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InfectionNCT01165398

Comprehensive Evaluation of a Central Line Simulation Course

An observational study of Infection, run by Lehigh Valley Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Infection
How many people
383 participants
Where
1 siteUnited States
Study dates
Dec 2008to Nov 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

Other trials in United States

About this study

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 Inconsistent and outdated clinical practices have been identified as key causative factors.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

Read the 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).

Conditions
Infection
Keywords
Education, central lines, infections, complications, Bundles
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01165398
Study groupRoleWhat they receive
Residents, PAs, mid level providersLehigh Valley Health Network residents, physician assistants, and mid level providers who place central lines and attend the central lines simulation course

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At time of complication or infection

Secondary outcomes (2)
  1. How does the quality of central line instruction relate to learner attitudes, knowledge, and compliance of the central line bundle?

    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.

    Measured: At time of complication or infection

  2. 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?

    Conduct a regression analysis utilizing time (in months) as the predicting variable and complication and infection rates as outcome variables.

    Measured: At time of complication or infection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2010 (estimated)
  2. Study startDec 2008
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01165398
Sponsor's protocol ID
1-20090107
Status last verified
Oct 2016
First submitted
12 Jul 2010
Last updated
14 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 12233868
  • 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.

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

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

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

    PubMed 2946271
  • 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)

Questions about this trial

What is this clinical trial studying?

An observational study of Infection, run by Lehigh Valley Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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? (time frame: At time of complication or infection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01165398, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.

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