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Comprehensive Evaluation of a Central Line Simulation Course

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marna Rayl Greenberg, Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT01165398
First received: July 12, 2010
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

Each year,"an estimated 250,000 cases of central line-associated bloodstream infections occur in U.S. hospitals, and an estimated 30,000 to 62,000 patients die as a result" (AHRQ 2008). The marginal cost to the health-care system is approximately $25,000 per episode (CDC 2002).Inconsistent and outdated clinical practices have been identified as key factors to this problem(5 Million Lives Campaign 2008). Subsequently, in order to improve overall healthcare delivery and outcomes, current and future healthcare professionals need to complement their clinical skills with systems-based skills such as: (a) delivering patient-centered care,(b) working in multidisciplinary care teams,(c) practicing evidence-based medicine,(d)focusing on quality improvement,and e)using information technology (IOM 2003).

Specific to the problems of central lines, during a February 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. According to the literature, risk of central lines complication tends to decrease with operator experience (Runyon, 1986).A failed catheter placement attempt is one of the strongest predictors of subsequent complications (Haire & Lieberman, 1995). 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.

Using Donald Kirkpatrick's Four-Level Evaluation model(Kirkpatrick and Kirkpatrick 2006) as a theoretical framework, this study analyzes the impact of a central lines simulation course on residents and mid-level providers' clinical performance and patient outcomes.It is the goal of this study 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.

Care bundles are groupings of best practices with respect to a disease process that individually improve care, but when applied together result in substantially greater improvement.The science supporting each bundle component is sufficiently established to be considered the standard of care (5 Million Lives Campaign 2008).The central line bundle is a group of evidence-based interventions for patients with intravascular central catheters that, when implemented together, result in better outcomes than when implemented individually.The central line bundle has five key components:

  1. Hand hygiene
  2. Maximal barrier precautions
  3. Chlorhexidine skin antisepsis
  4. Optimal catheter site selection, with subclavian vein as the preferred site for non-tunneled catheters
  5. Daily review of line necessity, with prompt removal of unnecessary lines Research Questions How does the quality of central line instruction relate to learner attitudes, knowledge, and compliance of the central line bundle? 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? How have central lines bundle compliance and central line-related complication and infection rates at LVHN changed over the past several years, and do those changes correspond to changes in policies and practice regarding central lines that have occurred since 2005? Objectives

1.Analyze the impact of a central line simulation course on learner, patient and business outcomes. 2.Incorporate 'standard of care' course improvements to enrich analysis of research. Hypotheses H0: There is no association among quality of central line instruction, learner knowledge, compliance of the central line bundle, complication and infection rates, and changes in policies and practice since 2005.

H1: There is an association among quality of central line instruction, learner knowledge, compliance of the central line bundle, complication and infection rates and changes in policies and practice since 2005.

Hc: There is a direct correlation among quality of central line instruction, learner knowledge, compliance of the central line bundle, and complication/infection rates.

Hk&b: There is a probably ratio among complication/infection rates from central lines based on variations in learner knowledge scores and bundle compliance.

Hp&p: There is a probability ratio among complication/infection rates from central lines based on changes in Lehigh Valley Health Network policies and practices over time (in months).


Condition
Education

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comprehensive Evaluation of a Central Line Simulation Course

Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • 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? [ Time Frame: At time of complication or infection ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • How does the quality of central line instruction relate to learner attitudes, knowledge, and compliance of the central line bundle? [ Time Frame: At time of complication or infection ] [ Designated as safety issue: Yes ]
    To measure the relationship between course participants' rating of teaching performance against subscale and overall scores of the central lines knowledge test,and scores from the Performance Check Critical Action worksheet against the total compliance scores. Focus group data will be analyzed to identify perceptions, practices, power dynamics, and barriers to using the checklist and other patient safety protocols of the procedure.

  • 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? [ Time Frame: At time of complication or infection ] [ Designated as safety issue: Yes ]
    Conduct a regression analysis utilizing time (in months) as the predicting variable and complication and infection rates as outcome variables.


Enrollment: 383
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Residents, physician assistants, and 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT01165398

Locations
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
Lehigh Valley Hospital
  More Information

Publications:
CDC. Guidelines for the prevention of intravascular catheter-related infections. MMWR. 2002;51(No. RR-10):1-26.
Kirkpatrick, D. Kirkpatrick, J. Evaluating Training Programs: The Four Levels. Third Edition, Berrett-Koehler Publishers, Inc. San Francisco, CA. 2006.

Responsible Party: Marna Rayl Greenberg, Director of Emergency Medicine Research, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT01165398     History of Changes
Other Study ID Numbers: 1-20090107
Study First Received: July 12, 2010
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
Education
central lines
infections
complications
Bundles

ClinicalTrials.gov processed this record on November 20, 2014