Effect of a tailored sepsis treatment protocol on patient outcomes in the Tikur Anbessa Specialized Hospital, Ethiopia: results of an interrupted time series analysis.

Abstract

Background: Despite improvement, sepsis mortality rates remain high, with an estimated 11 million sepsis-related deaths globally in 2017 (Rudd et. al, Lancet 395:200-211, 2020). Low- and middle-income countries (LMICs) are estimated to account for 85% of global sepsis mortality; however, evidence for improved sepsis mortality in LMICs is lacking. We aimed to improve sepsis care and outcomes through development and evaluation of a sepsis treatment protocol tailored to the Tikur Anbessa Specialized Hospital Emergency Department, Ethiopia, context.

Methods: We employed a mixed methods design, including an interrupted times series study, pre-post knowledge testing, and process evaluation. The primary outcome was the proportion of patients receiving appropriate sepsis care (blood culture collection before antibiotics and initiation of appropriate antibiotics within 1 h of assessment). Secondary outcomes included time to antibiotic administration, 72-h sepsis mortality, and 90-day all-cause mortality. Due to poor documentation, we were unable to assess our primary outcome and time to antibiotic administration. We used segmented regression with outcomes as binomial proportions to assess the impact of the intervention on mortality. Pre-post knowledge test scores were analyzed using the Student's t-test to compare group means for percentage of scenarios with correct diagnosis.

Results: A total of 113 and 300 patients were enrolled in the pre-implementation and post-implementation phases respectively. While age and gender were similar across the phases, a higher proportion (31 vs. 57%) of patients had malignancies in the post-implementation phase. We found a significant change in trend between the phases, with a trend for increasing odds of survival in the pre-implementation phase (OR 1.24, 95% CI 0.98-1.56), and a shift down, with odds of survival virtually flat (OR 0.95, 95% CI. 0.88-1.03) in the post-implementation phases for 72-h mortality, and trends for survival pre- and post-implementation are virtually flat for 90-day mortality. We found no significant difference in pre-post knowledge test scores, with interpretation limited by response rate. Implementation quality was negatively impacted by resource challenges.

Conclusion: We found no improvement in sepsis outcomes, with a trend for increasing odds of survival lost post-implementation and no significant change in knowledge pre- and post-implementation. Variable availability of resources was the principal barrier to implementation.

Trial registration: Open Science Framework osf.io/ju4ga . Registered June 28, 2017.