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Original article
a r t i c l e i n f o a b s t r a c t
Keywords:
Catheter Associated Urinary Tract Infection Background: Healthcare associated infections from indwelling urinary catheters lead to increased patient
(CAUTI) morbidity and mortality.
Direct observation
Aim: The purpose of this study was to determine if direct observation of the urinary catheter insertion
Intervention
procedure, as compared to the standard process, decreased catheter utilization and urinary tract infection
Protocol based-care intensive care unit
(ICU) rates.
Methods: This case control study was conducted in a medical intensive care unit. During phase I, a
retrospective data review was conducted on utilsiation and urinary catheter infection rates when practi-
tioners followed the institution’s standard insertion algorithm. During phase II, an intervention of direct
observation was added to the standard insertion procedure.
Results: The results demonstrated no change in utilization rates, however, CAUTI rates decreased from
2.24 to 0 per 1000 catheter days.
Conclusion: The findings from this study may promote changes in clinical practice guidelines leading to
a reduction in urinary catheter utilization and infection rates and improved patient outcomes.
© 2016 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.iccn.2016.12.003
0964-3397/© 2016 Elsevier Ltd. All rights reserved.
Please cite this article in press as: Galiczewski, J.M., Shurpin, K.M., An intervention to improve the catheter associated urinary tract
infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure. Intensive Crit Care Nurs (2017),
http://dx.doi.org/10.1016/j.iccn.2016.12.003
G Model
YICCN-2487; No. of Pages 9 ARTICLE IN PRESS
2 J.M. Galiczewski, K.M. Shurpin / Intensive and Critical Care Nursing xxx (2017) xxx–xxx
• Decreasing the incidents of CAUTI not only improves patient outcomes by reducing patient morbidity and mortality but can also
decrease medical costs.
• Protocol based algorithms for urinary catheter placement must include interventions that focus on adherence to general infection
control principles.
• Evidence supports the intervention of direct observation being added to the catheter placement algorithm to ensure adherence to
protocol.
• An invaluable benefit of direct observation is the ability to provide immediate constructive feedback that may improve practice.
Preventative measures for CAUTI such as catheter avoidance 2011). This study was conducted in a single hospital and did not
strategies, hand hygiene, perineal care, and daily necessity review collect continuous data on the units prior to the implementation of
to limit catheter days have been associated with decreased CAUTI the bundle intervention (Marra et al., 2011).
rates in ICUs (Chenoweth and Saint, 2013). Many institutions bun- Studies conducted in ICUs of hospitals that are members of
dle these interventions into protocol-based guidelines for catheter the International Nosocomial Infection Control Consortium (INICC)
insertion to standardize care based on the scientific evidence to were done to assess the impact of a multidimensional infection
improve patient outcomes (Clearinghouse, 2014). Globally, CAUTI control strategy on CAUTI rates (Kanj et al., 2013; Leblebicioglu
prevention efforts continue and nurses lead the effort to identify et al., 2013; Navoa-Ng et al., 2013; Rosenthal et al., 2012). This
interventions with the greatest impact on CAUTI rates. The purpose international study included 15 developing countrieswith a total
of this quality improvement study is to determine if direct observa- sample size of 56, 429 patients in 57 ICUs (Rosenthal et al., 2012).
tion of the urinary catheter insertion procedure, as compared to the Rosenthal et al. (2012) conducted a meta-analysis of the multiple
standard process, decreases urinary tract infection and utilization studies involved in the INICC to evaluate the impact of the bundle
rates. intervention strategy on CAUTI rates as a whole. The interven-
tions included in the bundle were: (1) proper hand hygiene, (2)
Review of literature to maintain collection bag lower than the level of the bladder, (3)
to maintain unobstructed urine flow, (4) to empty collection bag
Protocol -based care at regular intervals and avoid allowing the draining spigot to touch
the collection container, and (5) to monitor CAUTIs using standard-
Protocol-based care is used to implement evidence-based inter- ized criteria (Rosenthal et al., 2012). The results of the combined
ventions which improve patient outcomes and the overall quality studies were statistically significant with 253,122 urinary catheter
of care (Topal et al., 2005). The use of protocol-based care pro- days recorded). The CAUTI rate decreased from 7.68 to 4.95 per
vides the nurse with increasing autonomy and positively affects 1000 catheter days after implementation of the bundle interven-
delivery of care (Ilott et al., 2006; Rycroft-Malone et al., 2008). Clin- tion (Rosenthal et al., 2012). The strength of these combined studies
ical protocols are developed by healthcare teams and are based on were that they took place in multiple institutions, in different types
systematic review of the scientific evidence (Harbour and Miller, of adult ICU setting, in different countries and had large sample
2001). The strength of the evidence is graded and agencies devel- sizes. Limitations included a lack of resources to collect more data
oping protocol-based care policies must assess the applicability, on process surveillance and compliance with all interventions in
consistency and clinical impact of the evidence (Hadorn et al., 1996; the bundle (Kanj et al., 2013; Leblebicioglu et al., 2013; Navoa-Ng
Harbour and Miller, 2001). et al., 2013; Rosenthal et al., 2012).
Ilott et al. (2006) defined protocol-based care as “the stan- Inappropriate use of urinary catheters, improper insertion tech-
dardization of the processes of clinical care in documents, such as nique and poor management of the catheter once inserted have
protocols, pathways, algorithms or guidelines” (p. 548). In 1997, been identified as major factors that lead to unnecessary infec-
the Agency for Healthcare Research and Quality (AHRQ) created tions (Tatham et al., 2015; Tsai et al., 2015). A study by Tsai et al.
the National Guideline Clearinghouse (NGC) to represent protocol (2015) implemented a UTI care bundle that included a staff educa-
development that was in harmony with the Institution of Medicine tion session and an insertion and daily care checklist. The insertion
(IOM) (Clearinghouse, 2014). In 2014, the definition of protocol- and daily checklist included hand hygiene, perineum washing, care
based care was revised and defined as the standardization of care of the urine container, keeping a closed system and daily review
based on the scientific evidence to optimize patient outcomes of catheter necessity. The CAUTI rate decreased significantly after
(Clearinghouse, 2014). The CDC developed guidelines for CAUTI and implementation of the care bundle from 6.10% in 2013 to 3.47% in
hospitals that adopted the guidelines and implemented protocol- 2014 (Tsai et al., 2015). Another quality improvement study that
based care have decreased CAUTI rates (Gray, 2010). implemented insertion and maintenance care bundles based on
national guidelines had similar success in decreasing CAUTI rates
Implementation of protocol-based care bundles to prevent CAUTI and also identified the need to engage staff by conducting educa-
tion sessions and providing frequent feedback on patient outcomes
Evidence based research has identified interventions to combat (Tatham et al., 2015).
urinary catheter infection and utilization rates and these interven-
tions have been incorporated into protocol-based insertion bundles Measuring effectiveness of protocol-based care
(Flodgren et al., 2013; Gray, 2010). A multi-phase study conducted
in an ICU and two step down units (SDUs) in a Brazilian hospital Measuring protocol-based care is a challenge. Often, patient
that implemented CDC recommended protocols and the Institute outcomes, reduced length of stay (LOS) and improved documenta-
for Healthcare Improvement’s (IHI) bladder bundle (Marra et al., tion are used to determine the effectiveness of standardization of
2011). The results were statistically significant with a reduction in care (Rycroft-Malone et al., 2004). A study conducted by Rycroft-
the CAUTI rate in the ICU from 7.6 to 5 per 1000 catheter days and Malone et al. (2008) used a multifaceted approach to measure
in the SDUs from 15.3 to 12.9 per 1000 catheter days (Marra et al., protocol-based care which included: (1) direct observation of activ-
Please cite this article in press as: Galiczewski, J.M., Shurpin, K.M., An intervention to improve the catheter associated urinary tract
infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure. Intensive Crit Care Nurs (2017),
http://dx.doi.org/10.1016/j.iccn.2016.12.003
G Model
YICCN-2487; No. of Pages 9 ARTICLE IN PRESS
J.M. Galiczewski, K.M. Shurpin / Intensive and Critical Care Nursing xxx (2017) xxx–xxx 3
ities related to the standardization of care, (2) post-observation required intensive resources (Larson et al., 2004). It has also been
interviews with the multidisciplinary team to explore their views found that individuals who are being observed may change their
about the use and impact of standardization of care, (3) interviews behavior to be more compliant (Larson et al., 2004; Pedersen et al.,
with patients about their experience, (4) tracking patients during 1986). An invaluable benefit of direct observation is the ability to
their course of medical treatment and (5) review of relevant doc- provide immediate constructive feedback that improves practice
umentation. Quality monitoring using direct observation has been and may have a positive effect on patient outcomes (Ellingson et al.,
well validated as a method to measure effectiveness of a protocol 2014).
(Larson et al., 2004).
Direct observation
HAIs can be associated with several factors such as an inex-
Theoretical framework
perienced health professional performing the procedure, a gap in
knowledge, or failure to adhere to the recommended protocols
The chain of infection theory
(Muscedere et al., 2008; Safdar et al., 2002). Protocol-based care
bundles were developed for the ICU setting in 2006 to combat all
The chain of infection is a physiology theory based on the prin-
HAIs and when performed reliably should improve patient out-
ciples of epidemiology. The theory explains the processes that are
comes (Flodgren et al., 2013). A risk factor for developing CAUTI is
required for the transmission of pathogens from their existing envi-
failure to comply with the infection control practices in the protocol
ronment to a patient and for subsequent infection to occur (Mitchell
bundle during the insertion procedure (Flodgren et al., 2013).
and Gardner, 2014). There are six major components of the the-
Many studies addressing compliance with and effectiveness
ory: (1) infectious disease, (2) reservoir, (3) portal of exit, (4) mode
of protocol based-care using direct supervision or observation
of transmission, (5) portal of entry and (6) susceptible host (CDC,
focused on hand hygiene and central line associated blood stream
1992). Modern day infection control practices are put into place
infections(CLABSI). A large cross sectional study involving 250 hos-
to avoid the transmission of pathogens by breaking the chain of
pitals evaluated compliance with the CLABSI intervention bundle
infection (Mitchell and Gardner, 2014). A model has been created
and determined that the infection rate was decreased when the
by the CDC to illustrate this theory and the relationship between
institution had a clear written protocol, compliance was monitored
the components (Fig. 1).
through direct supervision and documentation, and compliance
As HAIs become a global patient safety issue, nurses need to
was rated as high (Furuya et al., 2011). A study by Frankel (2005)
adopt the role of infection preventionists (APIC, 2012). The basic
used the corporate Six Sigma performance improvement strategies
principles of the chain of infection are overlooked by healthcare
to decrease CLABSI rates. The interventions included were direct
workers on a daily basis and their hands are the most common
observation by the attending physician of all central line catheter
vehicle for transmission of pathogens (Allegranzi and Pittet, 2009).
insertions along with educational and policy change interventions.
According to the Association of Professionals in Infection Control
The result showed a decrease in CLABSI rates from 11 to 1.7 per
and Epidemiology (APIC), the infection preventionist nurse needs
1000 catheter days, a 650% improvement (Frankel 2005). Although
to become a new kind of leader who can engage all disciplines
direct observation was used as an intervention in this study, its
to work towards the common goal of breaking the chain of infec-
impact alone cannot be assessed due to it being bundled with Six
tion. Nurses spend the most time caring for patients; they need to
Sigma educational strategies and policy change interventions.
address this endemic patient safety issue and champion the cam-
In 2004, Larson et al. conducted a study comparing two methods
paign to improve infection rates and patient outcomes.
of assessing compliance with hand hygiene practices; they looked
at direct observation and self-reporting using a daily diary. The
sample size was adequate with 119 nurses yielding 1071 diary
entries and 206 hours of direct observation. The results showed that
the total number of hand hygiene episodes with direct observation Methods
were greater than with self reporting, however the results were
statistically insignificant (p = 0.32) (Larson et al., 2004). Limitations Setting and study design
to this study were most of the observation times occurred on the
day shift and in one hour intervals which were not representative This quasi-experimental case control study was conducted in
of the entire time period being studied. the medical ICU of a 603 bed tertiary academic medical center
A three phase observational study by Earl et al. (2001) was con- located in the northeastern section of the United States. This ICU
ducted in two SICUs and a MICU to monitor if the availability of provided acute care to adults with primarily medical illnesses.
alcohol-based gels conveniently located increased hand hygiene. Approval from the Quality Improvement/Nursing Research Com-
Phase1 consisted of observing hand hygiene practices with soap mittee was obtained prior to the start of this project. Informed
and water, phase 2 monitored hand hygiene after gel dispensers consent was not required as only de-identified aggregate data was
were placed in each unit and phase 3 monitored the adherence collected and there was no change in the standard of care.
rate of hand hygiene 10–14 weeks post intervention (Earl et al., The study was carried out in two phases. During phase I (n = 74),
2001). The results showed, with statistical significance, an increase a retrospective data review was conducted on utilization and
in adherence to hand hygiene in all of the units from phase 1 to 3; urinary catheter infection rates when practitioners followed the
the SICUs improved 58.9% and the MICU 29.4% from baseline (Earl institution’s standard insertion algorithm (Fig. 2). Catheter inser-
et al., 2001). Direct observation by educated personnel was used tion policies were based on the APIC and CDC guidelines (APIC,
to measure compliance with the hand hygiene protocol. This study 2014; CDC, 2015). During phase II (n = 64), an intervention of direct
consisted of 402 observational hours and was conducted during the observation by an educated observer was added to the standard
day and night to capture compliance on both shifts. insertion procedure. The practitioners on the unit served as the
Direct observation has become the “gold standard” of surveil- observers. Five day nurses and four night nurses volunteered to be
lance methods (Larson et al., 2004). It provides a direct measure trained as observers. This allowed the intervention to take place on
of compliance with and effectiveness of protocol-based care; how- both the day and night shift and capture all eligible patients at no
ever it is rarely used due to its high cost, time consumption and additional cost to the institution.
Please cite this article in press as: Galiczewski, J.M., Shurpin, K.M., An intervention to improve the catheter associated urinary tract
infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure. Intensive Crit Care Nurs (2017),
http://dx.doi.org/10.1016/j.iccn.2016.12.003
G Model
YICCN-2487; No. of Pages 9 ARTICLE IN PRESS
4 J.M. Galiczewski, K.M. Shurpin / Intensive and Critical Care Nursing xxx (2017) xxx–xxx
Please cite this article in press as: Galiczewski, J.M., Shurpin, K.M., An intervention to improve the catheter associated urinary tract
infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure. Intensive Crit Care Nurs (2017),
http://dx.doi.org/10.1016/j.iccn.2016.12.003
G Model
YICCN-2487; No. of Pages 9 ARTICLE IN PRESS
J.M. Galiczewski, K.M. Shurpin / Intensive and Critical Care Nursing xxx (2017) xxx–xxx 5
Fig. 2. * Based on Stony Brook Medicine Urinary Catheter Insertion for the Adult & Pediatric Patient Protocol algorithm (2015). Based on the APIC and the CDC Guidelines
(2015).
samples was statistically different (p < 0.05). Fisher’s exact test was regards to sex. The Chi Square test demonstrated that the percent-
used in place of the chi square test due to the small sample size. age of males and females was not different between the two groups
(p = 0.935).
Results
Please cite this article in press as: Galiczewski, J.M., Shurpin, K.M., An intervention to improve the catheter associated urinary tract
infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure. Intensive Crit Care Nurs (2017),
http://dx.doi.org/10.1016/j.iccn.2016.12.003
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YICCN-2487; No. of Pages 9 ARTICLE IN PRESS
6 J.M. Galiczewski, K.M. Shurpin / Intensive and Critical Care Nursing xxx (2017) xxx–xxx
Table 1
Demographics.
Catheter associated urinary tract infection rates catheter days in phase II when direct observation was added to the
urinary catheter insertion protocol. This change was not statisti-
The monthly rate of CAUTI ranged from 0 to 3.26 per 1000 cally significant (p = 0.098). Prior to the intervention, 3 out of 74
catheter days with a mean of 2.24 during phase I. The overall mean patients (4.1%) developed an infection attributable to the urinary
monthly rate of CAUTI in the MICU declined from 2.24 to 0 per 1000 catheter based on 2015 CDC guidelines. There were zero CAUTI
Please cite this article in press as: Galiczewski, J.M., Shurpin, K.M., An intervention to improve the catheter associated urinary tract
infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure. Intensive Crit Care Nurs (2017),
http://dx.doi.org/10.1016/j.iccn.2016.12.003
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J.M. Galiczewski, K.M. Shurpin / Intensive and Critical Care Nursing xxx (2017) xxx–xxx 7
Table 2
Percentages of Patients who Developed CAUTI.
occurrences reported for the 66 patients who had the catheter the intervention phase of direct observation of the catheter inser-
insertion procedure observed during phase II of the study (Table 2). tion procedure, although not statistically significant, will decrease
While the results of this study were not statistically significant healthcare costs and impact patient safety. Therefore, decreasing
(p = 0.253), they may be clinically relevant. CAUTI rates in vulnerable ICU patients is clinically relevant.
One of the most successful strategies to combat CAUTI is to
Discussion decrease the use of indwelling catheters. Most hospitals have devel-
oped indications for use of indwelling catheters that are often part
Reducing the incidents of CAUTI not only improves patient of the catheter insertion algorithm or protocol (Titsworth et al.,
outcomes but can also decrease medical costs. It has been well 2012). The indications are included to guide the practitioner in
established that CAUTI can lead to bacteremia and a prolonged determining if the patient requires a urinary catheter. The checklist
LOS (Chen et al., 2005).Treating a single episode of uncomplicated used in phase II of this study included a section for recording the
CAUTI costs between 1000 and 5000 dollars and increases LOS by hospital approved indication for use of the urinary catheter (Fig. 4).
2 to10.3 days (Gray, 2010; Laupland et al., 2002; Umscheid et al., This type of data was not collected during the retrospective data
2011). CAUTIs are the second leading cause of blood stream infec- review (phase I) so therefore it could not be compared to data from
tions and can add over 36,000 dollars per episode to the cost phase II.
(Titsworth et al., 2012). In addition, eliminating CAUTI has become During both phases of this quality improvement study, the mean
a global priority due to government funded insurance companies utilization rate remained the same at 71%. It was hypothesized
no longer providing payment for treatment (Burton et al., 2011). that utilization rates would decrease during phase II when urinary
Every CAUTI event exponentially increases an institutions financial catheterizations were being observed and the indications for usage
burden. were strictly adhered to. Currently in this MICU, Clinical Nurse Edu-
Up to 70% of CAUTI cases may be preventable if evidence based cators perform daily urinary catheter rounds and remind the ICU
protocols are followed during catheter insertion (Umscheid et al., practitioners of indications for catheter usage. These rounds were
2011). There is so much to gain, in terms of decreased mortal- common practice during both phases of this study and therefore
ity rates and healthcare costs, if practitioners adhere to infection could account for no change in utilization rate. Although this unit
control practices. The finding of zero CAUTI occurrences during made great strides since 2013 to decrease their utilization rate
Please cite this article in press as: Galiczewski, J.M., Shurpin, K.M., An intervention to improve the catheter associated urinary tract
infection rate in a medical intensive care unit: Direct observation of catheter insertion procedure. Intensive Crit Care Nurs (2017),
http://dx.doi.org/10.1016/j.iccn.2016.12.003
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YICCN-2487; No. of Pages 9 ARTICLE IN PRESS
8 J.M. Galiczewski, K.M. Shurpin / Intensive and Critical Care Nursing xxx (2017) xxx–xxx
from 84% to 71%, it remains above the NHSN catheter utilization Chen, Y.Y., Chou, Y.C., Chou, P., 2005. Impact of nosocomial infection on cost of illness
benchmark of 61% for critical care units (Casey et al., 2015) and length of stay in intensive care units. Infect. Control Hosp. Epidemiol. 26 (3),
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A limitation of this study is that it was conducted in a single ICU Chenoweth, C., Saint, S., 2013. Preventing catheter-associated urinary tract infec-
of a large tertiary academic teaching hospital and thus the gener- tions in the intensive care unit. Crit. Care Clin. 29 (1), 19–32, http://dx.doi.org/
alizability of the results may be limited to hospitals of similar size 10.1016/j.ccc.2012.10.005.
Clearinghouse, N.G., 2014. Guideline Attributes, Retrieved February 17, 2015 from
and type. Additionally, indication for catheter usage was only col- http.//www.guideline.gov/about/template-of-attributes.aspx.
lected during phase II of the study and although the information Earl, M.L., Jackson, M.M., Rickman, L.S., 2001. Improved rates of compliance with
was informative, it could not be compared to phase I. Another lim- hand antisepsis guidelines: a three-phase observational study. Am. J. Nurs. 101
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itation was the NHSN CAUTI definitions were updated in January
Ellingson, K., Haas, J.P., Aiello, A.E., Kusek, L., Maragakis, L.L., Olmsted, R.N., Yokoe,
2015 and all hospitals had to comply with the new reporting guide- D.S., 2014. Strategies to prevent healthcare-associated infections through hand
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Elpern, E.H., Killeen, K., Ketchem, A., Wiley, A., Patel, G., Lateef, O., 2009. Reducing
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the impact of direct observation during the insertion procedure Interventions to improve professional adherence to guidelines for prevention of
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valent intensive care unit. Intensive Care Med. 29 (7), 1077–1080, http://dx.doi.
org/10.1007/s00134-003-1767-2.
None. Marra, A.R., Sampaio Camargo, T.Z., Gonçalves, P., Sogayar, A.M.C.B., Moura, D.F.,
Guastelli, L.R., Edmond, M.B., 2011. Preventing catheter-associated urinary tract
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