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

Journal article

Thomas, L.H., Watkins, C.L., Sutton, C.J., Forshaw, D., Leathley, M.J., French, B., Burton, C., Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., The ICONS Project Team and The ICONS Patient, Public and Carer Involvement Groups 2014. Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial. Trials. 15 (509). https://doi.org/10.1186/1745-6215-15-509
AuthorsThomas, L.H., Watkins, C.L., Sutton, C.J., Forshaw, D., Leathley, M.J., French, B., Burton, C., Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., The ICONS Project Team and The ICONS Patient, Public and Carer Involvement Groups
Abstract

Background: Urinary 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.

Methods: We 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.

Results: It 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.

Conclusions: The 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.

KeywordsCluster randomised controlled trial; Feasibility; Stroke; Urinary incontinence
Year2014
JournalTrials
Journal citation15 (509)
PublisherBioMed Central
ISSN1745-6215
Digital Object Identifier (DOI)https://doi.org/10.1186/1745-6215-15-509
Official URLhttps://doi.org/10.1186/1745-6215-15-509
Publication dates
Print23 Dec 2014
Publication process dates
Accepted09 Dec 2014
Deposited15 Jun 2020
Output statusPublished
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Rycroft-Malone, J., Burton, C., Williams, L., Edwards, S., Fisher, D., Hall, B., McCormack, B., Nutley, S., Seddon, D. and Williams, R. 2016. Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions. National Institute of Health Research. https://doi.org/10.3310/hsdr04120
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French, B., Thomas, L.H., Harrison, J., Burton, C., Forshaw, D., Booth, J., Britt, D., Cheater, F.M., Roe, B. and Watkins, C.L. 2016. Implementing a Systematic Voiding Program for Patients With Urinary Incontinence After Stroke. Qualitative Health Research. 26 (10). https://doi.org/10.1177/1049732316630975
Implementing best practice in infection prevention and control. A realist evaluation of the role of intermediaries
Williams, L., Rycroft-Malone, J. and Burton, C. 2016. Implementing best practice in infection prevention and control. A realist evaluation of the role of intermediaries. International Journal of Nursing Studies. 60, pp. 156-167. https://doi.org/10.1016/j.ijnurstu.2016.04.012
Bringing critical realism to nursing practice: Roy Bhaskar's contribution
Williams, L., Rycroft-Malone, J. and Burton, C. 2016. Bringing critical realism to nursing practice: Roy Bhaskar's contribution. nursing philosophy: an international journal for healthcare professionals. 18 (2). https://doi.org/10.1111/nup.12130
Managers' use of nursing workforce planning and deployment technologies: protocol for a realist synthesis of implementation and impact
Burton, C., Rycroft-Malone, J., Williams, L., Davies, S., McBride, A., Hall, B., Rowlands, A.M. and Jones, A. 2016. Managers' use of nursing workforce planning and deployment technologies: protocol for a realist synthesis of implementation and impact. BMJ Open. 6 (8). https://doi.org/10.1136/bmjopen-2016-013645
Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions
Williams, L., Rycroft-Malone, J., Burton, C., Edwards,S., Fisher, D., Hall, B., McCormack, B., Nutley, S.M., Seddon, D. and Williams, R. 2016. Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions. BMJ Open. 6 (8). https://doi.org/10.1136/bmjopen-2016-011964
Strategies to prevent oral disease in dependent older people
Brocklehurst, P., Williams, L., Hoare, Z., Goodwin, T., McKenna, G., Tsakos, G., Chestnutt, I.G., Pretty, I., Wassall, R., Jerkovic-Cosic, K., Hayes, M., Watt, R.G. and Burton, C. 2016. Strategies to prevent oral disease in dependent older people. Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.CD012402
Process evaluations in neurological rehabilitation: a mixed-evidence systematic review and recommendations for future research
Masterson-Algar, P., Burton, C. and Rycroft-Malone, J. 2016. Process evaluations in neurological rehabilitation: a mixed-evidence systematic review and recommendations for future research. BMJ Open. 6 (11). https://doi.org/10.1136/bmjopen-2016-013002
Managing diabetes in people with dementia: protocol for a realist review
Bunn, F., Goodman, C., Rycroft Malone, J., Reece Jones, P., Burton, C., Rait, G., Trivedi, D., Bayer, A. and Sinclair, A. 2016. Managing diabetes in people with dementia: protocol for a realist review. Systematic Reviews. 5 (5). https://doi.org/10.1186/s13643-015-0182-4
Collaboration and co-production knowledge in healthcare: opportunities and challenges
Rycroft-Malone, J., Burton, C.R., Bucknall , T., Graham, I.D., Hutchinson, A. and Stacey, D. 2016. Collaboration and co-production knowledge in healthcare: opportunities and challenges. International Journal of Health Policy and Management. 5 (4), pp. 221-223. https://doi.org/10.15171/IJHPM.2016.08
Collective action for implementation: a realist evaluation of organisational collaboration in healthcare
Rycroft-Malone, J., Burton, C.R., Wilkinson, J., Harvey, G., McCormack, B., Baker, R., Dopson, S., Graham, I.D., Staniszewska, S., Thompson, C., Ariss, S., Melville-Richards, L. and Williams , L. 2016. Collective action for implementation: a realist evaluation of organisational collaboration in healthcare. Implementation Science : IS. 11 (17). https://doi.org/10.1186/s13012-016-0380-z
An occupational therapy intervention for residents with stroke-related disabilities in UK care homes (OTCH): cluster randomised controlled trial with economic evaluation
Sackley, C.M., Walker, M.F., Burton, C.R., Watkins,C.L, Mant, J., Roalfe, A.K., Wheatley, K., Sheehan, B., Sharp, L., Stant, K.E., Fletcher-Smith, J., Steel, K., Barton, G.R., Irvine, L. and Peryer, G. 2016. An occupational therapy intervention for residents with stroke-related disabilities in UK care homes (OTCH): cluster randomised controlled trial with economic evaluation. Health Technology Assessment. 20 (15). https://doi.org/10.3310/hta20150
Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care
Thomas, L. H., French, B., Sutton, C. J., Forshaw, D., Leathley, M. J., Burton, C., Roe, B., Cheater, F. M., Booth, J., McColl, E., Carter, B., Walker, A., Brittain, K., Whiteley, G., Rodgers, H., Barrett, J. and Watkins, C. L. 2015. Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care. NIHR Journals Library.
Collective action for knowledge mobilisation: a realist evaluation of the collaborations for leadership in applied health research and care
Rycroft-Malone, J., Burton, C., Wilkinson, J., Harvey, G., McCormack, B., Baker, R., Dopson, S., Graham, I., Staniszewska, S., Thompson, C., Ariss, S., Melville-Richards, L. and Williams, L. 2015. Collective action for knowledge mobilisation: a realist evaluation of the collaborations for leadership in applied health research and care. UK NIHR Journals Library. https://doi.org/10.3310/hsdr03440
An untapped resource: patient and public involvement in implementation comment on "Knowledge mobilization in healthcare organizations": a view from the resource-based view of the firm
Burton, C. and Rycroft-Malone, J. 2015. An untapped resource: patient and public involvement in implementation comment on "Knowledge mobilization in healthcare organizations": a view from the resource-based view of the firm. International Journal of Health Policy and Management. 4 (12), pp. 845-847. https://doi.org/10.15171/ijhpm.2015.150
Investigating preferences for support with life after stroke: a discrete choice experiment
Burton, C., Fargher, E., Plumpton, C., Roberts, G.W, Owen, H. and Roberts, E. 2014. Investigating preferences for support with life after stroke: a discrete choice experiment. BMC Health Services Research. 14 (63). https://doi.org/10.1186/1472-6963-14-63
Evaluating a systematic voiding programme for patients with urinary incontinence after stroke in secondary care using soft systems analysis and Normalisation Process Theory: findings from the ICONS case study phase.International journal of nursing studies
Thomas, L.H, French, B., Burton, C., Sutton, C., Forshaw, D., Dickinson, H., Leathley, M.J., Britt, D., Roe, B., Cheater, F.M, Booth, J., Watkins, C.L, ICONS Project Team, ICONS Patient and Public and Carer Involvement Groups 2014. Evaluating a systematic voiding programme for patients with urinary incontinence after stroke in secondary care using soft systems analysis and Normalisation Process Theory: findings from the ICONS case study phase.International journal of nursing studies. International Journal of Nursing Studies. 51 (10), pp. 1308-1320. https://doi.org/10.1016/j.ijnurstu.2014.02.009
Improving skills and care standards in the support workforce for older people: a realist review
Rycroft-Malone, J., Burton, C., Hall, B., McCormack, B., Nutley, S., Seddon, D. and Williams, L. 2014. Improving skills and care standards in the support workforce for older people: a realist review. BMJ Open. 4 (5). https://doi.org/10.1136/bmjopen-2014-005356
Does self-efficacy influence recovery and well-being in osteoarthritis patients undergoing joint replacement? A systematic review
Magklara, E., Burton, C. and Morrison, V. 2014. Does self-efficacy influence recovery and well-being in osteoarthritis patients undergoing joint replacement? A systematic review. Clinical Rehabilitation. 28 (9). https://doi.org/10.1177/0269215514527843
Towards a programme theory for fidelity in the evaluation of complex interventions.
Masterson-Algar, P., Burton, C., Rycroft-Malone, J., Sackley, C.M. and Walker, M.F. 2014. Towards a programme theory for fidelity in the evaluation of complex interventions. Journal of Evaluation in Clinical Practice . 20 (4), pp. 445 - 452. https://doi.org/10.1111/jep.12174
Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm.
Burton, C., Rycroft Malone, J., Robert, G., Willson, A. and Hopkins, A. 2014. Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm. BMJ Open. 4:e005650. https://doi.org/10.1136/bmjopen-2014-005650
Resource based view of the firm as a theoretical lens on the organisational consequences of quality improvement.
Burton, C. and Rycroft-Malone, J. 2014. Resource based view of the firm as a theoretical lens on the organisational consequences of quality improvement. International Journal of Health Policy and Management. 3 (3), pp. 113 - 115. https://doi.org/10.15171/ijhpm.2014.74
The study protocol of: 'Initiating end of life care in stroke: clinical decision-making around prognosis'.
Burton, C., Payne, S., Turner, M., Bucknall, T., Rycroft-Malone, J., Tyrell, P., Horne, M., Ntambwe, L.I., Tyson, S., Mitchell, H., Williams, S. and Elghenzai, S. 2014. The study protocol of: 'Initiating end of life care in stroke: clinical decision-making around prognosis'. BMC Palliative Care. 13 (55). https://doi.org/10.1186/1472-684X-13-55
What is rehabilitation potential? Development of a theoretical model through the accounts of healthcare professionals working in stroke rehabilitation services
Burton, C.R., Horne, M., Woodward-Nutt, K., Bowen, A. and Tyrrell, P. 2014. What is rehabilitation potential? Development of a theoretical model through the accounts of healthcare professionals working in stroke rehabilitation services. Disability and Rehabilitation. 37 (21), pp. 1955-1960. https://doi.org/10.3109/09638288.2014.991454