Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)

Summary

Background: High-volume antibiotic prescribing in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We will assess whether remotely delivered complex interventions including internet-based training for health care provider, and an educational intervention for parents could improve prescribing practices for respiratory tract infections (RTI) in Spain.

Methods: We will develop and evaluate the feasibility of two interventions in a 16-months randomized controlled factorial trial. Primary care (PC) centres will be allocated to one of the following four groups:

1. Intervention targeting healthcare providers (paediatricians, nurses and pharmacists): i) Internet based training about communication skills and optimal antibiotic prescribing (including delayed prescribing); ii) bimonthly antibiotic prescription feedback.
2. Intervention targeting parents: PC centres allocated to this group will display posters and flyers presenting a mobile app that will include information about respiratory tract infections and optimal use of antibiotics. The app can be used before, during and after the consultation, providing condition specific and patient tailored information.
3. Intervention targeting both providers and parents
4. No intervention.

During the trial duration we will conduct a process evaluation and a cost-effectiveness analysis. Our primary outcome will be change in the total antibiotic prescription rate. Our secondary outcomes will include: respiratory complications (e.g. pneumonia), antibiotic related adverse effects, repeated consultations, and antibiotic consumption in relation with antibiotic prescribing (delayed antibiotic prescribing). Assuming an average cluster size of 200 RTI consultations per centre, we will need to recruit 222 PC centres.

Conditions

• Acute Respiratory Tract Infections

Interventions

BEHAVIORAL

Communication skills training

This intervention consists of a course on communication skills for healthcare professionals. It will be done remotely via the internet and will include: communication skills training and optimal management of acute non-complicated RTI and delayed antibiotic prescription. Training modules will be delivered via a specific website password protected. Healthcare professionals will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI.

BEHAVIORAL

Mobile phone application on RTI

This intervention involves the use of a mobile phone application by parents and caregivers. The mobile app will provide information, education and interactive tools about acute noncomplicated respiratory tract infections. PC centres allocated to this group will display posters and flyers to inform parents and caregivers about the mobile app. Healthcare staff will also promote the use of this app by parents and caregivers. The app information will be useful before the consultation, and will also allow the patient to interact with the physician during the consultation, potentially improving share decision-making. Importantly, the app will allow tailoring the guidance provided according to the type of infection or the number of days with symptoms. Healthcare professionals in the primary care centres allocated to this group will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI.

Sponsors & Collaborators

• Fundació La Marató de TV3

  collaborator OTHER

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  lead OTHER

Principal Investigators

• Pablo Alonso Coello, PhD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-03

Primary Completion

2023-09-04

Completion

2023-09-05

Countries

• Spain

Study Locations