Implementation of Smart Triage combined with a quality improvement program for children presenting to facilities in Kenya and Uganda: An interrupted time series analysis.

PLOS DH (298/300 word limit) Sepsis occurs predominantly in low-middle-income countries. Sub-optimal triage contributes to poor early case recognition and outcomes from sepsis. We evaluated the impact of Smart Triage using improved time to intravenous antimicrobial administration in a multisite interventional study. Smart Triage was implemented (with control sites) in Kenya (February 2021-December 2022) and Uganda (April 2020-April 2022). Children presenting to the outpatient departments with an acute illness were enrolled. A controlled interrupted time series was used to assess the effect on time from arrival at the facility to intravenous antimicrobial administration. Secondary analyses included antimicrobial use, admission rates and mortality ([NCT04304235][1]). During the baseline period, the time to antimicrobials decreased significantly in Kenya (132 and 58 minutes) at control and intervention sites, but less in Uganda (3 minutes) at the intervention site. Then, during the implementation period in Kenya, the time to IVA at the intervention site decreased by 98 min (57%, 95% CI 81-114) but increased by 49 min (21%, 95% CI: 23-76) at the control site. In Uganda, the time to IVA initially decreased but was not sustained, and there was no significant difference between intervention and control sites. At the intervention sites, there was a significant reduction in IVA utilization of 47% (Kenya) and 33% (Uganda), a reduction in admission rates of 47% (Kenya) and 33% (Uganda) and a 25% (Kenya) and 75% (Uganda) reduction in mortality rates compared to the baseline period. We showed significant improvements in time to intravenous antibiotics in Kenya but not Uganda, likely due to COVID-19, a short study period and resource constraints. The reduced antimicrobial use and admission and mortality rates are remarkable and welcome benefits but should be interpreted cautiously as these were secondary outcomes. This study underlines the difficulty of implementing technologies and sustaining quality improvement in resource-poor health systems. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04304235 ### Clinical Protocols ### Funding Statement Yes ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics approval was obtained from Makerere University School of Public Health (MUSPH) Institutional Review Board (IRB00011353). The Ugandan National Council for Science and Technology (UNCST) (HS528ES) in Uganda provided approval for study activities to be conducted at Jinja Regional Referral Hospital and Gulu Regional Referral Hospital. The KEMRI Scientific and Ethics Review Unit (SERU) (KEMRI/SERU/CGMR-C/183/3958) provided approval for the study activities to be conducted at Mbagathi County Hospital and Kiambu County Hospital in Kenya. The study was also approved by the University of British Columbia Research Ethics Board in Canada (H19-02398-A006). The trial was registered on Clinical Trials.gov. Identifier: [NCT04304235][1], Registered 11 March 2020. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Study materials (protocol, data collection tools, data dictionary, software, analysis code, and metadata) are publicly available through the Pediatric Sepsis Data CoLaboratory’s (Sepsis CoLab) Dataverse on https://borealisdata.ca/dataverse/ST\_implementation . Due to the sensitive nature of clinical data and the potential risk for re-identification of research participants, the de-identified dataset is available through moderated access on the Sepsis CoLab Dataverse on https://borealisdata.ca/dataverse/ST\_implementation and through the KWTRP Research Data Repository Dataverse https://kemri-wellcome.org/dataverse/. Access to these data will be granted on a case-by-case basis following approval from the authors and the Data Governance Committees. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04304235&atom=%2Fmedrxiv%2Fearly%2F2024%2F02%2F11%2F2024.02.09.24302601.atom