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

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

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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 trial. / Ruiz, Rafa; Moragas, Ana; Trapero-Bertran, Marta; Sisó, Antoni; Berenguera, Anna; Oliva, Glòria; Borràs-Santos, Alícia; García-Sangenís, Ana; Puig-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.

I: Trials, Bind 20, Nr. 1, 740, 2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

Ruiz, R, Moragas, A, Trapero-Bertran, M, Sisó, A, Berenguera, A, Oliva, G, Borràs-Santos, A, García-Sangenís, A, Puig-Junoy, J, 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 2019, '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, bind 20, nr. 1, 740. https://doi.org/10.1186/s13063-019-3727-3

APA

Ruiz, R., Moragas, A., Trapero-Bertran, M., Sisó, A., Berenguera, A., Oliva, G., Borràs-Santos, A., García-Sangenís, A., Puig-Junoy, J., Cots, J. M., Morros, R., Mora, T., Lanau-Roig, A., Monfà, R., Troncoso, A., Abellana, R. M., Gálvez, P., Medina-Perucha, L., Bjerrum, L., ... Llor, C. (2019). 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, 20(1), [740]. https://doi.org/10.1186/s13063-019-3727-3

Vancouver

Ruiz R, Moragas A, Trapero-Bertran M, Sisó A, Berenguera A, Oliva G o.a. 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;20(1). 740. https://doi.org/10.1186/s13063-019-3727-3

Author

Ruiz, Rafa ; Moragas, Ana ; Trapero-Bertran, Marta ; Sisó, Antoni ; Berenguera, Anna ; Oliva, Glòria ; Borràs-Santos, Alícia ; García-Sangenís, Ana ; Puig-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. / 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. I: Trials. 2019 ; Bind 20, Nr. 1.

Bibtex

@article{08659c639c02478d9a02f2a07ab9eaf2,
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",
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.TRIAL REGISTRATION: ClinicalTrials.gov, NCT03931577.",
author = "Rafa Ruiz and Ana Moragas and Marta Trapero-Bertran and Antoni Sis{\'o} and Anna Berenguera and Gl{\`o}ria Oliva and Al{\'i}cia Borr{\`a}s-Santos and Ana Garc{\'i}a-Sangen{\'i}s and Jaume Puig-Junoy and Cots, {Josep M} and Rosa Morros and Toni Mora and Anna Lanau-Roig and Ramon Monf{\`a} and Amelia Troncoso and Abellana, {Rosa M} and Pau G{\'a}lvez and Laura Medina-Perucha and Lars Bjerrum and Isabel Amo and Nieves Barrag{\'a}n and Carl Llor",
year = "2019",
doi = "10.1186/s13063-019-3727-3",
language = "English",
volume = "20",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - 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)

T2 - study protocol for a cluster randomised controlled trial

AU - Ruiz, Rafa

AU - Moragas, Ana

AU - Trapero-Bertran, Marta

AU - Sisó, Antoni

AU - Berenguera, Anna

AU - Oliva, Glòria

AU - Borràs-Santos, Alícia

AU - García-Sangenís, Ana

AU - Puig-Junoy, Jaume

AU - Cots, Josep M

AU - Morros, Rosa

AU - Mora, Toni

AU - Lanau-Roig, Anna

AU - Monfà, Ramon

AU - Troncoso, Amelia

AU - Abellana, Rosa M

AU - Gálvez, Pau

AU - Medina-Perucha, Laura

AU - Bjerrum, Lars

AU - Amo, Isabel

AU - Barragán, Nieves

AU - Llor, Carl

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

U2 - 10.1186/s13063-019-3727-3

DO - 10.1186/s13063-019-3727-3

M3 - Journal article

C2 - 31847912

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 740

ER -

ID: 232553601