Improving trial recruitment through improved communication about patient and public involvement : an embedded cluster randomised recruitment trial

Background: Evidence is emerging that patient and public involvement in research (PPIR) may improve recruitment into randomised controlled trials, but the best methods to achieve improvement are unclear. Although many trials use PPIR to improve design and conduct, many do not communicate their use of PPIR clearly to potential participants. Directly communicating PPIR might encourage participation through increased patient confidence and trust in a trial. We aimed to develop and evaluate the impact on recruitment an intervention communicating PPIR in a trial to potential participants. Methods: This study was embedded in EQUIP, a cluster randomised controlled trial which allocated mental health teams in England to either a training intervention group to improve service user and carer involvement in care planning, or to a control group (no training). We conducted a cluster randomised trial of a recruitment intervention communicating PPIR, embedded within the EQUIP trial. The principles underlying the intervention were informed by a systematic review and a workshop that included mental health service users and trialists. Working with EQUIP PPIR partners (service users and carers) we developed the intervention using a leaflet to advertise the nature and function of the PPIR. Professional graphic design optimised readability and impact. Patients identified as potentially eligible for EQUIP were randomised to receive the leaflet or not, alongside the standard trial information. The primary outcome was the proportion of participants enrolled in EQUIP. The secondary outcome was the proportion expressing interest in taking part. Results: 34 clusters (mental health teams) were recruited, and 8182 potential participants were randomised. Preliminary analyses show that for the primary outcome, 4% of patients receiving the PPIR leaflet were enrolled vs. 5.3% in the control group. For the secondary outcome 7.3% of potential participants receiving the PPIR leaflet responded positively to the invitation to participate, vs. 7.9% in the control group. Future analyses will be by intention-to-treat and use logistic regression to estimate between-group odds ratios (ORs) and corresponding 95% confidence intervals. A planned secondary analysis will explore whether the impact of the intervention is moderated by age and gender. Conclusion: In preliminary analysis of this large trial, communicating PPIR demonstrated no benefits for improving the numbers of potential participants expressing interest in the trial, and reduced trial enrolment. Our findings contrast with the literature suggesting PPIR benefits recruitment. We will discuss the potential reasons for this finding, along with implications for future recruitment practice and research.