Clinicians as recruiters to dementia trials: lessons from the EVIDEM-E project

Letters to the Editor

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Clinicians as recruiters to dementia trials: lessons from the EVIDEM-E project ‘Evidenced based interventions in dementia’ (EVIDEM: www.EVIDEM.org.uk) is a 5-year research & development programme aiming to explore, evaluate and improve the quality of community based dementia care (Iliffe et al., 2008). The EVIDEM programme, like most clinical trials, relies on clinicians to recruit participants. Key NHS Stakeholders support was strong for EVIDEM and so we anticipated straightforward recruitment. However, this has not been the case; from a population exceeding 2000 people with dementia, one EVIDEM trial (EVIDEM-E: http:// www.evidem.org.uk/projects/evidem-e.htm) recruited 6 participants over 6 months through clinical teams, despite minimal exclusion criteria. Our enquiries suggested that this was due to clinicians not distributing invitations, rather than a lack of interest from people with dementia and their carers. With recruitment alarmingly low and struggling to understand the incongruity between verbal support and limited promotion of the study, we invited team managers, nurses, occupational therapists, physiotherapists and psychologists to a facilitated roundtable discussion on their perceptions of research, impediments to their role as recruiters and ways to enhance recruitment. The group described clinicians being challenged by patients ‘informed about the latest research’ reported in the mass media; this sometimes required provision of contrary opinion and reminders for patients that application of research findings are dependent on the quality of the research and clinical nuances. When recruiting to research, the group felt responsible as the source of the invitation, assuming a degree of accountability for the project’s value and conduct (Table 1a). This was seen as unreasonable as they had no part in its design and administration, and so recruiting might be perceived as potentially unrewarding or worse, detrimental to patients. While the group perceived the value of research, they also identified several concerns about recruiting their patients to EVIDEM-E (Table 1b–d). Understandably, recruitment was regarded as a low priority in consultations and easily ‘slipped off the radar’ (Table 1e). The group made 3 suggestions aimed to enhance the participants’ experience opposed to theirs as recruiters; the first suggestion involved increasing clinician workload (Table 1f–h). With regard to the Copyright # 2011 John Wiley & Sons, Ltd.

second, the EVIDEM programme attempts to ensure comprehensive stakeholder involvement (e.g. http:// www.evidem.org.uk/events/ss08-details.htm) (Iliffe et al., 2009; Cerga-Pashoja et al., 2010), but this does not seem to have influenced this group’s experiences. The final suggestion is outside the remit of EVIDEM, but is consistent with the overall themes of patient protection and making research involvement profitable for participants. The NHS appears a fertile environment in which to recruit to clinical and healthcare research; within a society that often undervalues older people, many clinicians and researchers are passionate advocates of broadening patient choice, including opportunities to participate in research. All participants are expected to give their informed consent and safeguards exist for those who are unable to. In our experience, people take part in research for many reasons, not always obvious, but include altruism and heterotelism; and, people who are not interested have a range of direct and indirect ways of showing this. Despite all this, clinicians appear apprehensive to recruit to low-risk research. Therefore, we support recent calls to quantify clinicians’ impact on recruitment and test ways of improving accruals (Rendell et al., 2007). We also agree more is needed to understand the experience of participating as a ‘control’, particularly in trials utilising a single blind design. There are several ways researchers can incentivise clinicians’ involvement in research. The group indicated their involvement should bring tangible reward for clinicians and participants (Table 1i). It is not enough that NHS Trusts financially gain through research involvement; how these resources enhance clinical services should be made explicit. Encouraging investment by including clinicians on research advisory groups may garner support; however, it is likely that a more widespread and involved approach is needed to improve practitioner engagement. Consulting clinicians on dissemination strategies might help them see the path from project to practice. Finally, developing flexible quick guides to recruitment may instill confidence when discussing individual projects with patients. These approaches all maintain clinicians as central to recruitment; an alternative could be direct contact between researchers and patients. This could potentially resolve many Int J Geriatr Psychiatry 2011; 26: 765–769.

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Letters to the Editor

Table 1 Themes emerging from group discussions about recruitment a. Clinician accountability for research b. Overburdening ‘vulnerable’ participants

c. Anxiety over the patients’ feelings after researcher withdrawal d. Concern that participants would be dissatisfied when allocated to a control group e. Low priority in individual clinical context

f. Continuation of treatment – themselves to be trained to deliver the EVIDEM-E intervention g. Feedback provided face to face to participants h. Provision of carer respite

i. Tangible rewards

recruitment challenges for clinician and researcher, while improving patient choice. In collaboration with North Thames Dementia & Neurodegenerative Diseases Research Network (DeNDRoN), we helped develop a Registry of people with dementia interested in research (‘DemReg’) (Ritchie and Rait, 2009); this is operational, but requires testing and refinement. Preliminary experience suggests it is an effective recruitment mechanism; 8 participants in 6 weeks were recruited from the Registry to EVIDEM-E.

‘What if they agree due to your relationship with them, when you’ve said this thing is going to be great. . .?’ ‘I was just wondering if you could take it [information pack] out and talk them [participants] through, rather than this big pack arriving. I’d be thinking ‘‘uau’’ I thought I was just going out on a walk. . .’ ‘From our perspective they have participated in research . . . but they got nothing to say: thank you very much. I think that kind of puts people off’. ‘We have to tell the client what is it they get out of this . . . what if they go on the control group and get nothing?’ ‘I don’t see it as likely that patients that will be offered some sort of treatment will ask: ‘‘why are you saying this is the best treatment?’’ and ask for a justification. Many of our patients would be grateful because what they are looking for is an outcome, they are not interested how we get there. They just want positive outcome’. ‘I think it would be really useful if we could do it [exercise intervention] ourselves and have a go. With proper training and under you observing it, I don’t see a reason why we couldn’t’. ‘You need to talk to people. The feedback is very important, whether it [the study] has success or not. At the end they [participants] should be given some feedback’. ‘I think that whilst . . . they might want to be involved and participate, but if the services are not going in to enable them to have a good night sleep . . . A lot of times carers will actually say: I want a break . . . That’s the expectation of the carer, that someone will do that. That’ll be the motivation’. ‘What’s in it for us?’

ation of data, in the writing of the report and in the decision to submit the report for publication. Ethical approval This work was conducted as part of the EVIDEM-E project which received ethical approval from East London 3 NHS REC (Ref: 09/H0701/67). Key Points

Declaration of authorship DL & AP were responsible for the idea and acquisition of the data. DL prepared the first draft, and as such takes responsibility for the integrity of the work from inception to the final version. All authors made substantial contributions to analysis and interpretation of data, revising the manuscript critically for important intellectual content and approve of the final version. Conflict of interest None of the Authors have any conflicts of interest to declare. The study sponsor has played no part in the study design, in the collection, analysis and interpretCopyright # 2011 John Wiley & Sons, Ltd.

 Clinicians are the link between NHS patients and

healthcare researchers and so are central to recruitment to health care research.  Recruitment rates from clinicians often do not meet the expectations of researchers and can significantly impact on the timetable of research projects.  Many clinicians are uncomfortable recruiting to research as they feel they are not familiar with the research topic, fear a negative impact upon their clinical relationship with the patient and believe that such work is a low priority in the clinical situation.  Involving the clinician later in the recruitment process may provide a solution.

Int J Geriatr Psychiatry 2011; 26: 765–769.

Letters to the Editor

Acknowledgements This study has received financial support from the National Institute for Health Research (NIHR) Programme Grants for Applied Research funding scheme (RP-PG-0606-1005). The views and opinions expressed therein do not necessarily reflect those of Central & North West London NHS Foundation Trust, the NHS, the NIHR or the Department of Health.

References Cerga-Pashoja A, Lowery D, Bhattacharya R, et al. 2010. Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial. BMC Trials 11(53). http://www.trialsjournal.com/ content/pdf/1745-6215-11-53.pdf (accessed 01/10/2010). Iliffe S, Manthorpe J, Warner J, et al. 2008. Making progress in psychosocial research in dementia. Dementia 7(2): 167–174. Iliffe S, Jain P, Wong G, et al. 2009. Evidence-based interventions in dementia: a pragmatic cluster-randomised trial of an educational inter-

Copyright # 2011 John Wiley & Sons, Ltd.

769 vention to promote earlier recognition and response to dementia in primary care (EVIDEM-ED). Aging Health 5(1): 51–59. Rendell JM, Merritt RK, Geddes J. 2007. Incentives and disincentives to participation by clinicians in randomised controlled trials (Review). Cochrane Database Syst Rev 2. Art. No.: MR000021. http://onlinelibrary. wiley.com/o/cochrane/clsysrev/articles/MR000021/pdf_fs.html (accessed 01/10/2010). Ritchie C, Rait GA. 2009. Registry of patients with dementia for clinical research. In Dementia Services Development Centre 3rd International Conference.

DAVID PETER LOWERY1,2, JAMES WARNER1,3, ARLINDA CERGA-PASHOJA1,2, INGELA THUNE´-BOYLE2 2 AND STEVE ILIFFE 1 Central & North West London NHS Foundation Trust, London, UK 2 University College London, London, UK 3 Imperial College London, London, UK Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.002/gps.2671

Int J Geriatr Psychiatry 2011; 26: 765–769.