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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01075516
• Collaborator: (none)
• Enrollment: 209
• Locations: 6
• Duration (Months): 40
• Patients Per Site: 34.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication of Cardiac Defibrillator

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 209 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: TARIFF Health Economics Evaluation Registry for Remote Follow up
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera S.Gerardo	Monza	Monza (MB)	Italy	20052
2	Casa di Cura Pederzoli	Peschiera del Garda	VR	Italy
3	Ospedale Careggi	Firenze		Italy
4	Ospedale Luigi Sacco	Milano		Italy
5	Ospedale Monaldi	Napoli		Italy
6	Ospedale San Filippo Neri	Roma		Italy	00135

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Massimo Santini, Prof., Ospedale San Filippo Neri, Roma, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01075516
• Other Study ID Numbers: CR 09 021 IT RC
• First Posted: Feb 25, 2010
• Last Update Posted: Mar 3, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Abbott Medical Devices: Remote Monitoring; ICD patients; EQ-5D questionnaire; remote follow up

Study Results

Participant Flow

Pre-assignment Detail	The sample size defined at least 100 pts per arm. The protocol allows few patients over in each of the 2 arms.

Arm/Group Title	Standard Follow Up	Remote Follow Up
Arm/Group Description	ICD patients followed through periodic in-hospital visits	ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Period Title: Overall Study
STARTED	107	102
COMPLETED	89	86
NOT COMPLETED	18	16

Baseline Characteristics

Arm/Group Title	Standard Follow-Up	Remote Follow-Up	Total
Arm/Group Description	Implantable cardioverter defibrillators (ICD) patients followed through periodic in-hospital visits	ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning	Total of all reporting groups
Overall Participants	107	102	209
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.9 (11.5)	69.7 (10.2)	69.3 (10.8)
Sex: Female, Male (Count of Participants)
Female	15 14%	16 15.7%	31 14.8%
Male	92 86%	86 84.3%	178 85.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Italy	107 100%	102 100%	209 100%
Implant Indication (Count of Participants)
Primary Prevention	83 77.6%	82 80.4%	165 78.9%
Secondary Precention	24 22.4%	20 19.6%	44 21.1%
New York Heart Association (NYHA) (participants) [Number]
I	25 23.4%	30 29.4%	55 26.3%
II	51 47.7%	33 32.4%	84 40.2%
III	28 26.2%	38 37.3%	66 31.6%
IV	3 2.8%	1 1%	4 1.9%
ejection fraction (EF)% (percentage of blood) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of blood]	32.2 (10.6)	31.8 (9.6)	32.0 (10.1)

Outcome Measures

1. Primary Outcome

Title	Economic Impact of Remote Monitoring on Hospitals and Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Follow Up	Remote Follow Up
Arm/Group Description	ICD patients followed through periodic in-hospital visits	ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Measure Participants	89	86
Mean (Standard Deviation) [Euro (€)]	1044.89 (1990.47)	482.87 (2488.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Follow Up, Remote Follow Up
	Comments
	Type of Statistical Test	Other
	Comments	Continuous data summarized as mean ± Standard Deviation (SD). For cost data Wilcoxon rank-sum test was used to compare costs across groups. The analysis evaluated HCS perspective of group membership impact (SC vs RM) on total health care cost, adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals)
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Follow Up	Remote Follow Up
Arm/Group Description	ICD patients followed through periodic in-hospital visits	ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Measure Participants	89	86
Mean (Standard Deviation) [Euro (€)]	886.67 (1979.13)	432.34 (2487.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Follow Up, Remote Follow Up
	Comments
	Type of Statistical Test	Other
	Comments	Continuous data are summarized as mean ± SD. For cost data the Wilcoxon rank-sum test was used to compare costs across groups. This analysis evaluated the impact of group membership (SC vs RM) on cardiovascular hospitalization timeframe (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Impact of Remote Monitoring on Patients' Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Standard Follow Up	Remote Follow Up
Arm/Group Description	ICD patients followed through periodic in-hospital visits	ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Measure Participants	87	79
Utility at baseline	0.8621 (0.1853)	0.8686 (0.1342)
Utility at 12 months	0.8463 (0.1846)	0.8703 (0.1618)
Quality Adjusted Life Years (Method 1)	0.8542 (0.1689)	0.8694 (0.1329)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Follow Up, Remote Follow Up
	Comments	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).
	Type of Statistical Test	Other
	Comments	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).
Statistical Test of Hypothesis	p-Value	0.80
	Comments	Comparison of utility at baseline from the EQ-5D-3L questionnaire.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Follow Up, Remote Follow Up
	Comments	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).
	Type of Statistical Test	Other
	Comments	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).
Statistical Test of Hypothesis	p-Value	0.38
	Comments	Comparison of utility at 12 months from the EQ-5D-3L questionnaire.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Standard Follow Up, Remote Follow Up
	Comments	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).
	Type of Statistical Test	Other
	Comments	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).
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Standard Follow Up		Remote Follow Up
Arm/Group Description	ICD patients followed through periodic in-hospital visits		ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
All Cause Mortality
	Standard Follow Up		Remote Follow Up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Follow Up		Remote Follow Up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/107 (19.6%)		34/102 (33.3%)
Cardiac disorders
Coronary Artery Disease	0/107 (0%)	0	1/102 (1%)	1
Heart Failure	8/107 (7.5%)	10	3/102 (2.9%)	3
General disorders
Cardiac Death	0/107 (0%)	0	3/102 (2.9%)	3
Death	2/107 (1.9%)	2	2/102 (2%)	2
Unknown cause of death	3/107 (2.8%)	3	4/102 (3.9%)	4
Immune system disorders
Colitis ulcerative	1/107 (0.9%)	1	0/102 (0%)	0
Infections and infestations
Infection	0/107 (0%)	0	1/102 (1%)	1
Injury, poisoning and procedural complications
Implant site infection	0/107 (0%)	0	1/102 (1%)	1
Pocket formation of decubitus	2/107 (1.9%)	2	2/102 (2%)	3
Subdural Hematoma	1/107 (0.9%)	1	0/102 (0%)	0
Musculoskeletal and connective tissue disorders
Motor disfunction	0/107 (0%)	0	1/102 (1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/107 (0%)	0	1/102 (1%)	1
Prostatic neoplasm	0/107 (0%)	0	1/102 (1%)	1
Renal Cancer	1/107 (0.9%)	1	1/102 (1%)	1
Nervous system disorders
Cerebrovascular accident	0/107 (0%)	0	1/102 (1%)	1
Ischemic stroke	0/107 (0%)	0	1/102 (1%)	1
Product Issues
Device inappropriate shock delivery	1/107 (0.9%)	1	3/102 (2.9%)	4
Device stimulation issue	0/107 (0%)	0	1/102 (1%)	1
Lead dislodgement	3/107 (2.8%)	3	6/102 (5.9%)	11
Device malfunction	1/107 (0.9%)	1	0/102 (0%)	0
Renal and urinary disorders
Renal failure	0/107 (0%)	0	1/102 (1%)	1
Surgical and medical procedures
Cardiac pacemaker insertion	0/107 (0%)	0	2/102 (2%)	2
Cardioversion	3/107 (2.8%)	3	2/102 (2%)	2
Hospitalization	2/107 (1.9%)	2	4/102 (3.9%)	5
Medical device repositioning	0/107 (0%)	0	1/102 (1%)	1
Mitral Valve replacement	0/107 (0%)	0	1/102 (1%)	1
Cardiovascular event prophylaxis	1/107 (0.9%)	1	0/102 (0%)	0
Vascular disorders
Aortic Aneurysm	0/107 (0%)	0	1/102 (1%)	1
Arterial disorder	1/107 (0.9%)	1	0/102 (0%)	0
Peripheral ischemia	3/107 (2.8%)	3	0/102 (0%)	0
Syncope	0/107 (0%)	0	1/102 (1%)	1
Hemorrage	0/107 (0%)	0	1/102 (1%)	1
Other (Not Including Serious) Adverse Events
	Standard Follow Up		Remote Follow Up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/107 (16.8%)		18/102 (17.6%)
Cardiac disorders
Atrial fibrillation	1/107 (0.9%)	1	0/102 (0%)	0
Heart Failure	3/107 (2.8%)	3	1/102 (1%)	1
Ventricular tachycardia	1/107 (0.9%)	1	0/102 (0%)	0
Eye disorders
Eye symptoms	2/107 (1.9%)	3	0/102 (0%)	0
Injury, poisoning and procedural complications
Fall	1/107 (0.9%)	1	0/102 (0%)	0
Investigations
Blood pressure dicreased	0/107 (0%)	0	1/102 (1%)	1
Product Issues
Device capturing issue	0/107 (0%)	0	2/102 (2%)	2
Device electrical impedence issue	0/107 (0%)	0	1/102 (1%)	1
Device inappropriate shock delivery	3/107 (2.8%)	4	0/102 (0%)	0
Device malfunction	1/107 (0.9%)	1	1/102 (1%)	1
Device pacing issue	4/107 (3.7%)	6	5/102 (4.9%)	5
Device stimulation issue	2/107 (1.9%)	4	2/102 (2%)	2
Device telemetry issue	0/107 (0%)	0	5/102 (4.9%)	5
Oversensing	2/107 (1.9%)	2	1/102 (1%)	1
Undersensing	0/107 (0%)	0	1/102 (1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.