Partnership for the Heart Remote Patient Monitoring for Patients with Congestive Heart Failure Dr. Stephanie Luecke, project communication 19.04.2007 ehealthconference 2007 Berlin Potentials in ehealth 1
Project focus Partnership... Partnership: Experts in Cardiology, Industry und Health Care for the Heart Development: Mobile sensor platform for remote patient monitoring Care for patients suffering from congestive heart failure (CHF) at home or elsewhere Early detection of complications allows early initiation of the appropriate therapy Clinical trial: 12 months In comparison to standard therapy, does Remote Patient Monitoring in patients with CHF increase patients' quality of life, reduce hospitalizations and reduce the mortality rate? 2
Project partners and responsibilities Development Project leadership Clinical trial Technical management Clinical trial management Sensor plattform for data transfer Platform for exchange of medical data (electronic patient record) System integration Hardware, operation Quality man. Study center 1 Open 24/ 7 Clinical trial management Study center 2 (Open 7-21/7) 3
Associated partners & grant Associated partners Support in patient recruitment Cross-sectional contracts between patients, medical partners, health care providers, TMC Grant: Federal Ministry of Economics and Technology Innovation program next generation media 11 projects in total, 2 in the field of health promotion www.nextgenerationmedia.de PfH facts and figures In total 4.9 million Euros (project no.: 01MG532) 7.3 million Euros investment by industry partners Project duration 2005-2008, clinical trial 7 07-7 08 www.partnership-for-the-heart.de 4
The Patient Monitoring System Patient Medical Partners Notification HOME EMERGENCY CALL Treatment TMC-physician Transmission via bluetooth Control Notification GP Cardiologist EKG + SpO 2 Transmission via mobile phone Transmission Blood pressure Activity Transmission path for health data Weight Communication paths in normal cases IMMEDIATE REACTION Ambulance Hospital phys. Communication paths in case of emergency 5
Patients measuring devices patient devices MMA ECG + SpO 2 Blood pressure How do you feel today? Activity Wheight 6
3 generations in the development of remote patient monitoring systems Vital parameters Data flow medical instruction Patient e.g.. ECG database I. GP/ Cardiologist II. weight blood pressure ECG call center In case of deviations GP/ Cardiologist Electronic health record III. weight blood pressure ECG TMC-physician Partnership for the Heart adjusted to individual needs GP/ Cardiologist Koehler F., Anker SD. J Am Coll Cardiol 2006;48:850-851 7
Reference indication CHF Indication Heart s ability to pump blood efficiently has been compromised Incidence About 1.5 million patients, around 200.000+ per year Every 10 th German over 65 progression No healing, high mortality, frequent hospitalizations Symptoms like shortness of breath, palpitations, fatigue, leg oedema (NYHA-classification I bis IV) costs Extremely cost-intensive around 3 billion Euros per year 8
Typical signs: shortness of breath, fatigue, leg oedema Source: SHAPE 9
Why remote patient monitoring in CHF? Gap between objective deterioration and subjective perception of cardiac function I feel healthy I am healthy STOP Stop before significant deterioration (emergency) Shorten time slot until detection t = max. 10
Trial design Trial aims 1. Superiority of remote patient monitoring compared with standard therapy in terms of Mortality rate Hospitalization Cost effectiveness 2. Superiority in terms of Life quality Neurohumoral status 3. Relative meaning of variables in terms of trial aim 1 Trial design Randomised, prospective, controlled, open, parallel, multicenter 475 patients (3:2) Remote patient monitoring for 12 months (07/07-07/08) Therapy based on guidelines Inclusion criteria Ejection fraction 35% Advanced CHF (NYHA II-III) Hospitalization (cardiac decompensation) within 18 months prior to the study Endpoints Primary endpoint days alive and out of hospital due to heart failure Secondary endpoints Overall mortality rate Cardiovascular mortality rate Frequency of overall nonelective hospitalizations Frequency of cardiovascular hospitalizations Plasma level of NT-proBNP Patients' quality of life Cost effectiveness 11
USPs of the PfH-System Aim System architecture 90 sec. EKG Waage Blutdruck Aktivität EKG- Streaming Patient Alarmknopf Haus- ServiceRuf- Basisstation BT MMA PSTN Actimon SMS GPRS ASC EDGE LMS TSB Krankenhaus TMC Frontend Berlin/ Stuttgart Nurse Admin Arzt Arzt criteria Controlled clinical trial catalogue of benefits of German health insurance funds Health economics Open platform concept Compatibility on national and on international level Expandable to other indications PfH Patient Übertragung via Bluetooth EKG + SpO2 Blutdruck Aktivität Usability and acceptance by the target group (60 years +) Care around the clock Gewicht Players in the health care system Cross-sector integration: Outpatients GPs / Cardiologists / inpatient physicians Health insurance funds 12
Outlook Remote patient monitoring and PfH Mass rollout Optimization Prototyping 2006 2008 2010 2015 Clinical Trial Expanding of applications Cost-effective operation Largest study in the German area on international scientific level The evidence of superiority is a conditio sine qua non to enter the catalogue of benefits of German health insurance funds Expanded system architecture Innovative sensors in heart failure Expanding to other clinical indications Innovative application fields Broad market acceptance 1) Workplaces 1) Changes in society Health care costs Technical innovations 1) Source: Team analysis based on Frost& Sullivan: Patient Monitoring 2004 13
Thanks for your attention! Get further information: www.partnership-for-the-heart.de, stephanie.luecke@charite.de Thanks to the Project Group: Head of the Project: Dr. Friedrich Koehler (Charité Berlin) Head of the Telemedical Center Stuttgart: Dr. Michael Schieber (Robert-Bosch-Krankenhaus Stuttgart) Technical management: Dr. Sascha Henke (Robert-Bosch GmbH) Electronic patient record: Dr. Peter Heinze (Intercomponentware AG) Sensor platfrom: Dr. Dominik Wegertseder (Actimon GmbH) Project management: Christian Scharlach (Theron Business Consulting GmbH) 19.04.2007 ehealthconference 2007 Berlin Potentials in ehealth Dr. Stephanie Luecke 14
Mögliche Erweiterung der Systemarchitektur mit Telematik-Infrastruktur Integration Telematik-Infrastruktur in PfH-System 1) Vorteile 120 sec. EKG Waage Blutdruck Aktivität EKG- Streaming Kartenlesegerät Selbst- Einschätzung Patient Alarmknopf Haus- Notruf BT Kartenlesegerät Telematikinfrastruktur egk MMA SMS GPRS EDGE PSTN Actimon ASC ega Krankenhaus TMZ Frontend Berlin/ Stuttgart LMS TSB ICW ega Pfleger Admin Arzt Arzt HBA HBA Hohe Bekanntheit: Größte TM-Studie zu CHF im deutschsprachigen Raum Durch BMWi gefördert Hohe Akzeptanz im Markt: Alle im Gesundheitsmarkt Beteiligten sind eingebunden Einfache Erweiterbarkeit: universelle Schnittstellen durch herstellerunabhängiges Plattformkonzept Schnelle Umsetzbarkeit: Kapazitäten zur Erweiterung um Telematik-Infrastruktur stehen nach Launch zum 01.07.07 zur Verfügung 1) Schematische Darstellung ASC: Actimon Server Center EKG: Elektrokardiogramm LMS: Leitstellen-Management-System BT: Bluetooth GPRS: General Packet Radio Service MMA: Mobile Medical Assistant EDGE: Enhanced Data Rates for GSM Evolution HBA: (elektronischer) Heilberufeausweis PSTN: Public Switched Telephone Network ega: elektronische Gesundheitsakte HSR: Haus-ServiceRuf (Bosch ST) SMS: Short Message Service egk: elektronische Gesundheitskarte LAN: Local Area Network TSB: Telemedical Service Bus ehealthconference 2007 Berlin Potentials in ehealth Dr. Stephanie Luecke 15
Wissenschaftlich anerkannte Studien zu Telemedizin bei Herzinsuffizienz TEN-HMS WHARF HHH 426 Patienten aus Deutschland, Großbritannien, Niederlande (2005) Vergleich Telemonitoring, Telefon-Unterstützung durch Schwester, Usual Care (2:2:1) über 450 Tage TM: Blutdruck, Puls, Gewicht, Herzrhythmus Geringere Mortalität durch TM und TU als UC (*), gleich häufige Einweisung bei TM und TU, kürzere Liegedauer bei TM (*) 280 Patienten aus den USA (2003) Vergleich Telemonitoring, Usual Care (1:1) über 6 Monate TM: Gewicht Kein Unterschied Hospitalisierung, Reduktion Mortalität bei TM um 56% (**) gegenüber UC 461 Patienten aus Großbritannien, Italien, Polen (2005) Vergleich Telemonitoring, Usual Care TM: EKG, Atmung (v.a. nachts) Reduktion Hospitalisierung TM gegenüber UC ehealthconference 2007 Berlin Potentials in ehealth Dr. Stephanie Luecke 16
Telemonitoring-Anbieter zur Herzinsuffizienz in Deutschland (I) Anycare IKK Thüringen, ktpbkk, HamburgMünchner: TeleMedCare Herz, u.a. mit Unfallkrankenhaus Berlin, Paracelsus-Klinik Schöneck Gewichtskontrolle über Funk ArztPartner Almeda AG KKH: Herzensgut Messung von Gewicht und ggf. Blutdruck Gesellschaft für Patientenhilfe AOK Berlin: Cordiva mit dem Unfallkrankenhaus Berlin Gewichtskontrolle mit Modemanschluss Getemed Städtisches Klinikum Brandenburg Kontrolle von Gewicht, Blutdruck, EKG, Atemfrequenz, O2-Sättigung Patient gibt Daten selbst ein ( VitaGuard ) ehealthconference 2007 Berlin Potentials in ehealth Dr. Stephanie Luecke 17
Telemonitoring-Anbieter zur Herzinsuffizienz in Deutschland (II) Institut für angewandte Telemedizin Medtronic/ Vitaphone Herz- und Diabeteszentrum NRW, CardGuard AG, Cignus Healthcare Systems GmbH, kein Versicherungspartner Messung von Gewicht, Blutdruck, ggf. EKG BKK Ford, BKK Audi u.a.: CorBene Messung von Blutdruck, Puls, EKG, Atemfrequenz und Gewicht nach Bedarf Philips Noch keine deutschen Kooperationspartner (USA, Niederlande) Übertragung via Fernseher mit Set-Top-Box ( Motiva ) PHTS TK: Programm Telemedizin fürs Herz mit der Deutschen Stiftung für chronisch Herzkranke und Hanseatischem Herzzentrum AOK Baden-Württemberg: Programm HeiTel mit Uniklinikum Heidelberg Verträge mit Sancura BKK, Taunus BKK, Debeka, Asklepios-Kliniken Messung von Gewicht, Blutdruck, Puls, EKG, Übertragung über Festnetz ( Paxiva EKG, Zertiva Gewicht, Blutdruck) ehealthconference 2007 Berlin Potentials in ehealth Dr. Stephanie Luecke 18