Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial

Background: Despite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an...

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Autores: Ruiz, Rafa, Moragas Moreno, Anna, Trapero Bertran, Marta, Sisó Almirall, Antoni, Berenguera, Anna, Oliva, Glòria, García Sangenís, Ana, Puig Junoy, Jaume, Cots Yago, José Ma. (José María), Morros Pedrós, Rosa, Mora, Toni, Lanau Roig, Anna, Monfà, Ramon, Troncoso Mariño, Amelia, Abellana Sangrà, Rosa Mari, Gálvez, Pau, Bjerrum, Lars, Amo, Isabel, Barragán, Nieves, Llor i Vilà, Carles, Borràs Santos, Alícia, Medina Perucha, Laura
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/181461
Acceso en línea:https://hdl.handle.net/2445/181461
Access Level:acceso abierto
Palabra clave:Atenció primària
Infeccions respiratòries
Primary care
Respiratory infections
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spelling Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trialRuiz, RafaMoragas Moreno, AnnaTrapero Bertran, MartaSisó Almirall, AntoniBerenguera, AnnaOliva, GlòriaGarcía Sangenís, AnaPuig Junoy, JaumeCots Yago, José Ma. (José María)Morros Pedrós, RosaMora, ToniLanau Roig, AnnaMonfà, RamonTroncoso Mariño, AmeliaAbellana Sangrà, Rosa MariGálvez, PauBjerrum, LarsAmo, IsabelBarragán, NievesLlor i Vilà, CarlesBorràs Santos, AlíciaMedina Perucha, LauraAtenció primàriaInfeccions respiratòriesPrimary careRespiratory infectionsBackground: Despite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres. Methods/design: A cluster randomised, factorial, controlled trial aimed at including 20 primary care centres (N = 2940 patients) with patients older than 18 years of age presenting for a first consultation with an ALRTI will be included in the study. Primary care centres will be identified on the basis of socioeconomic data and antibiotic consumption. Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the societal and national healthcare system perspectives, and the time horizon of the analysis will be 1 year. Two qualitative studies (pre- and post-clinical trial) aimed to identify the expectations and concerns of patients with ALRTIs and the barriers and facilitators of each intervention arm will be run. Family doctors and nurses assigned to the interventions will participate in a 2-h training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the year of the trial period. Primary outcomes will be antibiotic use within the first 6 weeks, duration of moderate to severe cough, and the quality-adjusted life-years. Secondary outcomes will be duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications. Healthcare costs will be considered and expressed in 2021 euros (year foreseen to finalise the study) of the current year of the analysis. Univariate and multivariate sensitivity analyses will be carried out. Discussion: The ISAAC-CAT project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual clinical guidelines.BioMed Central2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/181461Articles publicats en revistes (Fonaments Clínics)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1186/s13063-019-3727-3Trials, 2019, vol. 20, num. 740https://doi.org/10.1186/s13063-019-3727-3cc-by (c) Ruiz, Rafa et al., 2019https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1814612026-05-27T06:46:51Z
dc.title.none.fl_str_mv Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
title Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
spellingShingle Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
Ruiz, Rafa
Atenció primària
Infeccions respiratòries
Primary care
Respiratory infections
title_short Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
title_full Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
title_fullStr Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
title_full_unstemmed Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
title_sort Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): Study protocol for a cluster randomised controlled trial
dc.creator.none.fl_str_mv Ruiz, Rafa
Moragas Moreno, Anna
Trapero Bertran, Marta
Sisó Almirall, Antoni
Berenguera, Anna
Oliva, Glòria
García Sangenís, Ana
Puig Junoy, Jaume
Cots Yago, José Ma. (José María)
Morros Pedrós, Rosa
Mora, Toni
Lanau Roig, Anna
Monfà, Ramon
Troncoso Mariño, Amelia
Abellana Sangrà, Rosa Mari
Gálvez, Pau
Bjerrum, Lars
Amo, Isabel
Barragán, Nieves
Llor i Vilà, Carles
Borràs Santos, Alícia
Medina Perucha, Laura
author Ruiz, Rafa
author_facet Ruiz, Rafa
Moragas Moreno, Anna
Trapero Bertran, Marta
Sisó Almirall, Antoni
Berenguera, Anna
Oliva, Glòria
García Sangenís, Ana
Puig Junoy, Jaume
Cots Yago, José Ma. (José María)
Morros Pedrós, Rosa
Mora, Toni
Lanau Roig, Anna
Monfà, Ramon
Troncoso Mariño, Amelia
Abellana Sangrà, Rosa Mari
Gálvez, Pau
Bjerrum, Lars
Amo, Isabel
Barragán, Nieves
Llor i Vilà, Carles
Borràs Santos, Alícia
Medina Perucha, Laura
author_role author
author2 Moragas Moreno, Anna
Trapero Bertran, Marta
Sisó Almirall, Antoni
Berenguera, Anna
Oliva, Glòria
García Sangenís, Ana
Puig Junoy, Jaume
Cots Yago, José Ma. (José María)
Morros Pedrós, Rosa
Mora, Toni
Lanau Roig, Anna
Monfà, Ramon
Troncoso Mariño, Amelia
Abellana Sangrà, Rosa Mari
Gálvez, Pau
Bjerrum, Lars
Amo, Isabel
Barragán, Nieves
Llor i Vilà, Carles
Borràs Santos, Alícia
Medina Perucha, Laura
author2_role 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 Atenció primària
Infeccions respiratòries
Primary care
Respiratory infections
topic Atenció primària
Infeccions respiratòries
Primary care
Respiratory infections
description Background: Despite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres. Methods/design: A cluster randomised, factorial, controlled trial aimed at including 20 primary care centres (N = 2940 patients) with patients older than 18 years of age presenting for a first consultation with an ALRTI will be included in the study. Primary care centres will be identified on the basis of socioeconomic data and antibiotic consumption. Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the societal and national healthcare system perspectives, and the time horizon of the analysis will be 1 year. Two qualitative studies (pre- and post-clinical trial) aimed to identify the expectations and concerns of patients with ALRTIs and the barriers and facilitators of each intervention arm will be run. Family doctors and nurses assigned to the interventions will participate in a 2-h training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the year of the trial period. Primary outcomes will be antibiotic use within the first 6 weeks, duration of moderate to severe cough, and the quality-adjusted life-years. Secondary outcomes will be duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications. Healthcare costs will be considered and expressed in 2021 euros (year foreseen to finalise the study) of the current year of the analysis. Univariate and multivariate sensitivity analyses will be carried out. Discussion: The ISAAC-CAT project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual clinical guidelines.
publishDate 2019
dc.date.none.fl_str_mv 2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/181461
url https://hdl.handle.net/2445/181461
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1186/s13063-019-3727-3
Trials, 2019, vol. 20, num. 740
https://doi.org/10.1186/s13063-019-3727-3
dc.rights.none.fl_str_mv cc-by (c) Ruiz, Rafa et al., 2019
https://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Ruiz, Rafa et al., 2019
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv Articles publicats en revistes (Fonaments Clínics)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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