Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Acute Cough

NCT03931577 | Unknown

• 1 other identifier: P18/227
• Study Type: interventional
• Target: 2,940
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections; Cough

Keywords

Antimicrobial Stewardship; Cost-Benefit Analysis; Anti-Bacterial Agents; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Re-consultations and complications

  Day 42

• Duration of symptoms and duration of severe symptoms

  Day 42

• Antibiotic prescription at the baseline visit

  Baseline visit

• Drugs other than antibiotics

  Day 42

• Tests ordered by clinicians

  Day 42

Study Arms (4)

C-reactive protein rapid testing

EXPERIMENTAL

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

Enhancement of communication skills

EXPERIMENTAL

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

C-reactive protein + communication skills

EXPERIMENTAL

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; Procedure: Communication skill enhancement

Usual care

NO INTERVENTION

Usual care.

Interventions

C-reactive protein rapid testing DIAGNOSTIC_TEST

Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.

Also known as: CRP

C-reactive protein + communication skills; C-reactive protein rapid testing

Communication skill enhancement PROCEDURE

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.

Also known as: Leaflet provision

C-reactive protein + communication skills; Enhancement of communication skills

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Universitat Internacional de Catalunya: collaborator
• Fundacio d'Atencio Primaria: collaborator
• Universitat Pompeu Fabra: collaborator

Study Sites (1)

La Marina Health Center

Barcelona, Catalonia, 08038, Spain

Location

Related Publications (2)

• 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.

  PMID: 33338078 DERIVED

• 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.

  PMID: 31847912 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Cough

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosa Morros, MD PhD

  Clinical pharmacologist

  STUDY CHAIR

Central Study Contacts

Ana Moragas, MD PhD

CONTACT

0034600072170; anamaria.moragas@urv.cat

Ana Garcia-Sangenis, MD

CONTACT

0034934824124; agarcia@idiapjgol.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised factorial controlled trial.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 30, 2019
• Study Start: November 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: First 15 years after publication
• Access Criteria: On demand

Locations

ES (1)