Clinical trial NCT05901155: Impact of a Real-time Mentoring Tool on Antibiotic Prescription (medAL-mentor)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Health Care for Children
Keywords: Digital health
Antibiotic stewardship
Real-time mentoring
Benchmarking
Clinical decision support algorithm
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Tropical & Public Health Institute
name: Ifakara Health Institute
name: Mbeya Medical Research Centre-National Institute for Medical Research
First posted: 2023-06-13
Enrollment: 37000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of children prescribed an antibiotic in the intervention group (medAL-mentor) as compared to the control group (routine mentoring)
timeFrame: Day 0 (by the end of the consultation)
Secondary outcomes:
measure: Percentage of consultations with eligible children performed using ePOCT+
timeFrame: Day 0 (by the end of the consultation)
measure: Percentage of children in whom key signs have been checked by healthcare workers
timeFrame: Day 0 (by the end of the consultation)
measure: Percentage of children for whom appropriate diagnostic tests have been performed by healthcare workers
timeFrame: Day 0 (by the end of the consultation)
Other outcomes:
Locations:
city: Idiga
country: Tanzania
facility: Idiga Dispensary
state: Mbeya
city: Igoma
country: Tanzania
facility: Igoma Dispensary
state: Mbeya
city: Ilowelo
country: Tanzania
facility: Lwanjilo Dispensary
state: Mbeya
city: Inyala
country: Tanzania
facility: Inyala Health Center
state: Mbeya
city: Iwindi
country: Tanzania
facility: Iwindi Dispensary
state: Mbeya
city: Kimondo
country: Tanzania
facility: Kimondo Dispensary
state: Mbeya
city: Mbalizi
country: Tanzania
facility: Mbalizi Dispensary
state: Mbeya
city: Mjele
country: Tanzania
facility: Mjele Dispensary
state: Mbeya
city: Mjele
country: Tanzania
facility: Mshewe Dispensary
state: Mbeya
city: Mwabwowo
country: Tanzania
facility: Mwabwowo Dispensary
state: Mbeya
city: Santilya
country: Tanzania
facility: Santilya Health Center
state: Mbeya
city: Shuwa
country: Tanzania
facility: Shuwa Dispensary
state: Mbeya
city: Songwe
country: Tanzania
facility: Songwe viwandani Dispensary
state: Mbeya
city: Chikuti
country: Tanzania
facility: Chikuti Dispensary
state: Morogoro
city: Chirombora
country: Tanzania
facility: Chirombora Dispensary
state: Morogoro
city: Chita
country: Tanzania
facility: Chita Rural Dispensary
state: Morogoro
city: Idete
country: Tanzania
facility: Idete Dispensary
state: Morogoro
city: Idunda
country: Tanzania
facility: Idunda Dispensary
state: Morogoro
city: Ifakara
country: Tanzania
facility: Kibaoni Health Center
state: Morogoro
city: Ifakara
country: Tanzania
facility: Michenga Dispensary
state: Morogoro
city: Ifakara
country: Tanzania
facility: Sagamaganga Dispensary
state: Morogoro
city: Ketaketa
country: Tanzania
facility: Ketaketa Dispensary
state: Morogoro
city: Kichangani
country: Tanzania
facility: Kichangani Dispensary
state: Morogoro
city: Kisegese
country: Tanzania
facility: Kisegese Dispensary
state: Morogoro
city: Mbuga
country: Tanzania
facility: Mbuga Dispensary
state: Morogoro
city: Milola
country: Tanzania
facility: Milola Dispensary
state: Morogoro
city: Mngeta
country: Tanzania
facility: Mngeta Health Center
state: Morogoro
city: Sanje
country: Tanzania
facility: Sanje Dispensary
state: Morogoro
city: Sonjo
country: Tanzania
facility: Sonjo Dispensary
state: Morogoro
city: Udagaji
country: Tanzania
facility: Udagaji Dispensary
state: Morogoro
city: Utengule
country: Tanzania
facility: Utengule Dispensary
state: Morogoro
city: Mbeya
country: Tanzania
facility: Isyesye Dispensary
city: Mbeya
country: Tanzania
facility: Itagano Dispensary
city: Mbeya
country: Tanzania
facility: Itensa Dispensary
city: Mbeya
country: Tanzania
facility: Itezi Dispensary
city: Mbeya
country: Tanzania
facility: Itijy Dispensary
city: Mbeya
country: Tanzania
facility: Iyunga Health Center
city: Mbeya
country: Tanzania
facility: Ndanyela Dispensary
city: Mbeya
country: Tanzania
facility: Nzovwe Health Center
city: Mbeya
country: Tanzania
facility: Tembela Dispensary
Study officials:
References:
citation: Ellis J. All inclusive benchmarking. J Nurs Manag. 2006 Jul;14(5):377-83. doi: 10.1111/j.1365-2934.2006.00596.x.
citation: Thonon F, Watson J, Saghatchian M. Benchmarking facilities providing care: An international overview of initiatives. SAGE Open Med. 2015 Sep 23;3:2050312115601692. doi: 10.1177/2050312115601692. eCollection 2015.
citation: Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
citation: Willmington C, Belardi P, Murante AM, Vainieri M. The contribution of benchmarking to quality improvement in healthcare. A systematic literature review. BMC Health Serv Res. 2022 Feb 2;22(1):139. doi: 10.1186/s12913-022-07467-8.
citation: Piccoliori G, Mahlknecht A, Abuzahra ME, Engl A, Breitenberger V, Vogele A, Montalbano C, Sonnichsen A. Quality improvement in chronic care by self-audit, benchmarking and networking in general practices in South Tyrol, Italy: results from an interventional study. Fam Pract. 2021 Jun 17;38(3):253-258. doi: 10.1093/fampra/cmaa123.
citation: Hermans MP, Elisaf M, Michel G, Muls E, Nobels F, Vandenberghe H, Brotons C; OPTIMISE International Steering Committee. Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial. Diabetes Care. 2013 Nov;36(11):3388-95. doi: 10.2337/dc12-1853. Epub 2013 Jul 11.
citation: Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.