David Britt

Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial

BackgroundUrinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients.MethodsWe conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death.ResultsIt was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence.ConclusionsThe trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered.Trial registrationISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.

Implementing a Systematic Voiding Program for Patients With Urinary Incontinence After Stroke

We explored health professionals’ views of implementing a systematic voiding program (SVP) in a multi-site qualitative process evaluation in stroke services recruited to the intervention arms of a cluster randomized controlled feasibility trial during 2011-2013. We conducted semi-structured group or individual interviews with 38 purposively selected nursing, managerial, and care staff involved in delivering the SVP. Content analysis of transcripts used normalization process theory (NPT) as a pre-specified organization-level exploratory framework. Barriers to implementing the SVP included perceived lack of suitability for some patient groups, patient fear of extending hospital stay, and difficulties with SVP enactment, scheduling, timing, recording, and monitoring. Enablers included the guidance provided by the SVP, patient and relative involvement, extra staff, improved nursing skill and confidence, and experience of success. Three potential mechanisms of consistency, visibility, and individualization linked the SVP process with improvements in outcome, and should be emphasized in SVP implementation.

Assessing fidelity to complex interventions: the icons experience

Background Assessing fidelity to complex healthcare interventions in clinical trials is a challenging area. ‘ICONS’ is a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP), incorporating bladder training and prompted voiding, to promote post-stroke continence. Here we describe feasibility of one aspect of fidelity assessment: the day-to-day implementation of the SVP through analysis of clinical logs. Methods Nurses completed clinical logs daily, which included documenting: the toileting interval, proposed toileting times and times toileted. Clinical logs were sampled across trial sites. The original intention was to assess fidelity by exploring the degree of concordance between proposed times and times toileted. Initial analysis revealed the unfeasibility of this method due to documentation errors in toileting intervals and proposed times. Consequently, the planned method was changed to identification of key ‘quality indicators’ (QIs) for documentation of practice. Results The need to revise the method of measurement demonstrates the difficulty in assessing fidelity. Assessment of clinical logs revealed low levels of adherence to key quality indicators. However, it is unclear whether this indicates poor fidelity or an imprecise method of fidelity assessment. Conclusion