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.
Highlights
Sepsis is a major reason for preventable hospital deaths
German hospitals involved in the primary care of sepsis patients and committed to participate in a quality improvement process were invited to participate in the trial
We refer to hospitals receiving the intervention in phase 2 as “intervention hospitals”, and to the hospitals acting as controls in phase 2 as “control hospitals”
Summary
A cluster-randomized controlled trial on an educational intervention did not show improvements of sepsis management or outcome. We 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. 19 control hospitals included 4050 patients with sepsis and 21 intervention hospitals included 2526 patients. The proportion of patients receiving antimicrobial therapy within one hour increased in intervention hospitals, but not in control hospitals. During phase 2, intervention hospitals showed higher proportion of adequate initial antimicrobial therapy and de-escalation within 5 days. Quality improvement programs should include all elements of sepsis guidelines and provide hospitals with sufficient resources for quality improvement
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