Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care

Background and purpose We developed a new post-discharge system of care comprising a structured assessment covering longer-term problems experienced by stroke patients and carers, linked to evidence-based treatment algorithms and reference guides (the LoTS care system of care), to address the poor longer-term recovery experience by many stroke patients. Methods A pragmatic, multicentre, cluster randomised controlled trial of the LoTS care system of care. Eligible patients referred to community based Stroke Care Co-ordinators (SCCs) were randomised to receive the new system of care or usual practice. The primary outcome was improved patient psychological wellbeing (General Health Questionnaire-12 (GHQ-12)) at six months; secondary outcomes included functional outcomes for patients, carer outcomes and cost-effectiveness. Follow-up was through self-completed postal questionnaires at six and 12 months. Results Thirty-two stroke services were randomised (29 participated), 800 patients (399 control, 401 intervention) and 208 carers (100 control, 108 intervention) were recruited. In intention to treat analysis the adjusted difference in patient GHQ-12 mean scores at 6 months was -0.6 points (95% confidence interval -1.8 to 0.7, p-value 0.394) indicating no evidence of statistically significant difference between the groups. Costs of SCC inputs, total health and social care costs and QALY gains at six months, 12 months and over one year were similar between the groups. Conclusion This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared to usual SCC practice. Clinical Trial Registration—URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305.