Clinical trial NCT01413555: Multicenter Blood Culture Quality Improvement
Official title: Multicenter Implementation of a Quality Improvement Program to Reduce Blood Culture Contamination in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteremia
Keywords: blood culture
emergency department
quality improvement
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Community Health Network
name: CareFusion
First posted: 2011-08-10
Enrollment: 14889
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: False positive blood culture results due to specimen contamination with bacteria inhabiting patients' skin is a common problem in emergency departments (EDs) in the United States. Contaminated blood cultures lead to patient harm through unnecessary hospitalizations and ED visits, delays in surgery, unneeded antibiotics, and unnecessary procedures. The investigators have developed a multifaceted quality improvement improvement bundle (The Blood Culture QI Program) designed to minimize blood culture contamination in the ED. In this study, the investigators will implement the quality improvement bundle in six community hospital EDs and evaluate its effectiveness at reducing contamination.

Detailed description: The Blood Culture QI Program has four components: (1) education: content knowledge and standardized experiential training on sterile technique designed for ED nurses; (2) process redesign: change in patient safety attitude and conversion of blood culture collection from a clean to a sterile technique; (3) checklist use: reinforcement of optimal blood culture collection technique at the point of care; (4) feedback: systematic charting and reporting of contamination rates to the ED nurses who collect cultures. In order to convert blood culture collection into a fully sterile procedure, the investigators developed the Sterile Blood Culture Collection Kit, a novel materials kit that contains the equipment needed to collect a culture using sterile technique, including: (1) a 3ml solution of 2% chlorhexidine gluconate - 70% isopropyl alcohol (Chloraprep, CareFusion) skin prep device; (2) a sterile drape; (3) a sterile needle; and (4) gauze.

The investigators will evaluate the effectiveness of the Blood Culture QI Program after implementing it in six community hospital EDs. Our study will compromise six replications of an interrupted time series study wherein each replication will be powered for internal validity to test the hypothesis of decreasing the contamination rate by 50% at each site. A stepped wedge (also called multiple baseline) design will be used to implement the program across hospitals to evaluate the generalizability (external validity) of program effectiveness. The primary analysis will be an interrupted time series analysis at each site comparing the proportion of ED blood cultures contaminated during a post-implementation intervention period with a pre-intervention baseline period.

Eligibility criteria: Inclusion Criteria:

* Patients who have a blood culture ordered for clinical purposes in one of the participating centers during the study period.

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: Biweekly proportion of ED blood cultures contaminated
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Emergency Medicine
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Emergency Medicine
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Wesley H. Self, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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