NCT01165398

Brief Summary

An estimated 250,000 cases of central line-associated bloodstream infections occur in US hospitals annually, and an estimated 30,000 to 62,000 patients die as a result, the marginal cost of which to the health-care system is approximately $25,000 per episode. Inconsistent and outdated clinical practices have been identified as key causative factors. In order to improve overall healthcare delivery and outcomes, current and future healthcare professionals need to complement their clinical skills with systems-based skills. Specific to the problems of central lines, during a 2005 chart review of institutional patient safety issues, a LVHN internal quality committee found multiple cases involving the insertion of central lines, including cases involving arterial placement and malposition. The internal quality committee review revealed that newer residents were primarily involved in these cases. As a result of the committee's findings and review of the literature, a standardized Central Line Access and Placement course was designed as part of the incoming residents'orientation process. This study's goal was to contribute to the knowledge-base of health professional education and to build a sustainable model for one set of learning and development interventions, with the expectation that findings will have broad relevance for patient safety initiatives, health professional training and development programs, and healthcare delivery improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

July 12, 2010

Last Update Submit

October 13, 2016

Conditions

Keywords

Educationcentral linesinfectionscomplicationsBundles

Outcome Measures

Primary Outcomes (1)

  • How do variations among course participants in the quality of central line instruction, knowledge of central lines, central line bundle compliance, and other factors relate to the complication and infection rates of their patients?

    To determine the extent to which ratings of faculty teaching performance, central lines knowledge test scores, performance check scores, and bundle compliance scores, along with variables from the operator database (e.g., Job, Program/Unit, Course Date, Approximate Number of Lines Placed, Number of and/or ICU rotations), relate to complication rates and infection rates.

    At time of complication or infection

Secondary Outcomes (2)

  • How does the quality of central line instruction relate to learner attitudes, knowledge, and compliance of the central line bundle?

    At time of complication or infection

  • How have central lines bundle compliance and central line-related complication/infection rates at LVHN changed, and do those changes correspond to changes in policies and practice regarding central lines?

    At time of complication or infection

Study Arms (1)

Residents, PAs, mid level providers

Lehigh Valley Health Network residents, physician assistants, and mid level providers who place central lines and attend the central lines simulation course

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lehigh Valley Health Network residents, physician assistants, and nurse practitioners who place central lines and attend the central lines simulation course

You may qualify if:

  • Lehigh Valley Health Network residents, physician assistants, and nurse practitioners who place central lines and attend the central lines simulation course

You may not qualify if:

  • Those residents, physician assistants, and nurse practitioners who place central lines and attend the central lines simulation course, but do not wish to participate in the audio taped focus groups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (7)

  • AHRQ Awards $3 Million To Help Reduce Central Line-Associated Bloodstream Infections in Hospital ICUs. Press Release, October 1, 2008. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2008/clabipr.htm

    BACKGROUND
  • O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 Aug 9;51(RR-10):1-29.

    PMID: 12233868BACKGROUND
  • Haire WD, Lieberman RP. Defining the risks of subclavian-vein catheterization. N Engl J Med. 1994 Dec 29;331(26):1769-70. doi: 10.1056/NEJM199412293312609. No abstract available.

    PMID: 7605425BACKGROUND
  • Institute of Medicine, Health Profession Education Report. Washington, DC: National Academy Press, 2003.

    BACKGROUND
  • Kirkpatrick, D. Kirkpatrick, J. Evaluating Training Programs: The Four Levels. Third Edition, Berrett-Koehler Publishers, Inc. San Francisco, CA. 2006.

    BACKGROUND
  • Runyon BA. Paracentesis of ascitic fluid. A safe procedure. Arch Intern Med. 1986 Nov;146(11):2259-61.

    PMID: 2946271BACKGROUND
  • 5 Million Lives Campaign. Getting Started Kit: Prevent Central Line Infections How-to Guide. Cambridge, MA: Institute for Healthcare Improvement; 2008. (Available at www.ihi.org)

    BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

  • Marna R. Greenberg, DO

    Lehigh Valley Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Emergency Medicine Research

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 19, 2010

Study Start

December 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations