Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT (RESPECT)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This multi-center study will include patients ages >18 years with prolapse symptoms who have new patient consultations to Female Pelvic Medicine and Reconstructive Surgery providers.
After the new-patient consultation, patients will be contacted to see if they are interested in the study. If so, informed consent will be obtained before they complete a 1 page questionnaire that assesses their eligibility for participation.
The questionnaires are: Decisional Conflict Scale; Pelvic Floor Disorders Autonomy Preference Index; Control Preferences Scale; Pelvic Floor Distress Inventory (PFDI 20); Satisfaction with Decision Scale for Pelvic Floor Disorders; Impression questionnaire.
Patients will self-identify their zip-code on the patient impression questionnaire. This will enable a geographic analysis that will assess the relationships of neighborhood and commute on decision making.
For the purposes of this study, patients will self-identify their demographic information.
URM patients will be those who self-identify as having a non-Caucasian race and/or a Hispanic ethnicity. Providers seeing patients that are included in this study will also be consented prior to completing a 1 time demographics questionnaire. Additional clinical data will also be obtained.
Patients will be able to utilize interpreters to participate. Information regarding the use of interpreters will be collected. Questionnaires that are available in, and validated in, non-English languages will be used as appropriate.
The lead study site is Women & Infants Hospital/ Brown University, with additional study sites planning to participate in the study.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Julia K Shinnick, MD
- Número de teléfono: 48767 (401) 274 1122
- Correo electrónico: jshinnick@wihri.org
Ubicaciones de estudio
-
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02905
- Reclutamiento
- Women & Infants Hospital
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Contacto:
- Julia Shinnick
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Provider inclusion criteria consists of FPMRS providers at study sites seeing new patients with symptoms of pelvic organ prolapse. Patient inclusion criteria consists of new patients 18 years or older with symptoms of pelvic organ prolapse.
Exclusion Criteria:
- Provider exclusion criteria consists of providers who decline participation. Patient exclusion criteria consists of patients who decline participation, and those who cannot complete the study interventions with the assistance of an interpreter.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Under-represented minority
Non-English speaking and/or non-White
|
Decisional Conflict Scale
|
|
Non-under-represented minority
English-speaking and/or White
|
Decisional Conflict Scale
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Compare Decisional Conflict Scale scores measuring prolapse treatment-related decisional conflict reported by URMs to non-URMs after new patient consultations with FPMRS providers.
Periodo de tiempo: immediately on enrollment.
|
immediately on enrollment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Describe patient and clinical factors associated with increased scores on the Decisional Conflict Scale
Periodo de tiempo: immediately on enrollment.
|
perform chart review of patient's medical history, self-reported demographic variables, exam findings, symptom scores on the Pelvic Floor Distress Inventory and Decisional Conflict Scale scores
|
immediately on enrollment.
|
|
Identify variables correlated with discrepancies between patient-perceived and provider-perceived goals and treatment options
Periodo de tiempo: immediately on enrollment.
|
Chart review of patient's medical history, exam findings, self-reported demographic variables to investigate if they are correlated with differences in self-reported patient goals and perception of treatment options offered (this is not a named questionnaire, this is a questionnaire developed for the study).
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immediately on enrollment.
|
|
Explore variations in first-line treatments offered and/or selected for pelvic organ prolapse when stratified by race, ethnicity, and socioeconomic status.
Periodo de tiempo: immediately on enrollment.
|
Chart review of patient's medical history, exam findings, self-reported demographic background to investigate correlation with treatment patterns
|
immediately on enrollment.
|
|
Describe a possible correlation between race, ethnicity, and socioeconomic differences with scores on the Patient Autonomy Preferences Index and Patient Control Preferences Scale
Periodo de tiempo: immediately on enrollment.
|
Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scales.
|
immediately on enrollment.
|
|
Describe the association between race, ethnicity, and socioeconomic differences and scores on the Patient Satisfaction with Decision Scale
Periodo de tiempo: immediately on enrollment.
|
Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scale.
|
immediately on enrollment.
|
|
Investigate the relationship between Decisional Conflict Scale scores, Patient Satisfaction with Decision Making scores, and decisional instability 1 year after a new-patient visit.
Periodo de tiempo: 1 year
|
Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scales.
|
1 year
|
|
Investigate a correlation between Decisional Conflict Scale scores and zip-code
Periodo de tiempo: immediately on enrollment.
|
Review of whether distance driven to a hospital and/or living in a food desert is correlated with a higher Decisional Conflict Scale score.
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immediately on enrollment.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Julia K Shinnick, MD, Women & Infants Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- 1674479
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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