Optimized Recruitment to Drive Equitable Research in Stroke, Empowering Decision-making (ORDERed)

McMaster University

Status: Not yet enrolling

Conditions: Stroke; Stroke (CVA) or Transient Ischemic Attack

Treatments: Other: Traditional recruitment processes (TRADITIONAL); Other: Supported, women-centred and aphasia-friendly recruitment process (ORDERed)

Study type: Interventional

Funder types: Other

Identifiers

NCT07576647

ORDERed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,600 participants in 2 patient groups

Traditional Recruitment Processes (TRADITIONAL)

Other group

Description:

Traditional participant information letter and consent form only

Treatment:

Other: Traditional recruitment processes (TRADITIONAL)

Supported, women-centred and aphasia-friendly recruitment process (ORDERed)

Experimental group

Description:

Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and brochure (ORDER)

Treatment:

Other: Supported, women-centred and aphasia-friendly recruitment process (ORDERed)