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24-week period (Supplementary Fig. S1 online). The wards included medical and surgical wards, in addition to the intensive care unit (ICU). The study commenced in November 2017 and concluded in May 2018. A cross-sectional anonymous online survey was conducted at the end of the study period, in addition to a focus-group interview. The study was registered with the Australian and New Zealand Clinical Trial Registry (no. ACTRN12617001191381), and a study protocol has been published.3
Participants and eligibility
All hospitalized patients in eligible wards of the hospital who had an indwelling urinary catheter as part of their usual clinical care were included in the study. Patients <2 years old were excluded. The participants in the online survey and focus group were nursing staff; this group was chosen because they were directly involved in the intervention and urinary catheter care.
Ethics
Ethics approval was obtained from thehuman research ethics com- mittees of Avondale College of Higher Education (2017: 15) and Townville Hospital and Health Service (no. HREC17QTHS19). A waiver of individual patient consent was obtained for this study.
Randomization and blinding
Using computer-generated randomization, eligible wards in the hospital were randomly assigned to cross over to the intervention every 4 weeks over the trial duration. Randomization was per- formed by a person not involved in the study. The allocation was performed immediately prior to the commencement of the study. Wards were not blinded because it was not feasible to blind the staff to the intervention.
Intervention
The intervention was the use of the CATH TAG. The CATH TAG is an electronic device in the form of a sticker that attaches to the catheter bag with adhesive (Supplementary Fig. S2 online). It is lightweight and has a nonintrusive green light that flashes intermit- tently for a period of 24 hours upon activation. After 24 hours, the green flashing light changes to red, flashing with increased rapidity and visibility. The red flashing light is an indication that the nurse should reassess the need for a urinary catheter and should remove it if it is no longer required. There is no option for nurses to manipulate the flashing light or amend the flashing cycle. A variety of methods were used to raise awareness about the
how to use the CATH TAG, including wall posters, flyers, information leaflets, and engagement with the nursing managers at the ward level. These focused on the use of the CATH TAG and study, not catheterization practices or duration. Further details regarding the intervention, including fidelity, are detailed in supplementary material.
Outcomes
We considered two primary outcomes for the study: (1) urinary catheter duration and (2) the perceptions of nurses about the ease of use of the CATH TAG. In our initial protocol, the primary out- comes were the urinary catheter device utilization ratio and the per- ceptions of nurses. Prior to analysis, it became evident that the research team was not able to obtain patient-day data that aligned precisely with the date when a ward switched fromthe control to the
Brett G. Mitchell et al
Table 1. Characteristics of Study Participants with an Indwelling Urinary Catheter Variable
Control Phase, No. (%)
Participants Age
Median IQR
Sex
Female Male
Infectious diagnosis Yes
291 (48.9) 304 (51.1)
391 (65.7)
235 (41.1) 337 (58.9)
421 (73.6)
.05 .03
.05
intervention. Therefore, the team decided to amend the primary outcome to urinary catheter duration, which is consistent with the approach taken in other studies.2 The change was approved by the clinical trial registry prior to analysis being undertaken. Secondary outcomes included the number of cases of catheter-
associated asymptomatic bacteriuria per 100 catheter days, percep- tions of nurses about effectiveness of the CATH TAG, changes in ownership or interest by patients in catheter management, and barriers to the CATH TAG working successfully in various types of patients.
Perceptions of nurses
A phenomenological approach, seeking to understand the partic- ipants’ lived experience of a phenomenon, was the theoretical underpinning for the data collection and analysis methods used in association with the focus group. The purpose of the focus group was to gain an in-depth understanding of a sample of participants. Focus-group participants received a gift card to compensate them for their time because attendance occurred on their own time.
Statistical analysis
Catheter duration The analysis employed an intention-to-treat strategy and involved the inclusion of all patients in the randomized clusters in the analysis, regardless of any deviations from the study protocol. We used a Cox proportional hazards model to assess the rate of removal of cath- eters, with the duration of catheterization censored at the time of patient transfer and the intervention considered as a time-varying covariate. That is, the effect of the intervention was assumed to relate to the ward on which the patient was cared for. In this model, the hazard ratio (HR)represents the hazard of catheter removal, such that HR >1 represents earlier removal. In a subanalysis, we repeated the Cox proportional hazards regression, excluding patients in the inten- sive care unit (ICU). There is a strong rationale for subanalysis based on differing results between ICU and non-ICU settings for CAUTI interventions.4 In a sensitivity analysis,we repeated themodel, adjust- ing for sex, age and the presence of a primary infective diagnosis. We assessed the risk of bacteriuria using aconditional logistic regression, with intervention as the only independent variable, adjusted for clus- tering at the patient level.
Survey and focus group Mean responses to Likert questions were calculated. An indepen- dent t test was used to compare means. For reliability testing, we
595 66 54, 75
Intervention Phase, No. (%)
572 63 49, 73
P Value :::
<.01 <.01
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