Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial.

Peter Knapp,Natasha Mitchell,Ada Keding,David K Raynor,David Torgerson,Simon Gilbody,Jonathan Silcock,Janet Holt

doi:10.12688/f1000research.24051.1

Peter Knapp, Natasha Mitchell + Show 6 more

Open Access

https://doi.org/10.12688/f1000research.24051.1

Copy DOI

Abstract

Background: Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment. Methods: A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. Results: A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202). Conclusions: Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial. Registration: ISRCTN ID ISRCTN02202951; registered on 3 June 2009.

Highlights

Potential participants in randomised controlled trials are given information that is often long, technical and difficult to navigate[1,2,3]
Materials revised after user-testing have been shown to be preferred[7,8], a recent review concluded that optimised information has little or no impact on trial recruitment[9]
Design The study within a trial (SWAT) was conducted within CASPER, which investigated the effectiveness of behavioural activation in patients aged 65 years or older with sub-threshold levels of depression[15]

Summary

Introduction

Potential participants in randomised controlled trials are given information that is often long, technical and difficult to navigate[1,2,3]. They may lack understanding of important details about the trial[1,4,5], which limits their ability to make an informed decision about consent. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing.

Methods

Results

Conclusion