Clinical trial NCT01165398: Comprehensive Evaluation of a Central Line Simulation Course
Official title: Comprehensive Evaluation of a Central Line Simulation Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Education
central lines
infections
complications
Bundles
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
First posted: 2010-07-19
Enrollment: 383
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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 Inconsistent and outdated clinical practices have been identified as key causative factors.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.

Detailed description: 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).

Eligibility 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

Primary outcomes:
measure: 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?
timeFrame: At time of complication or infection
Secondary outcomes:
measure: How does the quality of central line instruction relate to learner attitudes, knowledge, and compliance of the central line bundle?
timeFrame: At time of complication or infection
measure: 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?
timeFrame: At time of complication or infection
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: Lehigh Valley Health Network
name: Marna R. Greenberg, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: Institute of Medicine, Health Profession Education Report. Washington, DC: National Academy Press, 2003.
citation: Kirkpatrick, D. Kirkpatrick, J. Evaluating Training Programs: The Four Levels. Third Edition, Berrett-Koehler Publishers, Inc. San Francisco, CA. 2006.
citation: Runyon BA. Paracentesis of ascitic fluid. A safe procedure. Arch Intern Med. 1986 Nov;146(11):2259-61.
citation: 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)