Intervention to improve antibiotic use in the community

ISRCTN	ISRCTN11636045
DOI	https://doi.org/10.1186/ISRCTN11636045
Secondary identifying numbers	PI19/01006

Submission date: 07/06/2021
Registration date: 12/06/2024
Last edited: 12/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Antibiotic resistance is an important public health problem, and Spain is the developed country with the highest consumption of antibiotics. 90% of this consumption is at the community level, especially for the treatment of upper respiratory infections which account for two-thirds of the community consumption. The aim of this study is to evaluate the effectiveness of a community intervention to improve the use of antibiotics in the treatment of upper respiratory infections.

Who can participate?
Primary care physicians and pharmacists in the study area

What does the study involve?
Primary care physicians will take two online courses about doctor-patient communication and diagnosis and treatment of upper respiratory infections. Community pharmacists take two online courses about pharmacist-patient communication and the management of upper respiratory infections.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Center for Biomedical Research in Epidemiology and Public Health Network (CIBERESP) (Spain)

When is the study starting and how long is it expected to run for?
November 2019 to December 2023

Who is funding the study?
Instituto de Salud Carlos III (Spain)

Who is the main contact?
Adolfo Figueiras, Adolfo.figueiras@usc.es

Contact information

Miss Olalla Vazquez Cancela
Public

Os Concheiros 52
Santiago De Compostela
15703
Spain

ORCID ID	0000-0001-5306-9587
Phone	+34 (0)630151474
Email	olallavazquez3@gmail.com

Study information

Study design	Cluster quasi-experimental controlled study
Primary study design	Interventional
Secondary study design	Cluster quasi-experimental controlled study
Study setting(s)	Community
Study type	Prevention
Participant information sheet	No participant information sheet available
Scientific title	Community intervention to improve antibiotic use
Study acronym	eRes+
Study hypothesis	The deficient training of the general population in the self-diagnosis and treatment of self-limited respiratory infections (flu, common cold, pharyngitis, acute bronchitis, rhinosinusitis) is associated with an increase in patient pressure on doctors and pharmacists for prescription and non-prescription antibiotics. The empowerment of patients in these diseases, together with interventions in doctors and pharmacists to improve their knowledge and attitudes in these pathologies and their communication skills with the patient, can decrease prescription and over-the-counter dispensing and, therefore, inappropriate and excessive use of antibiotics at the level community. H1. Health training for the general population on trivial respiratory diseases and self-care reduces the demand for antibiotics without prescription (pharmacies) and with prescription (primary care consultations) H2. Strengthening the knowledge and attitudes of health professionals reduces prescribing and dispensing antibiotics H3. Strengthening the communication skills of health professionals reduces prescribing and dispensing antibiotics
Ethics approval(s)	Approved 28/11/2019, Comité de ética de la investigación con medicamentos de Galicia (CEIm-G) (Galicia Drug Research Ethics Committee, Edificio Administrativo San Lázaro, 15703 Santiago De Compostela, Spain; +34 (0)881546425; ceic@sergas.es), ref: 2019/598
Condition	Antibiotic prescription and antibiotic dispensation by health professionals
Intervention	A multifaceted community intervention (multifactorial and multidisciplinary) is proposed that encompasses the three main people involved in the use of antibiotics: doctors, pharmacists, and the general population. The control group will not perform interventions but, like those of the group of intervention, they will be exposed to other campaigns that can be carried out simultaneously. Intervention in doctors and pharmacists in three sanitary health areas: A1. Online course on professional-patient communication: This will be offered free of charge in order to improve communication skills. The STAR model of training in training skills will be used. Communication, which has already been cost-effective in other settings. In this course (designed and carried out by psychologists from the research group) the expectations of patients and how to manage them, resources will be made available to improve patient communication and assertiveness techniques. A2. Online course on diagnosis and treatment of acute respiratory infections. A free online course to update knowledge about infection management respiratory will be designed by team members (clinical pharmacologists, specialists in family and community medicine, preventive, primary pharmacists) based on clinical guidelines. The course will be accredited by the continuing medical education system. In addition, this course will provide support material in the consultation for the doctor and to deliver to the patient. The courses will be offered in a face-to-face session in November 2021. In this session, the researchers will explain the aim of the study. The courses will be accredited by the continuing medical and pharmaceutical education system. In addition, this course will provide support material in the consultation for the health professional and to deliver to the patient. After the intervention, the researchers will compare the prescription and antibiotics sales in each group in the following year. B. Intervention in the community: Educational interventions will be carried out in the community indirectly through the health professionals on whom the intervention is carried out, and directly through the neighbourhood associations and city councils. The areas chosen to carry out the intervention will be those in which the main researchers are working at the time of the study.
Intervention type	Behavioural
Primary outcome measure	The number of monthly DHDs (the defined daily dose (DDD) per 1,000 inhabitants per day (DHD)) of each sanitary health area measured using pharmaceutical billing data and consumption data obtained from sales in pharmacies each month in the 12 months following the intervention
Secondary outcome measures	European Surveillance of Antimicrobial Consumption (ESAC) indicators: ratio of the consumption of broad-spectrum (J01 (CR+DC+DD+(F-FA01))) to the consumption of narrow-spectrum penicillins, cephalosporins and macrolides (J01(CE+DB+FA01)), measured using pharmaceutical billing data and consumption data obtained from sales in pharmacies each month in the 12 months following the intervention.
Overall study start date	28/11/2019
Overall study end date	31/12/2023

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	Both
Target number of participants	The medical doctors of 143 primary care centres and the pharmacist of 484 pharmacy offices
Participant inclusion criteria	Primary care physicians and community pharmacists
Participant exclusion criteria	Does not meet the inclusion criteria
Recruitment start date	01/09/2021
Recruitment end date	31/12/2021

Locations

Countries of recruitment

Spain

Study participating centre

Hospital Clinico Universitario de Santiago de Compostela

Choupana sn
Santiago de Compostela
15706
Spain

Sponsor information

Instituto de Salud Carlos III
Government

Avenida Monforte de Lemos nº4
Madrid
28029
Spain

Phone	+34 (0)981951192
Email	adolfo.figueiras@usc.es
Website	http://www.isciii.es/
"ROR"	https://ror.org/00ca2c886

Funders

Funder type

Charity

Fundación Instituto de Investigación Sanitaria de Santiago de Compostela
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Health Research Institute of Santiago de Compostela Foundation, The Health Research Institute of Santiago de Compostela Foundation, Fundación IDIS, IDIS Foundation, FIDIS
Location: Spain

Instituto de Salud Carlos III
Government organisation / National government

Alternative name(s): SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
Location: Spain

Results and Publications

Intention to publish date	02/05/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publication of articles in high impact journal and attendance at conferences.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Adolfo Figueiras (Adolfo.figueiras@usc.es).

Editorial Notes

15/06/2021: Trial's existence confirmed by Xunta de Galicia.