A multifaceted educational intervention improved anti-infectious measures but had no effect on mortality in patients with severe sepsis

Abstract

Sepsis is a major reason for preventable hospital deaths. A cluster-randomized controlled trial on an educational intervention did not show improvements of sepsis management or outcome. We now aimed to test an improved implementation strategy in a second intervention phase in which new intervention hospitals (former controls) received a multifaceted educational intervention, while controls (former intervention hospitals) only received feedback of quality indicators. Changes in outcomes from the first to the second intervention phase were compared between groups using hierarchical generalized linear models controlling for possible confounders. During the two phases, 19 control hospitals included 4050 patients with sepsis and 21 intervention hospitals included 2526 patients. 28-day mortality did not show significant changes between study phases in both groups. The proportion of patients receiving antimicrobial therapy within one hour increased in intervention hospitals, but not in control hospitals. Taking at least two sets of blood cultures increased significantly in both groups. During phase 2, intervention hospitals showed higher proportion of adequate initial antimicrobial therapy and de-escalation within 5 days. A survey among involved clinicians indicated lacking resources for quality improvement. Therefore, quality improvement programs should include all elements of sepsis guidelines and provide hospitals with sufficient resources for quality improvement.Trial registration: ClinicalTrials.gov, NCT01187134. Registered 23 August 2010, https://www.clinicaltrials.gov/ct2/show/study/NCT01187134 .

Figure 1

Inclusion of hospitals and patients.

Figure 2

Difference-in-differences analysis of primary and secondary outcomes. Analyses based on data of 40 participating hospitals. Adjusted odds-ratios and p-values result from hierarchical generalized linear models with a logit link adjusted for the covariates age, sex, origin of infection, focus of infection, location at onset of infection and vasopressor use during the first 12 h. Difference-in-differences tested by an interaction effect between study phase and group (control vs. intervention). No. of patients gives the number of cases with complete data both on outcome and confounders compared to the total number of cases were the respective outcome was measured. Intraclass correlations (ICC): 28-day-mortality, ICC = 0.02; Antimicrobial therapy before ODF or within 1 h, ICC = 0.08; Antimicrobial therapy within 1 h after ODF, ICC = 0.04; At least 2 sets of blood cultures, ICC = 0.06; Blood cultures before beginning of antimicrobial therapy, ICC = 0.08; Surgical source control before ODF or within 6 h, ICC = 0.05; Surgical source control after ODF within 6 h, ICC = 0.03. ODF: Organ dysfunction. Data on phase 1 have been previously published.

Figure 3

Comparison between groups during phase 2 of the trial regarding appropriateness and de-escalation of antimicrobial therapy. Analyses based on data of 29 participating hospitals. (a) Adjusted odds-ratios and p-values result from hierarchical generalized linear models with a logit link adjusted for the covariates age, sex, origin of infection, focus of infection, location at onset of infection and vasopressor use during the first 12 h. Since definitions of measures were changed between phases, no difference-in-difference analysis was possible. No. of patients gives the number of cases with complete data both on outcome and confounders compared to the total number of cases were the respective outcome was measured. Intraclass correlations (ICC): Appropriate initial antimicrobial therapy, ICC = 0.03; De-escalation within 5 days, ICC = 0.03. (b) Barplot on appropriateness of initial antimicrobial treatment. (c) Barplot on change of antimicrobial treatment within five days after sepsis onset.