Heidi Wald, Angela Richard, Brian Bandle, Regina Fink, Marie Boltz, Sung-Joon Min, Elizabeth Capezuti
Catheter-associated urinary tract infections (CAUTIs) are common among frail elders. CAUTI prevention relies on evidence-based nursing practices, few of which have been subject to multisite study. A cornerstone of prevention, surveillance can be used to provide feedback performance improvement. Researchers at the University of Colorado partnered with the Nurses Improving Care of Healthsystem Elders (NICHE) program to create the STOP CAUTI Workgroup to implement and test the impact of electronic surveillance of indwelling urinary catheter (IUC) use and CAUTI rates. Development of the STOP CAUTI Workgroup was based on a modification of the Johns Hopkins Hospital collaborative model, through a process to engage, educate, and establish an administrative framework prior to embarking on the study's execute and evaluate phases. Recruited from among 245 NICHE member hospitals, 20 hospitals completed all steps required to participate in the cluster-randomized controlled trial of audit and feedback in the reduction of CAUTI among hospitalized patients. In this paper, we detail the engage, educate, and establish stages of the project.
Hospitalization of older people carries a high risk of iatrogenic events, including pressure ulcers, falls, and hospital-acquired infections.1 These healthcare-associated conditions (HACs)—increasingly recognized by the larger medical community as unacceptable harms of medical care—are incorporated into quality measurement and value-based purchasing initiatives.2 Among HACs, catheter-associated urinary tract infections (CAUTIs) have received particular scrutiny. CAUTIs number over 500,000 cases per year in U.S. hospitals, accounting for 80 percent of nosocomial UTIs and 40 percent of all nosocomial infections.3 CAUTIs result in increased antibiotic use, prolonged hospitalizations, more severe infections, and occasionally death.4 They are expensive, resulting in a mean additional cost of $589–$656 per hospital stay4,5 and estimated costs to the U.S. health care system of $424 million dollars annually.
Despite these risks, the use of indwelling urinary catheters (IUCs) in hospitals is commonplace, and evidence exists that their inappropriate use is widespread.6 An estimated 25 percent of all hospitalized patients have IUCs, and elderly patients are more likely than younger patients to be catheterized and develop CAUTIs.7 Elderly patients catheterized without a specific medical indication are more likely to die and to have longer hospital stays than those without catheters.8 CAUTIs and IUCs may result in additional geriatric HACs, such as pressure ulcers and delirium.9,10
Concurrent, laboratory-based surveillance is central to CAUTI prevention efforts, but it is resource-intensive. Recent incentives have served to increase surveillance in intensive care units (ICUs).11 In the absence of data on catheter use and CAUTI rates, hospitals are unable to assess the impact of prevention initiatives. Electronic health records (EHRs) promise advances in efficiency and standardization of surveillance.12 However, this approach is untested.
Surveillance is a necessary but insufficient component of an effective infection control program. Evidence-based CAUTI prevention strategies fall into one of three categories: (a) avoidance and alternatives, (b) evidence-based care, and (c) early removal.13,14 Many of these strategies are poorly adopted.15 The best single-institution studies suggest that multicomponent interventions can successfully reduce the rates of CAUTIs by 60 to 70 percent.16,17
CAUTI prevention strategies highlight the critical role of high-quality nursing care in patient safety efforts. Many HACs are considered nursing-sensitive quality indicators. To successfully combat CAUTI and other HACs, a focus on building gerontological nursing capacity is crucial. Nurses Improving Care of Healthsystem Elders (NICHE) is a national program that provides educational resources to member hospitals about evidence-based geriatric nursing practice, focusing on the reduction of negative outcomes commonly experienced by older hospitalized patients. All NICHE hospitals support a local nurse coordinator.18 Thus, NICHE is well situated for the conduct of multisite quality improvement research targeted at geriatric HACs.
Project leaders chose a focus on early IUC removal in at-risk patients as the primary approach to CAUTI prevention because catheter duration is an important modifiable CAUTI risk factor.19 Audit and feedback of performance measures have been shown to be effective as a quality improvement strategy in health care.20 We postulated that the audit and feedback of IUC duration and CAUTI rates would lead to reductions in IUC duration and CAUTI incidence. This project, Surveillance and Tracking to Prevent CAUTI (STOP CAUTI), had two aims: (1) to disseminate an electronic method for tracking IUC duration and CAUTI surveillance, and (2) to determine the effect of data feedback care processes (IUC duration) and outcomes (CAUTI). We developed a multi-hospital collaborative within NICHE, the STOP CAUTI Workgroup, and conducted a cluster-randomized, controlled trial of audit and feedback of process and outcome measures in CAUTI prevention. Upon entry into data collection, sites were randomized to continued or delayed intervention. Figure 1 illustrates the project's design and associated timeline.
Substantial evidence exists that collaboratives of care providers designed to collect and share information can be effective in improving health care outcomes.21 To develop the STOP CAUTI Workgroup, we employed a modification of the Johns Hopkins Hospital collaborative model, which consists of four steps: engage, educate, execute, and evaluate.22 Because this research study required significant work to prepare for data collection, we added an additional "E," for "establish" (administrative framework).
In this paper, we describe the development of the STOP CAUTI Workgroup with regard to the following activities: engage and educate (recruitment, communication, and self-assessment) and establish administrative framework (contractual and regulatory oversight, validation of key data fields and processes). Facilities participating in these activities were positioned to take part in the execute and evaluate steps of the collaborative model—in this case, the cluster-randomized controlled trial of the effect of audit and feedback on IUC use and CAUTI rates among hospitalized patients.
Engage and Educate
An email call for interested facilities was issued to NICHE hospitals. NICHE coordinators who responded were provided with a detailed project description and invited to participate in an informational webinar. Those who retained a high level of interest were provided with additional information on the project's background, objectives, and timelines and participants' responsibilities. Hospitals agreeing to participate signed a letter of commitment that described in detail the responsibilities of study hospitals and the University of Colorado/NICHE study team.
Monthly conference calls and webinars provided a forum for exchange of information about the study, support and encouragement for achieving study milestones, education about the study topic and research methods, and facilitation of an esprit de corps among participating hospitals. A study website provided access to study materials and relevant links.a The study team maintained active email and telephone communication with NICHE coordinators and other hospital project staff, including participating information technology (IT) personnel. Additional steps to encourage active engagement included followup letters to chief nursing officers and face-to-face lunch meetings at NICHE annual conferences.
Self-Assessment: The STOP CAUTI Current Practice Survey
NICHE coordinators (n=20) were invited, in December 2009, to complete an electronic survey about baseline CAUTI prevention practices. The 25-item survey instrument, informed by an evidence-based literature review,13,23 was developed in the fall of 2009 and reviewed by an expert panel of nurse researchers, infection preventionists, and a physician prior to pilot testing. The instrument consisted of both quantitative and qualitative questions on IUC care practices including (1) equipment and alternatives to catheters, insertion practices, and maintenance techniques; (2) personnel, training and education, and catheter policies; and (3) documentation, surveillance, and removal reminders.
Respondents were encouraged to gather responses to survey items from relevant sources (e.g., nurses, infection preventionists) prior to completing the survey. They also were asked to send a copy of their hospital's current policies and procedures on IUC placement and management and CAUTI prevention. Email reminders were sent at 2 and 4 weeks post-survey launch. Data were entered into an SPSS database (version 17); survey items and demographics were summarized using descriptive statistics and tests of difference and association.
Establish Administrative Framework
Regulatory Oversight, Subcontracts, and Data Use Agreement
The Colorado Multiple Institutional Review Board (COMIRB) approved STOP CAUTI Workgroup activities under an expedited review process for the study coordinating center at the University of Colorado (CU), with waivers of HIPAA (Health Insurance Portability and Accountability Act of 1996) authorization and informed consent. In addition, each STOP CAUTI Workgroup hospital was asked to obtain local IRB review. Several participating hospitals were required to obtain authorization from internal nursing research committees prior to IRB review. The NICHE coordinators' experience with IRB processes varied widely. The CU study team provided technical support to the NICHE coordinators during this process by supplying the COMIRB expedited review application, responding to requests for additional information, reviewing hospital IRB applications, and developing responses to hospital research committee and IRB questions.
In addition, subcontracts were required with CU, the prime contractor, to partially compensate hospitals for time spent on study activities. A template subcontract and budgeting spreadsheet were provided by the study team, and a data use agreement was appended to each subcontract. The study team provided substantial support to NICHE coordinators in moving these processes forward.
Data Collection Protocol
Implementation of the data collection protocol was facilitated by the creation of a detailed data collection manual and webinars for IT personnel from each study site. The protocol specified (a) definitions of data elements, (b) validation procedures for IUC documentation, (c) report creation, (d) manual data collection, and (e) use of the REDCap (Research Electronic Data Capture) Send-it Tool for transmitting data files (a secure Web-based application designed to support data capture for research studies).24 Individual consultation was provided to IT staff at each hospital on the best methods for extracting EHR data elements and/or obtaining data manually. The STOP CAUTI sites submitted test data files prior to beginning actual data collection. Four sites without EHRs and one site with an EHR that could not provide reports were given detailed procedures for manual abstraction of data.
Validation of Data Elements
Hospitals that extracted data from EHRs were required to validate IUC documentation for each study unit prior to beginning data collection. The audit methodology was detailed in a series of conference calls and in the study data collection manual. The audits, conducted by nursing research or infection control personnel, occurred at the same time each day for a period of 1 to 4 weeks. During this time an auditor queried the EHR for IUC documentation for each patient on the study unit. These findings were compared with a manual clinical assessment, which was considered the gold standard for the validation. The manual clinical assessment consisted of a direct query of the patient's nurse about the presence or absence of an IUC for each patient on a given day. Because nurses provided direct care for IUCs, they generally had visualized the IUC themselves or received sign-out from the earlier shift regarding any voiding or IUC issues. If the nurses did not have knowledge of the IUC information, they generally consulted handwritten notes or the certified nursing assistants, or they returned to visualize the patients themselves. Hospitals conducted one of two types of audits. For sites where the IUC insertion and removal dates were extrapolated from daily nursing assessments, a validation was performed to verify the accuracy of the daily nursing assessment fields documenting the presence of an IUC. For sites where the catheter insertion and removal dates were directly taken from discrete date fields, the insertion and removal date fields were validated independently.
The nurse report was considered the gold standard test for the presence, insertion, or removal of an IUC. To assess the validity of IUC EHR documentation against the gold standard (Type I validation), we calculated a raw percent agreement. Values 90 percent or greater were considered excellent agreement; 75 percent to 89 percent, good agreement; and less than 75 percent, poor agreement. In addition, we reported sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). To assess the validity of insertion and removal date fields (Type II validation), we calculated raw percent agreement, sensitivity, and PPV. Because these validations were performed only on patients with catheters, specificity and NPV were not reported.
a. University of Colorado School of Medicine. NICHE: Nurses Improving Care for Healthsystem Elders. Stop CAUTI. Available at www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/hcpr/cauti/Pages/default.aspx. Accessed February 5, 2014.
Engage and Educate
Among the 245 NICHE member hospitals, 40 indicated interest, 21 submitted letters of commitment, and 20 completed the steps necessary to enter the study. Table 1 provides details about the STOP CAUTI hospitals and study units. When compared to the typical NICHE hospital, STOP CAUTI sites were not significantly different in terms of bed size, urban setting, teaching status, or ownership status. STOP CAUTI hospitals were more likely than typical NICHE hospitals to have "Magnet" designation (60 percent and 28 percent, respectively; p=.004).
The STOP CAUTI baseline practice survey revealed heterogeneity in the use of evidence-based interventions to prevent CAUTI (Table 2). The results were presented at the 2010 NICHE annual conference and are described elsewhere.25 The same survey was used in subsequent study years to track changes in prevention practices over the course of the study.
|Staffed beds (mean±SD)||476±253|
|Electronic medical record||80%|
|Study Units (n=25)|
|Staffed beds (mean±SD)||33±9|
|Registered nurses (mean±SD)||46±13|
|Nursing assistants (mean±SD)||18±5|
|Prevention Practice||% Employing Practice|
IUCs used (most frequent response reported by hospitals)
60 used hospital-wide
Alternatives to IUCs
|% responding frequently or always used
Adjuncts to IUCsSecurement devices
Personnel inserting IUCs
Routine care of urethral meatus
Documentation of output and IUC
IUC removal triggers
*Categories add up to more than 100% because respondents were able to choose more than one response.
Establishment of Administrative Framework
Regulatory Oversight, Subcontracts, and IRB
By August 2010, only 14 of the STOP CAUTI Workgroup sites had completed the IRB processes at their institutions. The six remaining hospitals completed local IRB processes by April 2011. By August 2010, subcontracts were fully executed for only 13 STOP CAUTI Workgroup sites, with the remaining seven hospitals completing this process by May 2011. Navigation of these administrative processes at participating hospitals caused significant delays in entering into data collection.
Data Collection Protocol
Sixteen hospitals employed EHRs from eight different vendors to capture the required study data. Fifteen hospitals were able to provide electronic reports that met the requirements for import into the STOP CAUTI database. Barriers to successful reporting included limited IT resources, difficulty supplying a unique study ID number and unique culture numbers, technical difficulty with the reporting software, difficulty separating text fields from numeric fields, and inconsistency in report layouts. Troubleshooting occurred through one-on-one support, although problems with reporting from one EHR system led to a multisite collaboration that resulted in successful reporting. In some instances, delays in report generation delayed initiation of data collection. For the five STOP CAUTI sites opting to participate using manual data collection, instructions were provided, and a customized Microsoft Excel™ spreadsheet was developed.
Validation of Data Elements
The 15 hospitals providing electronic data reports completed the validation. Five sites conducted validation of daily nursing assessment fields in seven units by determining the agreement between the nursing query and the EHR documentation of IUC presence for each day that each patient was on the unit (Table 3a). A total of 1,929 patient-days and 460 catheter-days were observed. All seven units had excellent nursing query and EHR agreement (95.3 percent–100 percent; CI range 92–100 percent), with 34 discrepancies noted (9.4 percent). The remaining 10 sites validated insertion and removal dates for 359 catheterizations in 13 units (Table 3b). Nine had good or excellent agreement, although the confidence intervals were wide for insertion dates (87 percent–100 percent; CI range 47–100 percent). These hospitals demonstrated good or excellent percent agreement for documented removal dates (78 percent–100 percent; CI range 39 percent–100 percent). Forty-five discrepancies were noted (7.8 percent of insertions and 4.7 percent of removals). After initial audits, hospital J increased completion of day-of-discharge documentation. These data were inclusive of their followup audit only. Hospital L identified major documentation problems requiring manual data collection.
A review of all discrepancies (n=79) demonstrated inaccuracies in insertion documentation (43% percent or removal documentation (35 percent), or were of undetermined cause (22 percent). The most common reasons for discrepancy included time lags (43 percent), missing data (16 percent), charting errors (11 percent), and artifact (8 percent).
The STOP CAUTI Workgroup went from concept to reality over the course of 18 months. During that period, the CU research team successfully engaged 20 diverse NICHE hospitals to participate in a complex quality improvement (QI) study. Creating a collaborative fostered efficiency, a sense of shared purpose, and a community of peers addressing the QI challenges of CAUTI prevention.
Lessons were learned in two areas: (a) establishment of administrative processes necessary for project participation, and (b) IT capacity and data validity. While local study coordinators were familiar with QI activities to reduce CAUTIs, few had experience in conducting human subjects research or familiarity with subcontracting processes. The majority of sites were able to accomplish the necessary administrative processes within a few months; however, some sites took more than a year. Individualized assistance was essential in facilitating study coordinators' ability to navigate unique IRB processes, applications, and requests. In general, frequent communications and the establishment of strong relationships between CU project staff and each of the hospital project teams were key to moving each hospital along in accomplishing the necessary administrative milestones.
In facilities with EHRs, the capacity to report required data fields exceeded expectations. In most instances, IT personnel were able to generate reports based on the data specifications provided. The collaborative STOP CAUTI approach proved particularly useful in troubleshooting reporting difficulty with one EHR system that was shared by four hospitals. Despite this success, there was sufficient variability in reporting that the CU project team needed to customize the import algorithm for nearly every hospital. Data validity was central to the success of this approach.
Although two recent reports in the literature demonstrate excellent agreement between electronic documentation and chart review,26,27 our validation activity found variability in the accurate documentation of IUC insertion and removal date fields, a validation approach not previously explored. While most of the hospitals had good or excellent documentation of insertion and removal dates, two sites (J and L) had documentation that was poor enough to warrant remediation or alternative data collection strategies. These validation data are limited by the small number of observations at some study sites due to shorter validation periods than stipulated. Longer validation periods would have increased the sample size and the accuracy of our estimates. Because the audits were carried out by clinical personnel at each site, we were unable to confirm that the audit protocols were completed as directed. In particular, we do not know whether the nurse who provided the clinical assessment had primary knowledge of the IUC. If she did not have primary knowledge and looked up the information in the EHR, these validations would be meaningless. An ideal approach might have employed direct observation of daily catheter presence. However, direct observation of insertions and removals would have required levels of staffing that were not feasible. Nonetheless, our experience suggests that hospitals wishing to track IUCs and CAUTIs electronically should periodically demonstrate the accuracy of insertion and removal documentation.
STOP CAUTI Workgroup sites participated in this project for very little compensation because of their affiliation with NICHE and their passion for the topic of CAUTI reduction. This enthusiasm alone was not sufficient to surmount all of the challenges that participation in a QI project of this scope entailed. To successfully embark on future collaborative, multisite QI efforts within NICHE, it would be advisable to build a funded research framework for participating NICHE hospitals that connects directly to research nursing professionals at each site. Despite these challenges, 20 STOP CAUTI Workgroup sites were able to enter into data collection (execute phase) between August 2010 and June 2011. The evaluate phase, with both qualitative and quantitative components, is ongoing.
|Hospital||Unit||Days||Patient-days||Catheter-days||Discrepancies||% Agreement (% CI)||Sensitivity||Specificity||PPV*||NPV**|
|A||1||10||308||71||4||98.7 (97, 99.7)||.99||.99||.96||1.00|
|2||12||234||89||11||95.3 (92, 98)||.97||.95||.92||.98|
|C||1||11||310||104||0||100 (99, 100)||1.00||1.00||1.00||1.00|
|D||1||10||274||50||6||97.8 (95, 99)||.92||.99||.96||.98|
|2||10||311||66||9||97.1 (95, 99)||.89||1.00||.99||.97|
|E||1||10||271||43||2||99.3 (97, 99.9)||1.00||.99||.96||1.00|
|Hospital||Unit||Days||Catheters||Insert / Removal Discrepancies||Insertion Date % Agreement (CI)||Insertion Sensitivity||Insertion PPV*||Removal Date % Agreement (CI)||Removal Sensitivity||Removal PPV*|
|F||1||10||39||6/2||88 (73, 96)||.97||.90||94 (80, 99)||1.00||.94|
|G||1||10||21||1/2||95 (76, 99.9)||.95||1.00||85 (55, 98)||.85||1.00|
|2||10||19||1/0||95 (74, 99.9)||.95||1.00||100 (66, 100)||1.00||1.00|
|H||1||29||71||2/0||97 (90, 99.7)||.97||1.00||100 (95, 100)||1.00||1.00|
|I||1||31||47||0/0||100 (93, 100)||1.00||1.00||100 (93, 100)||1.00||1.00|
|J||1&2||14||10||0/2||100 (66, 100)||1.00||1.00||78 (39, 97)||.78||1.00|
|K||1||15||23||1/0||94 (72, 99.9)||.94||1.00||100 (83, 100)||1.00||1.00|
|L||1||15||38||10/11||71 (48, 89)||.75||.94||64 (45, 81)||.69||.91|
|M||1||10||21||2/0||90 (70, 99)||.91||1.00||100 (83, 100)||1.00||1.00|
|N||1||6||34||2/0||94 (80, 99)||.94||1.00||100 (90, 100)||1.00||1.00|
|P||1||7||15||2/1||87 (60, 98)||.87||1.00||93 (68, 99.9)||.93||1.00|
|2||6||8||1/0||88 (47, 99.7)||.88||1.00||100 (54, 100)||1.00||1.00|
This project was funded under contract no. R18 HS 018377 from the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services. The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
Dr. Wald acknowledges the support of a Paul Beeson Career Development Award in Aging (NIA 5 K23 AG034544) from the National Institute on Aging, the John A Hartford Foundation, the Atlantic Philanthropies, the Starr Foundation, and an anonymous donor. The authors acknowledge the contributions of Joe Shuluk, BA, and Nina Shabbat, MPH. We also are indebted to the STOP CAUTI Workgroup NICHE coordinators: Suzanne Purvis, DNP, RN, GCNS-BC, University of Wisconsin Hospitals and Clinics; Eleanor Incalcaterra, MS, RN, BC, Robert Wood Johnson Hospital; Shirley Conway, RN, Addison Gilbert and Beverly Hospitals; Anita Meehan, RN, Akron General Medical Center; Mary Spear, RN, MSN, GCNS, John Muir Medical Center, Walnut Creek Campus; Cathy Hebert, RN, GCNS-BC, Mission Hospital; Deborah Raley, MSN, RN-BC, Northwest Community Hospital; Nicole Ortiz, RN, Ocean Medical Center; Arlene Horner, MS, RN, GCNS-BC, Sanford USD Medical Center; Denise Kresevic, RN, PhD, University Hospitals Case Medical Center; Carla Graf, RN and Daphne Stannard, RN, PhD, FCCM, University of California, San Francisco Medical Center; Judith Hamlin, MS, FNP, RN, CCM, David Martin, RN, ICP, and Christina Bond, MS, FACHE Crouse Hospital; Lynda Dimitroff, PhD, MSEd, RN, MCHES, Lynn Nichols, RN, and Sue Nickoley, RN, Rochester General Hospital; Anne Vanderbilt, MSN, RN, Cleveland Clinic; Sue Hartranft, RN, Morton Plant Mease Countryside Hospital; John Jorgensen, MPA, RN, Fort Sanders Regional Hospital; Paula Brabec, RN, MSN, DNP, and Carrie Murray, MS, RN, ACNS-BC, Aspirus Wausau Hospital; Deirdre Carolan, CRNP, PhD, GCNS, Inova Fairfax Hospital; Diane D'Ambra, MS, RN, WCC, WCN, Roger Williams Medical Center; Ann Dylis, RN, PhD, Lahey Clinic.
University of Colorado School of Medicine (HW, AR, BB, SM), University of Colorado Hospital (RF), University of Colorado College of Nursing (RF), Aurora, CO. New York University College of Nursing, New York, NY (MB, EC).
Address correspondence to: Heidi Wald, MD, MSPH, University of Colorado School of Medicine, Campus Box F480, 13199 E. Montview Ave, Suite 400, Aurora, CO 80045-7201; Email: email@example.com.
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