Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients

Complication of Cardiac Defibrillator Clinical Trial

— TARIFF  

Official title:

TARIFF Health Economics Evaluation Registry for Remote Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075516
• Other study ID #: CR 09 021 IT RC
• Status: Completed
• Start date: December 2009
• Est. completion date: April 2013

Study information

• Verified date: March 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: April 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients already implanted with ICD

• Patients able to be followed in the same centre during all the study

• Patients with age > 18

• Patients able to understand and to answer to EuroQoL Group 5-Dimension (EQ-5D) Questionnaire

Exclusion Criteria:

• Patients pregnant

• Patients unable to connect Merlin@home transmitters with Website Merlin.net (i.e.without telephonic analogic line or Global System for Mobile Communication (GSM)/Universal Mode Telecommunication System (UMTS) connection)

Related Conditions & MeSH terms

• Complication of Cardiac Defibrillator

Locations

Country	Name	City	State
Italy	Ospedale Careggi	Firenze
Italy	Ospedale Luigi Sacco	Milano
Italy	Azienda Ospedaliera S.Gerardo	Monza	Monza (MB)
Italy	Ospedale Monaldi	Napoli
Italy	Casa di Cura Pederzoli	Peschiera del Garda	VR
Italy	Ospedale San Filippo Neri	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. Epub 2007 Apr 10. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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: dem — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months follow-up
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	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).	baseline, 12 months