Impact of a Real-time Mentoring Tool on Antibiotic Prescription (medAL-mentor)

Study Overview
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Brief Summary
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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
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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 : To assess the impact of medAL-mentor on clinicians' uptake of ePOCT+ To assess the impact of medal-mentor on clinicians in terms of : Performance of key measurements and assessment of signs by clinicians 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).

Official Title
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Impact of medAL-mentor, a Real-time Mentoring and Benchmarking Tool, on Antibiotic Prescription Among Children in Primary Health Care Facilities in Tanzania

Conditions
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Primary Health Care for Children

Intervention / Treatment
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* Device: MedAL-mentor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Presenting for an acute medical or surgical condition Exclusion Criteria: Presenting for scheduled consultation for a chronic disease (e.g. HIV, tuberculosis, non-communicable diseases, malnutrition) Presenting for routine preventive care (e.g. growth monitoring, vitamin supplementation, deworming, vaccination)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedAL-mentor<br>In health facilities allocated to the medAL-mentor arm, the intervention will consist in : Providing tablets with ePOCT+ and initial training for use by healthcare workers Access to medAL-mentor for healthcare workers and the monitoring team Regular (at least every 2 weeks) supportive messages sent by the monitoring team to healthcare workers providing feedback from medAL-mentor Targeted phone calls and health facilities visits by the monitoring team based on medAL-mentor review Monitoring will be performed by the study team. | Device: MedAL-mentor<br>* 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).<br>|
| No Intervention: Routine mentoring<br>In health facilities allocated to the control arm, tablets with ePOCT+ will also be provided to healthcare workers with initial training, but subsequent mentoring will be conducted routinely: No access to medAL-mentor for healthcare workers or the monitoring team At least one message sent by the monitoring team to healthcare workers every two weeks, to inquire about any issues and trigger a site visit if needed At least one visit from the monitoring team in each health facility every two months Monitoring will be performed by the study team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children prescribed an antibiotic in the intervention group (medAL-mentor) as compared to the control group (routine mentoring) | Number of children for whom at least one systemic (oral or parenteral) antibiotic has been prescribed during consultation, over all eligible children, as reported by the healthcare workers in a routine registry | Day 0 (by the end of the consultation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of consultations with eligible children performed using ePOCT+ | Number of consultations completed with ePOCT+, over all consultations with eligible children as reported in a routine registry | Day 0 (by the end of the consultation) | 
| Percentage of children in whom key signs have been checked by healthcare workers | Number of children in whom key signs (temperature, weight, mid-upper arm circumference (MUAC), respiratory rate) have been checked by healthcare workers, over the total number of children for whom this was recommended, as reported by healthcare workers in ePOCT+ | Day 0 (by the end of the consultation) | 
| Percentage of children for whom appropriate diagnostic tests have been performed by healthcare workers | Number of children for whom diagnostic tests (haemoglobin and malaria tests) have been performed by healthcare workers, over the total number of children for whom diagnostic tests were recommended, as reported by healthcare workers in ePOCT+ | Day 0 (by the end of the consultation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital health, Antibiotic stewardship, Real-time mentoring, Benchmarking, Clinical decision support algorithm