Optimized Recruitment to Drive Equitable Research in Stroke, Empowering Decision-making (ORDERed) (ORDERed)
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ada Tang, PT PhD
- Número de teléfono: 905-525-9140
- Correo electrónico: atang@mcmaster.ca
Copia de seguridad de contactos de estudio
- Nombre: Hanna Fang
- Número de teléfono: 905-525-9140
- Correo electrónico: fangh@mcmaster.ca
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá
- Foothills Medical Centre
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Investigador principal:
- Aravind Ganesh, MD
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Contacto:
- Raksha Ramkumar
- Correo electrónico: raksha.ramkumar@ucalgary.ca
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British Columbia
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Vancouver, British Columbia, Canadá
- Vancouver General Hospital
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Contacto:
- Princess King-Azote
- Correo electrónico: princess.king-azote@ubc.ca
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Investigador principal:
- Lily Zhou, MD
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Ontario
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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Investigador principal:
- Amy Yu, MD
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Contacto:
- Tatjana Sukovic
- Correo electrónico: tatjana1.sukovic@sri.utoronto.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Traditional Recruitment Processes (TRADITIONAL)
Traditional participant information letter and consent form only
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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 address any further questions and determine the decision whether to enroll in the study.
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Experimental: Supported, women-centred and aphasia-friendly recruitment process (ORDERed)
Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and brochure (ORDER)
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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 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effectiveness - Enrollment rate
Periodo de tiempo: From initial contact with study coordinator to decision to participate (up to 30 days)
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Consented participants divided by total approached
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From initial contact with study coordinator to decision to participate (up to 30 days)
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Effectiveness - Efficiency
Periodo de tiempo: From initial contact with study coordinator to decision to participate (up to 30 days)
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Number of days and interactions between initial contact to decision to participate
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From initial contact with study coordinator to decision to participate (up to 30 days)
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Barriers and Facilitators
Periodo de tiempo: At time of enrollment decision to the StrokeGoRed study (consent or decline)
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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.
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At time of enrollment decision to the StrokeGoRed study (consent or decline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility - Reach
Periodo de tiempo: At the end of the recruitment period
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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)
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At the end of the recruitment period
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Feasibility - Adoption
Periodo de tiempo: At the end of the recruitment period
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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)
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At the end of the recruitment period
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Feasibility - Implementation
Periodo de tiempo: At the end of the recruitment period
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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)
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At the end of the recruitment period
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Feasibility - Maintenance
Periodo de tiempo: At the end of the recruitment period
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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)
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At the end of the recruitment period
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Isquemia cerebral
- Comportamiento
- Comportamiento Sexual
- Carrera
- Ataque Isquémico, Transitorio
- Coito
- Terapéutica
- Atención al paciente
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Cuidados paliativos
Otros números de identificación del estudio
- ORDERed
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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