Complication of Cardiac Defibrillator
Conditions
Keywords
Remote Monitoring, ICD patients, EQ-5D questionnaire, remote follow up
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Economic Impact of Remote Monitoring on Hospitals and Patients | 12 months follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) | 1 year | 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 |
| Impact of Remote Monitoring on Patients' Quality of Life | baseline, 12 months | 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). |
Countries
Italy
Participant flow
Pre-assignment details
The sample size defined at least 100 pts per arm. The protocol allows few patients over in each of the 2 arms.
Participants by arm
| Arm | Count |
|---|---|
| Standard Follow-Up Implantable cardioverter defibrillators (ICD) patients followed through periodic in-hospital visits | 107 |
| Remote Follow-Up ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning | 102 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 9 |
| Overall Study | Lost to Follow-up | 10 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Standard Follow-Up | Remote Follow-Up | Total |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 11.5 | 69.7 years STANDARD_DEVIATION 10.2 | 69.3 years STANDARD_DEVIATION 10.8 |
| ejection fraction (EF)% | 32.2 percentage of blood STANDARD_DEVIATION 10.6 | 31.8 percentage of blood STANDARD_DEVIATION 9.6 | 32.0 percentage of blood STANDARD_DEVIATION 10.1 |
| Implant Indication Primary Prevention | 83 Participants | 82 Participants | 165 Participants |
| Implant Indication Secondary Precention | 24 Participants | 20 Participants | 44 Participants |
| New York Heart Association (NYHA) I | 25 participants | 30 participants | 55 participants |
| New York Heart Association (NYHA) II | 51 participants | 33 participants | 84 participants |
| New York Heart Association (NYHA) III | 28 participants | 38 participants | 66 participants |
| New York Heart Association (NYHA) IV | 3 participants | 1 participants | 4 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Italy | 107 participants | 102 participants | 209 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 92 Participants | 86 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 107 | 18 / 102 |
| serious Total, serious adverse events | 21 / 107 | 34 / 102 |
Outcome results
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.
Time frame: 12 months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Follow Up | Economic Impact of Remote Monitoring on Hospitals and Patients | 1044.89 Euro (€) | Standard Deviation 1990.47 |
| Remote Follow Up | Economic Impact of Remote Monitoring on Hospitals and Patients | 482.87 Euro (€) | Standard Deviation 2488.1 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
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).
Time frame: baseline, 12 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Follow Up | Impact of Remote Monitoring on Patients' Quality of Life | Utility at baseline | 0.8621 score on a scale | Standard Deviation 0.1853 |
| Standard Follow Up | Impact of Remote Monitoring on Patients' Quality of Life | Utility at 12 months | 0.8463 score on a scale | Standard Deviation 0.1846 |
| Standard Follow Up | Impact of Remote Monitoring on Patients' Quality of Life | Quality Adjusted Life Years (Method 1) | 0.8542 score on a scale | Standard Deviation 0.1689 |
| Remote Follow Up | Impact of Remote Monitoring on Patients' Quality of Life | Utility at baseline | 0.8686 score on a scale | Standard Deviation 0.1342 |
| Remote Follow Up | Impact of Remote Monitoring on Patients' Quality of Life | Utility at 12 months | 0.8703 score on a scale | Standard Deviation 0.1618 |
| Remote Follow Up | Impact of Remote Monitoring on Patients' Quality of Life | Quality Adjusted Life Years (Method 1) | 0.8694 score on a scale | Standard Deviation 0.1329 |
Comparison: 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 EuroQoL Group 5-Dimension 3-Level Self-Report (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).p-value: 0.8t-test, 2 sided
Comparison: 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).p-value: 0.38t-test, 2 sided
Comparison: 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).p-value: 0.53t-test, 2 sided
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
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Follow Up | Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) | 886.67 Euro (€) | Standard Deviation 1979.13 |
| Remote Follow Up | Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) | 432.34 Euro (€) | Standard Deviation 2487.86 |
p-value: 0.003Wilcoxon (Mann-Whitney)