An occupational therapy intervention for residents with stroke-related disabilities in UK care homes (OTCH): cluster randomised controlled trial with economic evaluation

Journal article


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
AuthorsSackley, 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.
Abstract

Background
Care home residents with stroke-related disabilities have significant activity limitations. Phase II trial results suggested a potential benefit of occupational therapy (OT) in maintaining residents’ capacity to engage in functional activity.

Objective
To evaluate the clinical effectiveness and cost-effectiveness of a targeted course of OT in maintaining functional activity and reducing further health risks from inactivity for UK care home residents living with stroke-related disabilities.

Design
Pragmatic, parallel-group, cluster randomised controlled trial with economic evaluation. Cluster randomisation occurred at the care-home level. Homes were stratified according to trial administrative centre and type of care provided (nursing or residential), and they were randomised 1 : 1 to either the intervention or the control arm.

Setting
The setting was 228 care homes which were local to 11 trial administrative centres across England and Wales.

Participants
Care home residents with a history of stroke or transient ischaemic attack, including residents with communication and cognitive impairments, not receiving end-of-life care.

Intervention
Personalised 3-month course of OT delivered by qualified therapists. Care workers participated in training workshops to support personal activities of daily living. The control condition consisted of usual care for residents.

Main outcome measures
Outcome data were collected by a blinded assessor. The primary outcome at the participant level was the Barthel Index of Activities of Daily Living (BI) score at 3 months. The secondary outcomes included BI scores at 6 and 12 months post randomisation, and the Rivermead Mobility Index, Geriatric Depression Scale-15 and European Quality of Life-5 Dimensions, three levels, questionnaire scores at all time points. Economic evaluation examined the incremental cost per quality-adjusted life-year (QALY) gain. Costs were estimated from the perspective of the NHS and Personal Social Services.

Results
Overall, 568 residents from 114 care homes were allocated to the intervention arm and 474 residents from another 114 care homes were allocated to the control arm, giving a total of 1042 participants. Randomisation occurred between May 2010 and March 2012. The mean age of participants was 82.9 years, and 665 (64%) were female. No adverse events attributable to the intervention were recorded. Of the 1042 participants, 870 (83%) were included in the analysis of the primary outcome (intervention, n = 479; control, n = 391). The primary outcome showed no significant differences between groups. The adjusted mean difference in the BI score between groups was 0.19 points higher in the intervention arm [95% confidence interval (CI) –0.33 to 0.70, p = 0.48; adjusted intracluster correlation coefficient 0.09]. Secondary outcome measures showed no significant differences at all time points. Mean incremental cost of the Occupational Therapy intervention for residents with stroke living in UK Care Homes intervention was £438.78 (95% CI –£3360.89 to £1238.46) and the incremental QALY gain was 0.009 (95% CI –0.030 to 0.048).

Limitations
A large proportion of participants with very severe activity-based limitations and cognitive impairment may have limited capacity to engage in therapy.

Conclusion
A 3-month individualised course of OT showed no benefit in maintaining functional activity in an older care home population with stroke-related disabilities.

Future work
There is an urgent need to reduce health-related complications caused by inactivity and to provide an enabling built environment within care homes.

KeywordsOccupational therapy; Stroke-related disabilities; Communication impairements; Cognitive impairments; Controlled trial; Economic evaluation
Year2016
JournalHealth Technology Assessment
Journal citation20 (15)
PublisherNIHR Journals Library
ISSN1366-5278
Digital Object Identifier (DOI)https://doi.org/10.3310/hta20150
Official URLhttps://doi.org/10.3310/hta20150
Related URLhttps://www.journalslibrary.nihr.ac.uk/hta/hta20150/#/abstract
Publication dates
OnlineFeb 2016
Publication process dates
AcceptedSep 2015
Deposited22 May 2020
Supplemental file
Output statusPublished
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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
Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial.
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
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