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The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims of the study are to develop a hospital cost minimization analysis and a cost effectiveness analysis based on direct estimation of costs and quality of life deriving from remote follow-up (performed with Merlin@home and Merlin.net) compared to standard follow-up in the management of ICD implanted patients.
TARIFF is a prospective observational study aimed to measure direct, indirect costs and quality of life of all participants for the duration of the observational timeframe. Purpose of cost collecting is to include a complete set of medical services and productivity loses that could be directly affected by the different clinical Follow-Up (FU) pathway. The study consists of 2 phases: firstly standard follow up costs will be collected for 100 pts, then all costs associated to remote follow ups will be collected for other 100 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Follow Up | ICD patients followed through periodic in-hospital visits | ||
| Remote Follow Up | ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning |
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| Measure | Description | Time Frame |
|---|---|---|
| Economic Impact of Remote Monitoring on Hospitals and Patients | Costs analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective. | 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) | Comparison of Cardiovascular Hospitalizations costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow-up | 1 year |
| Impact of Remote Monitoring on Patients' Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Santini, Prof. | Ospedale San Filippo Neri, Roma, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera S.Gerardo | Monza | Monza (MB) | 20052 | Italy | ||
| Casa di Cura Pederzoli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18551743 | Background | Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE; Heart Rhythm Society; European Heart Rhythm Association; American College of Cardiology; American Heart Association; European Society of Cardiology; Heart Failure Association of ESC; Heart Failure Society of America. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm. 2008 Jun;5(6):907-25. doi: 10.1016/j.hrthm.2008.04.013. No abstract available. | |
| 19560096 |
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The sample size defined at least 100 pts per arm. The protocol allows few patients over in each of the 2 arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Follow Up | ICD patients followed through periodic in-hospital visits |
| FG001 | Remote Follow Up | ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Follow-Up | Implantable cardioverter defibrillators (ICD) patients followed through periodic in-hospital visits |
| BG001 | Remote Follow-Up | ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Economic Impact of Remote Monitoring on Hospitals and Patients | Costs analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective. | Posted | Mean | Standard Deviation | Euro (€) | 12 months follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Follow Up | ICD patients followed through periodic in-hospital visits |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Renato P. Ricci | Department of Cardiology, San Filippo Neri Hospital - Rome | renatopietroricci@tin.it |
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Evaluation of patient quality of life through Quality of Life (EQ-5D) questionnaire during follow up with/without using Merlin@Home system. Utility (patients' preferences) and Quality-adjusted life-year (QALY) scales were used. QALYs were based on utility, the EuroQoL EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (both ranges from 0 to 1). High score means better outcomes. One quality-adjusted life-year (QALY) is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). |
| baseline, 12 months |
| Peschiera del Garda |
| VR |
| Italy |
| Ospedale Careggi | Florence | Italy |
| Ospedale Luigi Sacco | Milan | Italy |
| Ospedale Monaldi | Naples | Italy |
| Ospedale San Filippo Neri | Roma | 00135 | Italy |
| Background |
| Morichelli L, Ricci RP. Remote monitoring of implantable devices: the European experience. Heart Rhythm. 2009 Jul;6(7):1077-80. doi: 10.1016/j.hrthm.2009.02.030. Epub 2009 Feb 24. No abstract available. |
| 19011260 | Background | Ricci RP, Morichelli L, Santini M. Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace. 2009 Jan;11(1):54-61. doi: 10.1093/europace/eun303. Epub 2008 Nov 16. |
| 18811805 | Background | Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x. |
| 18199570 | Background | Ricci RP, Morichelli L, Santini M. Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization. Europace. 2008 Feb;10(2):164-70. doi: 10.1093/europace/eum289. Epub 2008 Jan 16. |
| 18817497 | Background | Seto E. Cost comparison between telemonitoring and usual care of heart failure: a systematic review. Telemed J E Health. 2008 Sep;14(7):679-86. doi: 10.1089/tmj.2007.0114. |
| 17426062 | Background | Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10. |
| 18181908 | Background | Lunati M, Gasparini M, Santini M, Landolina M, Perego GB, Pappone C, Marzegalli M, Argiolas C, Murthy A, Valsecchi S; InSync ICD Italian Registry Investigators. Follow-up of CRT-ICD: implications for the use of remote follow-up systems. Data from the InSync ICD Italian Registry. Pacing Clin Electrophysiol. 2008 Jan;31(1):38-46. doi: 10.1111/j.1540-8159.2007.00923.x. |
| 22544910 | Background | Ricci RP, D'Onofrio A, Padeletti L, Sagone A, Vicentini A, Vincenti A, Morichelli L, Cavallaro C, Ricciardi G, Lombardi L, Fusco A, Rovaris G, Silvestri P, Guidotto T, Pollastrelli A, Santini M. Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF. Europace. 2012 Nov;14(11):1661-5. doi: 10.1093/europace/eus093. Epub 2012 Apr 27. |
| 24057266 | Result | Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Vincenti A, Padeletti L, Morichelli L, Fusco A, Vecchione F, Lo Presti F, Denaro A, Pollastrelli A, Santini M. Impact of in-clinic follow-up visits in patients with implantable cardioverter defibrillators: demographic and socioeconomic analysis of the TARIFF study population. J Interv Card Electrophysiol. 2013 Nov;38(2):101-6. doi: 10.1007/s10840-013-9823-5. Epub 2013 Sep 21. |
| 27614025 | Result | Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Rovaris G, Padeletti L, Morichelli L, Fusco A, De Vivo S, Lombardi L, Denaro A, Pollastrelli A, Colangelo I, Santini M. Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study. Heart Rhythm. 2017 Jan;14(1):50-57. doi: 10.1016/j.hrthm.2016.09.008. Epub 2016 Sep 8. |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All Subjects enrolled in Italian centers. Number of subjects | Number | participants |
|
| Implant Indication | Count of Participants | Participants |
|
| New York Heart Association (NYHA) | Count of participants in each grade. "NYHA Functional Class provides a classification of heart failure based on symptomatic limitations to activities of daily living and ranges from NYHA Functional Class I to IV: NYHA Functional Class I is defined as no limitations in physical activity and NYHA Functional Class IV is defined as the presence of heart failure symptoms resulting in inability to carry out any physical activity without discomfort | Number | participants |
|
| ejection fraction (EF)% | EF% is an Echo derived measurements in percentage | Mean | Standard Deviation | percentage of blood |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) | Comparison of Cardiovascular Hospitalizations costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow-up | Posted | Mean | Standard Deviation | Euro (€) | 1 year |
|
|
|
|
| Secondary | Impact of Remote Monitoring on Patients' Quality of Life | Evaluation of patient quality of life through Quality of Life (EQ-5D) questionnaire during follow up with/without using Merlin@Home system. Utility (patients' preferences) and Quality-adjusted life-year (QALY) scales were used. QALYs were based on utility, the EuroQoL EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (both ranges from 0 to 1). High score means better outcomes. One quality-adjusted life-year (QALY) is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). | The clinical benefit for patients were evaluated through EQ-5D questionnaire. The results of the questionnaire were used to measure the quality-adjusted life years (QALY). It was considered costs and EQ-5D values only for the patients alive who completed the questionnaires (87 SC and 79 RM). | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 months |
|
|
|
|
| 21 |
| 107 |
| 18 |
| 107 |
| EG001 | Remote Follow Up | ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning | 34 | 102 | 18 | 102 |
| Heart Failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac Death | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Unknown cause of death | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Implant site infection | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Pocket formation of decubitus | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Subdural Hematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Prostatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ischemic stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Device inappropriate shock delivery | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Device stimulation issue | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Lead dislodgement | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Medical device repositioning | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Mitral Valve replacement | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arterial disorder | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Syncope | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiovascular event prophylaxis | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Device malfunction | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Motor disfunction | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Colitis ulcerative | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hemorrage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eye symptoms | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blood pressure dicreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Device capturing issue | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Device electrical impedence issue | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Device inappropriate shock delivery | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Device malfunction | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Device pacing issue | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Device stimulation issue | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Device telemetry issue | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Oversensing | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
| Undersensing | Product Issues | MedDRA (10.0) | Systematic Assessment |
|
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| Quality Adjusted Life Years (Method 1) |
|
Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).
| For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1). | t-test, 2 sided | 0.38 | Comparison of utility at 12 months from the EQ-5D-3L questionnaire. | Other | Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals). |
| For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1). | t-test, 2 sided | 0.53 | Other | Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals). |