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Completed

NCT Number: NCT01413555

Multicenter Blood Culture Quality Improvement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Emergency Medicine, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Culture QI Program

Other

The Blood Culture QI Program contains four components:(1) education: content knowledge and standardized experiential training on sterile technique designed for ED nurses; (2) process redesign: conversion of blood culture collection from a clean to a sterile technique using the Blood Culture Sterile Kit; (3) a checklist outlining optimal use of the Kit; (4) feedback of blood culture contamination rates to ED nurses who collect them.

Other names: ChloraPrep

Primary outcomes

  1. Biweekly proportion of ED blood cultures contaminated

    Time frame: 1 year

    In an interrupted time series design, we will compare the proportion of blood cultures contaminated during an intervention period after the implementation of the Blood Culture QI Program to a baseline period before implementation. We will complete six separate interrupted time series analyses with one at each of six hospitals. The intervention and baseline period duration will be approximately one year at each hospital.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • C. R. Bard
  • Community Health Network

Registry information

Official study title

Multicenter Implementation of a Quality Improvement Program to Reduce Blood Culture Contamination in the Emergency Department

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2011
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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