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

Abbott Medical Devices209 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

209

Conditions

Complication of Cardiac Defibrillator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

Azienda Ospedaliera S.Gerardo

Monza, Monza (MB), Italy

Casa di Cura Pederzoli

Peschiera del Garda, VR, Italy

Ospedale Careggi

Florence, Italy

Ospedale Luigi Sacco

Milan, Italy

Outcomes

Primary Outcomes

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.

Time frame: 12 months follow-up

Secondary Outcomes

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

Time frame: 1 year

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).

Time frame: baseline, 12 months

Data from ClinicalTrials.gov

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