Hypothesis / aims of study
The CATHETER II qualitative study aimed to explore participants’ experience of long-term catheters (LTC), the acceptability of washout policies, and self-management, their experience of the CATHETER II trial and their satisfaction with outcomes. The objectives for the healthcare professionals (HCPs) were to explore their attitudes towards weekly prophylactic catheter washout and their views on the provision of training, and participants’ ability to enact wash-out behaviours.
Study design, materials and methods
This was a longitudinal qualitative study embedded within the CATHETER II, a community-based randomised controlled trial (RCT) in the United Kingdom (UK). Participants were recruited from the CATHETER II RCT. All participants received standard LTC care and were randomly allocated (1:1:1) to receive standard LTC care with either 1) weekly saline washouts, 2) weekly citric acid washouts or 3) no prophylactic washouts for up to 24 months. The trial methodology was in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines and the protocol of the trial, and this embedded qualitative study have been published (1, 2).
Semi-structured interviews with trial participants were conducted at two time points; once prior to the trial and 6-8 month after their participation in the trial. Semi-structured interview and focus group with Heath care professional were conducted at least 6 months after the RCT had been running in their sites. Data were analysed using the Theoretical Framework of Acceptability and Theoretical Domains Framework.
Results
50 (24 female, 26 male) CATHETER II trial participants took part in the study. Participants, aged between 23 and 100 years. All participants were living with LTC and deemed able to self-manage the washout and study documentation independently, or supported by the help of a carer. Seven health care professionals (5 female, 2 male) also participated in the qualitative study. HCPs included one urogynecologist and six research nurses with various nursing backgrounds (community, district, primary care, continence).
The participants had positive attitudes towards weekly prophylactic saline or acidic catheter washouts and other trial elements, such as washout training, catheter calendar and monthly phone calls. Their perceived effectiveness of, and optimism towards washouts, and their altruistic desire to contribute to research motivated them to take part in the RCT. HCPs highlighted the need for the RCT due to the current lack of robust evidence on best washout policies to guide clinical practice.
Participants and HCPs found the ‘ask’ of the CATHETER II trial and the weekly self-administered prophylactic washout policies to be feasible. Participants engaged in and adhered to all elements of the trial.
The participants found the catheter washout training provided during the RCT enhanced their self-efficacy, skills, and self-reported capability to carry out the washout procedures. Participants and HCPs agreed that self-management for prophylactic catheter washouts is both feasible and, following training, achievable without any need for additional support e.g. assistance from a HCP. This was the case for both in-person or virtual training. The catheter washout training package within the trial was praised as a key element in enabling participants to self-manage their LTC and washout. HCPs had a positive attitude regarding washouts and confirmed the participants’ willingness and ability to self-manage their catheter washout after the training provided.
Participants in the washout groups reported having positive outcomes from the weekly washout. These included reduced blockage, pain or infection, reduced need for HCP support, and greater psychological reassurance because of their newfound ability to self-manage potential complications. There were no notable differences in participants’ descriptions of their experience of the training, self-management of washout, and outcomes between saline and citric acid washout groups. HCPs attested to the participants understanding of and adherence to the weekly washouts and other elements of the trial.
Interpretation of results
This study shows acceptability, feasibility, and self-reported fidelity (e.g. demonstration of conducting the wash-out behaviour as per protocol) of the CATHETER II trial on a behavioural level for both patients and Health care professionals.
Self-management for prophylactic catheter washouts is both feasible and achievable without any need for additional support when appropriate training is provided. Washout training could be crucial in enhancing patients self-efficacy and skills and empowering them in self-management of their catheter care. Weekly prophylactic catheter washout could reduce the long-term catheter related complications.