European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco) (EuroEco)
BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient FU and cost-savings for the health care payer.
The EuroEco study:
- Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic consultations and regular check ups of the patient/ICD/CRT-D data received through the HM service.
- Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU.
- Compares the indicators of patients' safety between the two FU models.
|Ventricular Fibrillation Tachycardia, Ventricular Ventricular Flutter||Device: Home Monitoring provided by Biotronik ICD and CRT-D devices Device: No Home Monitoring||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)|
- Euro spent to follow up ICD and CRT-D patients [ Time Frame: 26 months ]
- Average number of in-hospital follow-up visits per patient [ Time Frame: 26 months ]
- Time to first in-hospital follow-up visit beyond the first post-implantation visit [ Time Frame: 12 months ]
- Effective financial impact on hospitals / physicians [ Time Frame: 26 months ]
- Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions) [ Time Frame: 26 months ]
- Proportion of patients with HM-triggered interventions that, without remote monitoring, would have first been discovered at a subsequent scheduled follow-up [ Time Frame: 26 months ]
- Incidence of inappropriate ICD shocks [ Time Frame: 26 months ]
- Changes in quality-of-life (SF-36) from baseline to the 12- and to 24-month follow-up visits [ Time Frame: 26 months ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: 1 = Home Monitoring
Remote monitoring of ICD and CRT-D function and patient status
Device: Home Monitoring provided by Biotronik ICD and CRT-D devices
Remote monitoring of ICD and CRT-D function and patient status may result in more effective follow-up and increased patient safety
Active Comparator: 2 = No Home Monitoring
Home Monitoring option is switched off
Device: No Home Monitoring
Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).
The EuroEco is a prospective, international, randomized study aimed at assessing the economic effects of BIOTRONIK Home Monitoring (HM) technology as compared with traditional follow up (FU) of ICD and CRT-D patients from two perspectives: 1) the cost-effectiveness for the payer of health care, and 2) the economic impact on the physician, hospital and patient. The study outlines a new model for the FU of ICD-and CRT-D patients based on a combination of in-clinic consultations and regular check ups of the patient data received through the HM service.
About 312 patients with an indication for ICD therapy and 104 patients with an indication for de novo CRT-D implantation should be enrolled. All patients will be implanted with BIOTRONIK ICD or CRT-D devices from the Lumax families and randomized (1:1) to the traditional, or to HM-based FU model. Traditional FU will be performed according to the local clinical practice. Patients in the HM study arm will first undergo local clinical FU routine until the first in-clinic visit after patient discharge. Thereafter routine in-clinic FUs are scheduled at 12 and 24 months. Three HM data checks should be carried out during each 12-month interval, to assess the patient/ICD/CRT-D status remotely.
In both (HM and no HM) groups, additional in-hospital FU may be scheduled any time the patients reports symptoms which are presumed to be cardiovascular symptoms. In the HM group, additional in-clinic FU may also be scheduled as a result of specific HM findings.
The following FU-related activities were accounted for: in-clinic consultations, patients contact, discussion with colleague physician, nurse or technician and arranging in clinic consultation. In HM patients, two additional HM-related FU activities were taken into account: 1) checking the website of BIOTRONIK HM Service Center, and 2) checking HM-related emails and faxes (provided by BIOTRONIK HM Service Center)..
Several tools were made available to document the time that physicians, nurses and technicians spend with these FU activities without disrupting their clinical routine much:
- designated case report forms
- a web-based time measurements software.
A user manual for time measurements was handed out to physicians, nurses and technicians to recommend which tool should be used in which clinical situation. The average time per patient followed according to the traditional FU model and the average time per patient followed by the HM-based FU model will be calculated for each of the three health care professionals considered (physicians, nurses and technicians). The difference in costs between the traditional and the HM-based FU will be assessed for statistical significance.
This trial may provide data warranting a change in the guidelines for the use of ICD and CRT-D devices featuring HM function, in that HM may justify a prolongation of the time interval between statutory routine in-clinic FU visits. Coupled with the fact that the information provided by HM helps physicians to recognize some otherwise unsuspected needs for additional FU visits, this may ultimately result in better and more cost-effective health care for all parts involved (patients, providers and payers).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776087
|Contact: Sascha Mrosk||+49 (0) 30 68905 ext firstname.lastname@example.org|
|Contact: Jochen Proff||+49 (0) 151 1631 ext email@example.com|
|Heart Rhythm Management Institute, Free University of Brussels||Terminated|
|Ziekenhuis Oost Limburg, Campus St. Jan||Recruiting|
|Principal Investigator: Maximo Rivero-Ayerza, Dr.|
|Jessa Ziekenhuis (Campus Virga Jesse)||Recruiting|
|Principal Investigator: Johan Vijgen, Dr.|
|Principal Investigator: Hein Heidbüchel, Prof. Dr.|
|University of Oulu||Active, not recruiting|
|Oulu, Finland, 90014|
|Helios Klinikum Aue||Recruiting|
|Aue, Germany, 08280|
|Principal Investigator: Klaus Malinowski, MD|
|Charité Berlin Campus Mitte||Recruiting|
|Berlin, Germany, 10117|
|Principal Investigator: Andrea Marek, Dr. med.|
|Städt. Klinikum St. Georg gGmbH||Active, not recruiting|
|Leipzig, Germany, 04129|
|Herzzentrum Leipzig, Abteilung Rhythmologie||Recruiting|
|Principal Investigator: Gerhard Hindricks, Prof. Dr. med.|
|Leiden Universitair Medisch Centrum||Recruiting|
|Leiden, Netherlands, 2333|
|Principal Investigator: Liselot van Erven, Dr.|
|Hospital Universitario La Paz||Active, not recruiting|
|La Paz, Spain|
|Hospital Universitario Puerta de Hierro Majadahonda||Active, not recruiting|
|Hospital Ntra.Sra.de la Candelaria||Recruiting|
|Principal Investigator: Rafael Romero, Dr.|
|Arrythmia Unit, Complejo Hospitalario de Vigo (Hospital Xeral)||Recruiting|
|Principal Investigator: Julio Beiras Torrado, Dr.|
|Cardiology, Aberdeen Royal Infirmary||Active, not recruiting|
|Aberdeen, United Kingdom|
|Cardiology, St. Peters Hospital/St. George's||Active, not recruiting|
|Chertsey, United Kingdom|
|Cardiology; Raigmore Hospital||Active, not recruiting|
|Inverness, United Kingdom|
|Study Chair:||Hein Heidbüchel, Prof. Dr.||ZU Gasthuisberg, Leuven, Belgium|