The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

Abstract

BackgroundPatient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants.MethodsThis is a cluster trial, embedded within a host trial (‘EQUIP’) recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation.ResultsThirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes.ConclusionTo our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research.Trial registration numbersISRCTN, ISRCTN16488358. Registered on 14 May 2014.Study Within A Trial, SWAT-26. Registered on 21 January 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1718-1) contains supplementary material, which is available to authorized users.

WITHDRAWN: Consumer Engagement in Health Care Policy, Research and Services: Methods and Effects.

“…Twelve inclusions were RCTs, and the remaining 11 were cluster RCTs [37][38][39][40][41][42][43][44][45][46][47]. Six studies included 100 or fewer participants [11,39,46,[48][49][50], nine studies had between 100 and 1,000 participants, and eight had more than 1,000 participants including three studies with over 20,000 participants [38,41,45].…”

“…Nine studies were set in (self-described) low socioeconomic countries and/or within disadvantaged communities [37,38,40,41,44,45,47,50,51]. The interventions for most studies took place within outpatient [51][52][53][54] or local community health clinics [37,39,43] or social support hubs [38,41,44,45] and two studies were conducted in hospital inpatient settings [49,55] one in a medical school [56], and one in aged care facilities [46].…”

“…The interventions were directed at people within various diagnostic groupings including mental illness [43,47,50,53,54]; pregnant and birthing women [38,41,44,45]; and chronic diseases [39,52] including smoking [40]. Other targeted participants were users of health care services such as participants undertaking hospital procedures [49,55], attending Oncology clinics [57], or attending Paediatric clinics [51].…”

“…Areas of consumer engagement: The majority of interventions were in the area of health services [15], predominantly in the development (and/or implementation) of the service itself; although two were more speci cally involved in developing patient information material [49,55], two in developing training material for health professionals who deliver health services [56,57]. Four studies engaged consumers in health-related research, spanning development, implementation and monitoring within the research process [42,43,53,54]. The nal four trials employed consumer engagement in the area of health policy, predominantly in developing priorities [39,47,48,58] but also in the development of a clinical practice guideline [11].…”

Patient Involvement in the Design of a Randomised Trial of Proton Beam Radiotherapy Versus Standard Radiotherapy for Good Prognosis Glioma

“…The feasibility of running randomised studies evaluating PBT in patients with glioma is an important consideration, particularly in respect of participants' views of a randomised design and the requirement for treatment at national centres. The value of patient and public involvement at an early stage in the development of research studies is well recognised in helping shape research proposals, making them more patient-centred and supporting recruitment [5,6].…”