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.
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
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 Inconsistent and outdated clinical practices have been identified as key causative factors.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:
- Hand hygiene
- Maximal barrier precautions
- Chlorhexidine skin antisepsis
- Optimal catheter site selection, with subclavian vein as the preferred site for non-tunneled catheters
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted19 Jul 2010 (estimated)
- Study startDec 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
- Investigators
- Marna R. Greenberg, DO, Principal investigator, Lehigh Valley Health Network
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 12233868Haire 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 7605425Institute 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 29462715 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)
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of a Central Line Simulation Course
- ClinicalTrials.gov ID
- NCT01165398
- Acronym / sponsor ID
- 1-20090107
- Conditions
- Infection
- Keywords
- Education, central lines, infections, complications, Bundles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Hand hygiene
- Maximal barrier precautions
- Chlorhexidine skin antisepsis
- Optimal catheter site selection, with subclavian vein as the preferred site for non-tunneled catheters
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- Lehigh Valley Health Network residents, physician assistants, and nurse practitioners who place central lines and attend the central lines simulation course
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- BackgroundAHRQ 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: PubMed 12233868O'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.
- Background: PubMed 7605425Haire 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.
- BackgroundInstitute of Medicine, Health Profession Education Report. Washington, DC: National Academy Press, 2003.
- BackgroundKirkpatrick, D. Kirkpatrick, J. Evaluating Training Programs: The Four Levels. Third Edition, Berrett-Koehler Publishers, Inc. San Francisco, CA. 2006.
- Background: PubMed 2946271Runyon BA. Paracentesis of ascitic fluid. A safe procedure. Arch Intern Med. 1986 Nov;146(11):2259-61.
- Background5 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)
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marna R. Greenberg, DO principal investigator
Lehigh Valley Health Network
1 site in 1 country: see every site and its status.
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.