Clinical trial NCT03931577: Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Acute Cough
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Tract Infections
Cough
Keywords: Antimicrobial Stewardship
Cost-Benefit Analysis
Anti-Bacterial Agents
Primary Health Care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
name: Fundacio d'Atencio Primaria
name: Universitat Pompeu Fabra
First posted: 2019-04-30
Enrollment: 2940
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Cluster randomised factorial controlled trial.
Primary purpose: TREATMENT

Brief summary: Despite their marginal benefit, about 60% of uncomplicated acute lower respiratory infections (ALRTI) are currently treated with antibiotics. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of point-of-care C-reactive protein (CRP) testing and the improvement of the communication skills being the most effective interventions, but most of the studies have been carried out outside Mediterranean countries. This study is aimed at evaluating the effect of a disease-focused intervention (CRP) and an illness-focused intervention (improvement of communication skills to optimise doctor-patient consultations and share-decision making with the aid of patient-centred leaflets) on antibiotic prescribing for patients with ALRTIs in Catalan primary care by means of a cluster, randomised, factorial, controlled trial. Primary care centres will be assigned to four trial arms: usual care, use of CRP testing, enhanced communication skills backed up with leaflets, or combined interventions. The main outcome will be antibiotic use within the first 6 weeks and the quality adjusted life years. A pharmacoeconomic analysis of the impact of these interventions will be assessed.

Detailed description: Background: Most antibiotics are prescribed in primary care, and most commonly for acute lower respiratory infections (ALRTI). Despite their marginal benefit, about 60% of these infections are currently treated with antibiotics in Catalonia, Spain. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of C-reactive protein (CRP) rapid testing and the improvement of the communication skills being the most effective interventions. However, most studies have been carried out outside Mediterranean countries. This study aims to evaluate the effectiveness and the efficiency of a continuous disease-focused intervention (CRP) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) 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=2,940 patients) with patients older than 18 years presenting for a first consultation with ALRTI, therefore with presence of infected acute cough of up to 3 weeks' duration as the predominant symptom. Centres, according to socioeconomic and antibiotic consumption, 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 perspective of public health system. A qualitative study aimed at identifying the expectations and concerns in patients with ALRTIs and the satisfaction of clinicians with the different interventions will also be performed. Clinicians assigned to the interventions will participate in a 2-hour training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the trial. Clinical effectiveness will be measured by the antibiotic use within the first 6 weeks and the quality adjusted life years and secondary outcomes will be duration of illness and severity of cough measured with a symptom diary, healthcare reconsultations, hospital admissions and complications. National health care perspective will be adopted and the temporal horizon of the analysis will be one year. Health care costs will be considered and expressed in € of the current year of the analysis. Univariate and multivariate sensitivity analysis will be carried out.

Discussion: The ISAAC-CAT project aims to improve the management of ALRTIs in primary care through use of two different clinicians' skills to help target antibiotic prescribing only to those most likely to benefit, and thereby reduce the risk of unnecessary exposure to antibiotics leading to adverse effects and/or the development of AMR without having a negative impact on health status, thus benefiting individual patients and society at large. This 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 guidelines.

Eligibility criteria: Inclusion Criteria:

* age equal or older than 18 years
* first consultation for acute cough (new cough or worsening of a previous cough) as the predominant symptom
* of up to 3 weeks' duration
* which the clinician believes to be an infectious acute lower respiratory tract infection

Exclusion Criteria:

* a working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, oesophageal reflux, or allergy
* use of antibiotics in the previous two weeks
* immunological deficiencies, and/or
* inability to provide informed consent or unable to follow the study procedures

Primary outcomes:
measure: Antibiotic use
timeFrame: Day 42
measure: Health status
timeFrame: Difference between baseline visit and day 42
Secondary outcomes:
measure: Re-consultations and complications
timeFrame: Day 42
measure: Duration of symptoms and duration of severe symptoms
timeFrame: Day 42
measure: Antibiotic prescription at the baseline visit
timeFrame: Baseline visit
measure: Drugs other than antibiotics
timeFrame: Day 42
measure: Tests ordered by clinicians
timeFrame: Day 42
measure: Patient satisfaction with care
timeFrame: Day 14
measure: Patient perception of the usefulness of the information received.
timeFrame: Day 14
measure: Patient future consulting intention
timeFrame: Day 14
measure: Serious adverse events
timeFrame: Day 42
measure: Absenteeism
timeFrame: Baseline visit
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: La Marina Health Center
state: Catalonia
Study officials:
affiliation: Clinical pharmacologist
name: Rosa Morros, MD PhD
role: STUDY_CHAIR
References:
citation: Medina-Perucha L, Garcia-Sangenis A, Moragas A, Galvez-Hernandez P, Cots JM, Lanau-Roig A, Borras A, Amo I, Monfa R, Llor C, Berenguera A. Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study. PLoS One. 2020 Dec 18;15(12):e0244432. doi: 10.1371/journal.pone.0244432. eCollection 2020.
citation: Ruiz R, Moragas A, Trapero-Bertran M, Siso A, Berenguera A, Oliva G, Borras-Santos A, Garcia-Sangenis A, Puig-Junoy J, Cots JM, Morros R, Mora T, Lanau-Roig A, Monfa R, Troncoso A, Abellana RM, Galvez P, Medina-Perucha L, Bjerrum L, Amo I, Barragan 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(1):740. doi: 10.1186/s13063-019-3727-3.