Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 16; no. 1; p. 141
• Main Authors: Green, Eric P, Catalani, Caricia, Diero, Lameck, Carter, E Jane, Gardner, Adrian, Ndwiga, Charity, Keny, Aggrey, Owiti, Philip, Israelski, Dennis, Biondich, Paul
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 09.04.2015; BioMed Central
• Subjects: Acquired immune deficiency syndrome; Adults; AIDS; Antitubercular agents; Antitubercular Agents - therapeutic use; Clinical Protocols; Clinical trials; Coinfection - prevention & control; Comparative analysis; Complications and side effects; Decision Support Techniques; Dosage and administration; Drug Prescriptions; Drug therapy; Drugs; Electronic Health Records; Health aspects; HIV; HIV (Viruses); HIV Infections - diagnosis; HIV Infections - epidemiology; HIV Infections - therapy; Human immunodeficiency virus; Humans; Isoniazid - therapeutic use; Kenya - epidemiology; Medical records; Medicine, Preventive; Methods; Practice Patterns, Physicians; Prescribing; Preventive health services; Reminder Systems; Research Design; Study Protocol; Technology application; Treatment Outcome; Tuberculosis; Tuberculosis - diagnosis; Tuberculosis - epidemiology; Tuberculosis - prevention & control; Kenya
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-015-0558-8

This document describes a research protocol for a study designed to estimate the impact of implementing a reminder system for medical providers on the use of isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya. People living with HIV have a 5% to 10% annual risk of developing active tuberculosis (TB) once infected with TB bacilli, compared to a 5% lifetime risk in HIV-negative people with latent TB infection. Moreover, people living with HIV have a 20-fold higher risk of dying from TB. A growing body of literature suggests that IPT reduces overall TB incidence and is therefore of considerable benefit to patients and the larger community. However, in 2009, of the estimated 33 million people living with HIV, only 1.7 million (5%) were screened for TB, and about 85,000 (0.2%) were offered IPT. This study will examine the use of clinical decision-support reminders to improve rates of initiation of preventative treatment in a TB/HIV co-morbid population living in a TB endemic area. This will be a pragmatic, parallel-group, cluster-randomized superiority trial with a 1:1 allocation to treatment ratio. For the trial, 20 public medical facilities that use clinical summary sheets generated from an electronic medical records system will participate as clusters. All HIV-positive adult patients who complete an initial encounter at a study cluster and at least one return encounter during the study period will be included in the study cohort. The primary endpoint will be IPT prescription at 3 months post the initial encounter. We will conduct both individual-level and cluster-level analyses. Due to the nature of the intervention, the trial will not be blinded. This study will contribute to the growing evidence base for the use of electronic health interventions in low-resource settings to promote high-quality clinical care, health system optimization and positive patient outcomes. Trial registration ClinicalTrials.gov NCT01934309, registered 29 August 2013.