Heart & Stroke-funded ORDER study will also improve understanding of why people choose to take part in research, and why they say no
A new CanStroke pilot study will evaluate two tools, developed by patient partners and researchers in Hamilton and Halifax, to try to increase the number of women and people with aphasia in stroke clinical trials.
ORDER (Optimizing Recruitment to Drive Equitable Research opportunity in stroke rehabilitation trials in Canada) is set to roll out as part of CanStroke’s CAMAROS trial at sites across Canada. Its goal is to address low participation rates among women and people with aphasia in stroke trials.
Researchers Dr. Ada Tang at McMaster University and Dr. Adria Quigley at Dalhousie University have received a $286K grant over three years from Heart & Stroke to conduct the pilot study.
“We are doing research on how to do research better,” Dr. Tang says. “By doing a study within a trial, we are actually building evidence on how to do trials better.”
Boosting recruitment in trials is important because women are under-represented in stroke research. The concern is that care decisions and practice guidelines may not be broadly applicable if they don’t reflect the diversity of the population.
“There is evidence that women have different outcomes after stroke,” Dr. Quigley adds. “They have higher mortality rates and they are less likely to be discharged home. This indicates that, already, we aren’t addressing the needs of women post-stroke. The first step is to recruit more women into trials so we can determine the best approach for improving stroke recovery for them.”
The ORDER study involves testing a new trial recruitment process with 446 potential participants of all genders, who are randomized into two groups.
“Women with lived experience are our patient partners on this study,” Dr. Tang emphasizes. “They are investigators on the grant. They have given a lot of input on developing the materials.”
In the hospital, one group of patients eligible for the trial will be shown an eight-minute video, loaded onto a tablet, and given a brochure that carefully lays out details of the research. Both tools are aphasia-friendly (accessible to people experiencing communication challenges after stroke.) The video and brochure use simple, concise language and images, and emphasize elements shown to be important to women in the decision-making process. The other group will receive the traditional recruitment process.
“What we understand is women don’t feel they have enough time to make a decision about coming into studies,” Dr. Tang explains. “We want to make sure we are giving them time to think about it and talk it over with their families.”
In the end, researchers will determine if the new approach increases the enrolment of women.
The CAMAROS trial, led by Dr. Sean Dukelow at the University of Calgary, was an ideal starting point to test this new strategy because it is evaluating the efficacy of coupling the drug Maraviroc (Celsentri) with exercise rehabilitation. Women may be more concerned about drug side-effects and are more risk adverse than men.
The ORDER pilot also includes a sub-study that involves surveys and interviews, led by a patient partner, with 30 of the potential trial participants to understand why some chose to enroll in research and others did not.
If found to be efficient and effective, the ORDER study will be scaled up for future CanStroke trials, as well as studies in the new StrokeGoRed research network, which is working to advance understanding of sex and gender differences in stroke prevention, care and recovery.