Optimized Recruitment to Drive Equitable Research in Stroke, Empowering Decision-making (ORDERed)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supported, women-centred and aphasia-friendly recruitment process (ORDERed), Traditional recruitment processes (TRADITIONAL).
- Who it may be relevant to
- Registry conditions: Stroke, Stroke (CVA) or Transient Ischemic Attack. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Stroke is a major health issue, especially for women, who are more likely than men to have worse outcomes and lower quality of life after a stroke. Yet, women are under-represented in stroke research, which limits how well treatments work for them. This study aims to change that by testing a new way to recruit women into stroke research using the ORDER toolkit, a set of easy-to-understand, women-focused materials like brochures and videos co-designed with patients. This new approach will be compared to the usual way of recruiting patients. The study will track how many people join, how long it takes to make a decision, and what influences participation. Patients and research coordinators will also share their feedback on the process. Our goal is to make stroke studies more inclusive so that research findings benefit everyone equally.
Detailed description
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:
1. Examine the effectiveness (enrollment rate, efficiency, and attrition) of a women-centred, aphasia-friendly recruitment and enrollment process (ORDERed) compared to traditional processes (TRADITIONAL); 2. Understand barriers and facilitators associated with enrolling in the host cohort study and stroke studies more broadly; and 3. 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.
Interventions
- Other Supported, women-centred and aphasia-friendly recruitment process (ORDERed)
In the ORDERed phase, the Site Coordinator will approach participants for interest in the cohort study by introducing the study and sharing a brochure and brief, women-centred, close-captioned video that further describes the study procedures. These recruitment materials were co-developed with patient partners with lived experience of stroke. The video and brochure will be available on a mobile tablet, with the brochure also available in hard copy. Materials include images representing diverse e - Other Traditional recruitment processes (TRADITIONAL)
With the traditional recruitment process (TRADITIONAL), participants are approached by the Site Coordinator for interest in the cohort study and presented with the standard participant information letter and full informed consent form. The information letter and consent form will be left with the potential participant to view again; the Coordinator will encourage them to share these materials with their family members or friends who may assist with decision making. The Coordinator will return to
Primary outcome measures
- Effectiveness - Enrollment rate [Time frame: From initial contact with study coordinator to decision to participate (up to 30 days)]
- Effectiveness - Efficiency [Time frame: From initial contact with study coordinator to decision to participate (up to 30 days)]
- Barriers and Facilitators [Time frame: At time of enrollment decision to the StrokeGoRed study (consent or decline)]
Secondary outcome measures (4)
- Feasibility - Reach [Time frame: At the end of the recruitment period]
- Feasibility - Adoption [Time frame: At the end of the recruitment period]
- Feasibility - Implementation [Time frame: At the end of the recruitment period]
- Feasibility - Maintenance [Time frame: At the end of the recruitment period]
Eligibility criteria
Participants eligible for StrokeGoRed hospitalized cohort are eligible for ORDERed:
Inclusion criteria
- All patients, regardless of age or baseline disability, seen in urgent TIA/stroke clinics and referred from the emergency department for suspected TIA or minor stroke will be included over one calendar year
Exclusion criteria
- There are no exclusion criteria
Participants eligible for StrokeGoRed hospitalized cohort are eligible for ORDERed:
Inclusion criteria
- Ischemic stroke
- Intracerebral hemorrhage
Exclusion criteria
- Cerebral venous thrombosis
- Subarachnoid hemorrhage
- Subdural hemorrhage
- Intracranial hemorrhage due to trauma or underlying mass
- Clinical transient ischemic attack without evidence of infarct on neuroimaging
- Imaging abnormality (e.g., dissection, carotid stenosis, vessel irregularity) without imaging or clinical evidence of stroke
- Stroke that occurred while being admitted for another reason
- Stroke that started more than 14 days prior to admission
- Stroke initially treated outside of Canada
- Stroke where inpatient stroke or neurology service was not consulted
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Canada · 3 centers
- Foothills Medical Centre — Calgary
- Vancouver General Hospital — Vancouver
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT07576647 · ORDERed