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

INTERVENTION: The researchers are recruiting 600 people who have a LTC from primary care, secondary care and care homes. They are randomising participants to one of three groups: 1. Saline washouts. A policy of weekly prophylactic normal saline catheter washouts plus standard LTC care 2. Acidic washouts. A policy of weekly prophylactic acidic (citric) catheter washouts plus standard LTC care 3. Standard LTC care only (i.e. no prophylactic catheter washouts) The researchers are following participants for 24 months to assess catheter blockages, infections, and complications, plus their quality of life, satisfaction, costs to the participant and NHS. They are exploring the views, attitudes, experiences and expectations of washouts with participants, nurses, and doctors. CONDITION: Catheter‐associated complications ; Nervous System Diseases PRIMARY OUTCOME: Any catheter blockage requiring intervention up to 24 months post randomisation, from the question ‘Have you had any catheter blockages since we last spoke to you?’ from patient‐reported monthly phone call CRF (monthly for 24 months) (Intervention is defined as any of the following: unplanned catheter removal or change or washout performed by the participant/ designated person or required unplanned visits to/from any healthcare provider, or hospital admission) INCLUSION CRITERIA: 1. Aged =18 years 2. Catheter has been in‐situ for =28 days 3. No plan for discontinuation of LTC at the time of recruitment 4. Able to undertake catheter washouts or has a designated person able to perform washouts 5. Able to complete the trial documentation or has a proxy able to complete the trial documentation 6. Any type and route of LTC can be included SECONDARY OUTCOME: ; 1. S‐CAUTI requiring antibiotics use from the questions ‘Have you had a urine infection since we last spoke to you?’ and ‘How many infections required antibiotics?’ from patient‐reported monthly phone call CRF (monthly for 24 months); 2. Duration of LTC in situ, catheter change due to other reasons than blockage; from the questions ‘Has there been discontinuation of long‐term catheter use?’, ‘For the (reported problem), what treatment did you have?’ and Answers ‘Catheter change’ from patient‐reported monthly phone call CRF (monthly for 24 months); 3. Adverse events; where participant has reported a treatment in the patient‐reported monthly phone call CRF (monthly for 24 months) and the question of the clinical team is asked ‘Is this a SAE? Please tick’; 4. Hospital admissions, GP/nurse outpatient visits for catheter‐related complications from the questions ‘Since we last spoke to you, have you had to stay in hospital overnight for any of the problems related to your catheter?’, ‘For the (reported problem), where did you have treatment or a consultation with a doctor or nurse?’ and possible answers ‘GP at home, Nurse at home, care home staff, GP at surgery, Nurse at practice, Self/informal carer, Staff at hospital’ from patient‐reported monthly phone call CRF (monthly for 24 months); 5. Generic quality of life assessed by EQ‐5D‐5L17 (EuroQol questionnaire – 5 dimensions – 5 levels) patient‐reported questionnaire; Timepoint(s): 0, 6, 12, 18, 24 months post‐randomisation; 6. Condition‐specific quality of life assessed by ICIQ‐LTCqol18 (International Consultation on Incontinence Modular Questionnaire – Long Term Catheter quality of life) patient‐reported questionnaire; Timepoint(s): 0, 6, 12, 18, 24 months post‐randomisation; 7. Adherence to allocated interventions; from the questions ‘Have you done a weekly washout since we last called you ?’, ‘Have you had any problems with the weekly washout?’, ‘Has your clinical care team recommended a change in washout frequency?’, ‘Has your clinical care team recommended a change in type of washout solution?’ and ‘Have you done any regular (preventative) washouts since we last called you?’ from patient‐reported monthly phone call CRF (monthly for 24 months); 8. Patients’ convenience and satisfaction assessed by an adapted version of the abbreviated Treatment Satisfaction Questionnaire for medication; Timepoint(s): 0,6,12,18,24 months post‐randomisation patient‐reported questionnaire; 9. Impact on day to day activities using the General Self‐Efficacy Scale (GSE)20 and ICECAP‐A (ICEpop CAPability measure for Adults) (= 65 years) or ICECAP‐O21 (ICEpop CAPability measure for Older people) > 65 years patient‐reported questionnaire; Timepoint(s): 0, 6, 12, 18, 24 months post‐randomisation; 10. Time and travel costs for patients and their relatives, friends or informal carers, from patient‐reported questionnaire questions ‘We wish to know how much money and time were spent by you and any companion in attending health care appointments or being admitted to hospital’, including travel costs, time and whether or not accompanied by another person.; Timepoint(s): 18 months post‐randomisation;