Randomised controlled trials often encounter problems in meeting recruitment targets, but insights from a recent successful trial can help future recruitment efforts.
It is not surprising that staff working in busy and demanding settings might consider the heavy onslaught of researchers, desperately trying to recruit participants, as an additional burden that has little pay off to either themselves or their clients.
A lack of time and training, complicated procedures and uninteresting research questions have been highlighted as further barriers to recruitment.
Early detection and intervention evaluation 2 (EDIE2) is a large scale multi-site randomised control trial of psychological intervention for young people who may be at risk of developing psychosis.
EDIE2 has recently come to the end of a successful three year recruitment period, with some sites reaching 100 per cent of their individual recruitment targets; an amazing feat for a trial of its size and nature.
So, what was behind this success and what insights can this give into the world of randomised control trial recruitment?
With these questions in mind a referrer feedback questionnaire was designed and circulated to people who had made referrals to EDIE2 over the past three years: 97 questionnaires were completed and returned between May and September 2009. The vast majority of the feedback received was extremely positive and indicted satisfaction with all aspects of the trial.
Of these respondents, 90 per cent agreed that the EDIE2 team were friendly and approachable and that they would be happy to contact the team about potential referrals in the future. At least 85 per cent of agreed with every statement relating to EDIE2’s assessment process, ie that their clients were seen quickly enough, that the approach to the assessment had benefited their clients; it had been a positive experience for them; and they had received good communication about the outcome of assessments.
Of those respondents who had referred somebody who had turned out to be suitable for the trial, 97 per cent said that they were happy with the support offered to that person.
There were some views that highlighted possible areas for improvement for EDIE2 although, overall, these were minimal.
Four referrers mentioned having problems getting through to EDIE2 via the telephone or having a slow response to phone messages. Five mentioned that they did not receive feedback following an assessment and two felt like their client has not been seen quickly enough after a referral.
The fact that only half of the participants would receive the psychological intervention was mentioned by four respondents. One mentioned that their client may have felt like they were in a “science project” rather than a service, one mentioned that their client had been “slightly confused” by the assessment process and one mentioned their client had become distressed when offered the standard £20 expense-cover at initial assessment.
Five referrers highlighted experiencing difficulties in terms of co-ordinating EDIE2 with other services that might be more appropriate for a client. This is indeed an issue that will need consideration when developing services for this population.
EDIE2 is filling a gap in traditional service configurations and as such there will inevitably be times where co-ordination between services is crucial in ensuring the best outcome for clients.
EDIE2 endeavoured to ensure strong links between such services to keep any such problems to a minimum.
At the end of the questionnaire, referrers were invited to make any other comments about their experiences with EDIE2. Any comments indicating areas for improvement have been referred to above.
Over three quarters of the comments (77 per cent) made in this section were extremely positive with regards to EDIE2’s team and approach.
Finally, over a third of the comments made in this section specifically mentioned the importance of EDIE2 and/or the need for services for this client group.
The trial was valued by referrers and was often seen a service rather than “just” a research trial. This too could perhaps be responsible for the recruitment success that EDIE2 enjoyed. Research for under-resourced and vulnerable client groups is not only an ethical priority but could also improve the likelihood of trials reaching their recruitment targets.
The specific approach that EDIE2 adopted throughout recruitment, ie to invest in training and liaison, to be friendly, accessible and approachable and to make things as easy as possible for referrers, combined with the lack of resources for this client group, seems to have culminated not only in successful recruitment but also in EDIE2 being highly valued by referrers.
This is all testament to the role that research can play in the “here and now” to the services and clients involved. Research does not have to be a burden, it can, in fact, be the exact opposite.
Jane Owens is assistant research psychologist, Paul French is associate director of early intervention services and Sophie Parker is a clinical psychologist for Greater Manchester West Mental Health Foundation Trust.