Volume 16 Supplement 2

3rd International Clinical Trials Methodology Conference

Open Access

Complexities of trial recruitment in the care home setting: an illustration via the DCM™epic (dementia care mapping™: to enable person-centred care in care homes) trial

  • Claire Surr2,
  • Amanda Lilley-Kelly1,
  • Liz Graham1,
  • Rebecca Walwyn1,
  • Robert Cicero1,
  • Alys Griffiths2,
  • Byron Creese3 and
  • Lucy Garrod4
Trials201516(Suppl 2):P96

https://doi.org/10.1186/1745-6215-16-S2-P96

Published: 16 November 2015

Conducting trials in care homes is complex on multiple levels. Here we focus on recruitment issues surrounding: a) care home selection to participate in research, b) selection and involvement of participants fulfilling various roles (residents, relatives, staff), c) consent in the context of the Mental Capacity Act, and d) scheduling researcher time to undertake complex recruitment processes across multiple care homes.

To ensure generalizability of results, EPIC care homes were selected to form a stratified random sample of a known sampling frame. This was done by first defining catchment areas around each of three participating UK hubs. Randomly ordered listings of all eligible care homes within those areas were then produced, with batches of care homes sent trial information and followed up by researchers.

Trial participation for a home requires agreement to take part from residents and their relatives (as personal consultees and providers of proxy data), as well as staff involvement to provide data (proxy and self) and be trained to deliver the DCM™ intervention. This requires complex, lengthy discussions with all parties, provision of tailored information sheets specific to intended role and capacity, and involvement of trial experts to explain DCM™ in more detail to staff.

The trial aims to recruit 50 care homes (750 residents) by the end of 2015. Thus there is the need to balance the complexity of processes with required speed of recruitment - a task which is achieved by detailed monitoring of projected researcher workload in relation to care home commitments and availability.

Authors’ Affiliations

(1)
University of Leeds
(2)
Leeds Beckett University
(3)
Kings College London
(4)
Oxford Health NHS Foundation Trust

Copyright

© Surr et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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