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La Telemedicina nella gestione della cronicità Andrea Di Lenarda President of Italian Association of Hospital Cardiologists Cardiovascular Center and University of Trieste, Italy What do we expect from Telemedicine especially in Heart Failure? 1. THAT CONTRIBUTES TO A MORE CAREFUL AND EFFECTIVE MANAGEMENT OF THE PATIENT BY REDUCING THE BARRIERS THAT HINDER THE PATHWAYS AND CONTINUITY OF CARE 2. THAT PARTICIPATES IN THE COMPLEX SET OF EVENTS THAT CAN IMPROVE THE QUALITY OF LIFE HOSPITALISATIONS Osservatorio Cardiovascolare Trieste AND REDUCE Rate and causes of 1-year hospital re-admissions (n=48549; 2.1/pt) A System-Wide Chronic Disease Management Program may allow an early and more frequent identification of clinical instability which should be rapidly managed and resolved so as to prevent avoidable hospitalisations. 56.6% Total re-hospitalisations 50.9% CV re-hospitalisations (46.1% HF re-hospitalisations) 49.1% non CV hospitalisations The new paradigm of Telemedicine: From a «reactive» to a «pro-active» approach Increase of filling pressure Dyspnea, oedema, weight increase Neurohormonal activation; Emergency Room/Hosp Impedence reduction Stable NYHA class Euvolemic; Stable NYHA class gg > 30 -21 a -7 -6 a -2 “Pro-active” Phase Osservatorio Cardiovascolare Trieste 0a5 “Reactive” Phase The new paradigm of Telemedicine: From a «reactive» to a «pro-active» approach Home days > 30 -21 to -7 -6 to -2 “Pro-active” Phase Osservatorio Cardiovascolare Trieste 0 to 5 “Reactive” Phase TELEMEDICINE & MANAGEMENT 1°) Effective transmission of clinical variables reliable for HF 2°) Qualified personnel receive informations to prescribe effective interventions 3°) Patients receive recommandations and prescriptions to be implemented - weight Integrated evaluation!! - Heart rate - Rhythm - Temperature - Impedence? - SaO2 - Creatinine - NA+/K+ - Hb, BNP? - Score (dyspnea) - Score (fatigue) - Treatment changes (diuretics,TELEMONITORING etc.) - Lifestyles changes - Others TELE-MANAGEMENT Revaluation to verify if the problem is solved or other interventions are needed modified by Desai AS and Stevenson LW, NEJM 2010 Osservatorio Cardiovascolare Trieste • A personalized hospital-discharge programme, founded on individuals’ needs and risk profiles, might be the best approach to plan the follow-up care of patients with chronic HF. • ICT will be helpful to disseminate clinical information to all health-care professionals in real time, and thus reduce the time and duplication of procedures and improve the overall care and health of patients. • Telemedicine has been used to support (not replace!) integrated care in the management of chronic diseases and, in particular, to provide education to improve self-management, enable information transfer (such as by telemonitoring), facilitate contact with health-care professionals (such as via telephone support and follow-up), and improve electronic records. Osservatorio Cardiovascolare Trieste Case manager, Continuity of Care, Multidisciplinary Team, GP’s role GP Specialist Nurse INTERNET Service Center WEB SITE Osservatorio Cardiovascolare Trieste But what are the risks? Osservatorio Cardiovascolare Trieste Cagliari 15/05 mobile-health tra rischi e 10 Consumer o Medical devices? • They perform the same function, but they give the same guarantees in terms of reliability? Hygiene? Precision? • You'd never allow to be treated with any drill? Osservatorio Cardiovascolare Trieste Top 10 hazards Osservatorio Cardiovascolare Trieste Cagliari 15/05 mobile-health tra rischi e benefici 13 … and more hazards • Potential for errors due to software bugs (most are not medical devices!) • Telemedicine does not substitute the emergency system • Risks of wrong/late/missing interpretation of the data and consequently wrong/late/missing decision (devices, variables, data, decision support systems, competence/responsibility of HC providers, integrated health network able to take in charge the problem) • Legal responsibility to take a clinical decision on the base of some (often incomplete) informations Osservatorio Cardiovascolare Trieste TELEMEDICINE & HEART FAILURE - Metanalysis (All cause mortality) - Osservatorio Cardiovascolare Trieste TELEMEDICINE & HEART FAILURE - Risultati dei Trials 1. Chaudhry SI et al N Engl J Med 2010, 2. Kholer F et al Circulation 2011, 3. Cleland J JACC 2009, 4. Mortara A et al Eur J Heart Fail 2009 2. 1. Telemonitoring Nurse supp. Usual care 3. 4. TELEMEDICINE & HEART FAILURE - Results of Trials Possible explanations for the negative results of most recent multicenter trials on the implementation of remote telemonitoring (TLM) in patients with HF • In the study design TLM is treated as a “drug” while only it is a system to improve the communication among health care providers. • None of the trials gives the methods of intervention in relation the significant changes in vital signs, and above all the procedures for verification that the recommendations are being followed by the patient. • The follow-up is always very short (6-12 months) for multicenter studies that use new technologies. • The choice of vital parameters to be monitored can not be appropriate to the individual case. • Often the TLM must be activated by the patient and is shown that in the long run this leads to an under-use of systems TLM especially if the patient does not receive a adequate feedback. • Poor patient adherence to the monitoring program. • The TLM can not be effective if it is not integrated in a treatment program with individualized control algorithms for each individual patient. CHAMPION STUDY MONITORING AND MANAGEMENT Reliable measure of PAP («pro-active» phase) Clear treatment goal (lower PAP) Well defined protocol of management («reactive» phase) Easy to verify the results of intervention >30% ad 1 aa The ECOST trial. Cumulative survival free from major adverse events in the intention to treat (A) and perprotocol (B) population. The COMPAS trial. Major adverse events (MAEs) were unchanged but face-to-face visits were reduced. Mabo P, Victor F, Bazin P, Ahres S, Babuti D, Da Guédon-Moreau L. Eur Heart J 2013; 34:605-14. CA et al. Eur Heart J 2012; 33:1105-11. TELEMONITORING PROGRAMS & DEVICES IN-HF Program 2662 835 240 Patients with chronic HF With indication to implantation but… Effectively implanted 1827 + 595 (91%) without devices and not monitored Dati IN-HF Outcome F. Oliva, A.Mortara et al submitted Which patients are more likely to benefit from Remote Telemonitorig? • Patients defined at high risk of events for worsening heart failure or CV hospitalisations (risk-driven management, NYHA class III e IV) • Patients in the vulnerable phase discharge (30 days – 3 months) after hospital • Patients with objective limitation due to functional, geographic, socioeconomical barriers Osservatorio Cardiovascolare Trieste TLM Rehospitalization is particularly high in the early phase after hospitalization 30 days from discharge Multiple HF Hosp. BNP++, Multimorbidity, CKD +, LVEF<40% 1 patient out of 4 is readmitted Osservatorio Cardiovascolare Trieste SmartCare The way to Integrated Care SmartCare Conventional Care SmartCare Services Service Models Health care silo Care protocols / pathways Health care centred pathways ICT / telehealth infrastructure Social care centred pathways SmartCare integrated pathways Cared-for & self-caring person Integrated Support Services (ICT) disempowered care recipient misinformation & patient risk suboptimal task distribution Social care silo Care plans / protocol ICT / telecare infrastructure Cared-for person Integrated data access Access to homebased Systems Coordination between provision steps taken Joint response to ad hoc requests Real-time communication Building Bocks SmartCare ICT Integration Infrastructure inclusive collaborative safety enhancing responsive Osservatorio Cardiovascolare Trieste efficient empowering FVG study design and enrolment inclusion criteria Design: local randomized study design (200 elderly citizens with HC/SC needs to be enrolled by the end of the study: 100 in usual care control group, 100 in ‘new ICT supported integrated care’ intervention group). Short and Long-Term Pathways: • Short term home monitoring (>3 mo). Before H discharge, multiprofessional H team together with district nurse select eligible care recipient according to a set of HC/SC inclusion criteria (eg Heart Failure, COPD, diabetes, social isolation) • Long term care (≥6 mo). Elderly individuals with chronic/stable, relevant health and/or social needs assessed by HC/SC staff at the joint point of referral (PUA). Osservatorio Cardiovascolare Trieste Results – General findings • 201 randomized patients (100 Intervention vs 101 Usual) • 19 early drop-out (12 Intervention vs 7 Usual care; 12 Short-term post-discharge vs 7 Longterm chronic) • 182 patients followed (88 Intervention vs 94 Usual care) • Follow-up 7.1±3.8 months (119 patient-year): – Short-term post-discharge vs Long-term chronic: 4.1±1.3 months vs 9.9±3.3 months) • Events (16 deaths; 126 Hospital/Health Care facility admissions; 1758 days of stay) – 16 deceased patients (8.8%; 13.4 deaths/100 patient-year) – 108 Hospitalizations (1342 days of hospital stay) – 18 Intermediate Care/Nursing Home admission (416 days) • Home Nursing Healthcare: 3053 total contacts (2.14 pt-month); 2417 (79.2%) Home Care, 160 (6.6%) unplanned; 536 (20.8%) Phone calls. Osservatorio Cardiovascolare Trieste Results: Main clinical findings All population (n=201) Intervention (n=100) Usual Care (n=101) p= 81±7.8 81.2±7.9 80.9±7.7 NS 53.8 60.2 47.9 NS Heart Failure (1st Dx) (%) 79.1 (52.7) 76.1 81.9 NS COPD (1st Dx) (%) 37.9 (17.6) 40.9 35.1 NS Diabetes (1st Dx) (%) 68.1 (29.7) 64.8 71.3 NS Charlson index ≥5 (%) 44.5 48.2 40.4 NS Prescription ≥7 Medications Living alone 58.2 60.2 56.4 NS 38% 32% 43% NS Reliant on care 43% 46% 40% NS Primary school 58% 57% 58% NS Age (years) Male gender (%) Osservatorio Cardiovascolare Trieste Short-term Post-discharge Pathway p=NS p=0.048 5.7 days saved in 3 months for 1 post-discharge intervention patients as compared to usual care pts Short-term Post-discharge Pathway Osservatorio Cardiovascolare Trieste Planned/Unplanned Contacts Short-term Post-discharge Pathway p=NS Osservatorio Cardiovascolare Trieste p=0.04 PRACTICAL GUIDE ON HOME HEALTH IN HEART FAILURE PATIENTS Tiny Jaarsma, Torben Larsen, Anna Strömberg “Most heart failure management programmes aim at optimisation of both pharmacological and non-pharmacological management and include assessment and intervention of risks and co-morbidity, optimised medical management, device therapy (pacemaker, cardiac resyncronisation therapy and implantable cardioverter defibrillator) education and self-care management, follow-up, access to health care and psychosocial…..” “Currently, the most optimal model for heart failure management is not known. Recent large-scaled studies show that not all models are equally successful to improve the outcomes, and these results indicate that a sophisticated approach to heart failure management is needed…” Int J Integr Care 2013; Oct-Dec It is in crisis that invention, discovery and large strategies are born. E. Einstein