Clinical trial NCT05166369: Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)
Official title: Optimisation of Antibiotic Prescription in Acute Non-complicated Respiratory Tract Infections in Children: a Multicenter Factorial Randomised Controlled Trial Targeting Health Professionals and Parents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Tract Infections
Keywords: Acute respiratory tract infection
Microbial Antibiotic Resistance
Communication skills training
Mobile app-based health information and education
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2021-12-21
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Multicenter, cluster, randomized, factorial, controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* None

Primary outcomes:
measure: Total antibiotic prescription rate
timeFrame: Three months (from 1st January 2022 to 31st March 2022)
Secondary outcomes:
measure: RTI complication rate
timeFrame: Three months (from 1st January 2022 to 31st March 2022)
measure: Hospital admission rate due to RTI
timeFrame: Three months (from 1st January 2022 to 31st March 2022)
measure: RTI Re-consultation rate
timeFrame: Three months (from 1st January 2022 to 31st March 2022)
measure: Antibiotic-related adverse events rate
timeFrame: Three months (from 1st January 2022 to 31st March 2022)
Other outcomes:
Locations:
city: Pasaia
country: Spain
facility: Osakidetza - Ambulatorio de Pasai San Pedro
state: Gipuzkoa
city: Palma De Mallorca
country: Spain
facility: Institut d'Investigació de les Illes Balears (IdISBa)
state: Illes Balears
city: Barcelona
country: Spain
facility: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
city: Pamplona
country: Spain
facility: Servicio Navarro de Salud - Osasunbidea
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Pablo Alonso Coello, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.