Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study
BackgroundThe use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to random...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2023 |
| País: | España |
| Recursos: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:2445/206223 |
| Acesso em linha: | https://hdl.handle.net/2445/206223 |
| Access Level: | acceso abierto |
| Palavra-chave: | SARS-CoV-2 Espanya Spain |
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Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT studyRodríguez Molinero, AlejandroCarot Sans, GerardEscrig, RoserTebé, CristianArce, JacoboPérez López, CarlosBallesta, SilviaVerdejo, GuillermoCedeño, ÁngelRiera Pagespetit, MarVivas Angeles, SofiaAlarcon, Jose L.Navarro, ItziarToro, SilviaMateo, LlorençTorres, Ana J.Delmás, GerardCamell, HelenaChamero, AntonioGasol, MontsePiera Jiménez, JordiBenaiges, DavidTikhomirova, LidiaTorrente, VicençMarimón, JesúsSaavedra Pérez, DavidMenendez, VioletaFranquet, ElisabetSierra, Luis M.López Diéguez, MaríaRodríguez, NuriaGonzales, JessicaMacho Pérez, OscarHuguet, SandraDegano, LucasPineda, FranciscoErrando, JavierEcaset Research GroupSARS-CoV-2EspanyaSARS-CoV-2SpainBackgroundThe use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting.MethodsMulticenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024.DiscussionThe scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript.Trial registrationNCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021.Springer Science and Business Media LLC2024202420232024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion11 p.application/pdfhttps://hdl.handle.net/2445/206223Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1186/s13063-023-07679-1Trials, 2023, vol. 24, num. 1https://doi.org/10.1186/s13063-023-07679-1cc by (c) Rodríguez Molinero, Alejandro et al., 2023http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2062232026-05-29T05:05:01Z |
| dc.title.none.fl_str_mv |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study |
| title |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study |
| spellingShingle |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study Rodríguez Molinero, Alejandro SARS-CoV-2 Espanya SARS-CoV-2 Spain |
| title_short |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study |
| title_full |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study |
| title_fullStr |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study |
| title_full_unstemmed |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study |
| title_sort |
Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study |
| dc.creator.none.fl_str_mv |
Rodríguez Molinero, Alejandro Carot Sans, Gerard Escrig, Roser Tebé, Cristian Arce, Jacobo Pérez López, Carlos Ballesta, Silvia Verdejo, Guillermo Cedeño, Ángel Riera Pagespetit, Mar Vivas Angeles, Sofia Alarcon, Jose L. Navarro, Itziar Toro, Silvia Mateo, Llorenç Torres, Ana J. Delmás, Gerard Camell, Helena Chamero, Antonio Gasol, Montse Piera Jiménez, Jordi Benaiges, David Tikhomirova, Lidia Torrente, Vicenç Marimón, Jesús Saavedra Pérez, David Menendez, Violeta Franquet, Elisabet Sierra, Luis M. López Diéguez, María Rodríguez, Nuria Gonzales, Jessica Macho Pérez, Oscar Huguet, Sandra Degano, Lucas Pineda, Francisco Errando, Javier Ecaset Research Group |
| author |
Rodríguez Molinero, Alejandro |
| author_facet |
Rodríguez Molinero, Alejandro Carot Sans, Gerard Escrig, Roser Tebé, Cristian Arce, Jacobo Pérez López, Carlos Ballesta, Silvia Verdejo, Guillermo Cedeño, Ángel Riera Pagespetit, Mar Vivas Angeles, Sofia Alarcon, Jose L. Navarro, Itziar Toro, Silvia Mateo, Llorenç Torres, Ana J. Delmás, Gerard Camell, Helena Chamero, Antonio Gasol, Montse Piera Jiménez, Jordi Benaiges, David Tikhomirova, Lidia Torrente, Vicenç Marimón, Jesús Saavedra Pérez, David Menendez, Violeta Franquet, Elisabet Sierra, Luis M. López Diéguez, María Rodríguez, Nuria Gonzales, Jessica Macho Pérez, Oscar Huguet, Sandra Degano, Lucas Pineda, Francisco Errando, Javier Ecaset Research Group |
| author_role |
author |
| author2 |
Carot Sans, Gerard Escrig, Roser Tebé, Cristian Arce, Jacobo Pérez López, Carlos Ballesta, Silvia Verdejo, Guillermo Cedeño, Ángel Riera Pagespetit, Mar Vivas Angeles, Sofia Alarcon, Jose L. Navarro, Itziar Toro, Silvia Mateo, Llorenç Torres, Ana J. Delmás, Gerard Camell, Helena Chamero, Antonio Gasol, Montse Piera Jiménez, Jordi Benaiges, David Tikhomirova, Lidia Torrente, Vicenç Marimón, Jesús Saavedra Pérez, David Menendez, Violeta Franquet, Elisabet Sierra, Luis M. López Diéguez, María Rodríguez, Nuria Gonzales, Jessica Macho Pérez, Oscar Huguet, Sandra Degano, Lucas Pineda, Francisco Errando, Javier Ecaset Research Group |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
SARS-CoV-2 Espanya SARS-CoV-2 Spain |
| topic |
SARS-CoV-2 Espanya SARS-CoV-2 Spain |
| description |
BackgroundThe use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting.MethodsMulticenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024.DiscussionThe scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript.Trial registrationNCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021. |
| publishDate |
2023 |
| dc.date.none.fl_str_mv |
2023 2024 2024 2024 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://hdl.handle.net/2445/206223 |
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https://hdl.handle.net/2445/206223 |
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Inglés |
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Inglés |
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Reproducció del document publicat a: https://doi.org/10.1186/s13063-023-07679-1 Trials, 2023, vol. 24, num. 1 https://doi.org/10.1186/s13063-023-07679-1 |
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cc by (c) Rodríguez Molinero, Alejandro et al., 2023 http://creativecommons.org/licenses/by/3.0/es/ info:eu-repo/semantics/openAccess |
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cc by (c) Rodríguez Molinero, Alejandro et al., 2023 http://creativecommons.org/licenses/by/3.0/es/ |
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openAccess |
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11 p. application/pdf |
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Springer Science and Business Media LLC |
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Springer Science and Business Media LLC |
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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Recercat. Dipósit de la Recerca de Catalunya |
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Recercat. Dipósit de la Recerca de Catalunya |
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