Clinical trials in stroke recovery are essential for establishing effective treatments, yet important groups, such as women and people with aphasia, have been consistently under-represented in stroke trials. This limits the generalizability of trial findings and impacts clinical care. Relevant to stroke is the critical time window for neuroplastic change that makes timely enrolment into stroke recovery trials of particular importance. There is a need to develop strategies to efficiently and effectively promote participation into stroke recovery trials.
The Optimizing Recruitment to Drive Equitable Research opportunity in stroke rehabilitation trials in Canada (ORDER) is a pilot "study within a trial" to look at a women-centred, aphasia-friendly recruitment method for a research trial examining whether a medication (Maraviroc), when combined with rehabilitation, can help with stroke recovery ("host trial").
The objectives of this pilot study are to:
1. Examine the feasibility of a women-centred, aphasia-friendly video and leaflet (ORDER) to supplement traditional detailed participant information letters, support recruitment, and drive enrollment in a stroke recovery randomized trial;
2. Understand the barriers and facilitators associated with enrolling in the host trial and stroke recovery trials more broadly;
3. Determine preliminary estimates of effect of ORDER compared to traditional recruitment and enrollment processes
The study will take place at the 10 sites across 6 provinces. The host trial is comparing Maraviroc vs. placebo, combined with 8 weeks of rehabilitation, to improve motor and sensory function.
Potential participants will be identified and approached 5 days to 8 weeks after stroke and randomized to: 1) Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and leaflet (ORDER), or 2) Traditional participant information letter and consent form only (TRAD). For the ORDER arm, the video and leaflet will be saved to a tablet and reviewed together with the Coordinator and potential participant. The Coordinator will engage in discussion about the host trial (prompting questions will be provided), and will offer to leave the tablet with the person, along with printed copies of the leaflet and participant information letter. They will be encouraged to share these materials with their family members or friends who may assist with decision making. For TRAD, the Coordinator will review the information letter and consent form, offer to leave these with the person to view again, and encourage them to share these materials with their family members or friends who may assist with decision making. For both arms, the Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial.
Objective 1 Feasibility will be determined as enrollment (# consented/approached, # women consented/total # consented) and efficiency (# days to decision, # interactions between Site Coordinator and potential participants), with a priori criteria for success for each indicator.
For Objective 2 (Barriers and facilitators), individuals will be invited to complete a survey or participate in key-informant, semi-structured interviews (15 enrolled, 15 declined, 10 Site Coordinators) to share their perceptions of the enrollment and consent process, reason(s) for declining to participate, and recruitment reach (# and characteristics of individuals enrolled through ORDER and TRAD). Purposive sampling will be used to obtain diversity across sex (males, females), gender (men, women, transgender, non-binary), and racial background and will train peer researchers with lived experience to conduct the interviews. The interview guide will be co-developed with our patient partners and the research team. Deductive content analysis of interview transcripts will be conducted and mapped to the Theoretical Domains Framework.
For Objective 3 (Preliminary estimates of effect), enrollment and efficiency will be compared between ORDER and TRAD, and Cohen's d and f will be calculated for unadjusted and adjusted analyses to help inform future large-scaled trials.
