefit/risk ratio.
- Detailed analysis of software-hardware
- Development of a training program through both frontal lessons and live demonstrations.
We also tested the efficacy of EMR in comparison with the MP. In particular we focused on the following “end points”:

- Comparison of MP and EMR in term of quality (such as clarity, complete drawing up, head for reading). In particular we compared 100 consecutive MP (year 2008) with 100 consecutive EMR (year 2012) of the Cardiology Unit. Analysis of quality was based on the compilation of check lists developed according to “Joint Commission International Quality Standards” and “Accreditation Canada”, criteria.
- To identify, by the use of a questioner, personnel’ prejudices associated with the introduction of EMR.
- Analysis of the risks potentially associated with EMR introduction. The analysis was performed by using FMEA/FMECA approach.
- To evaluate the level and the trend of clinical documents digitalization.

Results

Comparison of quality between MP and EMR showed that the latter was superior in almost all the 34 points of the checklist, reaching the maximum score in 25 over 34.
Questioners about satisfaction of the personnel showed a significant difference between medical doctors and nurses. In fact, while the satisfaction score was optimum in 12 over 15 questions for medical doctors, the level reach by nurses was significantly lower in all the items investigated.
Risk analysis performed by using FMEA/FMECA before and after EMR introduction allowed to identify errors/risks with high index of priority correlated to both the use of MP and EMR. We were able to demonstrate that these errors/risks were different between MP and EMR. In particular errors with high priority associated to MP used were absent after EMR introduction. On the contrary the following same therapy errors were more evident after EMR introduction. Results were used to perform risk re-analysis through periodic team discussion and implementation of preventive measures.
The trend of clinical digitalization was excellent. The high level of participation showed by the personnel involved mainly explains this finding.

Discussion and conclusion

The present study investigated the efficacy of a novel methodological approach for the EMR introduction in the clinical practice. Success is mainly based on a high level of involvement of Direzione Strategica Ospedaliera that is mandatory to obtain enough economic and personnel support for the project development.
EMR showed higher quality level compared to MP according to “Joint Commission International Quality Standards” and “Accreditation Canada”, standards. The analysis of the risks allowed demonstrating that MP and EMR used are associated with profound differences in term of risks related to hospitalization.
The excellent trend observed for the introduction of digitalized clinical documents in the different units represents an encouraging observation. This finding suggests that, by using adequate planning, training and appropriate methodological approaches (mainly based on appropriate risks evaluation) digitalization can be introduced in the everyday clinical practice without experiencing significant obstacles and improving the quality of health care.

Abstract (italian)

Riassunto

Introduzione

Il sempre più crescente interesse, anche da parte delle Istituzioni Pubbliche Governative, rendono inevitabile l’introduzione dell’ICT in Sanità (e-Health). Pur disponendo oggi di una enorme quantità di informazioni, talvolta già ben organizzate in sistemi software, le varie Aziende Sanitarie, ed all’interno di esse le singole Unità Operative, conservano purtroppo quest’ultime in sistemi distinti l’uno dall’altro e spesso non integrati fra loro.
Col il progetto ESCAPE l’Azienda ULSS 9 di Treviso ha realizzato un modello per la gestione dei referti firmati digitalmente, con distribuzione informatica degli stessi alle Unità Operative degli Ospedali (Treviso ed Oderzo) ed al cittadino. Questa prima iniziale esperienza di dematerializzazione dei singoli referti nell’ULSS 9 di Treviso ha creato la base di partenza per estendere tale processo a tutto il ricovero del paziente; tale Progetto è denominato OSCAR (Ospedale Senza CARta), volto a digitalizzare non più ogni singolo referto bensì tutta la documentazione clinica prodotta durante un ricovero, gettando quindi le basi per la costituzione, attraverso la Cartella Clinica Elettronica, anche del Fascicolo Sanitario Elettronico.
Tuttavia, nell’introdurre l’ICT in Sanità, non bisogna lasciarsi abbagliare da un atteggiamento eccessivamente trionfalistico, in quanto i pericoli collegati ad un così importante cambiamento possono essere paragonabili ad un salto nel vuoto. E questo non solo per i rischi in senso stretto “lavorativi” cui questo comporterebbe, ma anche onde evitare inutili sprechi economici che un investimento sbagliato determinerebbe.

Obiettivo

Finora in letteratura si posso reperire solo brevi interventi con cui taluni enfatizzano o palesano le loro perplessità circa l’impiego dell’ICT in Sanità. Nessuno ha tuttavia cercato di approcciare l’introduzione di una nuova “Health Technology” quale la Cartella Clinica Elettronica (CCE) con una impostazione metodologicamente corretta che miri ad identificare i rischi/vantaggi connessi a tale rivoluzione culturale, all’interno di un appurato e complesso Project Management volto a gestire il cambiamento nell’organizzazione, così da favorirne l’adozione e minimizzarne le conseguenze sfavorevoli. Ideare “ex novo” un tale approccio metodologico rappresenta l’obiettivo di questo lavoro.

Materiali e Metodi

In particolare questo lavoro ha focalizzato la sua attenzione sul processo di inserimento della CCE nell’ambito dell’Unità Operativa Complessa (U.O.C.) di Cardiologia. L’analisi di tale processo fornirà quindi la base di fattibilità per identificare peculiari criticità non prevedibili e correggerle prima di estendere il progetto a tutte la altre Unità Operative dell’ULSS 9.
Il modello organizzativo-metodologico ideato “ad hoc” ed adottato si compone di diversi punti, alcuni dei quali più strettamente di “Project Management”:
- uno studio di fattibilità economica volto ad stimare il bilancio costo/beneficio
- una dettagliata analisi software-hardware
- l’organizzazione di un programma di formazione del personale, sia “ex-catedra” che di assistenza “sul campo”.
Accanto a tali punti basati su aspetti di tipo manageriale, si è svolta anche una indagine valutativa dell’efficacia o meno dell’introduzione della CCE a fronte della preesistente Cartella Clinica Cartacea (CCC) e dei rischi a questa connessi, identificando degli specifici “end point” rappresentati da:

- comparazione della qualità (in termini di completezza di compilazione, chiarezza, facilità di lettura, …) della CCC precedentemente in uso nei confronti della nuova CCE. In particolare sono state confrontate 100 CCC consecutive dell’anno 2008 con 100 CCE consecutive dell’anno 2012 appartenenti alla U.O.C. di Cardiologia. Tale analisi di qualità è stata eseguita tramite compilazione di check list creata sulla base dei criteri “Joint Commission International Quality Standards” ed “Accreditation Canada”, riconosciuti a livello internazionale ed in uso nella ULSS 9 come standard di riferimento.
- Identificazione, mediante questionario, dei pregiudizi del personale all’assunzione della CCE così da impostare una politica di persuasione ed incoraggiamento volta a motivare il personale.
- Analisi del Rischio, volta ad identificare i possibili rischi connessi all’introduzione della CCE. Tale analisi, eseguita prima e dopo l’introduzione della CCE, ha permesso di far emergere quali fossero gli errori/rischi preesistenti alla CCE e quali quelli subentrati con la sua introduzione, così da cercare di prevenirli, attuando specifiche manovre correttive procedurali, od esser maggiormente pronti ad affrontarli qualora si verifichino. Il metodo scelto per tale analisi del rischio è il FMEA/FMECA.
- Valutazione del grado e dell’andamento di adozione della digitalizzazione della documentazione clinica dei pazienti.

Risultati

E’ stato condotto uno studio di fattibilità economica volto ad stimare il bilancio costo/beneficio con il quale la Direzione Strategica ha deciso di stanziare i fondi necessari alla realizzazione del progetto di informatizzazione OSCAR valutato come uno degli obiettivi prioritari dell’attuale mandato (quinquennio 2008-2012). E’ stata condotta una dettagliata analisi software-hardware relativamente al SIO esistente. Sono infine stati organizzati corsi di formazione del personale sia “ex catedra” che “sul campo”, gestiti direttamente dall’Azienda e riconosciuti con crediti ECM dalla Regione Veneto.
Accanto a queste considerazioni più strettamente correlate ad un ambito di “Project Management”, e pertanto poco quantificabili, l’indagine valutativa dell’efficacia o meno dell’introduzione della CCE a fronte della preesistente CCC e dei rischi a questa connessi, si è avvalsa di specifici “end point”, ideati “ad hoc” per questo lavoro, più adatti ad una loro parametrizzazione e pertanto più direttamente confrontabili.
Il confronto qualitativo della preesistente CCC rispetto alle CCE attraverso una check list creata sulla base dei criteri “Joint Commission International Quality Standards” ed “Accreditation Canada”, ha permesso di bene evidenziare come quest’ultima appaia superiore alla prima quasi in tutti i 34 punti identificati. Nello specifico permette di raggiungere il massimo punteggio in 25 di 34 punti.
La raccolta del grado di soddisfazione del personale all’adozione della CCE, tramite compilazione di questionari, ha permesso di documentare una marcata differenza fra personale medico ed infermieristico. Mentre infatti il punteggio di gradimento del personale medico si è attestato su buoni valori, addirittura ottimi in 12 quesiti su 15, quello del personale infermieristico è apparso nettamente inferiore a livello di tutti i quesiti.
L’analisi del rischio, condotta attraverso la metodica FMEA/FMECA prima dell’introduzione della CCE (ex-ante) e successivamente ad essa (ex-post), ha permesso di identificare gli errori/rischi con elevato indice di priorità (IPR > 20) correlati all’uso della CCC e della CCE. Come prevedibile tali errori/rischi appaiono essere del tutto dissimili fra loro; errori con elevata priorità presenti con l’uso della CCC scompaiono del tutto con l’introduzione della CCE, per lasciar tuttavia spazio ad altri potenzialmente ancor più temibili. L’adozione della CCC vedeva presenti 7 potenziali errori/rischi con significativo IPR: attinenti alla raccolta dei dati del paziente (registrazione informazioni cliniche all’ingresso, in primis eventuali allergie, ed errata/incompleta registrazione/aggiornamento dei parametri vitali); attinenti alla componente infermieristica assistenziale (in particolare mancata/incompleta raccolta dei bisogni assistenziali all’ingresso), ma anche mancato/incompleto aggiornamento dei diario infermieristico; attinenti alla terapia (mancato incompleto aggiornamento in grafica della terapia farmacologica, ma soprattutto da parte del personale infermieristico mancata/errata registrazione della terapia somministrata ed errata interpretazione della terapia scritta in grafica).
Con l’introduzione della CCE i potenziali errori/rischi si sono ridotti a 5, risultando però 2 di essi gravati da un IPR molto elevato. E’ scomparsa la componente di errore/rischio attinente alla attività infermieristico/assistenziale ed appare minimizzata quella relativa alla raccolta dati del paziente: Tuttavia, se da un lato la possibilità di mancata raccolta delle informazioni cliniche all’ingresso (fra cui le allergie) appare abbattuta, dall’altro emerge un nuovo ed inaspettato elemento di criticità rappresentato dalla possibilità di copiare in modo acritico i dati precedenti mancandone l’aggiornamento o reiterandone gli errori. Infine, anche la componente di errore/rischio relativa alla terapia, pur mutando sostanzialmente nella natura, non viene a scomparire ma anzi assume livelli superiori di criticità. Scompaiono i rischi precedentemente descritti, ma compare la tendenza a prescrivere scorrettamente la terapia e soprattutto c’è il pericolo di omettere parte della terapia quando la sua somministrazione sia troppo frammentata nell’arco della giornata.
Sono state pertanto adottate delle contromisure per cercare di limitare tali possibilità di rischio/errore. Inoltre si è strategicamente deciso di eseguire una sistematica ri-analisi del rischio, tramite successivi incontri periodici del team, così da verificare l’efficacia delle misure adottate per prevenirli, onde eventualmente modificarle, ma anche per identificare nuovi eventuali rischi precedentemente non emersi.
Infine è stata condotta una verifica del grado di adozione della digitalizzazione nei settori ove introdotta, il che ha evidenziato una suo ottimo trend di avanzamento. Questo è stato in particolare ottenuto mediante motivazione del personale coinvolto (anche introducendo tale obiettivo all’interno dei risultati di budget delle varie Unità Operative).

Discussione & Conclusioni

Il sempre più crescente interesse, anche da parte delle Istituzioni Pubbliche Governative, rendono inevitabile l’introduzione dell’ICT in Sanità (e-Health). Tuttavia, come in tutte le innovazioni, i passi devono essere prudentemente calcolati poiché i pericoli collegati ad un così importante cambiamento possono essere paragonabili ad un salto nel vuoto. Con il presente lavoro è stato definito un innovativo modello metodologico di approccio all’introduzione della CCE volto a definire un adeguato programma di Project Management, di valutazione di efficacia o meno di una tale introduzione e di analisi dei rischi connessi.
E’ innanzitutto emerso come l’impegno da parte della Direzione Strategica Ospedaliera debba essere totale, onde garantire un adeguato programma di investimento delle risorse economiche ed umane necessarie, in particolare per quanto riguarda la gestione della componente software/hardware la quale, data la sua capillarità e pervasività, viene a affermarsi come un servizio fondamentale ad assicurare il “normale” svolgimento dell’attività quotidiana, al pari del funzionamento di un impianto elettrico, che debba avere pertanto “sistemi di sicurezza e gruppi di continuità”. A tal fine l’ULSS 9 ha affidato in “outsourcing” la gestione dell’infrastruttura tecnologica del sistema informatico aziendale.
Non trascurabile appare inoltre l’organizzazione di programmi di formazione del personale sia “ex catedra” che “sul campo”, gestiti direttamente dall’Azienda e riconosciuti con crediti ECM dalla Regione Veneto, finalizzati a migliorare la confidenza del personale, in particolare di età più avanzata, con il mondo della tecnologia informatica, onde sia minimizzare il rischio che l’esistenza di “barriere digitali” (Digital Divide) rappresentino un freno alla diffusione della digitalizzazione, sia poter motivare personalmente in singoli usufruitori di tali sistemi affinché possano più facilmente superare le inevitabili difficoltà iniziali di adattamento. E’ ben dimostrato infatti in letteratura che la mancata individuazione e comprensione delle esigenze del personale sanitario da parte dei responsabili incaricati della realizzazione è la principale causa del fallimento dell’implementazione di una CCE (fino al 30% di fallimenti negli ultimi anni negli USA).
Proprio per tale motivo, e per poter più puntualmente rispondere alle esigenze degli operatori, è stato eseguito un sondaggio, mediante somministrazione di questionari, del grado di soddisfazione del personale medico ed infermieristico, che ha permesso di documentare come sia proprio quest’ultimo quello più scettico circa l’implementazione della CCE. Il giudizio del personale infermieristico è infatti complessivamente meno favorevole; pertanto è su questa categoria professionale che deve essere svolto il maggior lavoro di motivazione.
Del resto la CCE appare qualitativamente di molto superiore alla CCC secondo gli standard di riferimento della “Joint Commission International Quality Standards” ed “Accreditation Canada”, la cui ottemperanza rappresenta un elemento cardine per definire la qualità di un Ospedale e la possibilità o meno di un suo accreditamento.
Infine l’analisi del rischio, tramite la metodica FMEA/FMECA, ha permesso di identificare esattamente come gli errori/rischi presenti nel processo del paziente, dal suo ingresso fino alla sua dimissione, presenti con la CCC siano del tutto dissimili da quelli che compaiono con l’adozione della CCE, alcuni di essi peraltro non prevedibili. Con ciò è stato così possibile adottare degli accorgimenti procedurali atti a contenere i suddetti errori/rischi. Il prevedere inoltre rianalisi periodiche permetterà di verificare l’efficacia di tali accorgimenti e ad evidenziare la comparsa di eventuali nuovi errori/rischi precedentemente non riscontrati. Questo rappresenta la modalità migliore per procedere a quella riorganizzazione dei processi di lavoro tale da far si che l’introduzione dello strumento tecnologico, in un ambito socio-tecnico, non rischi di comportare un peggioramento in termini di efficienza e qualità, scongiurando il rischio che l’aggiungere ad una organizzazione vecchia uno strumento tecnologico vada a creare solamente una organizzazione vecchia e più costosa.
Considerati i numerosi fallimenti cui l’introduzione della CCE è andata incontro in passato, come riportato in letteratura, l’ottimo trend del grado di adozione della digitalizzazione nei settori ove introdotta evidenziato nell’ULSS 9 rappresenta un dato incoraggiante, che dimostra come, qualora introdotte seguendo un corretto approccio metodologico che vada a garantire un adeguata progettazione, stimare gli effettivi vantaggi/svantaggi riscontrati, analizzare i possibili errori/rischi connessi, anche tecnologie innovative, seppur gravate all’inizio da un elevato scetticismo, possano entrare nell’uso quotidiano garantendo miglioramenti senza di loro irraggiungibili.
Restano comunque aperti degli ambiti di discussione su punti fondamentali, quali: il rischio che l’eccessiva attenzione alla gestione elettronica dei dati induca il medico a guardare molto più lo schermo del PC che non il paziente; la maggior difficoltà nel garantire la privacy; la delicata questione della firma elettronica, che apre nuove prospettive finora del tutto inesplorate; il rischio di un eccessivo uso della tecnica “copia ed incolla”, come peraltro emerso dall’analisi FMEA, può portare ad un “plagiarismo clinico”, al pericolo in particolare per i medici più giovani di copiare invece che pensare, ed espone alla replicazione automatica degli errori; anche l’eccessivo uso di template e checkbox può ridurre la capacità di pensare e scrivere in maniera indipendente.

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EPrint type:Ph.D. thesis
Tutor:Pauletto, Paolo
Ph.D. course:Ciclo 24 > Scuole 24 > SCIENZE MEDICHE, CLINICHE E SPERIMENTALI > METODOLOGIA CLINICA E SCIENZE ENDOCRINOLOGICHE
Data di deposito della tesi:29 January 2013
Anno di Pubblicazione:29 January 2013
Key Words:Cartella Clinica Elettronica (CCE)/Electronic Medical Record (EMR) ICT (Information and Communication Technology) e-Health
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/09 Medicina interna
Struttura di riferimento:Dipartimenti > Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari
Dipartimenti > Dipartimento di Medicina
Codice ID:5633
Depositato il:14 Oct 2013 12:14
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