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Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community

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posted on 30.04.2020, 11:19 by Ricky Mullis, Maria Raisa Jessica Ryc Aquino, Sarah Natalie Dawson, Vicki Johnson, Sue Jowett, Elizabeth Kreit, Jonathan Mant, Marian Carey, Melanie Davies, Yvonne Doherty, Kamlesh Khunti, Lisa Lim, Bundy Mackintosh, Adrian Mander, Christopher McKevitt, Martin Roland, Stephen Sutton, Marion Walker, Elizabeth Warburton
INTRODUCTION:Survival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care. METHODS AND ANALYSIS:Improving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation. ETHICS AND DISSEMINATION:Favourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan. TRIAL REGISTRATION NUMBER:NCT03353519.

Funding

This study was funded by the National Institute for Health Research’s Programme Grant for Applied Research titled ‘Developing primary care services for stroke survivors’ reference PTC-RP-PG-0213 20001. The IPCAS trial is cosponsored by the University of Cambridge and NHS Cambridgeshire and Peterborough Clinical Commissioning Group.

History

Citation

BMJ Open, 2019, 9:e030285.

Author affiliation

Leicester Diabetes Centre

Version

VoR (Version of Record)

Published in

BMJ OPEN

Volume

9

Issue

8

Publisher

BMJ Publishing Group

eissn

2044-6055

Acceptance date

04/07/2019

Copyright date

2019

Publisher version

https://bmjopen.bmj.com/content/9/8/e030285

Spatial coverage

England

Language

English