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Published in: Trials 1/2015

Open Access 01-12-2015 | Research

Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model

Authors: Marina Koniotou, Bridie Angela Evans, Robin Chatters, Rachael Fothergill, Christopher Garnsworthy, Sarah Gaze, Mary Halter, Suzanne Mason, Julie Peconi, Alison Porter, A. Niroshan Siriwardena, Alun Toghill, Helen Snooks

Published in: Trials | Issue 1/2015

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Abstract

Background

Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.

Methods

In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.

Results

We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.

Conclusion

Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.

Trial registration

Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009
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Metadata
Title
Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model
Authors
Marina Koniotou
Bridie Angela Evans
Robin Chatters
Rachael Fothergill
Christopher Garnsworthy
Sarah Gaze
Mary Halter
Suzanne Mason
Julie Peconi
Alison Porter
A. Niroshan Siriwardena
Alun Toghill
Helen Snooks
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0821-z

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