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4HE 0)## 0ROJECT 4HE $EVELOPMENT OF A .ATIONWIDE 0ROGRAM FOR THE $IFFUSION OF 0)## IN )TALY Mauro Pittiruti, MD, Giancarlo Scoppettuolo, MD, Antonio LaGreca, MD - Catholic University Hospital, Rome, Italy Presented by Mauro Pittiruti at the 23rd AVA Meeting as a part of the Suzanne Herbst Award Lecture ʻThe GAVeCeLT story, or How we tried to change the approach to venous access in our country (and we did it...!)ʼ, Las Vegas, Sept. 15th, 2009.
Introduction: What is GAVeCeLT
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AVeCeLT (Gli Accessi Venosi Centrali a Lungo Termine) is the Italian Group for Long Term Central Venous Accesses, a non-profit nationwide network of experts in the field of venous access devices (VAD), founded in 1998 by a group of Italian surgeons and anesthesiologists (Pittiruti, 2006). At first, GAVeCeLTʼs interest was focused on any clinical problem of indication, insertion and management of long term VADs (i.e.: totally implantable venous ports and external tunneled catheters) used for chemotherapy, parenteral nutrition, palliative care, dialysis, and other long term intravenous treatments. In Italy, in the early 90s, long term venous accesses were scarcely utilized in clinical practice and mostly inserted by surgeons or - to a lesser extent - by anesthesiologists. Clinical indications for the use of such VADs were ill-defined; insertion was performed according to variable, self-taught techniques and there were no available guidelines for correct management of the device. Thus, GAVeCeLT was founded with the specific goal of improving and expanding the knowledge in this field, aiming to a better ʻevidence-basedʼ definition of indications, insertion techniques and maintenance procedures. From 1998 on, the GAVeCeLT group has rapidly expanded to include in its network a large number of health care professionals (such as nurses, nephrologists, radiologists, oncologists, nutritionists), and has started an impressive list of activities, covering all scientific and educational aspects of this very special, multi-disciplinary, multi-professional clinical area. Particularly important has been the role of nurses inside GAVeCeLT. Before 1999, nurses had a marginal role in the Italian health system. In 1999, the Italian laws changed, and the Nurse became officially a ʻProfessionalʼ with a specific role in the care of the patients. It is not surprising that one of the
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[email protected] DOI: 10.2309/java.14-4-4
2009
first areas which the ʻnewʼ Italian nurses felt as their own was vascular access (management of intravenous infusion; proper use of the patientsʼ veins; proper management of venous access devices; etc.). At the same time, though GAVeCeLT had started with a peculiar focus on long term VADs, during the following years the range of its interest expanded progressively to other venous devices and now it includes practically every kind of VAD and every aspect of intravenous infusion. GAVeCeLT is now regarded as a model of a non-profit, nationwide network of health care professionals, which has proven to be highly effective in improving scientific knowledge and health education in a multidisciplinary clinical area. This goal has been pursued through a multimodal methodology (an extensive use of the website www.gavecelt.info, as a scientific and educational tool; a nationwide network of experts linked by emails and e-newsletters; a dedicated journal founded in 2000, The Journal of Vascular Access; extensive collaborations with many scientific societies and clinical associations; close collaboration with commercial companies; etc.). GAVeCeLTʼs scientific activities in the last ten years include: a National Meeting exclusively dedicated to venous access devices, which is held every other year; four National Consensus Conferences focusing on different clinical and logistic aspects of venous access devices (Indications; Informed consent; DRG reimbursement; Catheter-related central venous thrombosis); a large number of clinical meetings, round tables and panel discussions organized inside National and International Meetings of different Medical and Nursing Societies of related areas (nutrition, surgery, anesthesiology, oncology, palliative care, etc.). GAVeCeLTʼs educational activities include: support and collaboration to hundreds of educational courses on VADs organized by hospitals, universities and associations of nurses or physicians; preparation and definition of specific, standardized GAVeCeLT courses for nurses and for physicians, focusing on indications, insertion and maintenance of VADs (see table I); diffusion of these original courses in large and small hospitals all over Italy; collection and diffusion of the major international guidelines dealing with insertion and management of long
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4ABLE ) %DUCATIONAL COURSES DEVELOPED BY '!6E#E,4 #/523%3 &/2 .523%3 s -ODULE BASIC NOTIONS OF NURSING VENOUS ACCESS s -ODULE ADVANCED NOTIONS PREVENTING COMPLICATIONS s -ODULE NURSING OF VENOUS ACCESS FOR ONCOLOGY s -ODULE NURSING OF VENOUS ACCESS FOR PARENTERAL NUTRITION s -ODULE NURSING OF VENOUS ACCESS FOR DIALYSIS s -ODULE PREVENTION OF CATHETER RELATED INFECTIONS s -ODULE 0)## INSERTION AND MAINTENANCE #/523%3 &/2 0(93)#)!.3 s #OURSE FOR ONCOLOGIST AND HEMATOLOGISTS MANAGEMENT OF 6!$ s #OURSE FOR SURGEONS AND ANESTHESIOLOGISTS INSERTION OF 6!$ s #OURSE OF 5LTRASOUND GUIDED CENTRAL VENIPUNCTURE
term venous access devices. Also, experts from GAVeCeLT have started (and are currently running) several official University courses on venous access devices (most importantly, a Master on venous access devices for physicians and one for nurses, both at the Catholic University of Rome) However, the most important achievements of GAVeCeLT in the period 2006-2009 were a few ambitious projects meant to modify substantially the culture of VADs in Italy: • The UltraSound (US) project (for the diffusion of ultrasound guided venipuncture). • The EKG project (for the diffusion of the EKG method for the position of the tip of central venous catheters). • The PICC project (for the diffusion of peripherally inserted central catheters). The ʻPICC projectʼ, phase one: the introduction of US guided PICC insertion at the Catholic University Hospital In the 90ʼs and in the first years of the new century, only very few centers in Italy were using PICCs. Main indications for PICCs were short-term chemotherapy in selected oncologic patients and home parenteral nutrition - for limited periods of time – in patients who had shown high intolerance to traditional VADs. In almost all cases, the insertion of such devices was performed via the “blind” technique (i.e. without ultrasound guidance) in the antecubital area. This approach was associated with a high percentage of implant failure (especially when PICC insertion was attempted in patients whose peripheral veins were compromised by long periodic hospitalization or by repeated intravenous injections, as in the case of drug addicts) and of local complications (kinking, displacements, thrombo-phlebitis). All these factors led to a very scarce diffusion of PICCs. On the other hand, the clinical utilization of PICCs in USA
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and UK had already been dramatically increasing starting from 2000, as a consequence of the diffusion of the micro-introducer technique with ʻmodified Seldingerʼ approach (Sansivero, 2000; Bowe-Geddes & Nichols, 2005) and of the technique of ultrasound-guided insertion, which significantly increased the number of successfully performed insertions and reduced the risk of local complications (Simcock, 2008; Nichols & Humphrey, 2008). Later on, it became clear that PICCs represented something totally new if compared to previous peripherally inserted catheters used in the 80s such as Drum Cartridge© (Abbott) or CavaFix© (BBraun), – especially in terms of biocompatibility of the new materials they were made of (silicon and third-generation polyurethane) – and with definitely larger potentialities. One of the most important features of PICCs, which is becoming increasingly evident from the literature, is their lower risk of catheter related bloodstream infection if compared to standard CVCs (Maki, Kluger & Crinich, 2006;Raad, Hanna & Maki, 2007;Skiest, Abbott, & Keiser, 2000). The main concern was still the incidence of venous thrombosis, though later studies have suggested that this complication can be minimized by using ultrasound insertion, accurate position of the tip of the catheter and by appropriate choice of the calibre of the catheter (Walshe, 2001; Hertzog & Waybill 2008; Grove, 2000; Chu, Cheng, Law, & Tso, 2007; Ong, Gibbs, Catchpole, Hetherington, & Harper, 2006). In 2005, at our Institution, the Catholic University Hospital in Rome (a large Hospital with about 1,300 beds), a group of physicians and nurses with long and consolidated experience in the field of vascular access - active members of GAVeCeLT - decided to implement the use of PICCs, considering them one of the most promising innovations in the field of vascular access devices, for both intrahospital (Ng, Ault, Elliott, & Maldonado, 1997; Gallieni, 2008) and extra hospital infusion treatments (Gorsky & Czaplewski 2004). For this purpose, we considered necessary to import a specific PICC insertion technique (ultrasound-guidance), which was already widely used at the Catholic University Hospital for non-tunnelled short-term CVC implants and also supported by GAVeCeLT as the “gold standard” of safe implants (NICE, 2002; AVA, 2008; ACS, 2008). Thus, in the summer of 2005, a first theoretical-practical course was arranged, focused on ultrasound guided PICC insertion. This course was held by UK nurses with a wide and consolidated experience in the field and was divided into two parts: a theoretical session (description of PICCs, ultrasound guidance applied to venous access placement, management of PICCs according to the most recent international guidelines) and a practical session, during which Italian physicians and nurses performed several insertions supervised by tutors. Of course, the physicians and nurses who took part in the course were all part of the Catholic University staff. In the months following the course, PICC insertions started in various wards of our Hospital, according to a progressive implementation project that first included the Oncology Unit and then the Infectious Diseases Department, and then all the other wards.
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The course attendees, who already shared a long professional cooperation relationship within GAVeCeLT, gradually gathered into a real team dedicated to vascular access devices and in particular to PICC. This team, initially formed by two surgeons, an infectious disease specialist and eight nurses, started to operate in our University Hospital, relying upon the various competencies of its members, through a well-organized set of activities which included selection and insertion of VADs as well as counselling on routine management and management of complications. The team was the practical application of what was suggested by most international guidelines (Alexander, 2009; Wenzel & Edmond 2006; Robinson, Mogensen, Grudinskas, Kohler, & Jacobs, 2005), with some original traits due to its multi-professional and multi-disciplinary makeup. Today this team continues to represent a unique reality in the field of vascular access. For the first time in our country, a wide-range project focused on vascular access devices was being developed; very soon, this became part of a wider “Risk Management” plan, started in the Catholic University Hospital in order to pursue safety and cost-effectiveness (Robinson et al. 2005). In that same year 2005, a relevant study by K. Kokotis (Kokotis, 2005) recognized the following aspects as causes of low effectiveness in the field of vascular access: 1. The absence of a team operating in the field of vascular access; 2. The lack of training of the hospital nursing staff; 3. The reduction of nursing personnel, that caused an increase in working hours and, consequently, less time for training; 4. The more and more compromised integrity of patientsʼ venous systems, due to the increase in the survival rate, in the chronicity of pathologies and the numerous comorbidities; 5. An increase in the number of diabetic patients and of patients undergoing steroid therapies and chemotherapy that compromise the venous system; 6. The existence of over 500 types of injectable prescription drugs with a very alkaline or very acid pH and/or with a high osmolarity causing cases of phlebitis, infiltration and extravasation, usually occurring not later than 48 hours after the start of the infusion; 7. The increasing number of patients who undergo different simultaneous intravenous therapies, which are often not compatible with one another; 8. The lack of a Vascular Access Planning at the moment when the patient is being hospitalized. As a logical consequence of these recommendations, the first step of our Risk Management Plan was the development of a team, specifically formed and trained to operate in the field of vascular access. As it can be easily guessed, the presence of a dedicated team increased and improved the already solid activity of long-term VAD insertion, but it also generated a growing increase in the insertion and use of PICCs and Midline catheters. Throughout the years, these devices have turned out to be so advantageous that the number of brachial insertions performed
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in the Catholic University Hospital increased from about 600 in 2006 to over 1200 in 2008. As the months passed, the success rate of brachial insertions rose to almost 100%, while local complications decreased from 30% to 2%, thanks to the adoption of a very standardized protocol that included ultrasound guided venipuncture and a modified Seldinger technique using a microintroducer kit (Pittiruti et al. 2007; Pittiruti et al. 2009). Current activities of our PICC team include: insertion of approximately 1200 PICC/Midline per year (number steadily increasing), in every ward of the hospital, exclusively by ultrasound guidance and micro-introducer technique; definition of hospital policies for VADs selection, insertion and management; monitoring of complications; counseling for VAD problems in the wards; training nurses of our hospital. The ʻPICC projectʼ, phase two: the diffusion of PICC in Italy from 2005 to 2009 Considering the remarkable enhancement of implant techniques, as well as PICC and Midline performances, it became even harder to understand why such devices had not spread yet in Italy. On the basis of data collected through a survey in 2005, a task force of GAVeCeLT experts hypothesized that the obstacles that could potentially slow down the diffusion of PICCs and Midlines in our Country were the following: 1. Nurses and physicians did not have a clear idea of the correct clinical indication of such devices; 2. There was no specific training course regarding the insertion and maintenance of PICCs; 3. Attempts to extending the clinical indication to PICCs and Midlines had often resulted in disappointment and frustration, due (a) to the limited availability of veins in hospitalized patients, who were usually referred to PICC or Midline insertion after weeks of exploitation of the vein of the arms, and (b) to the high incidence of local thrombophlebitis, associated with the ʻblindʼ insertion in the antecubital area and to the relative inexperience of the nurses who managed the access; 4. Nurses were concerned by the fact that insertion of PICC, being the insertion of a central venous access, might not be suitable to their professional profile. Considering all these elements, our group developed a nation-wide strategy consisting of various actions to be performed within the scientific and educational areas of GAVeCeLT, with the purpose of spreading the knowledge of PICCs and Midlines all over our country: 1. Focusing on indication of PICCs and Midlines during the national GAVeCeLT Congresses and during meetings and courses organized or patronized by GAVeCeLT, through dedicated sessions and symposia; 2. Participation of GAVeCeLT members in national Congresses, meetings and other cultural events organized to spread the knowledge of PICCs; 3. Development of a complex educational project about PICCs, consisting of: a. A one-day practical course dedicated to PICCs (the so-
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4. 5.
6.
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called ʻGAVeCeLT 7ʼ module) which has been held, and still is, in numerous hospitals all over Italy; b. A 3-day residential course on PICCs, which is periodically held at the Catholic University Hospital; c. A University Course organized at the Catholic University in Rome; d. Implementation of the activity dedicated to PICCs within the University Masters on vascular access devices, which have been held every academic year at the Catholic University in Rome since 2004. Implementation of the use of PICCs, in particular in those hospitals where GAVeCeLT members are most active; Collaboration of GAVeCeLT with the most important international associations dedicated to vascular access (AVA - Association of Vascular Access; INS – Infusion Nurses Society; RCN – Royal College of Nurses, etc.) and with various international experts of PICCs, to keep a high level of knowledge on this subject also in Italy; Original scientific contributions in the field of peripherally inserted VADs, such as our studies on the EKG method to verify the correct placement of the tip (Pittiruti et al. 2008); Insertion of numerous educational and scientific documents on various aspects of PICCs and Midlines (indication, insertion technique, ordinary management and management of complications) on GAVeCeLTʼs website (www.gavecelt. info) and on the European Vascular Access Networkʼs website (www.evanetwork.info) Training activities currently focused on PICCs
As mentioned above, the first and most significant training activities concerning PICCs ever arranged in Italy – focusing especially on the ultrasound-guided placement of such devices – come from the clinic experience of the PICC Team of the Catholic University of Rome and from the educational activities of GAVeCeLT. Today, GAVeCeLTʼs formative plan on PICCs is divided into three parts: a travelling course, a residential course and a University course. The travelling course organized by GAVeCeLT (so called ʻGAVeCeLT 7ʼ) is an original educational model inspired by other practice-oriented courses such as Basic Life Support, Advanced Life Support, Advanced Trauma Life Support and structured into 4 hours of traditional lectures and 4 hands-on “skills stations.” The course lasts one day, there are 4 teachers (both doctors and nurses) and 20-24 trainees who, during the practical skills station phase, are divided into small groups of 5-6 people (Pittiruti, Scoppettuolo et al., 2007). The four hours of theory cover the following subjects: a. discussion of PICC and Midline indications; algorithm for the proper choice of VAD, both inside and outside the hospital; b. accurate description of the placement technique: preliminary survey of PICC and Midline characteristics (materials, devices necessary for insertion, commercial kits and criteria of choice of the equipment itself); description of the ultrasound machines designed for vascular access and exposition
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of simple principles of ultrasound anatomy, so to recognize vascular structures; choice of the arm, choice of the site of puncture, ultrasound exploration of veins, detection of anatomic landmarks for the measurement of the catheter, description of the ultrasound-guided technique and the microintroducer technique; securement of catheters by sutureless devices; description of the correct technique of dressing the exit site; c. Nursing of PICC during ordinary management and prevention of complications, according to the most important international guidelines, such as the guidelines from CDC (OʼGrady et al., 2002), EPIC2 (Pratt et al., 2007), SHEA/ IDSA (Marschall et al., 2008) and ESPEN (Pittiruti, Hamilton, Biffi, Macfie, & Pertkiewicz, 2009), in addition to policies and recommendations from AVA, INS, RCN, British Committee for Standards in Haematology, etc.; d. Exposition of legal-medical considerations for nurses performing PICC insertions, supported by the opinion of GaveCeLT consultant forensic experts and by official documents of the Italian Federation of Nurses (IPASVI). All the educational material presented in these four lessons is also given to the trainees on electronic support (CDrom), along with the main papers on the subject and a full-length version of all related guidelines. As mentioned before, the practical part is divided into four skills stations (Fig.1), attended in rotation by the four groups of trainees. A. During the first skills station, ultrasound visualization of the basilic vein, the brachial veins, the brachial artery and the cephalic vein is performed on healthy volunteers (i.e. the trainees themselves). In order to do so, a description of the ultrasound machine and its main functions is presented, along with key information on the anatomy of arm veins; the trainee
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is taught how to properly place the patient and the ultrasound probe (detecting the characteristics of the veins suitable for insertion: compressibility, pulsatility and depth), so to get a proper visualization of each vein. B. In another skills station, PICC and Midline placement is performed via the “blind” technique on a ʻPeter PICCʼ © dummy (VataInc. Co.). During this station, it is shown how to properly choose the vein and the site of venipuncture using the “blind” technique instead of ultrasound and how to detect anatomic landmarks for PICC measurement; the “blind” technique itself is also shown (insertion into visible or palpable vein through splittable cannula needle), followed by catheter securement and dressing.
C. In the third skills station, it is shown how to place PICCs and Midlines using ultrasound-guidance and the micro-introducer technique, using an original simulator designed and realized for this purpose by GAVeCeLT (Fig.2). This model, which mimics a human arm, consists of a turkey leg through which a soft rubber tube is inserted. This simulator (or ʻphantomʼ) is very realistic and resembles a real human arm, since its tissues have the same echogenicity as human tissues; also, it is inexpensive and easily reproducible. The “vein,” represented by the soft rubber tube, looks like a 5-6 mm diameter basilic vein, in terms of compressibility, depth and pulsatility (the latter can be reproduced by the teacher squeezing the exposed part of the tube with quick and consecutive movements). Furthermore,
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the model is perfect for the simulation of the whole maneuver, including the penetration of the needle and the insertion of the micro-introducer through the vein wall. With such a simulator, the whole ultrasound-guided PICC/Midline implantation process via micro-introducer can be reproduced in an absolutely realistic fashion (Fig. 3 – 4 -5). D. During the last skills station, another type of manikin (Chester Chest©, VataInc. Co.) is used to show the ordinary management of various types of VAD, with practical demonstration of the use of several devices such as sutureless securing systems, chlorhexidine dressings, transparent dressings and needlefree connectors. Also, several maneuvers are demonstrated, such as flushing, locking with heparin, insertion of Huber needles, use of “safety devices,” etc. This training course has been held more than 50 times all over Italy between 2005 and 2008, in 21 different centers, training over 1,000 healthcare professionals (mostly nurses). The GAVeCeLTʼs residential course on ultrasound-guided placement of PICCs was developed later on, in 2008, and has already been held several times in the Catholic University Hospital. The purpose of this course is to achieve a better knowledge of what had been taught during the previously mentioned training course, by adding to the pre-clinical teaching (theory and skills stations) a proper clinical training. The course – meant for no more than 3 or 4 trainees at a time – lasts three days. It is structured according the so-called “4 + 4 + 4 +4” structure (4 hours of theory, 4 hours of skills stations, 4 clinical procedures seen, 4 clinical procedures performed by the trainee) (Table II). The activities performed during the first day are the same as the travelling course described above, with the addition of educational videos about PICC insertion and management, followed by an interactive discussion. The second and the third day are dedicated to the clinical training: the trainees assist in 4 PICC insertions performed by experts and then each one of them performs four clinical insertions, under the supervision of a tutor. In this course, if compared to the travelling course, the trainees establish a more direct contact with the clinical aspects of PICCs, since they have the opportunity to take an active part in all the significant phases of the procedure, such as the definition and the confirmation of the indication, the implantation itself and the solving of management problems. During this intensive 3-day course, there is also time enough to discuss the logistic and organizational aspects of a PICC team. The University course was developed very recently, in 2008, and is being held at the Catholic University Hospital once each academic year. At the end of the course, a university certification is given to the trainees. The course is divided into a pre-clinical training, wider and more articulated if compared to the above-described courses, and a quite extensive clinical training, as the trainees have the opportunity to take part - directly or indirectly – to a relevant number of insertions. Throughout the years, besides the above-described courses, PICCs have gained more and more relevance within the educational program of the University Masters on vascular access
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