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

BackgroundDespite 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/designA 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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03931577.

Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study

“…The qualitative research presented in this article is part of the ISAAC-CAT study [ 62 ], a project that includes a randomised controlled trial (RCT) that aims to compare three interventions (clinician disease-focused intervention; continuous training; treatment as usual) to reduce antibiotic prescribing for people with an ALRTI, in primary healthcare settings in Catalonia (Spain). A pre-intervention qualitative study (the research presented in this article) was designed to inform the development of the RCT, and to give an insight on socio-structural accounts to promote a responsible use of antibiotics and prevent AMR.…”

A Co-Design Process to Elaborate Educational Materials to Promote Appropriate Use of Antibiotics for Acute Lower Respiratory Tract Infections in Primary Healthcare in Catalonia (Spain)

“…The educational material will be used for the randomized controlled trial of the ISAAC-CAT project. 13 We expect this material to be useful for future research, clinical practice and health policies. And, ultimately, we expect it to contribute to tackling antimicrobial resistance.…”

“…The designed material cannot be presented in this publication to prevent any interference in the development of the randomized controlled trial of the ISAAC-CAT project where the educational material will be used. 13 Instead, examples of changes led by the participants in the material content will be provided.…”

“…1,2 This is the reason why public health programs have been developed around the globe, to design strategies that reduce inappropriate use of antibiotics. [3][4][5][6] The first aim of the policies planned by the World Health Organization is currently to "increase consciousness and knowledge around antimicrobial resistance through effective communication, education and training". 1 Highquality and effective health communication has become even more crucial in the context of the COVID-19 pandemic.…”

“…11,12 This paper presents a co-design process of educational materials to promote an appropriate use of antibiotics for acute lower respiratory tract infections (ALRTIs) in primary healthcare in Spain. This study is part of the ISAAC-CAT project, 13 a randomized controlled trial that aims to compare three interventions to reduce antibiotic prescription for ALRTIs in Catalonia (Spain).…”