Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05166369
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-11-24
Brief Title:
Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children OptimAP Study
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OptimAP
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 eg 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
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 eg 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 1111 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 1200 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None