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Confirmation of the Validity of the
Central-line Bundle as a Measure
of a Healthcare Intervention
Heather M. Gilmartin PhD, NP, CIC
Post-doctoral Nurse Fellow
Denver/Seattle Center of Innovation – Department of Veterans Affairs
Karen Sousa, PhD, RN, FAAN
Professor and Associate Dean of Research and Extramural Affairs
University of Colorado, Anschutz
College of Nursing
Disclaimer: The contents of this presentation do not represent the views of the
Department of Veterans Affairs or the United States Government.
Objectives
1. Define the central line (CL) bundle and
the influence of organizational context on
healthcare interventions and outcomes
2. Discuss the methods to test and confirm
the CL bundle as a latent variable model
What is a Central-line (CL)?
• Long, thin tube placed
in a vein that ends near
your heart
• Fluids, medications,
blood products,
monitoring, lab draws
• Used for critical
patients or those who
require long-term
medications
Central-line Associated Bloodstream
Infections (CLABSIs)
• The risk of CLABSIs in intensive care units
are high (Klevens et al., 2007)
– 31,000 estimated deaths per year
– $18,000 mean attributable cost per CLABSI
• Extended hospitalization
• Greater risk for other complications
• Loss of trust in healthcare system
IHI CL Bundle
 Perform hand hygiene prior to catheter insertion
 Use maximum sterile barrier precautions during
insertion
 Use alcoholic chlorhexidine (CHG) antiseptic for
skin preparation
 Avoid use of femoral vein when possible
 Assess need for CL daily, remove nonessential
catheters
http://www.ihi.org/resources/Pages/Changes/ImplementtheCentralLineBundle.aspx
CL Bundle Program
• Michigan Keystone Project:
– 66% reduction in CLABSIs for participating
ICUs (Pronovost et al., 2006)
– Reductions maintained 10 years after initial
study (Pronovost et al., 2015)
• Findings replicated in multiple settings
• Standard of practice for intensive care
units (Marschall et al., 2014)
Intervention Outcome
CL Bundle = Zero CLABSIs
Reality Check
Organizations report programs are hard to
fully implement and sustain
(Dixon-Woods et al., 2011)
“Popular accounts of CL bundle program have
often been simplistic and partial, perpetuating
the myth that the program’s achievements
can be traced to a “simple checklist” rather
than a complex social intervention” (Bosk et al., 2009)
Clinical Example
• Mr. Jones requires a CL for medication and cardiac
monitoring
• Ideal situation:
– Surgical team present and all equipment at bedside
– ICU nurse available to assist/monitor procedure
– Hand hygiene performed
– All staff don gloves/gown/mask/hat/eye protection
– Patient prepped with barrier precautions and CHG
– All others in room wearing a mask
– Subclavian vein is chosen
– Time out performed
– Line placed successfully
Equipment not
standardized and
easy to access
Nurses not
included in
rounds
“Check the box”
culture
RN not
comfortable
speaking up
Maximum barrier
precautions viewed
as ridiculous
Little
accountability to
safety processes
No policy
No training
What are the Challenges?
No belief in
“Time Out”
Organizational Context
• Organizational culture:
– Perceived values and roles
• Organizational climate:
– Practices and procedures
• Work environment:
– Teamwork, leadership, communication, resources
• Structural characteristics:
– Hospital size, teaching status, level of technology
Understanding how and why programs work, not
simply whether they work,
is crucial
(Dixon-Woods et al., 2011)
Intervention Outcome
Context
Learning Objective #2
• Discuss the methods to test and confirm
the CL bundle as a latent variable model
Intervention Outcome
Context
Methods
Sample:
• Prevention of Nosocomial Infection and Cost-effectiveness-
Refined (PNICER) Study (Stone et al., 2014)
• 614 U.S. hospitals reporting to NHSN
Methods:
• Secondary analysis using latent variable modeling
• Sample randomly split for exploration/confirmation
Variables:
• CL bundle = healthcare intervention
• CLABSI = outcome
• Context = work environment + climate instruments
Factor Analysis
• Multivariate statistical procedure
• Tests how well measured variables represent
the number of constructs
• Exploratory Factor Analysis:
– Data explored for number of factors to represent the
data
• Confirmatory Factor Analysis:
– Number of factors specified
– Confirms or rejects the theory
Exploratory Factor Analysis
Item Component 1
Factor Loading
Hand Hygiene .950
Max Barrier .957
CHG .941
Optimal Site .898
Daily Check .823
Component Table Matrix
Explained variance 61.21%
Cronbach's alpha = .84
Confirmatory Factor Analysis
Es mator: WLSMV
Chi-sq (5) = 7.15
P <.21
RMSEA = .04
CFI = .99
Healthcare
Interven on
HH
MAX
CHG
OPS
DAILY
.95
.94
.99
.81
.61
.11
.12
.01
.35
.37
.89
Implications for Research
Intervention Outcome
Context
Implications for Practice
• The CL bundle is more than just a
checklist
• Contextual factors need to be considered
• Investigate your environment – what are
your barriers?
Future Research
• Expand theory to other health outcomes
– Other healthcare-associated infections
– Falls/pressure ulcers
– Medication errors
• Validation of existing contextual data sources
to diagnose a units readiness to implement a
new patient safety initiative
– Annual Organizational Culture Survey
– AHRQ Annual Patient Safety Culture Survey
– Nurse Satisfaction Survey
Acknowledgements
• The authors would like to thank Dr. Pat
Stone for use of the P-NICER data for
secondary analysis, and the Infection
Preventionists who responded to the
survey.
• Funding for the P-NICER study was
provided by the National Institute of
Nursing Research (R01NR010107).
References
• Bate, P. (2014). Context is everything. In J. R. Bamber (Ed.), Perspectives on context: A selection of essays considering the
role of context in successful quality improvement (pp. 1-30). London, England: Health Foundation.
• Bosk, C.L., Dixon-Woods, M., Goeschel, C. A., & Pronovost, P.J. (2009). Reality check for checklists. The Lancet,
374(9688), 444-445.
• Dixon-Woods, M., Bosk, C.L., Aveling, E.L., Goeschel, C.A., & Pronovost, P.J. (2011). Explaining Michigan: Developing an
ex post theory of a quality improvement program. Milbank Quarterly, 89(2), 167-205. doi:
http://dx.doi.org/10.1111/j.1468-0009.2011.00625.x
• Furuya, E.Y., Dick, A., Perencevich, E.N., Pogorzelska, M., Goldmann, D., & Stone, P. (2011). Central line bundle
implementation in US intensive care units and impact on bloodstream infections. PLoS ONE [Electronic Resource], 6(1),
1-6. doi: http://dx.doi.org/10.1371/journal.pone.0015452
• Klevens, R.M., Edwards, J.R., Richards, C.L., Horan, T., Gaynes, R.P., Pollock, D.A., & Cardo, D.M. (2002). Estimating
healthcare-associated infections and deaths in US hospitals, 2002. Public Health Reports, 122, 160-166.
• Marschall, J., Mermel, L.A., Fakih, M., Hadaway, L., Kallen, A., O'Grady, N.P., . . . Yokoe, D.S. (2014). Strategies to prevent
central line–associated bloodstream infections in acute care hospitals: 2014 pdate. Infection Control and Hospital
Epidemiology, 35(7), 753-771. doi: 10.1086/676533
• Mitchell, P.H., Ferketich, S. , Jennings, B.M., & Care, American Academy of Nursing Expert Panel on Quality Health.
(1998). Quality health outcomes model. Image - the Journal of Nursing Scholarship, 30(1), 43-46. doi:
http://dx.doi.org/10.1111/j.1547-5069.1998.tb01234.x
• Pronovost, P., Goeschel, C.A., Colantuoni, E., Watson, S., Lubomski, L.H., Berenholtz, S., . . . Needham, D. (2010).
Sustaining reductions in catheter related bloodstream infections in Michigan intensive care units: Observational study.
British Medical Journal, 340(c309), 1-6. doi: http://dx.doi.org/10.1136/bmj.c309
• Stone, P., Pogorzelska-Maziarz, M., Herzig, C.T., Weiner, L.M., Furuya, E.Y., Dick, A., & Larson, E. (2014). State of infection
prevention in US hospitals enrolled in the National Health and Safety Network. American Journal of Infection Control,
42(2), 94-99. doi: http://dx.doi.org/10.1016/j.ajic.2013.10.003
Thank you
Questions?

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Confirmation of the Validity of the Central Line Bundle as a Measure of a Healthcare Intervention

  • 1. Confirmation of the Validity of the Central-line Bundle as a Measure of a Healthcare Intervention Heather M. Gilmartin PhD, NP, CIC Post-doctoral Nurse Fellow Denver/Seattle Center of Innovation – Department of Veterans Affairs Karen Sousa, PhD, RN, FAAN Professor and Associate Dean of Research and Extramural Affairs University of Colorado, Anschutz College of Nursing Disclaimer: The contents of this presentation do not represent the views of the Department of Veterans Affairs or the United States Government.
  • 2. Objectives 1. Define the central line (CL) bundle and the influence of organizational context on healthcare interventions and outcomes 2. Discuss the methods to test and confirm the CL bundle as a latent variable model
  • 3. What is a Central-line (CL)? • Long, thin tube placed in a vein that ends near your heart • Fluids, medications, blood products, monitoring, lab draws • Used for critical patients or those who require long-term medications
  • 4. Central-line Associated Bloodstream Infections (CLABSIs) • The risk of CLABSIs in intensive care units are high (Klevens et al., 2007) – 31,000 estimated deaths per year – $18,000 mean attributable cost per CLABSI • Extended hospitalization • Greater risk for other complications • Loss of trust in healthcare system
  • 5. IHI CL Bundle  Perform hand hygiene prior to catheter insertion  Use maximum sterile barrier precautions during insertion  Use alcoholic chlorhexidine (CHG) antiseptic for skin preparation  Avoid use of femoral vein when possible  Assess need for CL daily, remove nonessential catheters http://www.ihi.org/resources/Pages/Changes/ImplementtheCentralLineBundle.aspx
  • 6. CL Bundle Program • Michigan Keystone Project: – 66% reduction in CLABSIs for participating ICUs (Pronovost et al., 2006) – Reductions maintained 10 years after initial study (Pronovost et al., 2015) • Findings replicated in multiple settings • Standard of practice for intensive care units (Marschall et al., 2014)
  • 8. Reality Check Organizations report programs are hard to fully implement and sustain (Dixon-Woods et al., 2011) “Popular accounts of CL bundle program have often been simplistic and partial, perpetuating the myth that the program’s achievements can be traced to a “simple checklist” rather than a complex social intervention” (Bosk et al., 2009)
  • 9. Clinical Example • Mr. Jones requires a CL for medication and cardiac monitoring • Ideal situation: – Surgical team present and all equipment at bedside – ICU nurse available to assist/monitor procedure – Hand hygiene performed – All staff don gloves/gown/mask/hat/eye protection – Patient prepped with barrier precautions and CHG – All others in room wearing a mask – Subclavian vein is chosen – Time out performed – Line placed successfully
  • 10. Equipment not standardized and easy to access Nurses not included in rounds “Check the box” culture RN not comfortable speaking up Maximum barrier precautions viewed as ridiculous Little accountability to safety processes No policy No training What are the Challenges? No belief in “Time Out”
  • 11. Organizational Context • Organizational culture: – Perceived values and roles • Organizational climate: – Practices and procedures • Work environment: – Teamwork, leadership, communication, resources • Structural characteristics: – Hospital size, teaching status, level of technology
  • 12. Understanding how and why programs work, not simply whether they work, is crucial (Dixon-Woods et al., 2011) Intervention Outcome Context
  • 13. Learning Objective #2 • Discuss the methods to test and confirm the CL bundle as a latent variable model Intervention Outcome Context
  • 14. Methods Sample: • Prevention of Nosocomial Infection and Cost-effectiveness- Refined (PNICER) Study (Stone et al., 2014) • 614 U.S. hospitals reporting to NHSN Methods: • Secondary analysis using latent variable modeling • Sample randomly split for exploration/confirmation Variables: • CL bundle = healthcare intervention • CLABSI = outcome • Context = work environment + climate instruments
  • 15. Factor Analysis • Multivariate statistical procedure • Tests how well measured variables represent the number of constructs • Exploratory Factor Analysis: – Data explored for number of factors to represent the data • Confirmatory Factor Analysis: – Number of factors specified – Confirms or rejects the theory
  • 16. Exploratory Factor Analysis Item Component 1 Factor Loading Hand Hygiene .950 Max Barrier .957 CHG .941 Optimal Site .898 Daily Check .823 Component Table Matrix Explained variance 61.21% Cronbach's alpha = .84
  • 17. Confirmatory Factor Analysis Es mator: WLSMV Chi-sq (5) = 7.15 P <.21 RMSEA = .04 CFI = .99 Healthcare Interven on HH MAX CHG OPS DAILY .95 .94 .99 .81 .61 .11 .12 .01 .35 .37 .89
  • 19. Implications for Practice • The CL bundle is more than just a checklist • Contextual factors need to be considered • Investigate your environment – what are your barriers?
  • 20. Future Research • Expand theory to other health outcomes – Other healthcare-associated infections – Falls/pressure ulcers – Medication errors • Validation of existing contextual data sources to diagnose a units readiness to implement a new patient safety initiative – Annual Organizational Culture Survey – AHRQ Annual Patient Safety Culture Survey – Nurse Satisfaction Survey
  • 21. Acknowledgements • The authors would like to thank Dr. Pat Stone for use of the P-NICER data for secondary analysis, and the Infection Preventionists who responded to the survey. • Funding for the P-NICER study was provided by the National Institute of Nursing Research (R01NR010107).
  • 22. References • Bate, P. (2014). Context is everything. In J. R. Bamber (Ed.), Perspectives on context: A selection of essays considering the role of context in successful quality improvement (pp. 1-30). London, England: Health Foundation. • Bosk, C.L., Dixon-Woods, M., Goeschel, C. A., & Pronovost, P.J. (2009). Reality check for checklists. The Lancet, 374(9688), 444-445. • Dixon-Woods, M., Bosk, C.L., Aveling, E.L., Goeschel, C.A., & Pronovost, P.J. (2011). Explaining Michigan: Developing an ex post theory of a quality improvement program. Milbank Quarterly, 89(2), 167-205. doi: http://dx.doi.org/10.1111/j.1468-0009.2011.00625.x • Furuya, E.Y., Dick, A., Perencevich, E.N., Pogorzelska, M., Goldmann, D., & Stone, P. (2011). Central line bundle implementation in US intensive care units and impact on bloodstream infections. PLoS ONE [Electronic Resource], 6(1), 1-6. doi: http://dx.doi.org/10.1371/journal.pone.0015452 • Klevens, R.M., Edwards, J.R., Richards, C.L., Horan, T., Gaynes, R.P., Pollock, D.A., & Cardo, D.M. (2002). Estimating healthcare-associated infections and deaths in US hospitals, 2002. Public Health Reports, 122, 160-166. • Marschall, J., Mermel, L.A., Fakih, M., Hadaway, L., Kallen, A., O'Grady, N.P., . . . Yokoe, D.S. (2014). Strategies to prevent central line–associated bloodstream infections in acute care hospitals: 2014 pdate. Infection Control and Hospital Epidemiology, 35(7), 753-771. doi: 10.1086/676533 • Mitchell, P.H., Ferketich, S. , Jennings, B.M., & Care, American Academy of Nursing Expert Panel on Quality Health. (1998). Quality health outcomes model. Image - the Journal of Nursing Scholarship, 30(1), 43-46. doi: http://dx.doi.org/10.1111/j.1547-5069.1998.tb01234.x • Pronovost, P., Goeschel, C.A., Colantuoni, E., Watson, S., Lubomski, L.H., Berenholtz, S., . . . Needham, D. (2010). Sustaining reductions in catheter related bloodstream infections in Michigan intensive care units: Observational study. British Medical Journal, 340(c309), 1-6. doi: http://dx.doi.org/10.1136/bmj.c309 • Stone, P., Pogorzelska-Maziarz, M., Herzig, C.T., Weiner, L.M., Furuya, E.Y., Dick, A., & Larson, E. (2014). State of infection prevention in US hospitals enrolled in the National Health and Safety Network. American Journal of Infection Control, 42(2), 94-99. doi: http://dx.doi.org/10.1016/j.ajic.2013.10.003

Editor's Notes

  1. The bundle has also expanded to include practices such as: All staff should be educated and credentialed for the procedure and the bundle processes Bathe ICU patients with CHG on a daily basis Use a cart or kit to ensure all components are available Use ultrasound guidance for IJ insertions Disinfect catheter hubs, needleless connectors, injection ports prior to accessing Change dressing when wet or every 5-7 days Change administration sets every 96 hours or sooner Perform surveillance for CLABSI For high-risk patients: Use antiseptic or antimicrobial impregnated CVD Use CHG containing dressings Use an antiseptic hub cap port Use antimicrobial locks
  2. CL bundle polices do not guarantee reliable execution at the bedside (Furuya et al. 2011) Only when an ICU had a policy, monitored compliance, and had >95% compliance did CLABSI rates decrease (Furuya et al. 2011) For example, in a 2011 study by Pat Stone from Columbia University, it was reported that CL bundle policies do not guarantee reliable execution at the bedside.   In their sample of about 400 hospitals, only 49% of ICUs reported having a written CL bundle policy.   Of those that monitored compliance with the policy, only 38% (35 hospitals) reported very high compliance with the bundle.   The authors concluded that only when an ICU had a policy, monitored compliance, and had 95% or greater compliance did CLABSI rates decrease.
  3. To study the role of organizational context on interventions and outcomes, novel analytic methods are needed, for the concepts of context and interventions cannot be directly measured.
  4. Exploratory factor analysis is a modeling approach for studying hypothetical constructs by using a variety of observable proxies that can be directly measured. In the exploratory phase, the concern is determining how many factors are needed to explain the relationships within a given set of observed variables. Using a principal component analysis method, varimax rotation, the items loaded onto a single-factor with an eigenvalue over Kaiser’s criterion of one, with relatively high factor loadings (.82-.96) and explained 61.21% of the variance. To test for internal reliability of the items in the population, a cronbach's alpha was run. The result was acceptable for internal reliability at .84.
  5. This research shows that there are a multitude of factor that contribute to the successful implementation of patient safety programs. We should be using existing data to quantify the context of our units. If you can show administration that the scores from instruments indicate that you have issue with teamwork and communication, and a perceived low safety culture, you can ask to work on that, before a new program is slotted into your unit.