Title: 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
Funder: Chief Scientist Office, Scotland

Abstract: 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.

Lay abstract: Urinary catheters are soft tubes inserted into the bladder to drain urine. They are often used to help people with urinary incontinence and/or retention. The same type of catheter is used for men and women. In the UK, it has been estimated that in average 1:500 live with long-term catheters (LTC); rising significantly among patients living in care homes. LTC can be associated with number complications such as catheter blockage and urinary tract infections. These complications impact considerably on patients’ quality of life. We know this from interviews with patients that use LTC (www.healthtalk.org). They also have a substantial impact on NHS resources due to frequent emergency visits to and from nurses and GPs. Currently the best practice for LTC care is individualised to each patient’s needs and includes patient education about how to look after their LTC. Examples are hands and catheter hygiene; drinking plenty of water; and instructions on how to secure their catheter. Patients normally change their catheter bags every week while the catheter itself is changed by a nurse every 10-12 weeks in average (can differ according to type of catheter and patients circumstances). Current research tells us that catheter blockages may affect up-to half of all people with LTCs causing them significant pain, anxiety, incontinence and reliance on health resources including out of hours nursing visits and/or hospital admissions. There are two broad strategies to deal with the prevention and management of catheter blockage: more frequent change of the catheter and/or the use of liquid washout solutions to flush the catheters. Although the current clinical guidelines do not recommend prophylactic LTC washouts, they are currently used in clinical practice to prevent LTC blockage. We really don’t know enough about the benefits or harms of LTC washouts and whether we should recommend their widespread use or not. Nor do we know what the extra costs or savings for the NHS that might arise if prophylactic washouts were used routinely. Patients, doctors and nurses all agree that more and better research is urgently needed to try and answer these questions. We have designed a study specifically for this purpose, in our study patients with LTC have an equal chance of receiving either standard catheter care with or without prophylactic weekly catheter washouts. Patients that get a washout will receive either citric acid or saline fluid, so we can compare their effects on important outcomes. We will keep in touch with patients for 2 years and evaluate a range of outcome measures including the number of catheter blockages; catheter-associated urinary tract infections and other complications. We will also measure how satisfied patients are with the interventions they received, their quality of life, and any costs they experience, in addition to the costs to the NHS. We also think it is important to interview patients, nurses and doctors to explore their views, attitudes, experiences and expectations of washouts strategy. Our team of researchers and health professionals has a great deal of experience in designing and delivering studies of this nature. The team includes patients, nurses, urologists, GPs, and research leaders from the University of Aberdeen. We established a partnership with the Royal College of Nursing, British Association of Urology Nurses and Ageing UK to help us contact patients and nurses in the community and care homes. We are also working with Bladder Health UK (patient charity) to ensure our research is relevant to patients.

Research activity codes: 6.1 PHARMACEUTICALS;6.3 MEDICAL DEVICES
Health categories: RENAL AND UROGENITAL