Transforming the patient experience with telehealth in Europe : "Applying Evidence-Based Medicine in Telehealth" George E. Dafoulas, MD, MBA in HSM, PhDc etrikala, Municipality of Trikala 5 th Regional Health Authority of Thessaly and Sterea, Greece
Table of Contents Overview of current status and need for Evidence Based Medicine in telehealth RENEWING HEALTH preliminary clinical outcomes from Central Greece UNITED4HEALTH: Transforming Renewing Health outcomes in everyday clinical practice.
Action 75: Give Europeans secure online access to their medical health data and achieve widespread telemedicine deployment Undertake pilot actions to equip Europeans with secure online access to their medical health data by 2015 and to achieve by 2020 widespread deployment of telemedicine services. What is the problem? Sustainability of healthcare systems is at stake Why is EU action needed? "Patients' empowerment and deployment of telemedicine services are key to ensuring the sustainability of healthcare systems. Telemedicine is also an promising tool to improve mental health, increase the social impact of public health intervention, provide efficient health support in remote areas, and to respond to the shortage of healthcare professionals and the lack of financial resources."
Telehealth services face important challenges regarding: legal framework and liability issues harmonization of diagnosis related groups that can be treated by telemedicine accreditation of health professionals who provide telemedicine applications interoperability issues cost effectiveness reimbursement for telemedicine services COM(2008)689 Final November 2008
Evidence-based clinical practice is an approach to decisionmaking in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best. Ref. : Gray JAM. 1997. Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone.
Where clinical evidence comes from? Ref. :Health Information Technology Knowledge Base, (2010)The USA Office of the National Coordinator for Health Information Technology (ONC)
Remote monitoring (no implanted device) The optimum approach to non-invasive remote monitoring is uncertain, and RCTs performed to date have given inconsistent results and do not yet support a guideline recommendation. Structured telephone support Although a meta-analysis of RCTs suggests that structured telephone support in addition to conventional care may reduce the risk of hospitalization in patients with HF, few individual RCTs showed this benefit, and the evidence is not robust enough to support a guideline recommendation.
Telemedicine Standards and Clinical Guidelines are required
Renewing Health www.renewinghealth.eu
CURRENT EVIDENCE: Telemedicine use for diabetes care is feasible and acceptable. Its effectiveness though on improving HbA 1c, reducing costs while maintaining HbA 1c levels and improving other aspects of diabetes management still needs to be proved. Comparison of changes in HbA 1c control vs. intervention Reference : A. Farmer O. J. Gibson A systematic review of telemedicine interventions to support blood glucose self monitoring in diabetes, Diabetic Medicine, Volume 22, Issue 10, pages 1372-1378, 12 MAY 2005
Renewing Health multicenter trial cluster 2 : LONG-TERM TELEMONITORING OF PATIENTS WITH TYPE 2 DIABETES MELLITUS Primary Outcome Measures: Health related quality of life of the patients measured by the SF-36 version 2 questionnaire [ Time Frame: 12 months minimum- at the entry point of the intervention and the end. ] Glycated hemoglobin (HbA1c) levels at the entry point and after a period of 12 months.
Renewing Health RCT in Thessaly outomes: HBA1c LEVELS (Decrease in score denotes improvement) mean HBA1c (%) 1 st month 12 th month CONTROL 8.62 (1.43) 7.77 (0.78) p=0.000 (Wilcoxon Test) INTERVENTION 8.55 (1.38) 7.14 (0.61) p=0.000 (Wilcoxon Test) 10 9 8 7 6 5 4 3 2 1 0 1st month 12th month Control Interventi on
Renewing Health RCT in Thessaly outcomes: Mean differences (SD) in HBA1c levels at 1 st and 12 month between control and intervention group (Decrease in score denotes improvement) Control Intervention ΔHBA1c 0.85 (1.08) 1.41 (1.27) p=0.001 (a) a= Mann-Whitney U
Renewing Health RCT in Thessaly outomes: The Effect on Quality of Life (SF36v2 Physical Component Scale) IN CONTROL AND INTERVENTION GROUP AT 1 ST AND 12 TH MONTH mean score 1 st month 12 th month 54 53 CONTROL 50.99 (6.12 ) 49.73 (5.08) 52 51 Control p= 0.001 (Wilcoxon Test) INTERVENTION 52.01 (4.34 ) 53.19 (2.97) p=0.053 Wilcoxon Test 50 49 48 1st month 12th month Interventi on (Range 0-100, increase in scores denotes improvement)
Renewing Health RCT in Thessaly outomes: The Effect on Quality of Life (SF36v2 Mental Component Scale) IN CONTROL AND INTERVENTION GROUP AT 1 ST AND 12 TH MONTH mean scores 1 st month 12 th month CONTROL 48.19 (10.17) 44.95 (8.90) p= 0,000 (Wilcoxon Test) INTERVENTION 50.04 (8.42 ) 53.50(6.54) p= 0,000 (Wilcoxon Test) (Range 0-100, increase in score denotes improvement) 56 54 52 50 48 46 44 42 40 1st month 12th month control intervention
Renewing Health RCT in Thessaly outcomes: Mean differences (SD) in SF36 scores at 1 st and 12 th month between control and intervention group (increase in score denotes improvement) Control Intervention ΔPSC -1.2604 (3.80336) +1.1778 (3.80386) p=0.000 (a) ΔMSC -3.2418 (6.55071) +3.4616 (6.80885) p=0.000 (a) a= Mann-Whitney U test
Renewing Health Diabetes type 2 RCT in Thessaly outcomes Preliminary Conclusions: Our preliminary results indicate that home telemonitoring is more effective in improving glycemic control and health related Quality of Life in DMT2 patients compared with the usual care. Usual care model needs to address the aspects related to the health related Quality of Life in DMT2 patients, and not only focus in improving glycemic control.
CURRENT EVIDENCE: Home telehealth interventions for COPD were similar or better than usual care for quality of life and patient satisfaction outcomes, but the available evidence is limited. REFERENCE: J Polisena et al. Home telehealth for COPD, Journal of Telemedicine and Telecare 2010; 16: 120 127
Renewing Health multicenter trial cluster 4 : TELEMEDICINE FOLLOW UP AFTER HOSPITAL DISCHARGE FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION RENEWING HEALTH Secondary Outcome Measure (analyzed): Health related quality of life of the patients as measured by the SF- 36 version 2 questionnaire (Time Frame: 3 months - at the entry point of the intervention and the end)
Renewing Health RCT in Thessaly outcomes: THE EFFECT ON QUALITY OF LIFE (SF36V2 PCS) IN CONTROL AND INTERVENTION GROUP AT DISCHARGE AND 3 RD MONTH. At discharge At three months CONTROL Mean 35.05 (5.94) Mean 36.80 (6.10) P= 0.104, Wilcoxon Test INTERVENTION Mean 35.61 (7.99) Mean 36.60 (8.04) p= 0.058, Wilcoxon Test Range 0-100 increased in score denotes improvement)
Renewing Health RCT in Thessaly outcomes: THE EFFECT ON QUALITY OF LIFE (SF36V2 MCS) IN CONTROL AND INTERVENTION GROUP AT DISCHARGE AND 3 RD MONTH. At discharge Αt three months CONTROL Mean 36.96 (10.97) Mean 39.89 (10.06) p = 0.038, Wilcoxon Test INTERVENTION Mean 40.58 (12.29) Mean 42.25 (14.90) p= 0.156, Wilcoxon Test 44 42 40 Range 0-100 38 increased in score denotes improvement) 36 34 control intervention at discharge at 3rd month
Renewing Health RCT in Thessaly outcomes: Mean differences in SF36 scores at baseline and three month data between control and intervention group Control Intervention 2.93 (8.74) 1.66 (13.11) MSC mean difference 95% CI -1.26 (-5.40 to 2.87) p=0.546(b) Control Intervention PSC 1.75 (6.78) 0.99 (5.99) p=0.849 (a) b = unpaired T test a= Mann-Whitney U
COPD Renewing Health RCT in Thessaly: Patient Flow Diagram Assessed for eligibility= 315 Enrolment Excluded N=160 Not meeting inclusion criteria N=134 Declined to participate= 26 Randomized N=155 Allocated to intervention=85 Received Intervention N=85 Allocated to Standard =70 Received Standard treatment (Control)=70 Follow-up Lost to follow-up N=2 Discontinued intervention N=6: 5 left the program because they were not interested or they couldn t handle the equipment 1 the doctor decided to be excluded because he was hospitalized with TB Lost to follow-up= 38 4 didn t come V 1, 19 didn t come V 2, 15 didn t come either V 1 or V 2 ) Analysis Analyzed N=83 Analyzed N=32
COPD Renewing Health RCT in Thessaly outcomes- preliminary conclusions: From the preliminary analysis of this pilot site trial no evidence was found that home telemonitoring improves health-related Quality of Life in patients discharged from hospital after an exacerbation of COPD. Telehealth of COPD could assist to better follow up of the patients, by increasing the access of the patients to the health care services.
From RCT to everyday clinical practice: From Renewing Health to UnitedforHealth Randomized controlled trials have specific inclusion and exclusion criteria that are often quite restrictive, whereas Observational Studies usually apply to a much broader population and are frequently even population-based. Thus, extrapolation to the entire population may be unwise. On the other hand, the results for all patients in the observational studies are of great interest because they reflect actual practice patterns and because they allow subset analyses that will speak to precisely which patients benefit from each treatment/intervention.
United4Health objectives: Collect and assess data at large scale from across many regions and institutions in Europe that can be aggregated at European level; thus providing data. Adapt clinically validated services from some regions and institutions in Europe (Renewing Health partners) in the local setting of a large number of other regions and institutions (United4Health partners). Maximize the transferability of services and knowledge among European healthcare providers at such large scale and in close collaboration.
RENEWING HEALTH and UNITED4HEALTH are partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community Funding Ministry of Health and Social Solidarity of Greece Prefecture of Thessaly Municipality of Trikala
Partners of UNITED4HEALTH and RENEWING HEALTH in Central Greece 1. The 5th Regional Health Authority of Thessaly and Sterea (Regional University Health Authority Hospital) 2. e-trikala SA, a company owned by the Municipality of Trikala (competence center) 3. Digital Cities of Central Greece SA (Cities Net SA) a company owned by the 10 Municipalities of the Digital Community of Central Greece
Thank you for your attention! Ευχαριστώ για την προσοχή σας! gdafoulas@e-trikala.gr