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MAST and its application in RENEWING HEALTH
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    MAST and its application in RENEWING HEALTH MAST and its application in RENEWING HEALTH Presentation Transcript

    • MAST: the Model for Assessmentof Telemedicineand its application in theRENEWING HEALTH ProjectANNA KOTZEVA, on behalf of the MAST Working groupCatalan Agency for Health Information, Assessment and Quality, SpainMADoPA Seminar, June 2012, Paris
    • Contents Why do we need a global evaluation framework? How does MAST ensure such multidisciplinary assessment?Application of MAST in the RENEWING HEALTH project1. Project overview2. Outcomes assessed3. MAST tools to support study design, reporting and analysis2
    • Why do we needa global evaluation framework?
    • How does MAST ensure amultidisciplinary assessment?
    • Comprehensive development MethoTelemed project, financed by the EC (SMART 2008/0064) Based on:MAST(Manual & Toolkit)
    • Assessment defined as: A multidisciplinary process that summarizes and evaluatesinformation about the clinical, economic, organizational andsocio-ethical issues related to the use of telemedicine, in asystematic, unbiased and robust manner.Approach
    • The framework suggests 3 stages of assessment:I. Preceding considerationsII. Multidisciplinary AssessmentIII. Transferability of resultsStages and elements
    •  This stage is about “setting the context” Various aspects have to be taken into consideration, such as: Maturity of the technology used Selection of appropriate comparator/s Level, on which the assessment should be carried out – singlehospital, region, state Existing legislation on TM-based services ….I. Preceding considerations
    • WHAT should be assessed?1. Health problem and characteristics of the application2. Clinical effectiveness3. Safety4. Patient perspectives5. Economic aspects6. Organisational aspects7. Socio-cultural, ethical and legal aspectsII. Multidisciplinary assessmentDescriptiveDescriptiveEvaluation by outcome(systematic review ORempirical study)DOMAINS
    • HOW it should be assessed? Study design - Aim for highest possible level of evidence Outcome measures should be:• patient-important outcomes• based on scientific literature to enable comparison• validated instrumentsII. Multidisciplinary assessment
    •  Answers the question:Can results be generalized to other settings?This consideration has to be made within each of the domains! Examples of limitations for direct transferability of results: Country-specific reimbursement conditions Healthcare price/hour Values and culture influence user preferences and hence, satisfactionwith the new serviceIII. Transferability assessment?
    • Application of MASTin the RENEWING HEALTH project Project overview Outcomes assessed(based on MAST and adapted to each clinical conditionand to the specific context) MAST tools to support design, reporting and analysis(ensure quality and comparability)
    • Application of MASTin the RENEWING HEALTH project Project overview Outcomes assessed(based on MAST and adapted to each clinical conditionand to the specific context) MAST tools to support design, reporting and analysis(ensure quality and comparability)
    • RENEWING HEALTH is the largest pragmaticrandomized clinical trial in the area of telemedicine7158 patients84 centers21 pilots10 clusters3 diseases1 observ.9 RCTsDMCOPDCVDDM: Diabetes mellitus; COPD: Chronic Obstructive Pulmonary Disease; CVD: Cardio-vascular Disease
    • Cluster 4 COPDShort-term follow-up afterhospital dischargeCluster 3 DiabetesUlcer monitoring9 European regions involvedCluster 1 DiabetesMedium-term health coachingand life-long monitoringCluster 2 DiabetesLife-long monitoringCluster 5 COPDLife-longmonitoringCluster 6 CVDMedium-term healthcoaching and life-longmonitoringCluster 7 CVDRemote monitoring ofCongestive Heart FailureCluster 8 CVDRemote monitoring ofimplantable cardiacdevicesCluster 9/10 MultipathologyMonitoring of frail patientswith chronic diseasesCluster 10/11 CVDMedium-term healthcoaching and life-longmonitoring in CVD withhigh blood pressure
    • General objective:To produce high level evidence and decision support for EUhealth policies and regional authorities regarding the futuredeployment of Telemedicine services in those fields where theycan lead to improved care and reduced cost.18
    • COPD (cluster 4 - Catalonia)Data transmissionData accessGeneral PractitionerHospital & EPRHospital (Hospital Clínic & Hospital Mataró)Patient’s situation (at home)PatientVideoconference System & PatientPortalTelemonitoringdevicesClinical PatientManagement SystemNurseHospitalvideointerfaceInterface &GatewayCase ManagerNurseHospitalSpecialistCall Centre &Health coach
    • Telemedicine services have been piloted in many clinical areas in thelast 2 decades, but not always have been integrated into practiceMoreover, clinical outcomes of telemedicine on diabetes, COPD and CVDhave been measured in numerous trials internationally. And soon theresults of Whole System Demonstrator program will be availableRENEWING HEALTH Project is not envisioned to produce scientificevidence on clinical outcomes of telehealth, BUTa broader knowledge on benefits of telemedicine services through anumber of multidisciplinary outcomes
    • Application of MASTin the RENEWING HEALTH project Project overview Outcomes assessed(based on MAST and adapted to each clinical conditionand to the specific context) MAST tools to support design, reporting and analysis(ensure quality and comparability)
    • Clinical Health-related quality of lifeimprovement measured via SF-36v2® Mental health statusmeasured via Hospital Anxiety and Depression Scale (HADS) Other specific clinical outcomesfor ex. FEV1 in COPDFEV1: Forced Expiratory Volume in the 1st second; COPD: Chronic Obstructive Pulmonary Disease;
    • Assessed through a common questionnaireService User Technology Acceptability Questionnaire (SUTAQ)• self-administered, generic, especially designed for telehealth and telecare users• 22-items organized in 6 domains, Likert response scale• During the Whole System Demonstrators program in UK was submitted to 3500patients• In RH, translated and validated*into 10 European languages• Pilots in RH and WSD can be compared*Collaboration Agreement with UCL, Prof. Stan NewmanIncreasedaccessibilityPrivacy &DiscomfortSubstitutionto usual careSatisfactionCarepersonnelconcernsEnhancedcare□ □ □ □ □ □STRONGLYAGREEMODERATELYAGREEMILDLYAGREEMILDLYDISAGREEMODERATELYDISAGREESTRONGLYDISAGREEUser perspective - patient
    • User perspective - professionalAssessed using qualitative research methods (sub-study) Semi-structured interviews, focus groups Themes investigated: Expectations Experiences Satisfaction with the new service Change in roles in terms of responsibilities and tasks(nurse, physician) Perceived impact on patient-professional communication
    • EconomicFocus on reduction in healthcare cost due to: Progressive shift from hospital to primary, community andhomecare Increasing role of patients and informal caregivers in the careprocessCost of investments in the telemedicine applicationRunning costs of delivering telemedicine service and the comparator (patientlevel)- Time used by the staff- Time used by the patient- Use of utensils, devices etc.Each patients use of health care service (patient level)- Number of admissions- Number of bed days- Number of GP visits- Number of visits to emergency departmentReimbursement of the telemedicine service (business case)
    •  Impact on PROCESSES Workflow: Effects on number of patients treated, procedures performed etc. Staff: Changes in distribution of work (task shifting) Resources: Changes in working hours for each profession Training: Time spent on training to learn to use the application Internal communication External communication Impact on STRUCTURE Description and number of units collaborating in the production of the service Changes in organisation of generalist and specialist tasks Changes in geographical spread Changes in time spent on travel Impact on CULTURE Staff attitudes towards the application Staff experiences with the use of the applicationData used from:- economic data- description of intervention- interviews with staffOrganizational
    • Application of MASTin the RENEWING HEALTH project Project overview Outcomes assessed(based on MAST and adapted to each clinical conditionand to the specific context) MAST tools to support design, reporting and analysis(ensure quality and comparability)
    • Application of MAST in practice stimulates its furtherdevelopment and improvementA number of common templates were developed as atool to ensure the quality of the data and the analysis: Minimum dataset of common outcome measures Common template for Case Report Form (CRF) Guidance on coding and monitoring of collected data Guidance on data analysis and reporting of results within eachdomain
    • 1• Minimum dataset of COMMONOUTCOMES2• Compatible databases withCOMMON CODING OF VARIABLES3• Monthly monitoring of dataquality for each pilotAgreement among pilotsEnsures quality and comparability of data
    • Common plan for analysis and reportingGuide for analysis and reporting of results within each domain:1. Health problem and characteristics of the application2. Safety (adverse effects)3. Clinical effectiveness4. Patient perspectives5. Economic aspects6. Organisational aspects7. Socio-cultural, ethical and legal aspectsBased on CONSORT recommendations*Based on validation studies by WSDBased on guide by Drummond et al 2005Based on HTA Handbook (2007)*CONSORT for pragmatic trials Zwarenstein et al. (2008)
    • Example for COPD1. Health problem and characteristics of the application2. Safety3. Clinical effectiveness4. Patient perspectives5. Economic aspects6. Organisational aspects7. Socio-cultural, ethical and legal aspects• Disease description(epidemiology)• Description of thetechnology used(videoconference)Cost-effectiveness analysis, business caseInterviews with all professionals involvedRegister of adverse eventsFEV1, Quality of life, Mental healthNumber of readmissions (PRIMARY OUTCOME)Questionnaire SUTAQ (satisfaction, acceptability)Synthesis and description of the regulatoryframework in Catalonia
    • Advantages and limitations Advantages of MAST Multidisciplinary and very comprehensive Based on scientific evidence, on criteria for quality and onstakeholders’ needs Establishes a common standard for all stages of study development(design, data collection, analysis and reporting) Limitations of MAST Time consuming Only relevant in assessment of mature telemedicine applications Doesn’t give indications for prioritization when resources are limited More operational criteria are neededMAST 2.0ON THE WAY TO
    • By validating MAST in 21 different settings,RENEWING HEALTH has given huge boost to establishthe first widely accepted methodology for theevaluation of complex telemedicine interventions.In conclusion…
    • www.renewinghealth.euThank you!Anna Kotzevaakotzeva@gencat.cat