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

Pelvic Organ Prolapse Clinical Trial

Official title:
Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04977141
Study type Observational [Patient Registry]
Source Women and Infants Hospital of Rhode Island
Contact Julia K Shinnick, MD
Phone (401) 274 1122
Email jshinnick@wihri.org
Status Recruiting
Phase
Start date July 7, 2021
Completion date March 1, 2022
View Details
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