Multicenter Blood Culture Quality Improvement
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bacteremia |
Other: Blood Culture QI Program |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Multicenter Implementation of a Quality Improvement Program to Reduce Blood Culture Contamination in the Emergency Department |
- Biweekly proportion of ED blood cultures contaminated [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 33000 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Blood Culture QI Program |
Other: Blood Culture QI Program
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 Name: ChloraPrep
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Wesley H Self, MD | 615-936-0253 | wesley.self@vanderbilt.edu |
| Contact: Laurie A. Hawkins, MSHS, CCRP | 615-936-8053 | laurie.a.hawkins@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt Emergency Medicine | Recruiting |
| Nashville, Tennessee, United States, 37232-4700 | |
| Principal Investigator: Wesley H Self, MD, MPH | |
| Vanderbilt University Medical Center Emergency Medicine | Recruiting |
| Nashville, Tennessee, United States, 37232-4700 | |
| Contact: Wesley H Self, MD 615-936-0253 wes.self@vanderbilt.edu | |
| Contact: Laurie A Hawkins, BS, CCRP 615-936-8053 laurie.a.hawkins@vanderbilt.edu | |
| Principal Investigator: Wesley H Self, MD | |
| Principal Investigator: | Wesley H. Self, MD, MPH | Vanderbilt University |
More Information
Publications:
| Responsible Party: | Wesley H. Self, MD, MPH, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01413555 History of Changes |
| Other Study ID Numbers: | VHRPP - 101722 |
| Study First Received: | August 8, 2011 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
blood culture emergency department quality improvement |
Additional relevant MeSH terms:
|
Bacteremia Bacterial Infections Sepsis Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013