TY - JOUR
T1 - RELEASE-HF study
T2 - a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands
AU - van Eijk, Jorna
AU - Luijken, Kim
AU - Jaarsma, Tiny
AU - Reitsma, Johannes B.
AU - Schuit, Ewoud
AU - Frederix, Geert W. J.
AU - Derks, Lineke
AU - Schaap, Jeroen
AU - Rutten, Frans H.
AU - Brugts, Jasper
AU - de Boer, Rudolf A.
AU - Asselbergs, Folkert W.
AU - Trappenburg, Jaap C. A.
AU - RELEASE-HF Investigators
AU - Borleffs, C. Jan Willem
AU - van Dalen, Dirk H.
AU - Erol-Yilmaz, Ayten
AU - Handoko, M. Louis
AU - van Hout, Gerardus P. J.
AU - Houtgraaf, Jaco
AU - Jansen Klomp, Wouter W.
AU - Koudstaal, Stefan
AU - Linssen, Gerard C. M.
AU - van der Meer, Manon G.
AU - Post, Marco C.
AU - Sanders-van Wijk, Sandra
AU - Wierda, Eric
AU - Wouters, Stijn C. W.
N1 - Funding Information: JB received an independent research grant from Abbott for ISS paid to institution, and has had speaker engagements or advisory boards for AstraZeneca, Abbott, Bayer, Boehringer, Daiichi Sankyo, Novartis and Vifor in the past 5 years. RAdB has received research grants and/or fees from AstraZeneca, Abbott, Boehringer Ingelheim, Cardior Pharmaceuticals, Ionis Pharmaceuticals, Novo Nordisk and Roche, and has had speaker engagements with Abbott, AstraZeneca, Bayer, Bristol Myers Squibb, Novartis and Roche. CJWB has received speaker fees from AstraZeneca, Boehringer Ingelheim and Novartis. MLH is supported by the Dutch Heart Foundation (Dr E Dekker Senior Clinical Scientist Grant 2020T058) and CVON (2020B008 RECONNEXT). He received an investigator-initiated research grant from Vifor Pharma, an educational grant from Boehringer Ingelheim and Novartis, and speaker/consultancy fees from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, MSD, Novartis, Sankyo, Daiichi, Quinn and Vifor Pharma, all of which were not related to this study. Funding Information: This study is supported by the Netherlands Organization for Health Research and Development (ZonMw grant 852002141). Additional support has been received from the Dutch CardioVascular Alliance (DCVA). Hospitals receive €40 per included patient, paid by the RELEASE-HF study, with a complete 1-year follow-up (ie, data collected at three timepoints: at baseline, 6 months and 12 months from time since diagnosis). This funding is only related to hospitals participating in the RELEASE-HF study and will stop when the study is complete. The HF registry does not pay hospitals to participate in the registry. Funding Information: We would like to acknowledge all the study participants, cardiologists and nurses from all participating hospitals for setting up the RELEASE-HF study and the data collection in their hospitals. This study is supported by the Netherlands Organization for Health Research and Development (ZonMw grant 852002141). Additional support has been received from the Dutch CardioVascular Alliance (DCVA). Hospitals receive €40 per included patient, paid by the RELEASE-HF study, with a complete 1-year follow-up (ie, data collected at three timepoints: at baseline, 6 months and 12 months from time since diagnosis). This funding is only related to hospitals participating in the RELEASE-HF study and will stop when the study is complete. The HF registry does not pay hospitals to participate in the registry. Publisher Copyright: © Author(s) (or their employer(s)) 2024.
PY - 2024/1/4
Y1 - 2024/1/4
N2 - Introduction Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-) effective. Methods and analysis The RELEASE-HF ('REsponsible roLl-out of E-heAlth through Systematic Evaluation -Heart Failure') study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts. Ethics and dissemination The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.
AB - Introduction Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-) effective. Methods and analysis The RELEASE-HF ('REsponsible roLl-out of E-heAlth through Systematic Evaluation -Heart Failure') study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts. Ethics and dissemination The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.
UR - http://www.scopus.com/inward/record.url?scp=85181848078&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2023-078021
DO - https://doi.org/10.1136/bmjopen-2023-078021
M3 - Article
C2 - 38176879
SN - 2044-6055
VL - 14
SP - e078021
JO - BMJ Open
JF - BMJ Open
IS - 1
M1 - e078021
ER -