Women are under-represented in stroke research, ranging from acute stroke clinical trials, prevention, and rehabilitation studies, limiting the generalizability of research findings and impacting clinical care. Studies have found that women were more likely to be missed by recruiters, and when approached, were more likely to decline participation. Women are also more likely to consider the opinions of their spouse or friends when deciding to participate in studies. Data from the EMPOW-HER study suggest that women have more unanswered questions than men from the consent form and altruism is a greater motivator for research participation among women. This new knowledge led to the development of the ORDER toolkit, a women-centred and aphasia-friendly recruitment and enrollment toolkit that can be broadly applied to stroke studies. This study will investigate its effectiveness in the enrollment process of the StrokeGoRed (ORDERed).
ORDERed will use a pre-post design embedded within StrokeGoRed (Stroke in Women: Growing Opportunities to Realize optimal Evaluation, Diagnosis, and outcomes (StrokeGoRed)) to test the use of a supported, women-centred and aphasia-friendly recruitment and enrollment process.
The objectives of this study are to:
- Examine the effectiveness (enrollment rate, efficiency, and attrition) of a women-centred, aphasia-friendly recruitment and enrollment process (ORDERed) compared to traditional processes (TRADITIONAL);
- Understand barriers and facilitators associated with enrolling in the host cohort study and stroke studies more broadly; and
- Evaluate the feasibility (reach, adoption, implementation, and maintenance) of ORDERed.
ORDERed will use a pre-post design embedded within StrokeGoRed (Stroke in Women: Growing Opportunities to Realize optimal Evaluation, Diagnosis, and outcomes (StrokeGoRed)) to test the use of a supported, women-centred and aphasia-friendly recruitment and enrollment process. The site will begin with the usual enrollment process (TRADITIONAL) for the first part of the recruitment period (study letter and informed consent form), followed by the ORDERed toolkit for the latter half of the recruitment period.
The RE-AIM implementation science framework, consisting of five steps to translate research into action, will be used to evaluate the implementation of ORDERed. Traditional and ORDERed will be compared for Reach and Effectiveness, including enrollment rate (consented participants divided by total approached), efficiency (number of days and interactions between initial contact to decision to participate), and attrition (lost to follow-up divided by total enrolled) using a descriptive analysis stratified by sex. At the time of decision, participants will also be invited to complete a brief 15-minute web-based survey regarding the recruitment process and their decision making regarding participating in the study, including reason(s) for not participating. After the recruitment period, Coordinators will be invited to complete a survey about their perspectives of the Adoption of the ORDER toolkit, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (coordinators will be asked whether they would use this for future studies and potential barriers to implementation in future studies).
To assess the effectiveness of the ORDERed intervention compared with traditional recruitment methods, a logistic regression model will be used with a binary outcome indicating successful recruitment. Treatment group (ORDER vs. traditional recruitment) will be the primary independent variable, and prespecified covariates (e.g., age, sex, gender) will be included as adjustment variables. The analysis will be repeated stratified by sex.
