Multicenter Blood Culture Quality Improvement
Primary Purpose
Bacteremia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Culture QI Program
Sponsored by
About this trial
This is an interventional prevention trial for Bacteremia focused on measuring blood culture, emergency department, quality improvement
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
Sites / Locations
- Vanderbilt Emergency Medicine
- Vanderbilt University Medical Center Emergency Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood Culture QI Program
Arm Description
Outcomes
Primary Outcome Measures
Biweekly proportion of ED blood cultures contaminated
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01413555
First Posted
August 8, 2011
Last Updated
June 2, 2015
Sponsor
Vanderbilt University
Collaborators
Community Health Network, CareFusion
1. Study Identification
Unique Protocol Identification Number
NCT01413555
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Community Health Network, CareFusion
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
blood culture, emergency department, quality improvement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14889 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood Culture QI Program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood Culture QI Program
Other Intervention Name(s)
ChloraPrep
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biweekly proportion of ED blood cultures contaminated
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley H. Self, MD, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Emergency Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-4700
Country
United States
Facility Name
Vanderbilt University Medical Center Emergency Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-4700
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17021063
Citation
Archibald LK, Pallangyo K, Kazembe P, Reller LB. Blood culture contamination in Tanzania, Malawi, and the United States: a microbiological tale of three cities. J Clin Microbiol. 2006 Dec;44(12):4425-9. doi: 10.1128/JCM.01215-06. Epub 2006 Oct 4.
Results Reference
background
PubMed Identifier
12585951
Citation
Norberg A, Christopher NC, Ramundo ML, Bower JR, Berman SA. Contamination rates of blood cultures obtained by dedicated phlebotomy vs intravenous catheter. JAMA. 2003 Feb 12;289(6):726-9. doi: 10.1001/jama.289.6.726.
Results Reference
background
PubMed Identifier
17761739
Citation
Qamruddin A, Khanna N, Orr D. Peripheral blood culture contamination in adults and venepuncture technique: prospective cohort study. J Clin Pathol. 2008 Apr;61(4):509-13. doi: 10.1136/jcp.2007.047647. Epub 2007 Aug 30.
Results Reference
background
PubMed Identifier
1984535
Citation
Bates DW, Goldman L, Lee TH. Contaminant blood cultures and resource utilization. The true consequences of false-positive results. JAMA. 1991 Jan 16;265(3):365-9.
Results Reference
background
PubMed Identifier
10460041
Citation
Little JR, Murray PR, Traynor PS, Spitznagel E. A randomized trial of povidone-iodine compared with iodine tincture for venipuncture site disinfection: effects on rates of blood culture contamination. Am J Med. 1999 Aug;107(2):119-25. doi: 10.1016/s0002-9343(99)00197-7.
Results Reference
background
PubMed Identifier
19171686
Citation
Gander RM, Byrd L, DeCrescenzo M, Hirany S, Bowen M, Baughman J. Impact of blood cultures drawn by phlebotomy on contamination rates and health care costs in a hospital emergency department. J Clin Microbiol. 2009 Apr;47(4):1021-4. doi: 10.1128/JCM.02162-08. Epub 2009 Jan 26.
Results Reference
background
PubMed Identifier
9650937
Citation
Souvenir D, Anderson DE Jr, Palpant S, Mroch H, Askin S, Anderson J, Claridge J, Eiland J, Malone C, Garrison MW, Watson P, Campbell DM. Blood cultures positive for coagulase-negative staphylococci: antisepsis, pseudobacteremia, and therapy of patients. J Clin Microbiol. 1998 Jul;36(7):1923-6. doi: 10.1128/JCM.36.7.1923-1926.1998.
Results Reference
background
PubMed Identifier
17219512
Citation
Zwang O, Albert RK. Analysis of strategies to improve cost effectiveness of blood cultures. J Hosp Med. 2006 Sep;1(5):272-6. doi: 10.1002/jhm.115.
Results Reference
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