The complexities of maximising recruitment to complex intervention trials in child and adolescent...

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POSTER PRESENTATION Open Access The complexities of maximising recruitment to complex intervention trials in child and adolescent mental health services David Cottrell 1 , Liz Graham 2* , Amanda Farrin 2 From Clinical Trials Methodology Conference 2011 Bristol, UK. 4-5 October 2011 Objectives The HTA-funded SHIFT Trial (Self-Harm Intervention: Family Therapy) aims to recruit 832 young people fol- lowing self-harm, along with their primary care givers. Recruitment is scheduled to take place over 3 years, across three Hubsin the UK Greater Manchester, London and Yorkshire each involving approximately 15 Child & Adolescent Mental Health Services (CAMHS). Due to the complexities of set-up and the involvement of many clinicians in largely research-naïve services, recruitment has been slower than anticipated. The TMG thus agreed an intensive strategy to enhance the existing recruitment plan. Methods The key approach to immediate improvement in recruit- ment rates was intensive work with existing services. The common approach of involving additional sites was not a straight-forward option, given that trial-specific Family Therapists (FTs) work across services and form a team for rotational delivery of FT in each service. Inclu- sion of new sites would involve either an increase in FT workload (which may or may not be possible should existing services increase recruitment), or development of an entirely new group of services involving lengthy and costly employment of additional Therapists, plus the governance approvals required for each Trust. The main elements of this approach are a) passing on guidance regarding strategies employed in services already recruiting well to other CAMHS, b) a systematic, site-by-site approach with those identified as poor recruiters this involves phone calls from the Hub Leads to each PI, increased Researcher contact, identifi- cation of SHIFT Championsin each service location to ensure SHIFT is flagged at all relevant team meetings, c) MHRN CSO attendance at referral meetings to speci- fically flag eligible cases. Results This approach was initiated at the end of February 2011. Sites have responded positively and have been keen to identify champions and look at strategies to ensure SHIFT is flagged as part of routine practice. To date (August 2011) we have seen a promising increase in recruitment. Conclusions Strategies to ensure optimal recruitment in CAMHS require good local knowledge of the varying ways in which services operate to ensure a tailored approach to recruitment. Identification of Champions is proving suc- cessful. Increased Researcher and MHRN contact with sites, attendance at relevant team meetings, and mainte- nance of trial profile within each service is key. Acknowledgements The authors are presenting on behalf of the SHIFT trial team. The SHIFT Trial is supported by HTA-470772. Author details 1 School of Medicine, University of Leeds, Leeds, LS2 9NL, UK. 2 Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK. Published: 13 December 2011 doi:10.1186/1745-6215-12-S1-A122 Cite this article as: Cottrell et al.: The complexities of maximising recruitment to complex intervention trials in child and adolescent mental health services. Trials 2011 12(Suppl 1):A122. 2 Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK Full list of author information is available at the end of the article Cottrell et al. Trials 2011, 12(Suppl 1):A122 http://www.trialsjournal.com/content/12/S1/A122 TRIALS © 2011 Cottrell et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Transcript of The complexities of maximising recruitment to complex intervention trials in child and adolescent...

Page 1: The complexities of maximising recruitment to complex intervention trials in child and adolescent mental health services

POSTER PRESENTATION Open Access

The complexities of maximising recruitment tocomplex intervention trials in child andadolescent mental health servicesDavid Cottrell1, Liz Graham2*, Amanda Farrin2

From Clinical Trials Methodology Conference 2011Bristol, UK. 4-5 October 2011

ObjectivesThe HTA-funded SHIFT Trial (Self-Harm Intervention:Family Therapy) aims to recruit 832 young people fol-lowing self-harm, along with their primary care givers.Recruitment is scheduled to take place over 3 years,across three ‘Hubs’ in the UK – Greater Manchester,London and Yorkshire – each involving approximately15 Child & Adolescent Mental Health Services(CAMHS). Due to the complexities of set-up and theinvolvement of many clinicians in largely research-naïveservices, recruitment has been slower than anticipated.The TMG thus agreed an intensive strategy to enhancethe existing recruitment plan.

MethodsThe key approach to immediate improvement in recruit-ment rates was intensive work with existing services.The common approach of involving additional sites wasnot a straight-forward option, given that trial-specificFamily Therapists (FTs) work across services and form ateam for rotational delivery of FT in each service. Inclu-sion of new sites would involve either an increase in FTworkload (which may or may not be possible shouldexisting services increase recruitment), or developmentof an entirely new group of services involving lengthyand costly employment of additional Therapists, plusthe governance approvals required for each Trust.

The main elements of this approach are a) passing onguidance regarding strategies employed in servicesalready recruiting well to other CAMHS, b) a systematic,site-by-site approach with those identified as poorrecruiters – this involves phone calls from the Hub

Leads to each PI, increased Researcher contact, identifi-cation of SHIFT ‘Champions’ in each service location toensure SHIFT is flagged at all relevant team meetings,c) MHRN CSO attendance at referral meetings to speci-fically flag eligible cases.

ResultsThis approach was initiated at the end of February 2011.Sites have responded positively and have been keen toidentify champions and look at strategies to ensure SHIFTis flagged as part of routine practice. To date (August2011) we have seen a promising increase in recruitment.

ConclusionsStrategies to ensure optimal recruitment in CAMHSrequire good local knowledge of the varying ways inwhich services operate to ensure a tailored approach torecruitment. Identification of Champions is proving suc-cessful. Increased Researcher and MHRN contact withsites, attendance at relevant team meetings, and mainte-nance of trial profile within each service is key.

AcknowledgementsThe authors are presenting on behalf of the SHIFT trial team.The SHIFT Trial is supported by HTA-470772.

Author details1School of Medicine, University of Leeds, Leeds, LS2 9NL, UK. 2Clinical TrialsResearch Unit, University of Leeds, Leeds, LS2 9JT, UK.

Published: 13 December 2011

doi:10.1186/1745-6215-12-S1-A122Cite this article as: Cottrell et al.: The complexities of maximisingrecruitment to complex intervention trials in child and adolescentmental health services. Trials 2011 12(Suppl 1):A122.2Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK

Full list of author information is available at the end of the article

Cottrell et al. Trials 2011, 12(Suppl 1):A122http://www.trialsjournal.com/content/12/S1/A122 TRIALS

© 2011 Cottrell et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.