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

NCT05166369 | Completed

• 1 other identifier: 19/019-P
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 4

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. 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. 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. 3.Intervention targeting both providers and parents
4. 4.No intervention.

Conditions

Acute Respiratory Tract Infections

Keywords

Acute respiratory tract infection; Microbial Antibiotic Resistance; Communication skills training; Mobile app-based health information and education

Outcome Measures

Primary Outcomes (1)

• Total antibiotic prescription rate

  Total antibiotic prescription rate for patients between 0 and 14 years old (children).

  Three months (from 1st January 2022 to 31st March 2022)

Secondary Outcomes (4)

• RTI complication rate

  Three months (from 1st January 2022 to 31st March 2022)

• Hospital admission rate due to RTI

  Three months (from 1st January 2022 to 31st March 2022)

• RTI Re-consultation rate

  Three months (from 1st January 2022 to 31st March 2022)

• Antibiotic-related adverse events rate

  Three months (from 1st January 2022 to 31st March 2022)

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 training; Behavioral: 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.

Interventions

Communication skills training BEHAVIORAL

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.

Intervention targeted to healthcare providers (paediatricians, nurses and pharmacists) (ITHP); Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P)

Mobile phone application on RTI BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare professionals who care for children in primary care centres and community pharmacists of reference in four Autonomous Communities of Spain (Catalonia, Balearic Islands, Navarra and Basque Country).

You may not qualify if:

• None

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fundació La Marató de TV3: collaborator

Study Sites (4)

Institut d'Investigació de les Illes Balears (IdISBa)

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Osakidetza - Ambulatorio de Pasai San Pedro

Pasaia, Gipuzkoa, 20110, Spain

Location

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

Barcelona, 08041, Spain

Location

Servicio Navarro de Salud - Osasunbidea

Pamplona, Spain

Location

Related Publications (4)

• Andrews T, Thompson M, Buckley DI, Heneghan C, Deyo R, Redmond N, Lucas PJ, Blair PS, Hay AD. Interventions to influence consulting and antibiotic use for acute respiratory tract infections in children: a systematic review and meta-analysis. PLoS One. 2012;7(1):e30334. doi: 10.1371/journal.pone.0030334. Epub 2012 Jan 27.

  PMID: 22299036 RESULT

• Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.

  PMID: 20483949 RESULT

• Ranji SR, Steinman MA, Shojania KG, Gonzales R. Interventions to reduce unnecessary antibiotic prescribing: a systematic review and quantitative analysis. Med Care. 2008 Aug;46(8):847-62. doi: 10.1097/MLR.0b013e318178eabd.

  PMID: 18665065 RESULT

• Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.

  PMID: 23915885 RESULT

Study Officials

• Pablo Alonso Coello, PhD

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

  PRINCIPAL INVESTIGATOR

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: Multicenter, cluster, randomized, factorial, controlled trial.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 21, 2021
• Study Start: January 3, 2022
• Primary Completion: September 4, 2023
• Study Completion: September 5, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (4)