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
Autor/a
Ruiz, Rafa
Moragas, Ana
Trapero-Bertran, Marta
Sisó Almirall, Antoni
Berenguera, Anna
Oliva, Glòria
BORRAS SANTOS, ALICIA
García Sangenís, Ana
Cots, Josep-Maria
Morros, Rosa
Mora, Toni
Lanau-Roig, Anna
Monfà Escolà, Ramon
Troncoso Mariño, Amelia
Gálvez, Pau
Medina-Perucha, Laura
Bjerrum, Lars
Amo, Isabel
Barragán, Nieves
Llor, Carl
Fecha de publicación
2019-12-17ISSN
1745-6215
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.
Tipo de documento
Artículo
Versión del documento
Versión aceptada
Lengua
English
Materias (CDU)
338 - Situación económica. Política económica. Gestión, control y planificación de la economía. Producción. Servicios. Turismo. Precios
61 - Medicina
Palabras clave
Cost effectiveness
Cost-eficàcia
Atenció primària
Primary care (Medicine)
Atención primaria
Medicaments antibacterians
Antibacterial agents
Antibióticos
Páginas
9
Publicado por
BMC
Colección
20; 1
Publicado en
Trials
Citación
Ruiz, Rafa; Moragas, Ana; Trapero Bertran, Marta et al. «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, vol. 20, núm. 1, art. 740. Disponible en: <https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3727-3>. Fecha de acceso: 20 ene. 2020. DOI: 10.1186/s13063-019-3727-3
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