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Cluster randomized controlled trial

Forster, Anne, Young, John, Chapman, Katie, Nixon, Jane, Patel, Anita, Holloway, Ivana, Mellish, Kirste, Anwar, Shamaila, Breen, Rachel, Knapp, Martin ORCID: 0000-0003-1427-0215, Murray, Jenni and Farrin, Amanda (2015) Cluster randomized controlled trial. Stroke, 46 (8). pp. 2212-2219. ISSN 0039-2499

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Identification Number: 10.1161/STROKEAHA.115.008585


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.

Item Type: Article
Official URL:
Additional Information: © 2015 Bradford Teaching Hospitals NHS Foundation Trust
Divisions: Personal Social Services Research Unit
Subjects: R Medicine > RA Public aspects of medicine
Date Deposited: 11 Sep 2015 14:49
Last Modified: 20 Jul 2021 00:27

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