The CATHETER II study: Randomised Controlled Trial CompAring THE Clinical And CosT-Effectiveness Of VaRious Washout Policies Versus No Washout Policy In Preventing Catheter Associated Complications In Adults Living With Long-Term Catheters

Various washout policies are commonly used in adults living with long-term catheter (LTC) for management of catheter encrustations and blockage. The recent Cochrane review (2017) assessed the best available evidence and found insufficient evidence to determine whether prophylactic catheter washout policies had a beneficial or harmful effect on any of the outcomes in patients with LTC. The authors recommended a rigorous and methodologically robust RCT to assess the clinical and cost effectiveness of washout policies in patients with LTC. Research question: What is the clinical and cost-effectiveness, patient acceptability and satisfaction, and safety of weekly prophylactic catheter washout policies in addition to standard LTC care compared to standard LTC care only in adults living with LTC? Design: A pragmatic three-arm open multi-centre superiority RCT with internal pilot, economic analysis, and embedded qualitative component. Setting: Primary care including GP practices; secondary care, and care homes. Target Population: Eligible participants are adults aged >18 years, who have had a catheter in-situ for >/=28 days and for whom is planned that the catheter remains in situ on the long-term. Health technologies being assessed: • Intervention arm (A): Saline washouts. A policy of weekly prophylactic normal saline (NaCl 0.9%) catheter washouts plus standard LTC care. • Intervention arm (B): Acidic washouts. A policy of weekly prophylactic acidic (citric) catheter washouts plus standard LTC care. • Control arm (C): Standard LTC care only (i.e. no prophylactic catheter washouts) Outcome Measures: - Primary clinical outcome: catheter blockage requiring intervention up to 24 months post randomisation expressed as number per 1000 catheter days. Intervention is defined as any of the following: unplanned catheter removal or change or washout performed by the participant/carer or required unplanned visits to/from any healthcare provider, or hospital admission. - Primary economic outcome: incremental cost per quality adjusted life year (QALY) gained for each washout policy compared to standard LTC care only. - Secondary outcomes include: S-CAUTI; quality of life; discontinuation of LTC; duration of LTC in situ; catheter removal or change due to other reasons such as S-CAUTI, urinary Leakage, others; adverse events; patients’ satisfaction; healthcare costs and patient costs; hospital admissions, GP/ nurse outpatient visits for catheter related complications; adherence to allocated interventions; impact on day to day activities. Sample Size: Clinicians and PPI established that a minimum superiority margin of 25% reduction in LTC blockages is required for the NHS to adopt regular prophylactic catheter washout policy in patients living with LTC. Hence based on a reduction in rate of LTC blockages from 11.8/1000 days to 8.9/1000 days and 2-years follow-up, with 90% power and alpha 2.5% (for the two main comparisons of each of the intervention arms against control), and assuming a negative binomial distribution with dispersion parameter of 0.6 and ~20% drop-out; we will need to recruit 600 participants in total (200 in each arm). Study Timetable: Set-up/Qualitative: 6m; Recruitment: 18m; Follow-up: 24m; Analysis/reporting: 6m. Total duration 54 mths. Study Team: A strength of this application is the depth of experience in the study team. The team is led by key opinion leaders in the UK in nursing, primary care, care of the elderly; urology and infection control. The team is supported by almost all stake holders and UK CRC registered CTU (CHaRT) with world class record in design and delivery of logistically challenging clinical trials. The team has experienced trialists, statisticians, qualitative researchers, health economists. Early termination: Due to COVID-19, resultant pauses and slow recruitment an overall extension is required to complete recruitment and follow up. Further funding has not been secured. Recruitment ended August 2022. All participants will be followed up to August 2023 or to the 24 month timepoint, whichever timepoint is reached first, allowing for a minimum 12 months follow up. Qualitative and clinical data will be analysed as planned. Due to the small number of participants, health economics data will be reported without a full analysis.