NCT01413555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,889

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

August 8, 2011

Last Update Submit

June 2, 2015

Conditions

Keywords

blood cultureemergency departmentquality improvement

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (1)

Blood Culture QI Program

EXPERIMENTAL
Other: Blood Culture QI Program

Interventions

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.

Also known as: ChloraPrep
Blood Culture QI Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt Emergency Medicine

Nashville, Tennessee, 37232-4700, United States

Location

Vanderbilt University Medical Center Emergency Medicine

Nashville, Tennessee, 37232-4700, United States

Location

Related Publications (8)

  • 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.

    PMID: 17021063BACKGROUND
  • 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.

    PMID: 12585951BACKGROUND
  • 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.

    PMID: 17761739BACKGROUND
  • 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.

    PMID: 1984535BACKGROUND
  • 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.

    PMID: 10460041BACKGROUND
  • 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.

    PMID: 19171686BACKGROUND
  • 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.

    PMID: 9650937BACKGROUND
  • 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.

    PMID: 17219512BACKGROUND

MeSH Terms

Conditions

BacteremiaEmergencies

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Wesley H. Self, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor, Department of Emergency Medicine

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 10, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations