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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04782011
Study type Interventional
Source Makerere University
Contact Hanifah Nantongo, MSc
Phone +256773413926
Email hanyfah24@gmail.com
Status Not yet recruiting
Phase N/A
Start date March 2021
Completion date November 2021