NCT04977141

Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is trying to see if people from different backgrounds have different feelings when making treatment decisions about prolapse.

Detailed description

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.

Conditions

• Pelvic Organ Prolapse
• Prolapse, Urogenital

Interventions

Type	Name	Description
OTHER	Decisional Conflict Scale	Decisional Conflict Scale

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-12-01
• Completion: 2024-05-01
• First posted: 2021-07-26
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States