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| Name | Class |
|---|---|
| Swedish International Development Cooperation Agency (SIDA) | OTHER_GOV |
| Mbarara University of Science and Technology | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanifah Nantongo, MSc | Contact | +256773413926 | +256773413926 | hanyfah24@gmail.com |
| Hanifah Nantongo, MSc | Contact | +256702029996 | hnantongo@must.ac.ug |
| Name | Affiliation | Role |
|---|---|---|
| Jackson Mukonzo, PhD | Makerere University | Study Director |
| Vincent Batwala, PhD | Mbarara University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanifah Nantongo | Mbarara | Uganda |
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I do not intend to share the data
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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.
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Being a feasibility study that will use patient records, no blinding will be done.
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