Search

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

Abstract Background With the global shortage of skilled health workers estimated at 7.2 million, outpatient tuberculosis (TB) care is commonly task-shifted to lay health workers (LHWs) in many low- and middle-income countries where the shortages are greatest. While shown to improve access to care and some health outcomes including TB treatment outcomes, lack of training and supervision limit the effectiveness of LHW programs. Our objective was to refine and evaluate an intervention designed to address common causes of non-adherence to TB treatment and LHW knowledge and skills training needs. Methods We employed a pragmatic cluster randomized controlled trial. Participants included 103 health centres (HCs) providing TB care in four districts in Malawi, randomized 1:1 stratified by district and HC funding (Ministry of Health, non-Ministry funded). At intervention HCs, a TB treatment adherence intervention was implemented using educational outreach, a point-of-care reminder tool, and a peer support network. Clusters in the control arm provided usual care. The primary outcome was the proportion of patients with successful TB treatment (i.e., cure or treatment completion). We used a generalized linear mixed model, with district as a fixed effect and HC as a random effect, to compare proportions of patients with treatment success, among the trial arms, with adjustment for baseline differences. Results We randomized 51 HCs to the intervention group and 52 HCs to the control group. Four intervention and six control HCs accrued no eligible patients, and 371 of 1169 patients had missing outcome, HC, or demographic data, which left 74 HCs and 798 patients for analysis. Randomization group was not related to missing outcome, however, district, age, and TB type were significantly related and included in the primary analysis model. Among the 1153 patients with HC and demographic data, 297/605 (49%) and 348/548 (64%) in the intervention and control arms, respectively, had treatment success. The intervention had no significant effect on treatment success (adjusted odds ratio 1.35 [95% confidence interval 0.93–1.98]). Conclusion We found no significant effect of the intervention on TB treatment outcomes with high variability in implementation quality, highlighting important challenges to both scale-up and sustainability. Trial registration ClinicalTrials.gov NCT02533089 . Registered August 20, 2015.