Cluster Randomized Controlled Trial

The high prevalence and diversity of longer-term problems experienced by patients with stroke and their carers has long been recognized, but they remain poorly addressed by existing services. Postdischarge contact with therapy services is associated with improved outcomes. However, these interventions are generally time limited and have little effect on psychosocial outcome. National guidelines acknowledge that stroke should be regarded as a long-term condition, and the role of a Stroke Care Coordinator (SCC) to facilitate inputs for community-based patients with stroke and their families after initial (usually hospital-based) treatment is a recommended policy. However, procedures and processes of this role are unevenly developed, and there has been no robust evaluation. Using the Medical Research Council framework for the development and evaluation of complex interventions, incorporating systematic reviews, qualitative exploration, and intervention modeling, we developed an evidence-based system of care (longer-term stroke [LoTS] care) that aimed to meet the longer-term needs of patients with stroke and their carers living at home. The system of care incorporates a structured assessment focused on patientand carer-centered problems Background and Purpose—We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods—A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results—Thirty-two stroke services were randomized (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 General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions—This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration—URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. (Stroke. 2015;46:2212-2219. DOI: 10.1161/STROKEAHA.115.008585.)