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The role of the economic evaluation in the RENEWING HEALTH Project. Silvia Mancin
1. The role of the economic
evaluation in the RENEWING
HEALTH Project
Silvia Mancin
Arsenàl.IT
Veneto’s Research Centre for eHealth innovation
Bilbao, 27th June 2012
2. Background
The overall background of the project is a number of
EU conferences and reports describing
telemonitoring and the potential benefits of a wider
use of telemedicine applications in Europe.
Why telemonitoring is not widely diffused in health
systems?
11/10/12 2
3. Possible reasons
Evidences of contribution to quality of care
Technology
Organizative models
Physician/patients perspective
Legal aspects
Cost/effectiveness
X
Monies
11/10/12 3
4. RENEWING HEALTH:
REgioNs of Europe WorkINg toGether for HEALTH
• Programme: RENEWING HEALTH is the second Pilot Type
A eHealth project funded under the Competitiveness
and Innovation Framework Programme CIP ICT PSP
(Information and Communications Technologies –
Policy Support Programme)
• Project start date: 1st February 2010
• Total budget: 14.000.000 Euros
• EU contribution: 7.000.000 Euros
• European Regions involved: 9
• Patients involved: about 8000
5. AIM of RENEWING HEALTH
Validating, in real life settings and with a common
rigorous assessment methodology (MAST), the use
of existing Personal Health Systems for innovative
types of Telemedicine services used to monitor
chronic patients with
Cardiovascular Disease (CVD),
Chronic Obstructive Pulmonary Disease (COPD)
Diabetes
and prepare for their wider deployment.
6. Assessment Methodology:
MAST
MAST – Model for ASsessment of Telemedicine
New model for assessing the effectiveness and
contribution to quality of care of telemedicine
applications
A multi-disciplinary process that summarizes and
evaluates information about the medical, social,
economic and ethical issues related to the use of
telemedicine in a systematic, unbiased and robust
manner
7. Telemonitoring services
Cluster 1 Diabetes Cluster 6 CVD
Medium-term health Medium-term health
coaching and life-long coaching and life-long
monitoring monitoring
Cluster 2 Diabetes Cluster 7 CVD
Life-long monitoring Remote monitoring of
Congestive Heart
Failure
Cluster 3 Diabetes
Ulcer monitoring Cluster 8 CVD
Remote monitoring of
implantable cardiac
Cluster 4 COPD devices
Short-term follow-up after
hospital discharge
Cluster 10 Multi
pathology
Cluster 5 COPD Monitoring of frail
Life-long patients with chronic
monitoring deseases
8. Elegibility Criteria and Sample
Size – Cluster 5 COPD
Diagnosis of COPD, GOLD Class III-IV
Life expectance > 12 months
Patient able to use the equipment provided (alone or
assisted).
11/10/12 8
9. Elegibility Criteria and
Sample Size – HF Cluster 7
Age ≥ 65 years
Discharge from hospital after acute HF in the previous 3 months and EF < 40%
or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalisation
No comorbidities prevalent on CHF with life expectation < 12 months
No myocardial infarction or percutaneous coronary intervention in last 3
months, or scheduled
No coronary artery bypass, valve substitution or correction in last 6 months
Patient able to use the equipment provided (alone or assisted)
Being on waiting list for heart transplantation
Being enrolled in other trial
11/10/12 9
10. Veneto Region service
Specialist
Patient’s home Regional eHealth
Centre
Telemonitoring
devices
Gateway
2
3 7 General Practitioner
1
4
Patient Intervention service
6
5
Alarm device Regional Centre’s
Operator Social worker
Family/Caregiver
Data transmission
Data access through Home Care portal
10
10 Alarm management
Contact with the patient
11. Assessment Methodology: MAST- Model for
ASsessment of Telemedicine
HEALTH TECHNOLOGY
HEALTH TECHNOLOGY
ASSESSMENT
ASSESSMENT
Rigorous assessment
of
TELEMONITORING
SERVICES
11
14. Project timeline
Enrollment start: October 2011
Enrollment period: 6 months 12 months
Follow up period: 12 months
Final Results: December 2013
11/10/12 14
15. Veneto Region COPD
Consort
Assessed for elegibility (n=369)
Excluded (n=92)
Not meeting inclusion criteria (n=67)
Decline to participate (n=19)
Other reasons (n=6)
Randomised (n=277)
Allocated to intervention (n=198) Allocated to usual care (n=79)
Received allocated intervention (n=152)
Did not received intervention (n=8)
Waiting to receive intervention (n=37)
Lost to follow-up (n=3) Lost to follow-up (n=5)
Discontinued intervention (n=0) Discontinued intervention (n=0)
Analysed (n=0) Analysed (n=0)
Excluded from analysis (n=0) Excluded from analysis (n=0)
15
* 93% of Sample Size updated to 21 May 2012
16. Veneto Region HF
Consort
Assessed for elegibility (n=163)
Excluded (n=29)
Not meeting inclusion criteria (n=24)
Decline to participate (n=5)
Other reasons (n=0)
Randomised (n=134*)
Allocated to intervention (n=89) Allocated to usual care (n=45)
Received allocated intervention (n=61)
Did not received intervention (n=8)
Waiting for receiving intervention (n=20)
Lost to follow-up (n=2) Lost to follow-up (n=8)
Discontinued intervention (n=0) Discontinued intervention (n=0)
Analysed (n=0) Analysed (n=0)
Excluded from analysis (n=0) Excluded from analysis (n=0)
16
*43% of Sample Size update to 21 May 2012
22. Patients – Cluster 5
Patients’ distance from healthcare structure
Average distance (one way): 9,5 km
Average travelling time (one way): 15,4 minutes
23. Patients – Cluster 7
Patients’ distance from healthcare structure
Average distance (one way): 10,1 km
Average travelling time (one way): 17,5 minutes
25. Assessment Methodology: MAST- Model for
ASsessment of Telemedicine
HEALTH TECHNOLOGY
HEALTH TECHNOLOGY
ASSESSMENT
ASSESSMENT
Rigorous assessment
of
TELEMONITORING
SERVICES
25
26. Economic analysis
Societal Business Case
Perspective
• Broad: takes into account • Narrower: adopts the LHA’s
all kinds of resources and point of view
benefits
• Aim: assessing the service’s • Aim: assessing the
overall cost-effectiveness company’s financial return
when providing the service
Outcomes
• ICER (Incremental Cost- • Return on Investments (ROI)
effectveness ratio)– based • Total cost of intervention
on SF-6D’s QALYs • Break even analysis
• Cost per clinical event • DRG-rate
avoided (CEA)
27. Cost analysis and reporting
Describe resources, data collection and level of estimation
27
30. Veneto:
demographics
In the Veneto Region*:
• 20% of population is over 65
• 16.5% of the elderly population is at risk of poverty
• 68% of people over 75 years is suffering from at least
two chronic degenarative diseases
• 46% prelevance of multiple chronic diseases in the
population aged between 65 and 74
• Patients affected by COPD 238.000
• Patients affected by CHF 70.000
Rapporto Statistico 2011, Veneto Region
*
31. Expected Results
Carring out a detailed and rigorous
report to be used as a basis for decision
Validating a New model for the
assessment of telemedicine services
(Health Technology Assessment)
Guidelines for the European Countries
on how the european prototypes of
telemonitoring services can become
Large Scale Pilots.
FROM PILOT TO MARKET
32. Thank you for your attention
Silvia Mancin
smancin@consorzioarsenal.it
www.renewinghealth.eu
Editor's Notes
The term PHS means both the wearable/portable devices used to monitoring some clinical parameters and the integrated telemedicine services for the remote data control.
The model is a part of the results from the MethoTelemed project. The MethoTelemed project is a bid for the SMART 2008/0064: Assesing the effectiveness of telemedicine applications Il MAST è stato elaborato da Danesi e Norvegesi.
Tele-health Service The patient at his home uses the provided devices for the measurement of of his clinical parameters (heart rate, blood pressue, 1-lead ECG, pulse-oxymetry and weight if he has heart failure, pulse-oxymetry and heart rate if he has COPD and blood glucose level if he has diabetes). T he telemonitoring devices, used by the patient, collects the data and send them to the gateway device wirelessly. The gateway device transmits data collected by the patient to the server of a Regional eHealth Centre, where a group of operators are in charge of data management. The Centre’s operator checks the data sent by the patient accessing them through the Home Care portal. In case of clinical parameters out of normal range, the telemonitoring software detects the alarm situation that the operator has to manage following the standard protocol. In case of alarm situation, the operator contacts the patient to verify the alarm. If the alarm is verified, according to its severity, the operator contacts the GP of that patient or the Emergency Department. For the proper management of the alarm situation, after the notification by the Centre’s operator, the GP accesses the Home Care Portal to check patient data and take the proper actions. Any time they need, not only in case of alarms, the GPs can access the Home Care portal to monitor the patients health conditions. Tele-care Service The patient, in case of emergency, uses the alarm device provided to trigger an alarm The alarm device sends the alarm signal to the gateway The gateway device transmits the alarm to the Regional eHealth Centre The Centre’s operator checks the alarms sent by the patient accessing them through the Home Care portal The operator manages the alarm situation first contacting the patient to verify the alarm. Second, if the alarm is verified and depending on its severity, the operator contacts the patient’ s family and the Emergency Departiment and/or the Social Service. T he Centre’s operators calls periodically the patients to monitor their life conditions and quality of life.
MAST – Model for ASsessment of Telemedicine New model for assessing the effectiveness and contribution to quality of care of telemedicine applications A multi-disciplinary process that summarizes and evaluates information about the medical, social, economic and ethica l issues related to the use of telemedicine in a systematic, unbiased and robust manner
Tolto ADI 59 pazienti Motivazioni per la mancata attivazione: decesso (2), Volontà del paziente o dei familiari di uscire dallo studio (5), Problemi tecnici per l'installazione delle apparecchiature (1), Ricorrenti cambi di domicilio (1) Motivazioni per il dropout: Intervento: Decesso (3), Controllo: Decesso(2) Volontà del paziente o dei familiari di uscire dallo studio*(2), Problemi tecnici per l’istallazione apparecchiature (1)
Motivazioni per la mancata attivazione: decesso (2), Volontà del paziente o dei familiari di uscire dallo studio (5), Problemi tecnici per l'installazione delle apparecchiature (1), Ricorrenti cambi di domicilio (1) Motivazioni per il dropout: Intervento: Decesso (2), Trasferimento del paziente in casa di riposo* (3) Controllo: Decesso(1) Volontà del paziente o dei familiari di uscire dallo studio*(3), Trasferimento del paziente in casa di riposo* (3) Problemi tecnici per l’istallazione apparecchiature (1)
MAST – Model for ASsessment of Telemedicine New model for assessing the effectiveness and contribution to quality of care of telemedicine applications A multi-disciplinary process that summarizes and evaluates information about the medical, social, economic and ethica l issues related to the use of telemedicine in a systematic, unbiased and robust manner
Il numero di ultra 65enni in Veneto, oggi più di 975 mila pari al 20% della popolazione, crescerà del 45% da qui a vent'anni, e la variazione prevista sale addirittura al 67% per la fascia di età dei molto anziani, ossia dagli 80 anni in poi. Destano attenzione alcuni importanti conseguenze sociali ed economiche del fenomeno dell'invecchiamento. I territori in calo demografico e in cui la popolazione è prevalentemente anziana dovranno rivedere l'offerta di beni e servizi pubblici di base come la salute, il trasporto e la proposta residenziale; senza contare i cambiamenti negli equilibri familiari e l'aumento di potenziali anziani soli. Dal punto di vista economico gli anziani rappresentano un segmento vulnerabile della popolazione. In Veneto il 16,5% degli anziani è a rischio di povertà, più della popolazione complessiva (9,7%); maggiormente esposte le donne anziane, che incontrano serie difficoltà economiche date le pensioni mediamente più basse: circa 1 su 5 è a rischio di povertà. Mediamente un anziano veneto vive con una pensione di 11.300 euro, neanche mille euro al mese, poco meno della situazione nazionale. Oltre alla questione previdenziale, l'invecchiamento sta richiamando l'attenzione sul tema della sostenibilità della spesa pubblica sanitaria, specie per l'assistenza di lungo periodo: se è vero che la vita media si allunga, è vero anche che nell'ultima parte della vita l'anziano non sarà autosufficiente, anzi il periodo compreso tra l'insorgere della non autosufficienza e il decesso è destinato nel tempo a dilatarsi. Ad esempio, in Veneto il 68% delle persone di oltre 75 anni è affetto da almeno due malattie croniche degenerative, mentre per le persone di età 65-74 anni la prevalenza della multi cronicità è del 46%. L'evoluzione della spesa sanitaria dipenderà quindi non solo dall'invecchiamento, ma anche dall'incidenza della disabilità tra gli anziani, dal disequilibrio tra cure formali e informali, oltre che dalla tipologia di servizi che il sistema intende mettere a disposizione: residenziale, semiresidenziale o domiciliare, di natura economica o in forma di servizi. In Veneto la rete assistenziale rivolta agli anziani non autosufficienti è frutto di politiche che negli anni hanno prodotto una molteplicità di interventi in relazione alla complessità del bisogno sociale e sanitario. Inoltre, considerando l'importanza di mantenere l'anziano nel proprio ambiente familiare, abitativo e sociale, l'orientamento delle politiche regionali sta assecondando la permanenza della persona anziana presso il proprio domicilio, riservando l'accoglienza residenziale alle persone non altrimenti assistibili. Nel 2010 il Fondo regionale per la non autosufficienza ammonta a oltre 704 milioni di euro, in aumento rispetto all'anno precedente del 3,5%. Anche se la maggior parte delle risorse è destinato alla residenzialità per gli anziani (65%), le politiche regionali hanno inteso potenziare negli anni più recenti il finanziamento della domiciliarità, che oggi copre il 13% delle risorse.