Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Acute Cough (ISAAC-CAT)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Tract Infections; Cough
• Intervention / Treatment: Diagnostic test: C-reactive protein rapid testing; Procedure: Communication skill enhancement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2940
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08038
      • La Marina Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Usual care.
Experimental: C-reactive protein rapid testing; Continuous (workshop and monthly web-based training) disease-focused intervention with the use of C-reactive protein rapid testing.	Diagnostic test: C-reactive protein rapid testing; Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.; Other Names: CRP
Experimental: Enhancement of communication skills; Continuous (on-site and monthly online training) illness-focused intervention with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets.	Procedure: Communication skill enhancement; Continuous (on-site and monthly online training) illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) in the primary care practices.; Other Names: Leaflet provision
Experimental: C-reactive protein + communication skills; Continuous (workshop and monthly web-based training) disease-focused intervention with C-reactive protein rapid testing and on-site and continuous (monthly online training illness-focused intervention) with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets.	Diagnostic test: C-reactive protein rapid testing; Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.; Other Names: CRP; Procedure: Communication skill enhancement; Continuous (on-site and monthly online training) illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) in the primary care practices.; Other Names: Leaflet provision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic use	Number of antibiotics consumed (as documented in the CRFs and double-checked by the Pharmacy Unit of Institut Català de Salut that can track if the antibiotic has been dispensed at any of the Catalan pharmacies)	Day 42
Health status	Quality of life score obtained using the EuroQol questionnaire	Difference between baseline visit and day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-consultations and complications	Number of re-consultation for new or worsening symptoms, new signs, or hospital admission, assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data), and Number of complications regarding the ALRTI	Day 42
Duration of symptoms and duration of severe symptoms	Number of days until symptoms are rated daily as 0 (no problem) (information is reported by patients in self-completed diaries)	Day 42
Antibiotic prescription at the baseline visit	Number of antibiotic prescriptions at the baseline visit, differentiating immediate and delayed antibiotic prescribing, and antibiotic dispensing at the pharmacies	Baseline visit
Drugs other than antibiotics	Number of non-antibiotic prescriptions (reported by patients in self-completed diaries)	Day 42
Tests ordered by clinicians	Number of tests ordered by clinicians (reported in the CRF)	Day 42
Patient satisfaction with care	Patient satisfaction score reported in the symptom diary. Measured with a question that has used in previous studies: How satisfied are you with the consultation? Range from 0 (nothing satisfied) to 5 (extremely satisfied).	Day 14
Patient perception of the usefulness of the information received.	Patient perception score about the usefulness of the information received. Measured with a question that has used in previous studies: Do you consider that the information received from your doctor has been useful? Range from 0 (nothing useful) to 5 (extremely useful).	Day 14
Patient future consulting intention	Patient future consulting intention score. Measured with a question that has used in previous studies: Do you think you will attend the doctor in future occasions in case you present the same symptoms? Range from 0 (totally unlikely) to 5 (sure).	Day 14
Serious adverse events	Number of serious adverse events (assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data)	Day 42
Absenteeism	Number of days of sick leave (collected in the CRFs)	Baseline visit

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Universitat Internacional de Catalunya; Universitat Pompeu Fabra; Fundacio d'Atencio Primaria
• Investigators: Study Chair: Rosa Morros, MD PhD, Clinical Pharmacologist

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cost-Benefit Analysis; Primary Health Care; Anti-Bacterial Agents; Antimicrobial Stewardship
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Cough
• Other Study ID Numbers: P18/227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Reposition in SCENTIA
• IPD Sharing Time Frame: First 15 years after publication
• IPD Sharing Access Criteria: On demand
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No