De-implementation strategy to reduce unnecessary antibiotic prescriptions for ambulatory HIV-infected patients with upper respiratory tract infections in Mozambique: a study protocol of a cluster randomized controlled trial

• Published in: Implementation science : IS Vol. 19; no. 1; pp. 51 - 10
• Main Authors: Faiela, Candido, Moon, Troy D, Sidat, Mohsin, Sevene, Esperança
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 16.07.2024; BioMed Central; BMC
• Subjects: Acute respiratory infections; Adaptation; Adult; Algorithms; Ambulatory Care - methods; Ambulatory Care - organization & administration; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antibiotics; Antimicrobial stewardship; Bacterial infections; Clinical decision making; Clinical decision support tool; Clinical trials; Computerized physician order entry; De-implementation; Decision Support Systems, Clinical; Drug therapy; Evidence-based medicine; Feedback; Female; Health aspects; Health care; Health facilities; HIV; HIV (Viruses); HIV infection; HIV Infections - drug therapy; Human immunodeficiency virus; Humans; Implementation Science; Inappropriate Prescribing - prevention & control; Inappropriate Prescribing - statistics & numerical data; Infection; Infections; Intervention; Low income groups; Male; Medical research; Medicine, Experimental; Mozambique; Multicenter Studies as Topic; Patients; Practice Patterns, Physicians' - statistics & numerical data; Prescription writing; Prescriptions; Primary health care; Primary Health Care - organization & administration; Protocol; Randomized Controlled Trials as Topic; Respiratory Tract Infections - drug therapy; Study Protocol; Workers; Mozambique; Clinical decision support tool; Mozambique; HIV; Implementation science; Acute respiratory infections; Antimicrobial stewardship; De-implementation; Protocol
• ISSN: 1748-5908; 1748-5908
• DOI: 10.1186/s13012-024-01382-8

Antibiotics are globally overprescribed for the treatment of upper respiratory tract infections (URTI), especially in persons living with HIV. However, most URTIs are caused by viruses, and antibiotics are not indicated. De-implementation is perceived as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excessive or inappropriate antibiotic use for URTI, through the employment of evidence-based interventions to reduce these practices. Research into strategies that lead to successful de-implementation of unnecessary antibiotic prescriptions within the primary health care setting is limited in Mozambique. In this study, we propose a protocol designed to evaluate the use of a clinical decision support algorithm (CDSA) for promoting the de-implementation of unnecessary antibiotic prescriptions for URTI among ambulatory HIV-infected adult patients in primary healthcare settings. This study is a multicenter, two-arm, cluster randomized controlled trial, involving six primary health care facilities in Maputo and Matola municipalities in Mozambique, guided by an innovative implementation science framework, the Dynamic Adaption Process. In total, 380 HIV-infected patients with URTI symptoms will be enrolled, with 190 patients assigned to both the intervention and control arms. For intervention sites, the CDSAs will be posted on either the exam room wall or on the clinician´s exam room desk for ease of reference during clinical visits. Our sample size is powered to detect a reduction in antibiotic use by 15%. We will evaluate the effectiveness and implementation outcomes and examine the effect of multi-level (sites and patients) factors in promoting the de-implementation of unnecessary antibiotic prescriptions. The effectiveness and implementation of our antibiotic de-implementation strategy are the primary outcomes, whereas the clinical endpoints are the secondary outcomes. This research will provide evidence on the effectiveness of the use of the CDSA in promoting the de-implementation of unnecessary antibiotic prescribing in treating acute URTI, among ambulatory HIV-infected patients. Findings will bring evidence for the need to scale up strategies for the de-implementation of unnecessary antibiotic prescription practices in additional healthcare sites within the country. ISRCTN, ISRCTN88272350. Registered 16 May 2024, https://www.isrctn.com/ISRCTN88272350.