Abstract
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. 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. 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. 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. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305.
Highlights
Background and PurposeWe 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 to address the poor longer-term recovery experienced by many patients with stroke
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
Using the Medical Research Council framework for the development and evaluation of complex interventions,[8] incorporating systematic reviews, qualitative exploration, and intervention modeling, we developed an evidence-based system of care that aimed to meet the longer-term needs of patients with stroke and their carers living at home
Summary
A pragmatic, multicentre, cluster randomized controlled trial of this system of care. The trial was a pragmatic cluster randomized controlled trial of the clinical and cost-effectiveness of the LoTS care system of care delivered by community-based SCCs compared with SCC usual practice. Eligibility of the SCC service was confirmed before randomization by completion of a questionnaire and semistructured interview describing the service and client group (these were repeated midway through recruitment and after 12-month follow-up). This information was used for stratification to provide context for trial implementation and monitor any potential contamination or confounding between the 2 arms of the trial. The models were adjusted for the patient-level covariates (level 1): baseline Barthel Index (prestroke and poststroke), sex, age, living circumstances (living alone versus with carer), stroke severity reflected by speech and language impairment (normal/impaired), baseline 6-Item Cognitive Impairment Test score (normal/impaired cognitive function), and patient baseline score for the outcome measure; and the following stroke unit-level covariates (level 2): quality of stroke unit (National Sentinel Stroke Audit score), referral rate, and SCCs working alone versus within a community multidisciplinary team
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