NCT05166369|Completed

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

OptimAP

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

19/019-P

Study Type

interventional

Actual enrollment (reported)

222

Locations

1 country

Sites

Timeline

Study Start

January 3, 2022

Actual (reported)

Primary Completion

September 4, 2023

Actual (reported)

Study Completion

September 5, 2023

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 222 participants
Study completion date: September 5, 2023
Actual (reported)
Listed locations: 1 countries · 4 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 24, 2021
Actual (reported)
First Posted
December 21, 2021
Actual (reported)
Study Start
January 3, 2022
Actual (reported)
Primary Completion
September 4, 2023
Actual (reported)
Study Completion
September 5, 2023
Actual (reported)

Last Updated: September 28, 2023
Status Verified: September 2023
Last Update Submitted: September 26, 2023

Conditions

Acute Respiratory Tract Infections

Keywords

Acute respiratory tract infectionMicrobial Antibiotic ResistanceCommunication skills trainingMobile app-based health information and education

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Intervention targeted to healthcare providers (paediatricians, nurses and pharmacists) (ITHP)

EXPERIMENTAL

Professionals in the PC centres allocated to this group will receive a complex intervention, delivered remotely, which will include the following components: i) Web based training that will include: communication skills training and optimal management of acute non-complicated RTI, including a specific training on delayed antibiotic prescription. ii) By-monthly feedback about the rate of antibiotic prescription and consumption for RTI, center level and individual pediatrician level (information automatically gathered from electronic health records).

Behavioral: Communication skills training

Intervention targeted to parents (ITP)

EXPERIMENTAL

PC centres allocated to this group will display posters and flyers to inform parents and/or caregivers about a mobile app. It will provide detailed information about respiratory tract infections and optimal use of antibiotics. The app will include information that will be of use before the consultation, but it 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 number of days with symptoms. The app will be accessible through an app store or directly using a QR (quick response) code to facilitate uptake. 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, at center level and individual pediatrician level (information automatically gathered from electronic health records).

Behavioral: Mobile phone application on RTI

Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P)

EXPERIMENTAL

Centres allocated to this group will receive the two interventions described above (intervention targeted to parents plus intervention targeted to providers).

Behavioral: Communication skills trainingBehavioral: Mobile phone application on RTI

Control group

NO INTERVENTION

The centers allocated to this arm of the study will continue with their usual care. To avoid a potential Hawthorne effect (observer effect) these centers will not be informed about their participation as controls.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Intervention targeted to healthcare providers (paediatricians, nurses and pharmacists) (ITHP)

Intervention targeted to parents (ITP)

Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P)

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (4)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Intervention targeted to healthcare providers (paediatricians, nurses and pharmacists) (ITHP)

Intervention targeted to parents (ITP)

Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P)

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (4)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations