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    Claus Duedal Pedersen

    Head of Unit

    Odense University HospitalRegion of Southern Denmark

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    It all takes time

    RENEWING HEALTH in a nutshell

    Evaluating telemedicine

    Results & Expectations

    Table of Content

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    In 1747

    Scurvy =Skrbug/Skrbjugg/Skorbut/Niekingas/Keripukki/Szkorbut

    Scurvy rife, massiveimpact on cost of life,capacity to fight

    James Lind tested 12 illmen with treatmentsincluding lemon juice(vitamin C)

    Successfulfirst clinicaltrial?

    So it was adopted

    in 1800

    In 1747....

    3

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    Need for knowledge

    EU commission found:

    Lack of high quality evidence on the

    effectiveness of telemedicine:

    A main barrier for wider use

    And the EU project, RENEWING HEALTH, was

    funded as a pilot A, PSP-ICT project.

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    Project start date: 1stof February 2010

    Project duration: 47 months

    Total budget: 14.000.000 Euros EU contribution: 7.000.000 Euros

    26 pilot sites, grouped in 10 clusters and

    distributed over 9 EU regions

    RENEWING HEALTHin a nutshell

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    It comprises all the relevantstakeholders

    Regional Health Authorities

    Regional Healthcare Providers Competence Centres in Telemedicine

    Patient and professional (through their

    associations)

    Industrial companies (through their

    associations)

    Consortium

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    Region Syddanmark DenmarkRegione del Veneto ItalyNorrbottens Lns Landsting (County Council of Norrbotten) SwedenLulea Tekniska Universitet - Centre for Distance-spanning

    Healthcare SwedenHelse Nord RHF - Northern Norway Regional Health Authority NorwayUniversitetssykehuset Nord-Norge HF (Norwegian Centre for

    Integrated Care and Telemedicine) NorwayMinisterio de Salut - Generalitat de Catalunya SpainAgncia d'avaluaci de Tecnologia i Recerca Mdiques

    (Catalan Agency for Health Technology Assessment and

    Research) SpainEtel-Karjalan sosiaali- ja terveydenhuollon kuntayhtym(South Karelia Social and Health Care District) FinlandAnaptyxiaki Diadimotiki Eteria Psifiakes Polis Kentrikis Elladas

    AE OTA (Intermunicipal Development Company Digital Cities

    of Central Greece S.A.) GreeceAnaptyxiaki Etaireia Dimou Trikkaion Anaptyxiaki Anonymi

    Etaireia OTA (e-Trikala AE) Greece

    Consortium

    9

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    Municipality of Trikala GreeceDiikisi 5th Ygionomikis Periferias D.Y.P.E. Thessalias kai

    Stereas Ellados (Regional Health Authority of Sterea &

    Thessaly) GreeceEuropean Patients Forum LuxembourgEuropean Health Telematics Association BelgiumContinua Health Alliance Private Stichting BelgiumFundaci TicSalut SpainKrankenanstalten Betriebsgesellschft AustriaLand Krnten AustriaPflegewerk Managementgesellschaft Germany

    Consortium

    10

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    Consortium

    Regione Veneto (I) Norrbotten County (S)

    (DK) North Norway (N)

    South Karelia (F) Catalonia (E)

    The Regions

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    Consortium

    Carinthia (A) Central Greece (GR)

    Berlin (D)

    The Regions

    http://www.telemed.no/http://www.telemed.no/http://www.telemed.no/http://www.telemed.no/
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    Consortium

    The Competence Centres

    http://www.technologiestiftung-berlin.de/de/technologiestiftung/http://www.telemed.no/http://www.telemed.no/http://www.telemed.no/http://www.telemed.no/
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    Consortium

    The patients, industrial andeHealth Associations

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    Objectives

    15

    Quality

    ofLife

    10,000

    1,000

    100

    10

    1

    Adapted from Intel

    SpecialtyClinic

    CommunityHospital

    ICU

    Acute Care

    Assisted

    Living

    Skilled

    Nursing Facility

    ResidentialCare

    Independent,

    Healthy Living

    Community

    Clinic

    Chronic Disease

    Management

    Doctors

    Office

    Tele-homecare

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    Clinical objectives improving the quality of life of chronic patients who,

    for just the three chronic diseases addressed in theProject, account for well over 15% of the EU adult

    population by removing anxiety about health conditions

    reducing the need for the patient to use emergencyservices and/or hospital stays

    avoiding and/or slowing down the worsening of their

    disease and the insurgence of complications providing clinical evidence that, at least for certain

    chronic diseases, a telemedicine-based delivery networkcan supply healthcare services at least of the same clinicalquality and reliability as those supplied through a

    traditional healthcare delivery network

    Objectives

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    Patient/user perspective objectives providing coherent clinical services through ICT thattake into proper consideration patients andprofessional users needs, capabilities, risks andbenefits

    implementing solutions that support theempowerment of the patients and increase patientssatisfaction

    demonstrating that the implementation oftelemedicine services improves the professionalsatisfaction of the involved healthcare professionals.

    measuring patients, relatives, informal caregiversand healthcare professionals satisfaction (through

    questionnaires)

    Objectives

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    Economic objectives containing the cost of care for chronic

    patients to maintain the health system

    sustainable in spite of the demographic

    changes

    reducing the reliance of chronic patients on

    the expensive care facilities and replacing

    them with more affordable homecare

    Objectives

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    Organisational objectives cutting across the traditional fences among

    different levels of care

    creating an organisational model for

    telemedicine services that ensures a safe, clearand efficient pathway for patients in theirjourney through the healthcare system

    promoting active participation of the patients

    in the organisational model

    measuring the organisational impact oftelemedicine in both a qualitative andquantitative manner

    Objectives

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    Size 20 partners + 5 Competence Centres 7.900 patients in the Intervention Group

    21 pilot sites

    10 different telemedicine services Multicultural character

    Partners come from 11 different EUcountries nicely covering Northern, Central

    and Southern Europe

    Evaluation methodology

    Randomised Controlled Trials

    MAST

    The numbers

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    RH Organisation

    03/11/2013 21

    7158 patients

    84 centres

    21 pilots

    10 clusters

    3 diseases

    9 countries

    1 observ.

    9 RCTsDM

    COPD

    CVD

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    RH clusters

    Cluster

    PATHOLOGY

    VENETO

    SYDDANMAR

    K

    NORRBOTTE

    N

    NORWAY

    CATALONIA

    S.KARELIA

    THESSALY

    CARINTHIA

    BERLIN

    N

    Cluster 1

    DM

    X X X X 755

    Cluster 2 X X X 930

    Cluster 3 X 400

    Cluster 4

    COPD X X X 826

    Cluster 5 X X X 625

    Cluster 6

    CVD

    X X 475

    Cluster 7 X X 465

    Cluster 8 X 2080

    Cluster 11 X 450

    Cluster 10 X 152

    TOTAL 7158

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    Why clusters

    The concept of clusters has been introduced for: grouping existing telemedicine services,

    although using heterogeneous technological

    platforms, according to their aim, timing and

    duration of the intervention increasing the statistical power of the trials by

    aggregating data from the various pilots of a samecluster

    promoting close collaboration and sharing ofexperience among teams which have neverworked together before RENEWING HEALTH

    i i i

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    Minimum requirements

    for a cluster

    All pilots belonging to a same cluster willshare a common set of primaryindicators

    Each cluster of pilots will operate as amulti-centre clinical trial (aggregationof data)

    For each cluster a Scientific Trial

    Protocol will be elaborated thatincludes, a.o., a detailed description ofobjectives, design, methodology,

    outcomes, statistical considerations

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    Two examples of services

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    Patients situation (at home) Hospital (Odense University Hospital & Svendborg Hospital)

    PATIENT

    NURSE

    ALARM

    6

    2

    DATA TRANSMISSION DATA ACCESS ALARM MANAGEMENT

    3

    HOSPITAL VIDEO

    INTERFACE

    PATIENT

    BRIEFCASE

    1

    HOSPITAL

    INFORMATIO

    N

    SYSTEM

    MONITORING

    5

    TELEMONITORING

    DEVICES

    4

    Cluster 4: COPD

    Southern Denmark (DK)

    26

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    Cluster 4: COPD

    Southern Denmark (DK)

    1. A COPD patient admitted with exacerbation is discharged fromhospital and a Patient Briefcase with video interface is installed in thepatients home

    2. Daily for 1-2 weeks, a specialised nurse will make a scheduled tele-consultation with the patient, who is at home

    3. Through her computer at the hospital, the nurse can connect to thepatient via video. Beside the video screen, she has access to thepatients electronic patient record on a second screen

    4. During the video consultation, the patient is asked to use the twomeasurement devices (spirometry and pulse-oximetry), which theyreceived along with the Patient Briefcase

    5. The data from the devices are transmitted through the Briefcase to aseparate system at the hospital. The nurse can view themeasurements on a third screen in her office. Based the conversation,observations and measurements, the nurse is able to assess thepatients condition and take appropriate actions

    6. If a patient experiences a worsening in their condition during the day,they can use an alarm button on the Briefcase and they are in direct

    contact with the hospital.

    Cl t 1 M bil lf h l

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    Patients situation Intermediary Organisation Research server

    52

    DATA TRANSMISSION GP ACCESS THROUGH CARE PORTAL (FUTURE!) CONTACT BY HEALTH COACH, CLINICIANS (GP/SPECIALIST)

    31

    4

    PATIENT GENERAL

    PRACTITIONER

    DATABASE

    HEALTH COACH RESEARCHER

    TELEMONITORING

    DEVICE

    GATEWAY

    & APP

    28

    Cluster 1: Mobile self-helptool for T2 diabetes

    Northern Norway (NO)

    Cl t 1 M bil lf h l

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    Cluster 1: Mobile self-helptool for T2 diabetes (NO)

    1. Patient set goals for what kind of food intake and physical exercisethat is wanted the next period.

    2. Patient measure blood glucose level with glucose meter

    3. Glucose meter transfer data automatic to mobile phone byBluetooth

    4. Patient adds food intake and activity manually on the phoneapplication

    5. Patient gets response from application on how the personal setgoals are met within the defined period.

    Parallel activities to this registration process:

    Patient will have contact with the health coach in parallel to usingthe application, where relevant health related questions and resultsare discussed.

    The patients will have regular consultations with their physicianwhere they will be able to share their application data, if theychoose to do so.

    Responsibility and control of their data lies 100% by the patient.

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    Evaluating the services

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    The MAST model

    If the purposes of an assessment of telemedicine applicationsare:

    To describe effectiveness and contribution to quality of care

    AND

    To produce a basis for decision making

    The relevant assessment should be defined as:

    The assessment of telemedicine should be a multidisciplinary process thatsummarizes

    and evaluates information about the medical, social, economic and ethicalissues related to

    the use of telemedicine in a systematic, unbiased, robust manner.

    MASTModel for ASsessment of Telemedicine

    MAST

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    Purpose of MAST To generate knowledge for evidence-based decision-making, by

    guiding the assessment of studies on effectiveness of telemedicineimplementation

    Definition of proposed assessment:

    Based on scientific methods and studies

    HTA approach

    A multidisciplinaryprocess that summarizes and evaluates information

    about the medical, social, economic and ethical issues related to the use oftelemedicine in a systematic, unbiased, robust manner.

    MASTPurposes and basis

    32

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    Multidisciplinary assessment (domains):

    1. Health problem and characteristics of the

    application

    2. Safety

    3. Clinical effectiveness

    4. Patient perspectives

    5. Economic aspects

    6. Organisational aspects7. Socio-cultural, ethical and legal aspects

    Elements in MAST

    Transferability

    assessment:

    Cross-border

    Scalability

    Generalizability

    33

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    Current status

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    Results so far

    We have recruited 75 % of all patients in the

    studyi.e. xxx patients

    We have 3 PhDs in the pipeline

    We are aiming for at least X of scientific

    articles

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    Conclusions

    We have recruited 75 % of the patients: Appr. 5500

    RENEWING HEALTH is the largest ongoing Randomised

    study of telemedicine in EU

    Results? December 2013but so far it looks good!

    Follow: www.RenewingHealth.eu

    http://www.renewinghealth.eu/http://www.renewinghealth.eu/
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    i h lth

    Thank You for yourattention