Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)
- Conditions
- Acute Respiratory Tract Infections
- Registration Number
- NCT05166369
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 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.
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.
- Detailed Description
This project will evaluate the effectiveness of two complex interventions to optimize the use of antibiotics in acute uncomplicated respiratory tract infections (RTI). We will first develop the different components of the interventions and evaluate their feasibility (user testing). We will then conduct a multicenter, randomized, controlled trial to evaluate the effectiveness of the overall intervention and its two main constituents in reducing antibiotic consumption. For this reason we will implement a 2x2 factorial randomized cluster clinical trial based on healthcare practices. They will be randomized to receive the intervention targeted to parents, intervention targeted health care professionals, both interventions, or none of them. We will need to recruit a sample size of 222 primary care centres, allocated in a ratio of 1:1:1:1 to one of the four intervention groups (assuming an average cluster size of 200 RTI consultations per centre). Study setting will be defined as primary care centres in four Autonomous Communities in Spain (Catalonia, Balearic Islands, Navarra and Basque Country) with a total of more than 600 PC centers, 1,200 pediatricians, and more of one million children. Finally, during the trial duration, we will conduct a process evaluation and an economic evaluation with a cost-effectiveness analysis.
The interventions include the main characteristics of successful interventions to reduce antibiotic prescribing identified in a systematic review: engage children, occur prior to an illness episode, employ delayed prescribing, and provide guidance on specific symptoms (Andrews 2012). Furthermore, the factorial design will inform about their relative merits and the process evaluation about the potential effect of the individual components.
The research team in in Barcelona (Spain) will coordinate the overall running of the project. A research coordinator in Barcelona will run the day to day of the project from day one under the supervision of the principal investigator. The research teams in four different Spanish Autonomous Communities will contribute to all the stages (intervention development, clinical trial, and economic and process evaluation). Patient representatives will be involved in the project as co-investigators and members of the Steering Committee. Throughout the project groups of parents at each of the regions will be providing feedback.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- 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).
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Total antibiotic prescription rate Three months (from 1st January 2022 to 31st March 2022) Total antibiotic prescription rate for patients between 0 and 14 years old (children).
- Secondary Outcome Measures
Name Time Method RTI complication rate Three months (from 1st January 2022 to 31st March 2022) Rate of clinical complications of respiratory tract infection (e.g. pneumonia, otitis media, sinusitis).
Antibiotic-related adverse events rate Three months (from 1st January 2022 to 31st March 2022) Antibiotic-related adverse events rate (as registered in clinical records).
Hospital admission rate due to RTI Three months (from 1st January 2022 to 31st March 2022) Hospital admission rate due to a RTI or a related complication at 30 days after index RTI consultation.
RTI Re-consultation rate Three months (from 1st January 2022 to 31st March 2022) RTI re-consultations rates at 7, 14, or 31 days after index RTI consultation.
Trial Locations
- Locations (4)
Osakidetza - Ambulatorio de Pasai San Pedro
🇪🇸Pasaia, Gipuzkoa, Spain
Institut d'Investigació de les Illes Balears (IdISBa)
🇪🇸Palma De Mallorca, Illes Balears, Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Servicio Navarro de Salud - Osasunbidea
🇪🇸Pamplona, Spain
Osakidetza - Ambulatorio de Pasai San Pedro🇪🇸Pasaia, Gipuzkoa, Spain