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The Influence of an Antimicrobial Peripherally Inserted Central Catheter on Central Line-Associated Bloodstream Infections in a Hospital Environment
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The Influence of an Antimicrobial Peripherally Inserted Central Catheter on Central Line-Associated Bloodstream Infections in a Hospital Environment Glenell S. Rutkoff, MSN, RN, CGRN Chula Vista Medical Center, Chula Vista, CA
Abstract Background: Federal agencies such as the Centers for Disease Control and Prevention have mandated reduction of hospitalacquired infections and recommended the use of antimicrobial catheters in clinical settings where central line-associated bloodstream infection (CLABSI) rates have remained high. The Infusion Nurses Society also recommends antimicrobial catheters for specific patient populations. At a California hospital, evidence-based infection prevention strategies for CLABSI prevention had been in effect for several years, but the CLABSI rate remained at an unacceptable level. For this reason, the effect of an antimicrobial peripherally inserted central catheter (PICC) on the incidence of CLABSI was studied. Methods: A quasiexperimental design was used with concurrent data collection on patients in an intervention group who received an antimicrobial PICC. Retrospective data were collected for patients in a nonintervention group who received nonantimicrobial PICCs the previous year. Results: The 257 patients in the nonintervention group experienced 8 CLABSIs with an infection rate of 4.18/1,000 line days. The 260 subjects in the intervention group experienced 1 CLABSI with an infection rate of 0.47/1,000 line days. The decrease in the number of infections per 1,000 line days for the intervention group was statistically significant. Conclusions: The use of an antimicrobial PICC in conjunction with current infection prevention practices resulted in a statistically significant decrease in infection rate, which supports the recommendation for continued use of antimicrobial catheters. Treatment cost savings, which overcame the higher initial cost for the devices, were found to be an additional benefit of using antimicrobial catheters. Keywords: antimicrobial catheter, central line-associated bloodstream infection, CLABSI, peripherally inserted central catheter, PICC
Background years-long public/private campaign in the United States to minimize central line-associated bloodstream infections (CLABSIs) has so far produced mixed results. Notable success has been achieved in critical care unit settings
A
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2014.06.002 Copyright Ó 2014, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved. indicates that continuing education contact hours are available for this activity. Earn the contact hours by reading this article and completing the test available at www.avainfo.org/JAVACE.
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by institutions implementingdand enforcing use ofdbest practices and preventive technologies. That success has not yet been matched in the general setting of acute care hospitals.1 The prevention and elimination of CLABSIs in critical care units became the focus of research more than a decade ago.2 As a result, infection prevention strategies have been steadily adopted as standard practice for reducing CLABSI rates in intensive care units throughout the country.1 Studies by the Centers for Disease Control and Prevention (CDC) document sharp reductions in the incidence of these infections. A retrospective study on the incidence of central line infections published in 2011 by the CDC estimated that during 2001, 43,000 central line infections occurred in patients cared for in US critical care units.1 By 2009 that number had decreased to approximately 18,000 central line infections in patients cared for in
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Table 1. Rationale for Undertaking an Antimicrobial PICC Study d
d
Above-benchmark central line-associated bloodstream infection rate in this California facility National central line-associated bloodstream infection reduction strategies were not specific to the hospital’s current circumstances, where catheters were present in the acute care environment and many were PICCs
d
Availability of an antimicrobial PICC without a relevant evidence base in acute care environments
d
Opportunity to reduce risk of central line-associated bloodstream infection-related deaths
d
Central line-associated bloodstream infection-related costs
d
Accountability by nursing leadership for supporting infection reduction strategies
d
Influence of nurse leadership-designed research on frontline nursing behavior
PICC ¼ peripherally inserted central catheter.
US critical care units. The reduction was credited to widespread implementation of evidence-based central line insertion practices.1 But CLABSI rates remain high in general in acute care hospitals. The just-cited CDC report estimated that as many as 23,000 CLABSIs occurred in US general care wards during 2009.1 The CDC, Joint Commission, and the Centers for Medicare and Medicaid Services responded by promoting a national goal of 50% reduction in CLABSIs across acute care environments by 2013.1 Nursing leadership will have to play a major role in achieving CLABSI rate reductionsdboth by driving the implementation of best practices and technologies and by promoting compliance with their nursing staff. There is a paucity of research about how to reduce CLABSI rates in acute care wards when compared with critical care units. The CDC has identified the difficulties faced by hospitals when attempting to reduce the incidence of CLABSI outside of critical care units.1 The organization called for additional research in acute care areas to identify strategies that would successfully eliminate patient risk in those environments. In line with these needs, our 241-bed, not-for-profit California community hospital undertook a study to analyze the effect of an antimicrobial peripherally inserted central catheter (PICC) on the incidence of PICC-associated CLABSI across adult care units. The study was undertaken for several related reasons (see Table 1). Above-benchmark CLABSI rate The CDC guidelines include the following category 1A (highest level) recommendation for the use of antimicrobial/ antiseptic central venous catheters: “Use a chlorhexidine/silver sulfadiazine-impregnated or minocycline/rifampin impregnated CVC in patients whose catheter is expected to remain in place >5 days if, after successful implementation of a comprehensive strategy to reduce rates of CLABSI, the CLABSI rate is not decreasing. The comprehensive strategy should include at minimum the following three components: 1) education of caregivers who insert and maintain catheters, 2) use of maximal sterile barrier precautions, and 3) a >0.5% chlorhexidine preparation with alcohol for skin antisepsis during CVC insertion.”3
The study hospital introduced a program in 2006 that focused on strategies to reduce rates of CLASBI. These strategies included assessment of line necessity, a central venous catheter (CVC) insertion checklist, intensive education on central line and PICC insertion, the use of maximum barrier precautions, and use of chlorhexidine/alcohol skin preparation before catheter insertion. Despite these measures, our CLABSI rate remained at an unacceptable leveldas of 2012, it was reported by the California Department of Public Health to be in the 25th percentile for the state.4 Thus, the hospital conditions detailed by the CDC described the hospital in our study. The Infusion Nurses Society, an organization recognized as the global authority in infusion nursing, has also developed practice standards that address benchmark CLABSI rates. Standard of Practice 32dwhich addresses central venous access devices, nontunneled catheters, PICCs, tunneled catheters, and implanted portsdidentifies specific patient populations that should receive antimicrobial PICCs when it states, “The nurse should collaborate with the multidisciplinary team to consider use of anti-infective catheters in the following circumstances: expected dwell points of more than 5 days; CRBSI rate remains high even after employing other protective strategies, neutropenic, transplant, burn, hemodialysis, or critically patients, catheter insertion or exchange with infection or bacteremia; or for emergency situations.”5 Evidence Base Not Specific to Hospital Circumstances The scientific evidence supporting the CDC recommendation reflected research solely conducted in critical care environments. Whereas some might expect that such research would be generalizable across all acute health care settings, the nursing models, clinical practices, and patient priorities are different between acute and critical care. In addition, the evidence base for the CDC recommendation covered only 1 type of vascular device: a CVC. Our hospital more widely used PICCs than CVCs in its general, acute care units, in part because PICCs are longer dwelling. During 2011 in our facility, PICCs were associated with approximately 68% of CLABSIs.
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Availability of Antimicrobial PICCs Without a Relevant Evidence Base A new antimicrobial PICC (Arrow PICC with Chloragþard Technology; Teleflex Inc, Reading, PA) was released to the vascular access market during 2011. This catheter is Food and Drug Administration-cleared with antimicrobial and antithrombogenic claims. Our literature review found no scientific studies of the effects of this particular PICC on CLABSIs in hospital environments. Opportunity to Reduce Risk of CLABSI-related Deaths CLABSIs are life-threatening, with a morality rate of 12% to 25%.6 According to the CDC, an estimated 30,000 to 62,000 patients die every year from central line infections they acquired while hospitalized.7 Our hospital recorded 17 CLABSIs during 2011din other words, 17 patients at higher risk of death as a result of contracting a serious, but preventable, hospital-acquired complication. CDC Director Tom Frieden recently stated, “Preventing blood stream infections is not only possibledit should be expected.”2 CLABSI-related Costs Although our hospital’s primary motivation for the study was to determine the influence of antimicrobial PICCs on patient safety, hospital leadership recognized that fewer infections would reduce infection-related costs. The costs associated with CLABSIs vary in the literature from $3,000 to as much as $36,000.2 Our hospital’s 17 CLABSIs in 2011 thus resulted in unfunded costs of between $51,000 to >$500,000, because the Centers for Medicare and Medicaid Services and many private insurers no longer reimburse for these infections. In addition to these direct costs, the hospital may have potentially experienced poor standing in its region and reduced patronage due to its low ranking in a California Department of Public Health report released during 2012 on CLABSIs in California hospitals. The report, which compared infection rates across similar levels of care, showed our hospital to have a higher-than-average incidence of PICC-related CLABSIs compared with its peer institutions. Accountability Lack of accountability by hospital leaders has been a major impediment to achieving 0 health care-associated infection tolerance.8 Shared accountability and teamwork have been viewed as key facilitators in implementing effective infection prevention strategies.9 Individuals responsible for guaranteeing accountability not only include direct caregivers but also the chief executive officer, upper management, administrative leaders, and unit managers. These individuals contribute to infection reduction through measures such as continued readiness and ongoing demonstration of successful infection prevention outcomes. Nursing leadership in our hospital chose to lead the way for PICCassociated CLASBI reduction by incorporating the antimicrobial PICC into a clinical study.
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Influence of Nurse Leadership-designed Research on Frontline Nurse Behavior When nursing leaders design a study to be relevant to current clinical situations in frontline nurses’ environments of care, the research is more likely to be accepted by frontline nurses and have a positive influence on their attitudes, beliefs, and behaviors. In other words, nurses are potentially more likely to transition from traditional nursing practices to new evidence-based clinical practices. This may be even truer if nurses see that by complying with unit-specific quality measures they can make a positive contribution to federal and state initiatives. CLABSI is preventable and all must assume responsibility for the use of evidence-based practices to successfully eliminate these dangerous hospital-acquired infections. Patient safety, health care reform, cost management, and social benefit were all drivers of the national initiatives calling for decreases in the incidence of CLABSI across hospitals in the United States. National guidelines and standards of practice provide clear identification of the best practices to prevent and eliminate central line infections. Our study of an antimicrobial PICC’s effect on the incidence of CLABSI across critical and acute care wards was consistent with initiatives/recommended practices by the CDC and the Infusion Nurses Society. The study also provided nurses, health care providers, and infection prevention professionals with evidence of the PICC’s benefit regarding current infection prevention strategies. Methods The hypothesis for this research was that the use of an antimicrobial PICC will demonstrate a decrease in the PICCassociated CLABSI rate for the acute and critical care environments of our hospital. To investigate this, a quasiexperimental design consisting of 1 intervention group and 1 historical control group was selected. This design was chosen because it enabled the researcher to avoid ethical issues associated with withholding a treatment from patients while still using a current intervention to evaluate the effect of an antimicrobial PICC on CLABSI incidence. This approach is appropriate when attempting to use statistics to determine the effects of an intervention and draw conclusions about its effects.9 Independent crosschecking of data input for accuracy was done with the assistance of vascular access team nurses. The patient groups compared in our study were not assumed by the researcher to be equivalent in all ways before the intervention of the antimicrobial catheter. Descriptive and inferential statistics were used to demonstrate similarity for all variables except the antimicrobial catheter. Although the use of a randomized study with concurrent controls would have been optimal, historical controls can be used when a randomized study is not possible and their use does not introduce bias. In this study, there were no temporal effects that would introduce bias and statistical tests were used to compare demographic characteristics. For purposes of this study, a CLABSI was defined according to criteria set forth by the CDC/National Healthcare Safety Network (NHSN), as follows: “A laboratory-confirmed
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bloodstream infection (LCBI) where central line (CL) or umbilical catheter (UC) was in place for >2 calendar days on the date of event, with day of device placement being Day 1, and a CL or UC was in place on the date of event or the day before. If a CL or UC was in place for >2 calendar days and then removed, the LCBI criteria must be fully met on the day of discontinuation or the next day. If the patient is admitted or transferred into a facility with a central line in place (e.g., tunneled or implanted central line), and that is the patient’s only central line, day of first access as an inpatient is considered Day 1. ‘Access’ is defined as line placement, infusion or withdrawal through the line.”10 In our study, temperature spikes of >38.5 C generally triggered a physician’s order to obtain a blood culture. Other considerations that could initiate a blood culture included suspected sepsis in the presence of vascular access devices. One set of blood cultures was obtained from 1 lumen of the PICC, whereas the other set was drawn from a peripheral site. Laboratory personnel thoroughly trained in obtaining blood cultures were responsible for performing this procedure. Setting/Participants The setting for the study was a 241-bed community hospital in California. The hospital offers a full range of medical services, including but not limited to emergency, critical care, telemetry, oncology, medical/surgical, and obstetrics. The study included approximately 260 patients each in both the nonintervention and intervention groups. The participants in the study consisted of adult hospitalized patients requiring insertion of a single- or dual-lumen PICC. Patients in the nonintervention group included adult, hospitalized patients who received an unprotected single- or dual lumen PICC during a 6-month period (ie, 180 days) between August 2010 and February 2011. Patients in the intervention group included adult, hospitalized patients who had the study antimicrobial PICC placed during a 6-month (ie, 180 days) period between August 2011 and February 2012. Exclusion criteria for both groups encompassed any patient with a triple-lumen PICC (because the study antimicrobial PICC was not yet available in a triple lumen configuration) or any patient who needed a different type of vascular access device. All PICC insertions were performed by specially trained registered nurses who were members of the hospital’s vascular access team. Our hospital’s Department of Infection Prevention also participated in the research by collecting CLABSI data in accordance with methods and definitions used by the NHSN in its standardized process for identification of central line-associated infections. Our Department of Infection Prevention tabulated percentages of acute care nursing compliance with evidence-based central line maintenance practices for both study groups. There is 1 caveat about the study population. During the data collection period, an E-study clinical drug-trial program was in progress at our hospital. The program was researching antibiotics used for chronic wound infection. Our study population included a younger inpatient group receiving E-study medications via PICC. This could possibly have influenced
Table 2. Data Collection Details Indication for peripherally inserted central catheter
Intravenous therapy >6d Medication incompatibility Central access required for medications or medical condition Poor peripheral access
Subject environment
Surgical Medical and oncology Medical/surgical intensive care unit Telemetry
Gender
Male Female
Ethnicity
Hispanic Asian White Black Other
the significance of the variable for age. This matter is considered in more detail in the Discussion section. Data Collection Concurrent data were collected on 260 patients during a 6-month period (ie, 180 days) who received an antimicrobial PICC. Retrospective data were collected for 257 patients who received a PICC without antimicrobial properties during a 6-month period (ie, 180 days) during the previous year. Our study utilized primary data collection for the intervention group and secondary data collected from retrospective chart reviews for the nonintervention group. Some information collected was numerical by nature; for example, line days, patient age, and CLABSI rate. Population characteristics (gender and ethnicity), indication of line placement, and patient’s area of care were coded to facilitate analysis of group characteristics for population matching. The nominal data shown in Table 2 were collected and coded through retrospective chart review for the nonintervention group and through concurrent observation of the intervention group. Interval and ratio variables were collected concurrently and through retrospective chart review (ie, age, length of catheter dwell time as number of line days, and CLABSI rate). Data Analysis The type of data to be analyzed and the desired goal of the testing determined the tests chosen to analyze the data in our study. The 2 patient groups were considered to be independent. Initially, raw data were explored and examined for frequencies. The groups were compared on demographic variables using Fisher exact tests or c2 tests for categorical data. Continuous variables for the 2 groupings were compared using the 2tailed independent t test. Multivariate logistic regression
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analysis was done to determine significance of age, gender, unit of care, and use of an antimicrobial catheter (intervention) as predictors of infection. Estimates of standard errors of parameters used a 95% confidence interval (CI). A P value .05 determined statistical significance. Human Subjects Protection Before undertaking this project, the researcher completed the National Institutes of Health Office of Extramural Research basic training course “Protecting Human Research Participants.” The research was conducted in compliance with the Good Clinical Practice and the Health Insurance Portability and Accountability Act regulations. Patient privacy was protected during all data collection. Written permission to proceed with the research was obtained by the researcher through our hospital’s institutional review board. The PICC product inserted for this research was used in accordance with Food and Drug Administration-approved labeling and was commercially available. The PICC did not pose unusual or additional risk to patients beyond the common risks associated with central line placement, and any requirement for separate informed consent was waived by the institutional review board. Informed consent was provided by the ordering physician and written consent was obtained by the inserter per current policy of our hospital. Results We determined that the outcome data yielded by the research is not attributable to demographic variables. The intervention and nonintervention groups were analyzed independently for population comparison, measurement of the variables affecting incidence of CLABSI, and the relationship of the antimicrobial catheter to PICC-associated bloodstream infection rates. The 2 groups were found to be not significantly different when they were compared using c2 for homogeneity of age, gender (P ¼ .09), ethnicity (P ¼ .047), and unit (P ¼ .01). The mean ages for the nonintervention group and intervention group were 65 years and 62 years, respectively. The inclusion of patients and catheters from both critical and acute care environments was an important aspect of this study. Both the intervention and nonintervention groups were independently analyzed for distribution of patient location across 4 of our hospital’s care departments. Independent analysis of both groups showed a sampling of patients from all areas of care (see Table 3). Surgical patients (a total of 115 from nonintervention and intervention groups) included any patient who had undergone a surgical intervention or procedure. Our hospital has a full perioperative service, including general and vascular surgery; orthopedics; urology; neurosurgery; ear, nose, and throat; and gynecology. Patients from the medical services and oncology care unit (a total of 131 patients from the nonintervention and intervention groups) were composed of patients with medical complications such as diabetes, respiratory ailments, and gastrointestinal difficulties and oncology patients receiving chemotherapy, treatment for complications of cancer or chemotherapy, and/or diagnosis/management for
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Table 3. Patient Demographics
Characteristic
Intervention Control group group (n ¼ 260) (n ¼ 257)
Age (y), mean
62
65
Male gender, %
52
44
117
108
Asian
33
39
White
107
107
Black
3
3
Other
0
0
Medical and oncology
69
62
Surgery
66
49
Medical/surgical intensive care
58
91
Telemetry
66
55
Ethnicity, % Hispanic
Unit of care, %
new malignancies. The largest number of patients included in the study were from the critical care area (a total of 149 from the nonintervention and intervention groups). These patients required a more intense level of care than other patients and included patients with both surgical and medical critical illnesses. Finally, patients from the telemetry unit (a total of 121 for both groups) consisted of medical and surgical patients who required cardiac monitoring as part of their care. The logistic regression analysis determined if there was an effect of the patient and catheter variables on the probability of CLABSI. For the purpose of this research, the data collected for the variables of gender, ethnicity, indication for line, area of care, intervention PICC, and age were included in the model. Statistical significance of each relationship was defined as P < .05 with a CI of 95%. A total of 517 patients in the dataset were included in the model. To measure if certain independent variables increased or decreased the odds of developing a CLABSI, the reference variable (no infection) was coded as 0 and the variable trying to be predicted (infection) was coded as 1. The model summary indicated 3.8% to 23.5% of the variance in the dependent variable was due to the model. The Hosmer and Lemeshow test showed that the model was a good fit with the data (P ¼ .224) and the overall percentage of how many cases were predicted correctly by the model was 98.3%. The logistic regression found age to be the only statistically significant value (P ¼ .027) predictor.
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Table 4. Central Line Maintenance Bundle Practices d
Scheduled central line dressing change every 7 days and as needed
d
Line-access devices changed every Monday and Thursday
d
Alcohol-impregnated caps on all access ports
d
Central line dressing integrity assessment
Nursing compliance with our hospital’s evidence-based central line maintenance practices was considered by the researcher to be a confounding variable. The criteria used in the central line maintenance bundle included the practices listed in Table 4. This bundle of central line maintenance practices was implemented in 2009 after careful review of well-documented clinical interventions that support recognized strategies to reduce CLASBIs. Nursing demonstrated 95.8% compliance with central line maintenance bundles for the nonintervention patients and 96.2% compliance for the intervention patients. The total number of line days was 1,912 for the nonintervention group and 2,124 for the intervention group. No patients in either group had a PICC pulled and then replaced or had >1 CLABSI. The 257 patients in the nonintervention group experienced a total of 8 CLABSIs with an associated infection rate of 4.18/1,000 line days. The 260 patients in the intervention group experienced 1 CLABSI with an associated infection rate of 0.47/1,000 line days. The decrease in the rate of infections per 1,000 line days was statistically significant using a c2 test (P ¼ .013). The odds ratio was 8.92 (95% CI, 1.143190.4). The effect of the intervention in the logistic regression analysis was not significant (P ¼ .053) (Table 5). Discussion Our study hypothesis was that the use of an antimicrobial PICC would demonstrate a decrease in the PICC-associated
CLABSI rate for the acute and critical care environments in our hospital. PICC-related bloodstream infections were in fact found less frequently in patients with the antimicrobial PICC compared with patients with nonmicrobial PICCs. The nonintervention group had a total of 8 CLABSIs (rate ¼ 4.18/1,000 catheter days). There was 1 CLABSI (rate ¼ 0.47/1,000 catheter days) in the intervention group. The relationship between the decrease in the number of infections per 1,000 line days and the antimicrobial PICC was significant when conducting the crosstab c2 test (P ¼ .013). The odds ratio was 8.92 (95% CI, 1.143-190.4). The effect of the intervention in the logistic regression analysis was not significant (P ¼ .053). The antimicrobial PICC appears to have resulted in a substantial reduction in the number of infections and a statistically significant decrease in the CLABSI rate. It is our opinion that the evidence supports the continued use of the antimicrobial PICC. Regarding the variables in our study, descriptive and inferential statistical methods and a multivariable regression model were used to analyze the data. Both the intervention and nonintervention groups were found to be well matched except for the variable for age. Age was identified in the regression analysis as the only statistically significant predictor of infection (P ¼ .027; df ¼ 1) but extraneous factors in the hospital of study may have influenced this finding. In particular, an E-study clinical drug-trial program may have influenced the significance of the variable for age. Clinical drug trials on antibiotics used for chronic wound infection were in progress during the period of time of data collection for both study groups. The trial patients included a younger inpatient demographic with PICCs inserted for administration of study medications. Among the 8 CLABSIs identified in the nonintervention group, 3 were in patients younger than age 40 years. The 1 CLABSI associated with the intervention group was an oncology patient aged 45 years requiring chemotherapy for acute lymphocytic leukemia. Whereas age was considered to be statistically significant in our study, the determination of age as a predictor of infection was not found in the
Table 5. Data Based on Dwell Times Patient group Data collected
Nonintervention
Intervention
1,912
2,124
Mean number of line days per month
318
354
Longest catheter dwell time, d
82
88
Shortest catheter dwell time, d
1
1
Mean catheter dwell time, d
11
10
Number of CLABSIs identified
8
1
4.18
0.47
Total number of line days
CLABSI rate per 1,000 line days CLABSI ¼ central line-associated bloodstream infection.
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review of literature for this project. In our opinion, age was not a generalizable finding for populations outside of our hospital. CLABSI research with a focus on the relationship of age to incidence would undoubtedly be interesting, but a more detailed collection of patient diagnosis and underlying comorbidities with associated risk factors for CLABSIs in younger patients might provide clearer relevance as a predictor of central line infection. Low compliance with evidence-based maintenance bundles by nursing staff is a primary reason patients develop central line infections.6 Our study’s confounding variable of nursing compliance with evidence-based central line maintenance practices was reported by our Department of Infection Prevention as percentages. Nursing compliance for the nonintervention and intervention groups was roughly the same; that is w 96%, which would be considered excellent in most institutions. Despite this relatively high compliance rate, 8 CLABSIs occurred in the nonintervention group. Only 1 occurred in the intervention group, suggesting that adding an additional layer of protection with an antimicrobial PICC can have a positive influence on infection risk even when compliance with central line care practices is very high. Selection of patients for inclusion in our study was based on those patients who had PICCs placed during a specific 6month time period. Conditions and diagnoses in each group that could affect the CLABSI results could not be effectively tracked in any orderly pattern. Various diagnoses and conditions; for example, length-of-stay, underlying disease process, presence of multiple vascular access devices, total parenteral nutrition, and emergency insertion, can contribute to an increased CABSI rate, so patients with any of these conditions may have influenced the results. There was a statistically significant decrease in the rate of CLABSI from 4.18/1,000 catheter days to 0.47/1,000 catheter days when the antimicrobial PICC was used. This reduced rate is below the national mean expected rate of 1.3/1,000 catheter days as shown by NHSN for distribution of CLABSI in medical/surgical units with >15 beds.11 We thus believe that use of an antimicrobial PICC in conjunction with current infection prevention practices should be considered by facilities similar to our hospital. The results of our study should be confirmed with a more robust study involving multiple institutions. Our research has established that use of an antimicrobial PICC resulted in substantial cost savings for our hospital. The increased cost associated with the use of the antimicrobial PICC was approximately $7.50 per catheter, representing an increase of approximately $2,000 for the 260 catheters inserted in the intervention group. The estimated savings by our hospital as a result of avoiding 7 CLABSIs was approximately $16,500 per infection or $115,500. The overall cost savings are consistent with previous research cited by the CDC, which notes: “Certain catheters and cuffs that are coated or impregnated with antimicrobial or antiseptic agents can decrease the risk for [catheter-related bloodstream infections (CRBSIs)] and potentially decrease hospital costs associated with treating CRBSIs, despite the additional acquisition cost of an antimicrobial/antiseptic impregnated catheter.”3
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Limitations There are limitations affecting the applicability of this study. The 2 study groups were not fully comparable with respect to underlying conditions or admitting diagnosis that might have predisposed the patients to CLABSI. The variables collected on each diagnosis varied greatly between patients and did not offer a pattern to code effectively for known CLABSI risk factors. A more detailed and organized review of each patient’s medical record with classifications of the patients’ comorbidities by the known risk factors for CLABSI may have provided the necessary data to code more accurately. The same data could then have been included in the regression analysis to determine if admitting diagnosis or underlying condition was a predictor of infection. Our choice to forego randomization of the study patients due to ethical considerations weakens the applicability of the research because of the limitations of the quasiexperimental design. A randomized double-blinded experimental design is considered to be the gold standard when attempting to determine the true effect of interventions.9 Our study instead contrasted an intervention group, using primary data, with a nonintervention group and its secondary, retrospective data. The quasiexperimental design could only provide evidence of probability. The above-mentioned retrospective data for the nonintervention group was another limitation. In addition, the inability of the researcher to determine the significance of nursing compliance with maintenance practices could have introduced bias into this study. Finally, our study’s generalizability is questionable due to its small size. Recommendations for Practice National guidelines and established standards of practice for vascular access are intended to prevent complications and improve patient outcomes. In particular, recommendations by the CDC and Infusion Nurses Society are considered authoritative for vascular access practice because they are based on the most robust evidence and research available in the field. For this reason, hospitals widely incorporate multiple CDC and Infusion Nurses Society recommendations with regard to peripherally inserted CVCs. With many infection control experts now agreeing that a 0 CLABSI rate is achievable and therefore the only acceptable result, it may be time to consider if CDC and Infusion Nurses Society recommendations regarding antimicrobial catheters should be more tightly followed. The reduced CLABSI rate and treatment cost savings achieved at our hospital when the antimicrobial PICC was used support this notion. Those results are consistent with the evidence supporting the CDC and Infusion Nurses Society recommendations for antimicrobial catheter use. In particular, specific patient populations (eg, burn, oncology, total parenteral nutrition, and critical care) who are at heightened risk for CLABSI may greatly benefit from incorporation of antimicrobial PICCs into hospital practice. PICCs are necessary, lifesaving devices but they can be associated with potentially fatal complications. Inclusion of an antimicrobial PICC would be a prudent step in reducing central linerelated morbidity and mortality.
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Conclusions Our study showed a statistically significant decrease in the rate of CLABSI from 4.18/1,000 catheter days to 0.47/1,000 catheter days when the antimicrobial PICC was used. This reduced rate is below the national mean expected rate of 1.3/1,000 catheter days shown by NHSN for distribution of CLABSI in medical/surgical units >15 beds.11 Treatment cost savings were found to be an additional benefit of using an antimicrobial catheter. They overcame the higher initial cost for the devices, in line with findings cited by the CDC. Our study was an initial step toward using nursing research to propose a change to current central line infection prevention strategies in our hospital. Because the research did show a reduction in the number of CLABSIs and a statistically significant decrease in the CLABSI rate per group, we believe the findings should be disseminated to frontline nursing staff to demonstrate why it may be clinically advantageous to incorporate antimicrobial PICCs into current infection prevention practices. Use of our study’s findings in this manner would serve as a relatable example to frontline nurses of how to use nursing research in evidence-based practice. A recommendation for integration of antimicrobial PICCs into current infection prevention practices should be considered at facilities that are similar to our hospital if there is the historical inability to reduce CLABSI rates through the use of current infection prevention practice. This is consistent with CDC recommendations for the use of an antimicrobial catheter and the Infusion Nurses Society standards of practice for inclusion of an antimicrobial PICC for specific patient populations and patient scenarios, the savings to our hospital for unfunded expenses associated with hospital-acquired infections, and a commitment to patient safety that includes the obligation to prevent hospital-acquired infections such as CLABSI. Acknowledgment The author received assistance with statistical analysis and revisions from Teleflex Inc when responding to reviewers’ comments about the original manuscript. Disclosures The author has no conflicts of interest to disclose.
References 1. Centers for Disease Control and Prevention. Central lineassociated blood stream infectionsdUnited States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011;60(8):243-248. 2. Evans G. CLABSI prevention success pressures hospitals to adopt similar programs. Hosp Infect Control Prev. 2011;38(4):37-41. 3. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infection. Am J Infect Control. 2011;39(4 Suppl 1):S1-S34. 4. California Department of Public Health. Central lineassociated bloodstream infection (CLABSI) and central line insertion practices (CLIP) in California Hospitals, 2012. http://www.cdph.ca.gov/programs/hai/Pages/CentralLine AssociatedBloodstreamInfections-CLABSI-Reports.aspx. Accessed February 15, 2012. 5. Infusion Nurses Society. Infusion nursing standards of practice. J Infus Nurs. 2011;34(1 Suppl):S1-S110. 6. Marschall J. Catheter-associated bloodstream infections: looking outside of the ICU. Am J Infect Control. 2008;36(Suppl):S172.e5-S172.e8. 7. Agency for Healthcare Research and Quality. AHRQ’s 2009 funded projects to prevent healthcare-associated infections. AHRQ Pub. No. 09(10)-P013e1. http://www.ahrq.gov/ research/findings/factsheets/errors-safety/haify09/haify09. pdf. Published October 2009. Accessed March 3, 2012. 8. Uchida M, Stone PW, Conway LJ, Pogorzelska M, Larson EL, Raveis VH. Exploring infection prevention: policy implications from a qualitative study. Policy Polit Nurs Pract. 2011;12(2):82-89. 9. Jarvis WR. The Lowbury Lecture. The United States approach to strategies in the battle against healthcareassociated infections, 2006: transitioning from benchmarking to zero tolerance and clinician accountability. J Hosp Infect. 2007;65(Suppl 2):3-9. 10. Centers for Disease Control and Prevention. Deviceassociated module CLABSI. http://www.cdc.gov/nhsn/ PDFs/pscManual/4PSC_CLABScurrent.pdf. Published January 2014. Accessed March 22, 2014. 11. Houser J. Nursing Research: Reading, Using, and Creating Evidence. 1st ed. Sudbury, MA, Jones and Bartlett Publishers, 2008.
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A R T I C L E
The Influence of an Antimicrobial Peripherally Inserted Central Catheter on Central Line-Associated Bloodstream Infections in a Hospital Environment Glenell S. Rutkoff, MSN, RN, CGRN Chula Vista Medical Center, Chula Vista, CA
Abstract Background: Federal agencies such as the Centers for Disease Control and Prevention have mandated reduction of hospitalacquired infections and recommended the use of antimicrobial catheters in clinical settings where central line-associated bloodstream infection (CLABSI) rates have remained high. The Infusion Nurses Society also recommends antimicrobial catheters for specific patient populations. At a California hospital, evidence-based infection prevention strategies for CLABSI prevention had been in effect for several years, but the CLABSI rate remained at an unacceptable level. For this reason, the effect of an antimicrobial peripherally inserted central catheter (PICC) on the incidence of CLABSI was studied. Methods: A quasiexperimental design was used with concurrent data collection on patients in an intervention group who received an antimicrobial PICC. Retrospective data were collected for patients in a nonintervention group who received nonantimicrobial PICCs the previous year. Results: The 257 patients in the nonintervention group experienced 8 CLABSIs with an infection rate of 4.18/1,000 line days. The 260 subjects in the intervention group experienced 1 CLABSI with an infection rate of 0.47/1,000 line days. The decrease in the number of infections per 1,000 line days for the intervention group was statistically significant. Conclusions: The use of an antimicrobial PICC in conjunction with current infection prevention practices resulted in a statistically significant decrease in infection rate, which supports the recommendation for continued use of antimicrobial catheters. Treatment cost savings, which overcame the higher initial cost for the devices, were found to be an additional benefit of using antimicrobial catheters. Keywords: antimicrobial catheter, central line-associated bloodstream infection, CLABSI, peripherally inserted central catheter, PICC
Background years-long public/private campaign in the United States to minimize central line-associated bloodstream infections (CLABSIs) has so far produced mixed results. Notable success has been achieved in critical care unit settings
A
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2014.06.002 Copyright Ó 2014, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved. indicates that continuing education contact hours are available for this activity. Earn the contact hours by reading this article and completing the test available at www.avainfo.org/JAVACE.
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by institutions implementingdand enforcing use ofdbest practices and preventive technologies. That success has not yet been matched in the general setting of acute care hospitals.1 The prevention and elimination of CLABSIs in critical care units became the focus of research more than a decade ago.2 As a result, infection prevention strategies have been steadily adopted as standard practice for reducing CLABSI rates in intensive care units throughout the country.1 Studies by the Centers for Disease Control and Prevention (CDC) document sharp reductions in the incidence of these infections. A retrospective study on the incidence of central line infections published in 2011 by the CDC estimated that during 2001, 43,000 central line infections occurred in patients cared for in US critical care units.1 By 2009 that number had decreased to approximately 18,000 central line infections in patients cared for in
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Table 1. Rationale for Undertaking an Antimicrobial PICC Study d
d
Above-benchmark central line-associated bloodstream infection rate in this California facility National central line-associated bloodstream infection reduction strategies were not specific to the hospital’s current circumstances, where catheters were present in the acute care environment and many were PICCs
d
Availability of an antimicrobial PICC without a relevant evidence base in acute care environments
d
Opportunity to reduce risk of central line-associated bloodstream infection-related deaths
d
Central line-associated bloodstream infection-related costs
d
Accountability by nursing leadership for supporting infection reduction strategies
d
Influence of nurse leadership-designed research on frontline nursing behavior
PICC ¼ peripherally inserted central catheter.
US critical care units. The reduction was credited to widespread implementation of evidence-based central line insertion practices.1 But CLABSI rates remain high in general in acute care hospitals. The just-cited CDC report estimated that as many as 23,000 CLABSIs occurred in US general care wards during 2009.1 The CDC, Joint Commission, and the Centers for Medicare and Medicaid Services responded by promoting a national goal of 50% reduction in CLABSIs across acute care environments by 2013.1 Nursing leadership will have to play a major role in achieving CLABSI rate reductionsdboth by driving the implementation of best practices and technologies and by promoting compliance with their nursing staff. There is a paucity of research about how to reduce CLABSI rates in acute care wards when compared with critical care units. The CDC has identified the difficulties faced by hospitals when attempting to reduce the incidence of CLABSI outside of critical care units.1 The organization called for additional research in acute care areas to identify strategies that would successfully eliminate patient risk in those environments. In line with these needs, our 241-bed, not-for-profit California community hospital undertook a study to analyze the effect of an antimicrobial peripherally inserted central catheter (PICC) on the incidence of PICC-associated CLABSI across adult care units. The study was undertaken for several related reasons (see Table 1). Above-benchmark CLABSI rate The CDC guidelines include the following category 1A (highest level) recommendation for the use of antimicrobial/ antiseptic central venous catheters: “Use a chlorhexidine/silver sulfadiazine-impregnated or minocycline/rifampin impregnated CVC in patients whose catheter is expected to remain in place >5 days if, after successful implementation of a comprehensive strategy to reduce rates of CLABSI, the CLABSI rate is not decreasing. The comprehensive strategy should include at minimum the following three components: 1) education of caregivers who insert and maintain catheters, 2) use of maximal sterile barrier precautions, and 3) a >0.5% chlorhexidine preparation with alcohol for skin antisepsis during CVC insertion.”3
The study hospital introduced a program in 2006 that focused on strategies to reduce rates of CLASBI. These strategies included assessment of line necessity, a central venous catheter (CVC) insertion checklist, intensive education on central line and PICC insertion, the use of maximum barrier precautions, and use of chlorhexidine/alcohol skin preparation before catheter insertion. Despite these measures, our CLABSI rate remained at an unacceptable leveldas of 2012, it was reported by the California Department of Public Health to be in the 25th percentile for the state.4 Thus, the hospital conditions detailed by the CDC described the hospital in our study. The Infusion Nurses Society, an organization recognized as the global authority in infusion nursing, has also developed practice standards that address benchmark CLABSI rates. Standard of Practice 32dwhich addresses central venous access devices, nontunneled catheters, PICCs, tunneled catheters, and implanted portsdidentifies specific patient populations that should receive antimicrobial PICCs when it states, “The nurse should collaborate with the multidisciplinary team to consider use of anti-infective catheters in the following circumstances: expected dwell points of more than 5 days; CRBSI rate remains high even after employing other protective strategies, neutropenic, transplant, burn, hemodialysis, or critically patients, catheter insertion or exchange with infection or bacteremia; or for emergency situations.”5 Evidence Base Not Specific to Hospital Circumstances The scientific evidence supporting the CDC recommendation reflected research solely conducted in critical care environments. Whereas some might expect that such research would be generalizable across all acute health care settings, the nursing models, clinical practices, and patient priorities are different between acute and critical care. In addition, the evidence base for the CDC recommendation covered only 1 type of vascular device: a CVC. Our hospital more widely used PICCs than CVCs in its general, acute care units, in part because PICCs are longer dwelling. During 2011 in our facility, PICCs were associated with approximately 68% of CLABSIs.
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Availability of Antimicrobial PICCs Without a Relevant Evidence Base A new antimicrobial PICC (Arrow PICC with Chloragþard Technology; Teleflex Inc, Reading, PA) was released to the vascular access market during 2011. This catheter is Food and Drug Administration-cleared with antimicrobial and antithrombogenic claims. Our literature review found no scientific studies of the effects of this particular PICC on CLABSIs in hospital environments. Opportunity to Reduce Risk of CLABSI-related Deaths CLABSIs are life-threatening, with a morality rate of 12% to 25%.6 According to the CDC, an estimated 30,000 to 62,000 patients die every year from central line infections they acquired while hospitalized.7 Our hospital recorded 17 CLABSIs during 2011din other words, 17 patients at higher risk of death as a result of contracting a serious, but preventable, hospital-acquired complication. CDC Director Tom Frieden recently stated, “Preventing blood stream infections is not only possibledit should be expected.”2 CLABSI-related Costs Although our hospital’s primary motivation for the study was to determine the influence of antimicrobial PICCs on patient safety, hospital leadership recognized that fewer infections would reduce infection-related costs. The costs associated with CLABSIs vary in the literature from $3,000 to as much as $36,000.2 Our hospital’s 17 CLABSIs in 2011 thus resulted in unfunded costs of between $51,000 to >$500,000, because the Centers for Medicare and Medicaid Services and many private insurers no longer reimburse for these infections. In addition to these direct costs, the hospital may have potentially experienced poor standing in its region and reduced patronage due to its low ranking in a California Department of Public Health report released during 2012 on CLABSIs in California hospitals. The report, which compared infection rates across similar levels of care, showed our hospital to have a higher-than-average incidence of PICC-related CLABSIs compared with its peer institutions. Accountability Lack of accountability by hospital leaders has been a major impediment to achieving 0 health care-associated infection tolerance.8 Shared accountability and teamwork have been viewed as key facilitators in implementing effective infection prevention strategies.9 Individuals responsible for guaranteeing accountability not only include direct caregivers but also the chief executive officer, upper management, administrative leaders, and unit managers. These individuals contribute to infection reduction through measures such as continued readiness and ongoing demonstration of successful infection prevention outcomes. Nursing leadership in our hospital chose to lead the way for PICCassociated CLASBI reduction by incorporating the antimicrobial PICC into a clinical study.
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Influence of Nurse Leadership-designed Research on Frontline Nurse Behavior When nursing leaders design a study to be relevant to current clinical situations in frontline nurses’ environments of care, the research is more likely to be accepted by frontline nurses and have a positive influence on their attitudes, beliefs, and behaviors. In other words, nurses are potentially more likely to transition from traditional nursing practices to new evidence-based clinical practices. This may be even truer if nurses see that by complying with unit-specific quality measures they can make a positive contribution to federal and state initiatives. CLABSI is preventable and all must assume responsibility for the use of evidence-based practices to successfully eliminate these dangerous hospital-acquired infections. Patient safety, health care reform, cost management, and social benefit were all drivers of the national initiatives calling for decreases in the incidence of CLABSI across hospitals in the United States. National guidelines and standards of practice provide clear identification of the best practices to prevent and eliminate central line infections. Our study of an antimicrobial PICC’s effect on the incidence of CLABSI across critical and acute care wards was consistent with initiatives/recommended practices by the CDC and the Infusion Nurses Society. The study also provided nurses, health care providers, and infection prevention professionals with evidence of the PICC’s benefit regarding current infection prevention strategies. Methods The hypothesis for this research was that the use of an antimicrobial PICC will demonstrate a decrease in the PICCassociated CLABSI rate for the acute and critical care environments of our hospital. To investigate this, a quasiexperimental design consisting of 1 intervention group and 1 historical control group was selected. This design was chosen because it enabled the researcher to avoid ethical issues associated with withholding a treatment from patients while still using a current intervention to evaluate the effect of an antimicrobial PICC on CLABSI incidence. This approach is appropriate when attempting to use statistics to determine the effects of an intervention and draw conclusions about its effects.9 Independent crosschecking of data input for accuracy was done with the assistance of vascular access team nurses. The patient groups compared in our study were not assumed by the researcher to be equivalent in all ways before the intervention of the antimicrobial catheter. Descriptive and inferential statistics were used to demonstrate similarity for all variables except the antimicrobial catheter. Although the use of a randomized study with concurrent controls would have been optimal, historical controls can be used when a randomized study is not possible and their use does not introduce bias. In this study, there were no temporal effects that would introduce bias and statistical tests were used to compare demographic characteristics. For purposes of this study, a CLABSI was defined according to criteria set forth by the CDC/National Healthcare Safety Network (NHSN), as follows: “A laboratory-confirmed
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bloodstream infection (LCBI) where central line (CL) or umbilical catheter (UC) was in place for >2 calendar days on the date of event, with day of device placement being Day 1, and a CL or UC was in place on the date of event or the day before. If a CL or UC was in place for >2 calendar days and then removed, the LCBI criteria must be fully met on the day of discontinuation or the next day. If the patient is admitted or transferred into a facility with a central line in place (e.g., tunneled or implanted central line), and that is the patient’s only central line, day of first access as an inpatient is considered Day 1. ‘Access’ is defined as line placement, infusion or withdrawal through the line.”10 In our study, temperature spikes of >38.5 C generally triggered a physician’s order to obtain a blood culture. Other considerations that could initiate a blood culture included suspected sepsis in the presence of vascular access devices. One set of blood cultures was obtained from 1 lumen of the PICC, whereas the other set was drawn from a peripheral site. Laboratory personnel thoroughly trained in obtaining blood cultures were responsible for performing this procedure. Setting/Participants The setting for the study was a 241-bed community hospital in California. The hospital offers a full range of medical services, including but not limited to emergency, critical care, telemetry, oncology, medical/surgical, and obstetrics. The study included approximately 260 patients each in both the nonintervention and intervention groups. The participants in the study consisted of adult hospitalized patients requiring insertion of a single- or dual-lumen PICC. Patients in the nonintervention group included adult, hospitalized patients who received an unprotected single- or dual lumen PICC during a 6-month period (ie, 180 days) between August 2010 and February 2011. Patients in the intervention group included adult, hospitalized patients who had the study antimicrobial PICC placed during a 6-month (ie, 180 days) period between August 2011 and February 2012. Exclusion criteria for both groups encompassed any patient with a triple-lumen PICC (because the study antimicrobial PICC was not yet available in a triple lumen configuration) or any patient who needed a different type of vascular access device. All PICC insertions were performed by specially trained registered nurses who were members of the hospital’s vascular access team. Our hospital’s Department of Infection Prevention also participated in the research by collecting CLABSI data in accordance with methods and definitions used by the NHSN in its standardized process for identification of central line-associated infections. Our Department of Infection Prevention tabulated percentages of acute care nursing compliance with evidence-based central line maintenance practices for both study groups. There is 1 caveat about the study population. During the data collection period, an E-study clinical drug-trial program was in progress at our hospital. The program was researching antibiotics used for chronic wound infection. Our study population included a younger inpatient group receiving E-study medications via PICC. This could possibly have influenced
Table 2. Data Collection Details Indication for peripherally inserted central catheter
Intravenous therapy >6d Medication incompatibility Central access required for medications or medical condition Poor peripheral access
Subject environment
Surgical Medical and oncology Medical/surgical intensive care unit Telemetry
Gender
Male Female
Ethnicity
Hispanic Asian White Black Other
the significance of the variable for age. This matter is considered in more detail in the Discussion section. Data Collection Concurrent data were collected on 260 patients during a 6-month period (ie, 180 days) who received an antimicrobial PICC. Retrospective data were collected for 257 patients who received a PICC without antimicrobial properties during a 6-month period (ie, 180 days) during the previous year. Our study utilized primary data collection for the intervention group and secondary data collected from retrospective chart reviews for the nonintervention group. Some information collected was numerical by nature; for example, line days, patient age, and CLABSI rate. Population characteristics (gender and ethnicity), indication of line placement, and patient’s area of care were coded to facilitate analysis of group characteristics for population matching. The nominal data shown in Table 2 were collected and coded through retrospective chart review for the nonintervention group and through concurrent observation of the intervention group. Interval and ratio variables were collected concurrently and through retrospective chart review (ie, age, length of catheter dwell time as number of line days, and CLABSI rate). Data Analysis The type of data to be analyzed and the desired goal of the testing determined the tests chosen to analyze the data in our study. The 2 patient groups were considered to be independent. Initially, raw data were explored and examined for frequencies. The groups were compared on demographic variables using Fisher exact tests or c2 tests for categorical data. Continuous variables for the 2 groupings were compared using the 2tailed independent t test. Multivariate logistic regression
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analysis was done to determine significance of age, gender, unit of care, and use of an antimicrobial catheter (intervention) as predictors of infection. Estimates of standard errors of parameters used a 95% confidence interval (CI). A P value .05 determined statistical significance. Human Subjects Protection Before undertaking this project, the researcher completed the National Institutes of Health Office of Extramural Research basic training course “Protecting Human Research Participants.” The research was conducted in compliance with the Good Clinical Practice and the Health Insurance Portability and Accountability Act regulations. Patient privacy was protected during all data collection. Written permission to proceed with the research was obtained by the researcher through our hospital’s institutional review board. The PICC product inserted for this research was used in accordance with Food and Drug Administration-approved labeling and was commercially available. The PICC did not pose unusual or additional risk to patients beyond the common risks associated with central line placement, and any requirement for separate informed consent was waived by the institutional review board. Informed consent was provided by the ordering physician and written consent was obtained by the inserter per current policy of our hospital. Results We determined that the outcome data yielded by the research is not attributable to demographic variables. The intervention and nonintervention groups were analyzed independently for population comparison, measurement of the variables affecting incidence of CLABSI, and the relationship of the antimicrobial catheter to PICC-associated bloodstream infection rates. The 2 groups were found to be not significantly different when they were compared using c2 for homogeneity of age, gender (P ¼ .09), ethnicity (P ¼ .047), and unit (P ¼ .01). The mean ages for the nonintervention group and intervention group were 65 years and 62 years, respectively. The inclusion of patients and catheters from both critical and acute care environments was an important aspect of this study. Both the intervention and nonintervention groups were independently analyzed for distribution of patient location across 4 of our hospital’s care departments. Independent analysis of both groups showed a sampling of patients from all areas of care (see Table 3). Surgical patients (a total of 115 from nonintervention and intervention groups) included any patient who had undergone a surgical intervention or procedure. Our hospital has a full perioperative service, including general and vascular surgery; orthopedics; urology; neurosurgery; ear, nose, and throat; and gynecology. Patients from the medical services and oncology care unit (a total of 131 patients from the nonintervention and intervention groups) were composed of patients with medical complications such as diabetes, respiratory ailments, and gastrointestinal difficulties and oncology patients receiving chemotherapy, treatment for complications of cancer or chemotherapy, and/or diagnosis/management for
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Table 3. Patient Demographics
Characteristic
Intervention Control group group (n ¼ 260) (n ¼ 257)
Age (y), mean
62
65
Male gender, %
52
44
117
108
Asian
33
39
White
107
107
Black
3
3
Other
0
0
Medical and oncology
69
62
Surgery
66
49
Medical/surgical intensive care
58
91
Telemetry
66
55
Ethnicity, % Hispanic
Unit of care, %
new malignancies. The largest number of patients included in the study were from the critical care area (a total of 149 from the nonintervention and intervention groups). These patients required a more intense level of care than other patients and included patients with both surgical and medical critical illnesses. Finally, patients from the telemetry unit (a total of 121 for both groups) consisted of medical and surgical patients who required cardiac monitoring as part of their care. The logistic regression analysis determined if there was an effect of the patient and catheter variables on the probability of CLABSI. For the purpose of this research, the data collected for the variables of gender, ethnicity, indication for line, area of care, intervention PICC, and age were included in the model. Statistical significance of each relationship was defined as P < .05 with a CI of 95%. A total of 517 patients in the dataset were included in the model. To measure if certain independent variables increased or decreased the odds of developing a CLABSI, the reference variable (no infection) was coded as 0 and the variable trying to be predicted (infection) was coded as 1. The model summary indicated 3.8% to 23.5% of the variance in the dependent variable was due to the model. The Hosmer and Lemeshow test showed that the model was a good fit with the data (P ¼ .224) and the overall percentage of how many cases were predicted correctly by the model was 98.3%. The logistic regression found age to be the only statistically significant value (P ¼ .027) predictor.
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Table 4. Central Line Maintenance Bundle Practices d
Scheduled central line dressing change every 7 days and as needed
d
Line-access devices changed every Monday and Thursday
d
Alcohol-impregnated caps on all access ports
d
Central line dressing integrity assessment
Nursing compliance with our hospital’s evidence-based central line maintenance practices was considered by the researcher to be a confounding variable. The criteria used in the central line maintenance bundle included the practices listed in Table 4. This bundle of central line maintenance practices was implemented in 2009 after careful review of well-documented clinical interventions that support recognized strategies to reduce CLASBIs. Nursing demonstrated 95.8% compliance with central line maintenance bundles for the nonintervention patients and 96.2% compliance for the intervention patients. The total number of line days was 1,912 for the nonintervention group and 2,124 for the intervention group. No patients in either group had a PICC pulled and then replaced or had >1 CLABSI. The 257 patients in the nonintervention group experienced a total of 8 CLABSIs with an associated infection rate of 4.18/1,000 line days. The 260 patients in the intervention group experienced 1 CLABSI with an associated infection rate of 0.47/1,000 line days. The decrease in the rate of infections per 1,000 line days was statistically significant using a c2 test (P ¼ .013). The odds ratio was 8.92 (95% CI, 1.143190.4). The effect of the intervention in the logistic regression analysis was not significant (P ¼ .053) (Table 5). Discussion Our study hypothesis was that the use of an antimicrobial PICC would demonstrate a decrease in the PICC-associated
CLABSI rate for the acute and critical care environments in our hospital. PICC-related bloodstream infections were in fact found less frequently in patients with the antimicrobial PICC compared with patients with nonmicrobial PICCs. The nonintervention group had a total of 8 CLABSIs (rate ¼ 4.18/1,000 catheter days). There was 1 CLABSI (rate ¼ 0.47/1,000 catheter days) in the intervention group. The relationship between the decrease in the number of infections per 1,000 line days and the antimicrobial PICC was significant when conducting the crosstab c2 test (P ¼ .013). The odds ratio was 8.92 (95% CI, 1.143-190.4). The effect of the intervention in the logistic regression analysis was not significant (P ¼ .053). The antimicrobial PICC appears to have resulted in a substantial reduction in the number of infections and a statistically significant decrease in the CLABSI rate. It is our opinion that the evidence supports the continued use of the antimicrobial PICC. Regarding the variables in our study, descriptive and inferential statistical methods and a multivariable regression model were used to analyze the data. Both the intervention and nonintervention groups were found to be well matched except for the variable for age. Age was identified in the regression analysis as the only statistically significant predictor of infection (P ¼ .027; df ¼ 1) but extraneous factors in the hospital of study may have influenced this finding. In particular, an E-study clinical drug-trial program may have influenced the significance of the variable for age. Clinical drug trials on antibiotics used for chronic wound infection were in progress during the period of time of data collection for both study groups. The trial patients included a younger inpatient demographic with PICCs inserted for administration of study medications. Among the 8 CLABSIs identified in the nonintervention group, 3 were in patients younger than age 40 years. The 1 CLABSI associated with the intervention group was an oncology patient aged 45 years requiring chemotherapy for acute lymphocytic leukemia. Whereas age was considered to be statistically significant in our study, the determination of age as a predictor of infection was not found in the
Table 5. Data Based on Dwell Times Patient group Data collected
Nonintervention
Intervention
1,912
2,124
Mean number of line days per month
318
354
Longest catheter dwell time, d
82
88
Shortest catheter dwell time, d
1
1
Mean catheter dwell time, d
11
10
Number of CLABSIs identified
8
1
4.18
0.47
Total number of line days
CLABSI rate per 1,000 line days CLABSI ¼ central line-associated bloodstream infection.
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review of literature for this project. In our opinion, age was not a generalizable finding for populations outside of our hospital. CLABSI research with a focus on the relationship of age to incidence would undoubtedly be interesting, but a more detailed collection of patient diagnosis and underlying comorbidities with associated risk factors for CLABSIs in younger patients might provide clearer relevance as a predictor of central line infection. Low compliance with evidence-based maintenance bundles by nursing staff is a primary reason patients develop central line infections.6 Our study’s confounding variable of nursing compliance with evidence-based central line maintenance practices was reported by our Department of Infection Prevention as percentages. Nursing compliance for the nonintervention and intervention groups was roughly the same; that is w 96%, which would be considered excellent in most institutions. Despite this relatively high compliance rate, 8 CLABSIs occurred in the nonintervention group. Only 1 occurred in the intervention group, suggesting that adding an additional layer of protection with an antimicrobial PICC can have a positive influence on infection risk even when compliance with central line care practices is very high. Selection of patients for inclusion in our study was based on those patients who had PICCs placed during a specific 6month time period. Conditions and diagnoses in each group that could affect the CLABSI results could not be effectively tracked in any orderly pattern. Various diagnoses and conditions; for example, length-of-stay, underlying disease process, presence of multiple vascular access devices, total parenteral nutrition, and emergency insertion, can contribute to an increased CABSI rate, so patients with any of these conditions may have influenced the results. There was a statistically significant decrease in the rate of CLABSI from 4.18/1,000 catheter days to 0.47/1,000 catheter days when the antimicrobial PICC was used. This reduced rate is below the national mean expected rate of 1.3/1,000 catheter days as shown by NHSN for distribution of CLABSI in medical/surgical units with >15 beds.11 We thus believe that use of an antimicrobial PICC in conjunction with current infection prevention practices should be considered by facilities similar to our hospital. The results of our study should be confirmed with a more robust study involving multiple institutions. Our research has established that use of an antimicrobial PICC resulted in substantial cost savings for our hospital. The increased cost associated with the use of the antimicrobial PICC was approximately $7.50 per catheter, representing an increase of approximately $2,000 for the 260 catheters inserted in the intervention group. The estimated savings by our hospital as a result of avoiding 7 CLABSIs was approximately $16,500 per infection or $115,500. The overall cost savings are consistent with previous research cited by the CDC, which notes: “Certain catheters and cuffs that are coated or impregnated with antimicrobial or antiseptic agents can decrease the risk for [catheter-related bloodstream infections (CRBSIs)] and potentially decrease hospital costs associated with treating CRBSIs, despite the additional acquisition cost of an antimicrobial/antiseptic impregnated catheter.”3
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Limitations There are limitations affecting the applicability of this study. The 2 study groups were not fully comparable with respect to underlying conditions or admitting diagnosis that might have predisposed the patients to CLABSI. The variables collected on each diagnosis varied greatly between patients and did not offer a pattern to code effectively for known CLABSI risk factors. A more detailed and organized review of each patient’s medical record with classifications of the patients’ comorbidities by the known risk factors for CLABSI may have provided the necessary data to code more accurately. The same data could then have been included in the regression analysis to determine if admitting diagnosis or underlying condition was a predictor of infection. Our choice to forego randomization of the study patients due to ethical considerations weakens the applicability of the research because of the limitations of the quasiexperimental design. A randomized double-blinded experimental design is considered to be the gold standard when attempting to determine the true effect of interventions.9 Our study instead contrasted an intervention group, using primary data, with a nonintervention group and its secondary, retrospective data. The quasiexperimental design could only provide evidence of probability. The above-mentioned retrospective data for the nonintervention group was another limitation. In addition, the inability of the researcher to determine the significance of nursing compliance with maintenance practices could have introduced bias into this study. Finally, our study’s generalizability is questionable due to its small size. Recommendations for Practice National guidelines and established standards of practice for vascular access are intended to prevent complications and improve patient outcomes. In particular, recommendations by the CDC and Infusion Nurses Society are considered authoritative for vascular access practice because they are based on the most robust evidence and research available in the field. For this reason, hospitals widely incorporate multiple CDC and Infusion Nurses Society recommendations with regard to peripherally inserted CVCs. With many infection control experts now agreeing that a 0 CLABSI rate is achievable and therefore the only acceptable result, it may be time to consider if CDC and Infusion Nurses Society recommendations regarding antimicrobial catheters should be more tightly followed. The reduced CLABSI rate and treatment cost savings achieved at our hospital when the antimicrobial PICC was used support this notion. Those results are consistent with the evidence supporting the CDC and Infusion Nurses Society recommendations for antimicrobial catheter use. In particular, specific patient populations (eg, burn, oncology, total parenteral nutrition, and critical care) who are at heightened risk for CLABSI may greatly benefit from incorporation of antimicrobial PICCs into hospital practice. PICCs are necessary, lifesaving devices but they can be associated with potentially fatal complications. Inclusion of an antimicrobial PICC would be a prudent step in reducing central linerelated morbidity and mortality.
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Conclusions Our study showed a statistically significant decrease in the rate of CLABSI from 4.18/1,000 catheter days to 0.47/1,000 catheter days when the antimicrobial PICC was used. This reduced rate is below the national mean expected rate of 1.3/1,000 catheter days shown by NHSN for distribution of CLABSI in medical/surgical units >15 beds.11 Treatment cost savings were found to be an additional benefit of using an antimicrobial catheter. They overcame the higher initial cost for the devices, in line with findings cited by the CDC. Our study was an initial step toward using nursing research to propose a change to current central line infection prevention strategies in our hospital. Because the research did show a reduction in the number of CLABSIs and a statistically significant decrease in the CLABSI rate per group, we believe the findings should be disseminated to frontline nursing staff to demonstrate why it may be clinically advantageous to incorporate antimicrobial PICCs into current infection prevention practices. Use of our study’s findings in this manner would serve as a relatable example to frontline nurses of how to use nursing research in evidence-based practice. A recommendation for integration of antimicrobial PICCs into current infection prevention practices should be considered at facilities that are similar to our hospital if there is the historical inability to reduce CLABSI rates through the use of current infection prevention practice. This is consistent with CDC recommendations for the use of an antimicrobial catheter and the Infusion Nurses Society standards of practice for inclusion of an antimicrobial PICC for specific patient populations and patient scenarios, the savings to our hospital for unfunded expenses associated with hospital-acquired infections, and a commitment to patient safety that includes the obligation to prevent hospital-acquired infections such as CLABSI. Acknowledgment The author received assistance with statistical analysis and revisions from Teleflex Inc when responding to reviewers’ comments about the original manuscript. Disclosures The author has no conflicts of interest to disclose.
References 1. Centers for Disease Control and Prevention. Central lineassociated blood stream infectionsdUnited States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011;60(8):243-248. 2. Evans G. CLABSI prevention success pressures hospitals to adopt similar programs. Hosp Infect Control Prev. 2011;38(4):37-41. 3. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infection. Am J Infect Control. 2011;39(4 Suppl 1):S1-S34. 4. California Department of Public Health. Central lineassociated bloodstream infection (CLABSI) and central line insertion practices (CLIP) in California Hospitals, 2012. http://www.cdph.ca.gov/programs/hai/Pages/CentralLine AssociatedBloodstreamInfections-CLABSI-Reports.aspx. Accessed February 15, 2012. 5. Infusion Nurses Society. Infusion nursing standards of practice. J Infus Nurs. 2011;34(1 Suppl):S1-S110. 6. Marschall J. Catheter-associated bloodstream infections: looking outside of the ICU. Am J Infect Control. 2008;36(Suppl):S172.e5-S172.e8. 7. Agency for Healthcare Research and Quality. AHRQ’s 2009 funded projects to prevent healthcare-associated infections. AHRQ Pub. No. 09(10)-P013e1. http://www.ahrq.gov/ research/findings/factsheets/errors-safety/haify09/haify09. pdf. Published October 2009. Accessed March 3, 2012. 8. Uchida M, Stone PW, Conway LJ, Pogorzelska M, Larson EL, Raveis VH. Exploring infection prevention: policy implications from a qualitative study. Policy Polit Nurs Pract. 2011;12(2):82-89. 9. Jarvis WR. The Lowbury Lecture. The United States approach to strategies in the battle against healthcareassociated infections, 2006: transitioning from benchmarking to zero tolerance and clinician accountability. J Hosp Infect. 2007;65(Suppl 2):3-9. 10. Centers for Disease Control and Prevention. Deviceassociated module CLABSI. http://www.cdc.gov/nhsn/ PDFs/pscManual/4PSC_CLABScurrent.pdf. Published January 2014. Accessed March 22, 2014. 11. Houser J. Nursing Research: Reading, Using, and Creating Evidence. 1st ed. Sudbury, MA, Jones and Bartlett Publishers, 2008.
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