Optimized Recruitment to Drive Equitable Research in Stroke, Empowering Decision-making (ORDERed)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
There are no exclusion criteria
Ischemic stroke
Intracerebral hemorrhage
Cerebral venous thrombosis
Trial design
Design model
Parallel
Treatments tested in this trial
Supported, women-centred and aphasia-friendly recruitment process (ORDERed)
Other interventionIn 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 ethnocultural backgrounds and gender identities and feature the lead researcher and a patient partner. The Coordinator will watch the video with the potential participant, discuss the study, and answer questions. Participants may keep the tablet and printed materials to review and share with family, friends, or healthcare providers before making a decision about enrollment.
Traditional recruitment processes (TRADITIONAL)
Other interventionWith 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 address any further questions and determine the decision whether to enroll in the study.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Traditional Recruitment Processes (TRADITIONAL)Other 1 intervention
Group B: Supported, women-centred and aphasia-friendly recruitment process (ORDERed)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness - Enrollment rate
Consented participants divided by total approached
Time frame
From initial contact with study coordinator to decision to participate (up to 30 days)2
Effectiveness - Efficiency
Number of days and interactions between initial contact to decision to participate
Time frame
From initial contact with study coordinator to decision to participate (up to 30 days)3
Barriers and Facilitators
All participants, whether or not they consent to the cohort study, will be invited to complete a brief 15-minute web-based survey regarding the recruitment process and their decision making regarding study participation, including reason(s) for participating or not participating.
Time frame
At time of enrollment decision to the StrokeGoRed study (consent or decline)Secondary outcomes
1
Feasibility - Reach
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
Time frame
At the end of the recruitment period2
Feasibility - Adoption
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
Time frame
At the end of the recruitment period3
Feasibility - Implementation
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
Time frame
At the end of the recruitment period4
Feasibility - Maintenance
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
Time frame
At the end of the recruitment periodSponsors and contacts
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Source ClinicalTrials.gov