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 i...
| Autores: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2019 |
| País: | España |
| Institución: | Universitat Pompeu Fabra |
| Repositorio: | Repositorio Digital de la UPF |
| OAI Identifier: | oai:repositori.upf.edu:10230/44669 |
| Acceso en línea: | http://hdl.handle.net/10230/44669 http://dx.doi.org/10.1186/s13063-019-3727-3 |
| Access Level: | acceso abierto |
| Palabra clave: | Cost-effectiveness Cost-utility Effectiveness Anti-bacterial agents Prescribing Acute cough Respiratory tract infections Antimicrobial stewardship Qualitative research Incremental cost-utility ratio Primary healthcare |
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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, AnaTrapero-Bertran, MartaSisó, AntoniBerenguera, AnnaOliva, GlòriaBorràs Santos, AlíciaGarcía Sangenís, AnaPuig i Junoy, JaumeCots, Josep M.Morros, RosaMora, ToniLanau Roig, AnnaMonfà, RamonTroncoso, AmeliaAbellana, Rosa M.Gálvez, PauMedina Perucha, LauraBjerrum, LarsAmo, IsabelBarragán, NievesLlor, CarlCost-effectivenessCost-utilityEffectivenessAnti-bacterial agentsPrescribingAcute coughRespiratory tract infectionsAntimicrobial stewardshipQualitative researchIncremental cost-utility ratioPrimary healthcareBackground 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.The research is being funded by a grant from the Fundació La Marató de TV3 (reference no. 201820).BMC202020202019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/44669http://dx.doi.org/10.1186/s13063-019-3727-3reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésTrials. 2019 Dec 17;20:740This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/)http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/446692026-06-12T07:21:37Z |
| 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 Cost-effectiveness Cost-utility Effectiveness Anti-bacterial agents Prescribing Acute cough Respiratory tract infections Antimicrobial stewardship Qualitative research Incremental cost-utility ratio Primary healthcare |
| 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, Ana Trapero-Bertran, Marta Sisó, Antoni Berenguera, Anna Oliva, Glòria Borràs Santos, Alícia García Sangenís, Ana Puig i Junoy, Jaume Cots, Josep M. Morros, Rosa Mora, Toni Lanau Roig, Anna Monfà, Ramon Troncoso, Amelia Abellana, Rosa M. Gálvez, Pau Medina Perucha, Laura Bjerrum, Lars Amo, Isabel Barragán, Nieves Llor, Carl |
| author |
Ruiz, Rafa |
| author_facet |
Ruiz, Rafa Moragas, Ana Trapero-Bertran, Marta Sisó, Antoni Berenguera, Anna Oliva, Glòria Borràs Santos, Alícia García Sangenís, Ana Puig i Junoy, Jaume Cots, Josep M. Morros, Rosa Mora, Toni Lanau Roig, Anna Monfà, Ramon Troncoso, Amelia Abellana, Rosa M. Gálvez, Pau Medina Perucha, Laura Bjerrum, Lars Amo, Isabel Barragán, Nieves Llor, Carl |
| author_role |
author |
| author2 |
Moragas, Ana Trapero-Bertran, Marta Sisó, Antoni Berenguera, Anna Oliva, Glòria Borràs Santos, Alícia García Sangenís, Ana Puig i Junoy, Jaume Cots, Josep M. Morros, Rosa Mora, Toni Lanau Roig, Anna Monfà, Ramon Troncoso, Amelia Abellana, Rosa M. Gálvez, Pau Medina Perucha, Laura Bjerrum, Lars Amo, Isabel Barragán, Nieves Llor, Carl |
| 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 |
Cost-effectiveness Cost-utility Effectiveness Anti-bacterial agents Prescribing Acute cough Respiratory tract infections Antimicrobial stewardship Qualitative research Incremental cost-utility ratio Primary healthcare |
| topic |
Cost-effectiveness Cost-utility Effectiveness Anti-bacterial agents Prescribing Acute cough Respiratory tract infections Antimicrobial stewardship Qualitative research Incremental cost-utility ratio Primary healthcare |
| 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. |
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2019 |
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2019 2020 2020 |
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http://hdl.handle.net/10230/44669 http://dx.doi.org/10.1186/s13063-019-3727-3 |
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http://hdl.handle.net/10230/44669 http://dx.doi.org/10.1186/s13063-019-3727-3 |
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Inglés |
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Inglés |
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Trials. 2019 Dec 17;20:740 |
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