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

NCT05901155 | Completed

• 1 other identifier: 2020-02800_substudymedalmentor
• Study Type: interventional
• Target: 37,000
• Locations: 1 country
• Sites: 40

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.

Conditions

Primary Health Care for Children

Keywords

Digital health; Antibiotic stewardship; Real-time mentoring; Benchmarking; Clinical decision support algorithm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of consultations with eligible children performed using ePOCT+

  Day 0 (by the end of the consultation)

• Percentage of children in whom key signs have been checked by healthcare workers

  Day 0 (by the end of the consultation)

• Percentage of children for whom appropriate diagnostic tests have been performed by healthcare workers

  Day 0 (by the end of the consultation)

Study Arms (2)

MedAL-mentor

EXPERIMENTAL

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

Routine mentoring

NO INTERVENTION

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.

Interventions

MedAL-mentor DEVICE

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).

MedAL-mentor

Eligibility Criteria

• Age: 1 Day - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Presenting for an acute medical or surgical condition

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (40)

Idiga Dispensary

Idiga, Mbeya, Tanzania

Location

Igoma Dispensary

Igoma, Mbeya, Tanzania

Location

Lwanjilo Dispensary

Ilowelo, Mbeya, Tanzania

Location

Inyala Health Center

Inyala, Mbeya, Tanzania

Location

Iwindi Dispensary

Iwindi, Mbeya, Tanzania

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Kimondo Dispensary

Kimondo, Mbeya, Tanzania

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Mbalizi Dispensary

Mbalizi, Mbeya, Tanzania

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Mjele Dispensary

Mjele, Mbeya, Tanzania

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Mshewe Dispensary

Mjele, Mbeya, Tanzania

Location

Mwabwowo Dispensary

Mwabwowo, Mbeya, Tanzania

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Santilya Health Center

Santilya, Mbeya, Tanzania

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Shuwa Dispensary

Shuwa, Mbeya, Tanzania

Location

Songwe viwandani Dispensary

Songwe, Mbeya, Tanzania

Location

Chikuti Dispensary

Chikuti, Morogoro, Tanzania

Location

Chirombora Dispensary

Chirombora, Morogoro, Tanzania

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Chita Rural Dispensary

Chita, Morogoro, Tanzania

Location

Idete Dispensary

Idete, Morogoro, Tanzania

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Idunda Dispensary

Idunda, Morogoro, Tanzania

Location

Kibaoni Health Center

Ifakara, Morogoro, Tanzania

Location

Michenga Dispensary

Ifakara, Morogoro, Tanzania

Location

Sagamaganga Dispensary

Ifakara, Morogoro, Tanzania

Location

Ketaketa Dispensary

Kataketa, Morogoro, Tanzania

Location

Kichangani Dispensary

Kichangani, Morogoro, Tanzania

Location

Kisegese Dispensary

Kisegese, Morogoro, Tanzania

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Mbuga Dispensary

Mbuga, Morogoro, Tanzania

Location

Milola Dispensary

Milola, Morogoro, Tanzania

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Mngeta Health Center

Mngeta, Morogoro, Tanzania

Location

Sanje Dispensary

Sonjo, Morogoro, Tanzania

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Sonjo Dispensary

Sonjo, Morogoro, Tanzania

Location

Udagaji Dispensary

Udagaji, Morogoro, Tanzania

Location

Utengule Dispensary

Utengule, Morogoro, Tanzania

Location

Isyesye Dispensary

Mbeya, Tanzania

Location

Itagano Dispensary

Mbeya, Tanzania

Location

Itensa Dispensary

Mbeya, Tanzania

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Itezi Dispensary

Mbeya, Tanzania

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Itijy Dispensary

Mbeya, Tanzania

Location

Iyunga Health Center

Mbeya, Tanzania

Location

Ndanyela Dispensary

Mbeya, Tanzania

Location

Nzovwe Health Center

Mbeya, Tanzania

Location

Tembela Dispensary

Mbeya, Tanzania

Location

Related Publications (7)

• Ellis J. All inclusive benchmarking. J Nurs Manag. 2006 Jul;14(5):377-83. doi: 10.1111/j.1365-2934.2006.00596.x.

  PMID: 16787472 BACKGROUND

• 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.

  PMID: 26770800 BACKGROUND

• 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.

  PMID: 17173212 BACKGROUND

• 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.

  PMID: 35109824 BACKGROUND

• 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.

  PMID: 33184661 BACKGROUND

• 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.

  PMID: 23846810 BACKGROUND

• 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.

  PMID: 26864410 BACKGROUND

Related Links

• Dynamic study website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 13, 2023
• Study Start: June 5, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 17, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TA (40)