Multicenter Blood Culture Quality Improvement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Community Health Network
CareFusion
Information provided by (Responsible Party):
Wesley Self, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01413555
First received: August 8, 2011
Last updated: June 11, 2013
Last verified: August 2011
  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

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 2013
Estimated Primary Completion Date: December 2013 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413555

Locations
United States, Tennessee
Vanderbilt Emergency Medicine
Nashville, Tennessee, United States, 37232-4700
Vanderbilt University Medical Center Emergency Medicine
Nashville, Tennessee, United States, 37232-4700
Sponsors and Collaborators
Vanderbilt University
Community Health Network
CareFusion
Investigators
Principal Investigator: Wesley H. Self, MD, MPH Vanderbilt University
  More Information

Publications:

Responsible Party: Wesley Self, Asst Professor, Department of Emergency Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01413555     History of Changes
Other Study ID Numbers: VHRPP - 101722
Study First Received: August 8, 2011
Last Updated: June 11, 2013
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 August 26, 2014