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 (Institut Català de la Salut)
Moragas, Ana (Institut Català de la Salut)
Trapero-Bertran, Marta (Universitat Internacional de Catalunya. Institut de Recerca en Avaluació i Polítiques Públiques)
Sisó, Antoni (Fundació Atenció Primària)
Berenguera, Anna (Universitat Autònoma de Barcelona)
Oliva, Glòria (Generalitat de Catalunya. Departament de Salut)
Borrás Santos, Alícia (Universitat Internacional de Cataluña. Institut Albert J. Jovell de Salut Pública y Pacients)
Garcia-Sangenis, Ana (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Puig-Junoy, Jaume (Universitat Pompeu Fabra)
Cots, Josep María (Universitat de Barcelona)
Morros, Rosa. (Universitat Autònoma de Barcelona)
Mora, Toni (Universitat Internacional de Catalunya. Institut de Recerca en Avaluació i Polítiques Públiques)
Lanau-Roig, Anna (Institut Català de la Salut)
Monfà, Ramon (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Troncoso, Amelia (Institut Català de la Salut)
Abellana, Rosa (Universitat de Barcelona. Departament de Fonaments Clínics)
Gálvez-Hernández, Pablo (Universitat Internacional de Cataluña. Institut Albert J. Jovell de Salut Pública y Pacients)
Medina-Perucha, Laura (Universitat Autònoma de Barcelona)
Bjerrum, Lars (Centre for General Practice. Department of Public Health. University of Copenhagen)
Amo, Isabel (Universitat Internacional de Cataluña. Institut Albert J. Jovell de Salut Pública y Pacients)
Barragán-Brun, Nieves (Institut Català de la Salut)
Llor, Carl (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)

Fecha:	2019
Resumen:	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. Trial registration: ClinicalTrials. gov, NCT03931577.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Cost-effectiveness ; Cost-utility ; Effectiveness ; Anti-bacterial agents ; Prescribing ; Acute cough ; Respiratory tract infections ; Antimicrobial stewardship ; Qualitative research ; Incremental cost-utility ratio ; Primary healthcare
Publicado en:	Trials, Vol. 20 (December 2019) , p. 740, ISSN 1745-6215

DOI: 10.1186/s13063-019-3727-3
PMID: 31847912

9 p, 1.2 MB

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