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

Antibiotic Utilization Clinical Trial

Official title:

Feasibility of Using the Chemical Classification System/Defined Daily Doses Tool to Monitor Antibiotic Use at Primary Healthcare Facilities in Southwestern Uganda

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04782011
• Other study ID #: SBS-HDREC-564
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: November 2021

Study information

• Verified date: February 2021
• Source: Makerere University
• Contact: Hanifah Nantongo, MSc
• Phone: +256773413926
• Email: hanyfah24[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will evaluate the feasibility of using the ATC/DDD in three districts of Southwestern Uganda. The unit of intervention will be a health facility. Eighteen (18) randomly selected government owned health facilities at levels II, III and IV will be split evenly between the intervention and non intervention arms. Antibiotic prescriptions of new adult (in-patients and ambulatory) patients with antibiotic utilization records from the selected facilities will be enrolled in the study. The intervention is the introduction of the ATC/DDD plus the training on its importance and use by healthcare providers. The facilities selected will be far apart from each other to avoid contamination. Intervention arm: The ATC/DDD tool shall be piloted in all selected facilities of the 3 randomly selected districts of Mbarara, Bushenyi and Kasese. The prescribers at these facilities will be trained about the importance and usability of the ATC/DDD tool. A pre and post assessment of the prescribers understanding of the tool's usability will be done prior to piloting the tool. This will guide the focus of the training and any other necessary support after the training. The trained prescribers will use the latest tool version to evaluate drug utilization of antibiotics (anti-infectives for systemic use) used at their respective facility levels for a period of 6 months. Prescriptions and drug administration reviews will be done in three phases and for 5 days following the National Medical Stores delivery schedule for medicines, that is, shortly after delivery of drugs (phase 1), midway (phase 2) and towards the end of the delivery period (phase 3). The evaluation will involve computation of antibiotic utilization parameters using the latest version of the ATC/DDD by both the trained healthcare providers and an independent research team. Findings will be compared for both groups to ensure implementation infidelity. . Patients and antibiotic utilization records: 1. For inpatients: On the day of patient recruitment, health workers will routinely conduct baseline assessment of the consented patients to obtain data on demographics, clinical conditions and medications. Daily reviews of patients shall be conducted as routinely done by the clinicians until discharge, referral, death or loss to follow-up. A data extraction template will then be used to capture both baseline and daily follow-up patient information . Medication data will be obtained from the patient's hospital file (clinical notes, treatment sheets and drug administration charts), dispensing records of ward units, pill count validation of a patient's oral medication (capsules, tablets,) and of unused injectable medicine vials or ampoules in the possession of the patient or the caregiver. This will be done on a daily basis. 2. For ambulatory patients: Only prescription data will be obtained from Out-patient Department (OPD) registers, dispensing logs and/or patients' charts using a data extraction template. Non-intervention arm: These will continue with the standard practice. However, the research team will collect data during the respective phases highlighted in the intervention arm for computation using the latest version of the ATC/DDD tool and comparison.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1406
• Est. completion date: November 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

3. Patients: New male and female adult patients (18 years and above) receiving antibiotic medication will be enrolled.

4. Antibiotic utilization records: Antibiotic prescriptions and administration charts for new patients at selected health facilities.

Exclusion Criteria:

1. Patients: Those who are too sick to cooperate

2. Prescriptions: Ineligible prescriptions and the prescriber cannot be reached for clarifications.

Related Conditions & MeSH terms

• Antibiotic Utilization
• ATC/DDD

Intervention

Behavioral:
• ATC/DDD
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.

Locations

Country	Name	City	State
Uganda	Hanifah Nantongo	Mbarara

Sponsors (3)

Lead Sponsor	Collaborator
Makerere University	Mbarara University of Science and Technology, Swedish International Development Cooperation Agency (SIDA)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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