Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)
Condition: Acute Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

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.
    

Intervention name(s): Communication skills training; Mobile phone application on RTI
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Multicenter, cluster, randomized, factorial, controlled trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute respiratory tract infection; Microbial Antibiotic Resistance; Communication skills training; Mobile app-based health information and education