Using the ATC/DDD to Monitor Antibiotic Use at Lower Primary Care Facilities in Southwestern Uganda

NCT04782011 | Unknown

• 1 other identifier: SBS-HDREC-564
• Study Type: interventional
• Target: 1,406
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non blinded two arm cluster randomized control trial, aimed at assessing the feasibility of using the Anatomical Therapeutic Chemical Classification/define Daily Doses system tool to monitor antibiotic use at lower primary levels of care in Uganda.

Conditions

ATC/DDD; Antibiotic Utilization

Keywords

ATC/DDD; Antibiotic utilization; Lower primary care facilities; Southwestern Uganda

Outcome Measures

Primary Outcomes (1)

• Trends in antibiotic utilization for both the intervention and non intervention arms

  Computation of antibiotic utilization parameters across the different facility levels will be done using the latest version of the ATC/DDD tool. Antibiotic use by clinical condition data will be analyzed using working diagnoses that will be classified into diagnostic groups using the latest version of the International Classification of Diseases, Clinical Modification (ICD-10-CM) diagnosis codes as a guide. Findings of both arms will be compared.

  3 months

Study Arms (2)

ATC/DDD arm

EXPERIMENTAL

The intervention is the introduction of the ATC/DDD including the training of healthcare workers on its importance and usage in monitoring antibiotic use. The unit of intervention will be a health facility. Antibiotic prescriptions and antibiotic utilization records for adult patients (in-patients and ambulatory) from the selected facilities will be enrolled in the study.

Behavioral: ATC/DDD

Control arm

NO INTERVENTION

The health care workers will continue with standard practice. However, the research team will collect data on antibiotic prescriptions and antibiotic utilization for adult patients (in-patients and ambulatory) from the selected facilities. The data will be compared with that of the intervention arm.

Interventions

ATC/DDD BEHAVIORAL

The intervention is the introduction of the ATC/DDD including the training on its importance and usage in monitoring antibiotic use at a given primary care facility.

ATC/DDD arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Health facility: The facility will be government owned that receives antibiotics from National Medical Stores using the current schedule and has no ongoing antibiotic use related intervention study.
• Prescribers: Male and female prescribers at primary care facilities in the selected districts of Mbarara, Bushenyi and Kasese will be recruited. Prescribers with an experience of at least 3 months in antibiotic prescribing and inventory at these facilities will be included in the study. These shall be identified through the in-charges of the respective facilities.
• Patients: New male and female adult patients (18 years and above) receiving antibiotic medication will be enrolled.
• Antibiotic utilization records: Antibiotic prescriptions and administration charts for new patients at selected health facilities.

You may not qualify if:

• Patients: Those who are too sick to cooperate
• Prescriptions: Ineligible prescriptions and the prescriber cannot be reached for clarifications.

Sponsors & Collaborators

• Makerere University: lead
• Swedish International Development Cooperation Agency (SIDA): collaborator
• Mbarara University of Science and Technology: collaborator

Study Sites (1)

Hanifah Nantongo

Mbarara, Uganda

Location

Study Officials

• Jackson Mukonzo, PhD

  Makerere University

  STUDY DIRECTOR

• Vincent Batwala, PhD

  Mbarara University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Hanifah Nantongo, MSc

CONTACT

+256773413926; hanyfah24@gmail.com

Hanifah Nantongo, MSc

CONTACT

+256702029996; hnantongo@must.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Being a feasibility study that will use patient records, no blinding will be done.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The number of health facilities will be split evenly between the intervention and non intervention arms. These will be randomly selected in the districts of Mbarara, Bushenyi and Kasese.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)