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
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- dc.contributor.author Ruiz, Rafa
- dc.contributor.author Moragas, Ana
- dc.contributor.author Trapero-Bertran, Marta
- dc.contributor.author Sisó, Antoni
- dc.contributor.author Berenguera, Anna
- dc.contributor.author Oliva, Glòria
- dc.contributor.author Borràs Santos, Alícia
- dc.contributor.author García Sangenís, Ana
- dc.contributor.author Puig i Junoy, Jaume
- dc.contributor.author Cots, Josep M.
- dc.contributor.author Morros, Rosa
- dc.contributor.author Mora, Toni
- dc.contributor.author Lanau Roig, Anna
- dc.contributor.author Monfà, Ramon
- dc.contributor.author Troncoso, Amelia
- dc.contributor.author Abellana, Rosa M.
- dc.contributor.author Gálvez, Pau
- dc.contributor.author Medina Perucha, Laura
- dc.contributor.author Bjerrum, Lars
- dc.contributor.author Amo, Isabel
- dc.contributor.author Barragán, Nieves
- dc.contributor.author Llor, Carl
- dc.date.accessioned 2020-05-25T08:45:47Z
- dc.date.available 2020-05-25T08:45:47Z
- dc.date.issued 2019
- dc.description.abstract 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.en
- dc.description.sponsorship The research is being funded by a grant from the Fundació La Marató de TV3 (reference no. 201820).
- dc.format.mimetype application/pdf
- dc.identifier.citation Ruiz R, Moragas A, Trapero-Bertran M, Sisó A, Berenguera A, Oliva G, Borràs-Santos A, García-Sangenís A, Cots JM, Morros R, Mora T, Lanau-Roig A, Monfà R, Troncoso A, Abellana RM, Gálvez P, Medina-Perucha L, Bjerrum L, Amo I, Barragán N, Llor C. 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. Trials. 2019 Dec 17;20:740. DOI: 10.1186/s13063-019-3727-3
- dc.identifier.doi http://dx.doi.org/10.1186/s13063-019-3727-3
- dc.identifier.issn 1745-6215
- dc.identifier.uri http://hdl.handle.net/10230/44669
- dc.language.iso eng
- dc.publisher BMC
- dc.relation.ispartof Trials. 2019 Dec 17;20:740
- dc.rights This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/)
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by/4.0/
- dc.subject.keyword Cost-effectivenessen
- dc.subject.keyword Cost-utilityen
- dc.subject.keyword Effectivenessen
- dc.subject.keyword Anti-bacterial agentsen
- dc.subject.keyword Prescribingen
- dc.subject.keyword Acute coughen
- dc.subject.keyword Respiratory tract infectionsen
- dc.subject.keyword Antimicrobial stewardshipen
- dc.subject.keyword Qualitative researchen
- dc.subject.keyword Incremental cost-utility ratioen
- dc.subject.keyword Primary healthcareen
- dc.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 trialen
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion