Talking to everyone about clinical research

Posted on July 15, 2013 by

0


Strokes often cause patients to have problems with language comprehension and communication. So how do you communicate information to those patients about being involved in the clinical trials crucial to understanding and treating stroke?

Peter Coleman from the Stroke Association tells us about a clinical trials information booklet the Association have published with Zena Jones of the NIHR Stroke Research Network (NIHR SRN) specially tailored to patients with aphasia (difficulty in of the comprehending and formulating language), and other communication disabilities caused by stroke.

Background

Stroke Association and the NIHR SRN have worked closely together since 2006 in developing policies and procedures for involving people affected by stroke in research.

In 2010, Stroke Association identified a need for a clear and concise explanation of clinical trials for people affected by stroke and their carers. Previously, people invited to participate in a clinical trial received specific information about that trial, but little or no information setting the context of what a clinical trial is, what they could expect from the trial, their rights, details about consent, ethics, and other general information about trials in stroke. We found that staff recruiting to trials were spending a lot of time explaining to participants what a clinical trial was and other general information which took time away from explaining about the specifics of the study.

Stroke Association and NIHR SRN both felt that a specific information booklet outlining general details of clinical trials, relevant to stroke, would be a useful way to address these issues.

This would allow more time for participants to understand the study, enable them to digest general information about trials, and then ask questions to help them to make an informed decision.

Together, we developed and published Clinical Trials and Stroke, which was subsequently made available to researchers and support staff recruiting individuals to stroke trials, and widely included in patient information packs.

But what about patients with communication disabilities?

About a third of patients who have a stroke experience some degree of communication disability or aphasia. It is often difficult to recruit those individuals into clinical trials, because they have the same questions as people who are unaffected, but are unable to understand the trials literature that is often provided, and which doesn’t take account of communication disability.

Consequently, SRN and Stroke Association identified an opportunity to address this issue by publishing an aphasia-friendly version of the Clinical Trials and Stroke Booklet.

How did we go about it?

We set up a project group including staff from both organisations, researchers, and stroke survivors affected by aphasia. The group worked together to translate the existing booklet into a more easily understood format that maintained the key information about clinical trials, whilst emphasising accessibility and minimising text.

Next, we engaged a designer to prepare appropriate illustrations that could be used to support the meaning of the text. Stroke Association had previously commissioned a set of aphasia-friendly information cards from researchers at the University of Sheffield, and so had access to a designer who understood the importance of clear and unambiguous illustrations to supplement content.

So this page answering frequently asked questions about consent…

Clinical Trials and Stroke P9

Was made into three aphasia-friendly pictures.

SAS Information Booklet P19 SAS Information Booklet P18 SAS Information Booklet P17

We circulated initial prototype widely to researchers, stroke survivors, carers, speech and language therapists and other professionals working with people affected by aphasia. The project group considered the comments and feedback on the format, text and illustrations, and after a further iterative process, signed off a final version of the booklet which went into production in early 2013.

The booklet was officially launched on 21 May 2013 in order to coincide with International Clinical Trials day.

Has it worked?

The booklet has been positively received and widely distributed among stroke research staff. People affected by aphasia and their carers have found it a useful tool when discussing participation in research.

Overall, we found that simply providing information about a specific study wasn’t enough, and that participants often wanted more general information first so they could understand what was being asked of them. We also found that in order to develop an appropriate way of communicating, it was important to ask people, and not to make assumptions. Collaborative working between organisations and stroke survivors works well – stroke survivors are key to developing materials.

We are particularly grateful to Graham McGuire, stroke survivor with aphasia, and lay member of the NIHR SRN and who was a key contributor to the process.

Posted in: AMRC, Research