Infection Clinical Trial
Official title:
Comprehensive Evaluation of a Central Line Simulation Course
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 Inconsistent and outdated clinical practices have been identified as key causative factors.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.
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2002).Inconsistent and outdated clinical practices have been identified as key factors to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).
;
Observational Model: Cohort, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04529421 -
Assocation Between In-person Instruction and COVID-19 Risk
|
||
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
| Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
| Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
| Recruiting |
NCT00342589 -
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
|
||
| Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
| Completed |
NCT03296423 -
Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly
|
Phase 4 | |
| Withdrawn |
NCT04217252 -
Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
|
N/A | |
| Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
| Recruiting |
NCT02905552 -
Myelodysplasic Syndromes and Risk Factors for Infection
|
N/A | |
| Withdrawn |
NCT02904434 -
Gastrointestinal Implications of Voriconazole Exposure
|
||
| Active, not recruiting |
NCT02768454 -
Antimicrobials Stewardship by Pharmacist
|
N/A | |
| Completed |
NCT02219776 -
Decreasing Infection In Arthroscopic Shoulder Surgery
|
N/A | |
| Completed |
NCT02210169 -
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
|
N/A | |
| Recruiting |
NCT02098226 -
Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts
|
N/A | |
| Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
| Terminated |
NCT01441206 -
Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
|
Phase 1 | |
| Completed |
NCT01434797 -
Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
|
||
| Completed |
NCT01159834 -
Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)
|
N/A |