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

OBJECTIVE: To evaluate the clinical efficacy of an established programme of occupational therapy in maintaining functional activity and reducing further health risks from inactivity in care home residents living with stroke sequelae. DESIGN: Pragmatic, parallel group, cluster randomised controlled trial. SETTING: 228 care homes (>10 beds each), both with and without the provision of nursing care, local to 11 trial administrative centres across the United Kingdom. PARTICIPANTS: 1042 care home residents with a history of stroke or transient ischaemic attack, including those with language and cognitive impairments, not receiving end of life care. 114 homes (n=568 residents, 64% from homes providing nursing care) were allocated to the intervention arm and 114 homes (n=474 residents, 65% from homes providing nursing care) to standard care (control arm). Participating care homes were randomised between May 2010 and March 2012. INTERVENTION: Targeted three month programme of occupational therapy, delivered by qualified occupational therapists and assistants, involving patient centred goal setting, education of care home staff, and adaptations to the environment. MAIN OUTCOME MEASURES: Primary outcome at the participant level: scores on the Barthel index of activities of daily living at three months post-randomisation. Secondary outcome measures at the participant level: Barthel index scores at six and 12 months post-randomisation, and scores on the Rivermead mobility index, geriatric depression scale-15, and EuroQol EQ-5D-3L questionnaire, at all time points. RESULTS: 64% of the participants were women and 93% were white, with a mean age of 82.9 years. Baseline characteristics were similar between groups for all measures, personal characteristics, and diagnostic tests. Overall, 2538 occupational therapy visits were made to 498 participants in the intervention arm (mean 5.1 visits per participant). No adverse events attributable to the intervention were recorded. 162 (11%) died before the primary outcome time point, and 313 (30%) died over the 12 months of the trial. The primary outcome measure did not differ significantly between the treatment arms. The adjusted mean difference in Barthel index score at three months was 0.19 points higher in the intervention arm (95% confidence interval -0.33 to 0.70, P=0.48). Secondary outcome measures also showed no significant differences at all time points. CONCLUSIONS: This large phase III study provided no evidence of benefit for the provision of a routine occupational therapy service, including staff training, for care home residents living with stroke related disabilities. The established three month individualised course of occupational therapy targeting stroke related disabilities did not have an impact on measures of functional activity, mobility, mood, or health related quality of life, at all observational time points. Providing and targeting ameliorative care in this clinically complex population requires alternative strategies.Trial registration Current Controlled Trials ISRCTN00757750.The OTCH study was funded by the UK National Institute for Health Research Health Technology Assessment programme (08/14/30). The results will be published in full in Health Technology Assessment. All researchers acted independently to the funding body. The funding body had no role in designing the study, data collection, analysing and interpreting the data, or writing the report. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the funding body, the NHS, or the Department of Health. The research team acknowledge the support of the NIHR, through the Comprehensive Clinical Research Network, in particular, Jacqueline Briggs and Rhian Hughes. The corresponding author (GP) confirms full access to all the data in the study and had final responsibility for the decision to submit for publication.This is the published version of the article, originally published in the British Medical Journal, 2015; 350 doi: 10.1136/bmj.h468 (Published 05 February 2015)