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

Adwoa Hughes-Morley, Mark Hann, Claire Fraser, Karina Lovell, Oonagh Meade, Bridget Young, Lindsey Cree, Donna More, Peter Bower

Research output: Chapter in Book/Report/Conference proceedingConference contribution


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.
Original languageEnglish
Title of host publicationJournal of Epidemiology and Community Health
PublisherJournal of Epidemiology & Community Health
Number of pages2
Publication statusPublished - 1 Sept 2016

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