Smart Discharges to improve post-discharge health outcomes in children in Rwanda

<p><strong>Background:</strong> The Smart Discharges studies in Uganda have enrolled over 10,000 children under-five with sepsis and have shown that death after hospital discharge occurs in 5-8% of patients, which is as common as death during the primary admission. The Smart Discharges evidence-based risk-prediction tool guides clinical interventions focused on education and post-discharge follow-up and improves healthcare-seeking behaviors and essential medical interventions among vulnerable children. Most importantly, these studies have preliminarily demonstrated that the prediction tool paired with these clinical interventions may substantially reduce post-discharge mortality up to 20-30%; however, these findings have not been validated outside of Uganda. The Smart Discharges project is now ready to expand the project borders and begin external validation research of the prediction tool in Rwanda. <br> <br><strong>Objective(s):</strong> This study aims to: (1) characterize the epidemiology of post-discharge mortality among a representative cohort of 1000 children under 5 years of age from two hospitals in Rwanda; and (2) externally validate the Smart Discharges risk-prediction tool in a representative cohort of children from Rwanda. <br> <br><strong>Methods:</strong> This study is a prospective observational cohort study that will be conducted between February 2022 and May 2023 at 2 hospitals in Northern and Central Rwanda, the University Teaching Hospital of Kigali (CHUK) in Nyarugenge District and Ruhengeri Referral Hospital in Musanze District. The study will enroll 1,000 children under 5 years of age between the two study sites. Following enrollment a research nurse will obtain and record clinical and demographic variables required for model validation including vital signs, oxygen saturation, anthropometric data, prior care seeking, co-morbidities and diagnoses. A rapid diagnostic test using blood, which will require a finger prick to collect < 0.5ml of blood, will be conducted to assess the patient's HIV status, malaria parasitemia, lactate, and hemoglobin (hemocue). All enrolled children will receive phone follow-up from study staff at 2-, 4- and 6 months following hospital discharge for research purposes. Verbal autopsies, often used in this context to determine cause of death, will be conducted for all children who die following discharge.<br> <br><strong>Ethics Declaration:</strong> Institutional review boards at the University of British Columbia (H21-02795), the University of California San Francisco (21-34663), the University Teaching Hospital of Kigali (EC/CHUK/1/005/2022), and the University of Uganda (No 573/CMHS IRB/2022) approved the study.</p>