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

NCT ID: NCT03931577

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2940 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-12-31

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.

Conditions

Respiratory Tract Infections; Cough

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-reactive protein rapid testing

Continuous (workshop and monthly web-based training) disease-focused intervention with the use of C-reactive protein rapid testing.

Group Type: EXPERIMENTAL

C-reactive protein rapid testing

Intervention Type: DIAGNOSTIC_TEST

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

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.

Group Type: EXPERIMENTAL

Communication skill enhancement

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

C-reactive protein rapid testing

Intervention Type: DIAGNOSTIC_TEST

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

Communication skill enhancement

Intervention Type: 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.

Usual care

Usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: PROCEDURE

Other Intervention Names

CRP; Leaflet provision

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: collaborator

Fundacio d'Atencio Primaria

OTHER

Sponsor Role: collaborator

Universitat Pompeu Fabra

OTHER

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosa Morros, MD PhD

Role: STUDY_CHAIR

Clinical pharmacologist

Locations

La Marina Health Center

Barcelona, Catalonia, Spain

Countries

Spain

Central Contacts

Ana Moragas, MD PhD

Role: CONTACT

Phone: 0034600072170

Email: anamaria.moragas@urv.cat

Ana Garcia-Sangenis, MD

Role: CONTACT

Phone: 0034934824124

Email: agarcia@idiapjgol.org

Facility Contacts

Josep M Cots, MD PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 33338078 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31847912 (View on PubMed)

Other Identifiers

P18/227

Identifier Type: -

Identifier Source: org_study_id