Impact of a Real-time Mentoring Tool on Antibiotic Prescription (medAL-mentor)
Condition: Primary Health Care for Children
Study type: Interventional

Summary: 
      The goal of this ancillary study, part of the DYNAMIC project, is to reduce antibiotic
      prescription and improve the quality of care for children in primary care in Tanzania using a
      near real-time mentoring tool (called medAL-mentor), based on a monitoring and benchmarking
      dashboard and feedback by the monitoring team. The main question to be answered is: Can
      real-time mentoring, based on clinical decision support algorithm data, improve healthcare
      workers' compliance with guidelines - and therefore quality of care for paediatric
      outpatients? Health providers in participating health facilities will receive either the
      medAL-mentor tool and feedback from the monitoring team (intervention group), or standard
      mentoring (control group), so that the impact on antibiotic prescription and other quality of
      care indicators can be compared between the two arms.
    

Detailed description: 
      ePOCT+ is a paediatric digital clinical decision support algorithm for health workers in
      primary care facilities in Tanzania. The objective is to improve the integrated management of
      acutely ill children aged 1 day to 14 years and reduce inappropriate antibiotic
      prescriptions.

      Preliminary findings from the first phase of the DYNAMIC project, an open-label cluster
      randomized controlled study performed in 40 health facilities, showed a reduction in
      antibiotic prescription by health providers from about 70% in the control arm to 23% in
      health facilities using ePOCT+, with similar clinical outcomes in children at day 7.
      Nevertheless, uptake of ePOCT+ and antibiotic prescription in the intervention arm were very
      heterogeneous across health facilities.

      Benchmarking in healthcare is defined as "a process of comparative evaluation and
      identification of the underlying causes leading to high levels of performance". The findings
      and experiences of different institutions are shared, and elements of best practices are
      adopted to improve performance. Benchmarking has been promoted for years by infectious
      diseases societies as a component of hospital antimicrobial stewardship programs, to reduce
      antibiotic prescription. Benchmarking has also been shown to be an effective incentive to
      improve the quality of care in various settings, including primary care practice.
      Unfortunately, published initiatives have largely come from high-income countries.

      In the context of the DYNAMIC project, we developed a near real-time mentoring tool,
      medAL-mentor, based on a monitoring and benchmarking dashboard using data collected through
      ePOCT+. The tool provides direct feedback to health workers on their performance, based on
      several clinical indicators (including antibiotic prescription), in comparison with data from
      other health facilities. The monitoring team will target calls and monitoring visits to
      health facilities based on these indicators and use the dashboard to facilitate discussions
      with healthcare workers.

      This ancillary study, MedAL-mentor, aims to assess whether this real-time mentoring tool
      based on data generated by a clinical decision support algorithm, as well as feedback from
      the mentoring team, improves healthcare workers' compliance with guidelines - and therefore
      the quality of care for sick children at primary care level.

      More specifically, the study objectives are :

      Primary objective :

      To determine whether the provision of medAL-mentor, a digital mentoring tool, decreases
      antibiotic prescription by primary care clinicians using a clinical decision support
      algorithm (ePOCT+) for the management of sick children

      Secondary objectives are :

        1. To assess the impact of medAL-mentor on clinicians' uptake of ePOCT+

        2. To assess the impact of medal-mentor on clinicians in terms of :

             1. Performance of key measurements and assessment of signs by clinicians

             2. Compliance with the recommendations related to point-of-care tests (for malaria and
                haemoglobin)

      This open-label, parallel cluster randomized controlled study is embedded in the second phase
      of the DYNAMIC project in Tanzania. The intervention consists of providing direct access to
      medAL-mentor to the healthcare workers. The mentoring team will target calls and monitoring
      visits to health facilities based on medAL-mentor indicators and use the dashboard to
      facilitate discussions with healthcare workers during the monitoring visits. Since the
      intervention takes place at the healthcare worker level and their practices are influenced by
      the context of the health facility they are working in, randomization at the health facility
      level rather than at the health worker level was chosen.

      40 health facilities using ePOCT+ for the first time during the second phase of the DYNAMIC
      project will be randomly selected and assigned to two groups (randomization 1:1,
      intervention: control). Health workers in health facilities randomized to the intervention
      group will receive feedback on their performance through direct access to medAL-mentor and
      regular mobile messages, as well as targeted phone calls and visits by the monitoring team
      based on the medAL-mentor dashboard. Health facilities from the control group will receive
      standard monitoring (regular messages to check for any issues and regular site visits),
      without access to medAL-mentor (neither for the health workers nor for the monitoring team).
    

Intervention name(s): MedAL-mentor
Intervention type(s): Device
Intervention description(s): MedAL-mentor is a near real-time monitoring and benchmarking dashboard based on data collected through ePOCT+, providing direct feedback on several clinical indicators (antibiotic prescription, performance of key measurements, signs, and diagnostic tests).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study involves two arms: intervention and control. Health facilities will serve as clusters, with half of the facilities (20) receiving the intervention and the other half serving as controls (20). Health facilities will be randomized to their respective study arm. A parallel design (all health facilities start at the same time) will be used.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Digital health; Antibiotic stewardship; Real-time mentoring; Benchmarking; Clinical decision support algorithm