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

Sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05901155

Collaborator

Swiss Tropical & Public Health Institute (Other), Ifakara Health Institute (Other), Mbeya Medical Research Centre-National Institute for Medical Research (Other)

12,800

Enrollment

Locations

Arms

3.8

Anticipated Duration (Months)

320

Patients Per Site

83.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Health Care for Children	Device: MedAL-mentor	N/A

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 :

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12800 participants

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.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)

Masking Description:

Masking is not possible.

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jun 5, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MedAL-mentor 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 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).
No Intervention: Routine mentoring 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.

Arm

Intervention/Treatment

Experimental: MedAL-mentor

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

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).

No Intervention: Routine mentoring

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.

Outcome Measures

Primary Outcome Measures

Percentage of children prescribed an antibiotic in the intervention group (medAL-mentor) as compared to the control group (routine mentoring) [Day 0 (by the end of the consultation)]
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

Secondary Outcome Measures

Percentage of consultations with eligible children performed using ePOCT+ [Day 0 (by the end of the consultation)]
Number of consultations completed with ePOCT+, over all consultations with eligible children as reported in a routine registry
Percentage of children in whom key signs have been checked by healthcare workers [Day 0 (by the end of the consultation)]
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+
Percentage of children for whom appropriate diagnostic tests have been performed by healthcare workers [Day 0 (by the end of the consultation)]
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+

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country
1	Idiga Dispensary	Idiga	Mbeya	Tanzania
2	Igoma Dispensary	Igoma	Mbeya	Tanzania
3	Lwanjilo Dispensary	Ilowelo	Mbeya	Tanzania
4	Inyala Health Center	Inyala	Mbeya	Tanzania
5	Iwindi Dispensary	Iwindi	Mbeya	Tanzania
6	Kimondo Dispensary	Kimondo	Mbeya	Tanzania
7	Mbalizi Dispensary	Mbalizi	Mbeya	Tanzania
8	Mjele Dispensary	Mjele	Mbeya	Tanzania
9	Mshewe Dispensary	Mjele	Mbeya	Tanzania
10	Mwabwowo Dispensary	Mwabwowo	Mbeya	Tanzania
11	Santilya Health Center	Santilya	Mbeya	Tanzania
12	Shuwa Dispensary	Shuwa	Mbeya	Tanzania
13	Songwe viwandani Dispensary	Songwe	Mbeya	Tanzania
14	Chikuti Dispensary	Chikuti	Morogoro	Tanzania
15	Chirombora Dispensary	Chirombora	Morogoro	Tanzania
16	Chita Rural Dispensary	Chita	Morogoro	Tanzania
17	Idete Dispensary	Idete	Morogoro	Tanzania
18	Idunda Dispensary	Idunda	Morogoro	Tanzania
19	Kibaoni Health Center	Ifakara	Morogoro	Tanzania
20	Michenga Dispensary	Ifakara	Morogoro	Tanzania
21	Sagamaganga Dispensary	Ifakara	Morogoro	Tanzania
22	Ketaketa Dispensary	Ketaketa	Morogoro	Tanzania
23	Kichangani Dispensary	Kichangani	Morogoro	Tanzania
24	Kisegese Dispensary	Kisegese	Morogoro	Tanzania
25	Mbuga Dispensary	Mbuga	Morogoro	Tanzania
26	Milola Dispensary	Milola	Morogoro	Tanzania
27	Mngeta Health Center	Mngeta	Morogoro	Tanzania
28	Sanje Dispensary	Sanje	Morogoro	Tanzania
29	Sonjo Dispensary	Sonjo	Morogoro	Tanzania
30	Udagaji Dispensary	Udagaji	Morogoro	Tanzania
31	Utengule Dispensary	Utengule	Morogoro	Tanzania
32	Isyesye Dispensary	Mbeya		Tanzania
33	Itagano Dispensary	Mbeya		Tanzania
34	Itensa Dispensary	Mbeya		Tanzania
35	Itezi Dispensary	Mbeya		Tanzania
36	Itijy Dispensary	Mbeya		Tanzania
37	Iyunga Health Center	Mbeya		Tanzania
38	Ndanyela Dispensary	Mbeya		Tanzania
39	Nzovwe Health Center	Mbeya		Tanzania
40	Tembela Dispensary	Mbeya		Tanzania

Sponsors and Collaborators

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Swiss Tropical & Public Health Institute
Ifakara Health Institute
Mbeya Medical Research Centre-National Institute for Medical Research