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

Women and Infants Hospital of Rhode Island

Status

Completed

Conditions

Pelvic Organ Prolapse

Prolapse, Urogenital

Treatments

Other: Decisional Conflict Scale

Study type

Observational

Funder types

Other

Identifiers

NCT04977141

1674479

Details and patient eligibility

About

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

Full 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.

Enrollment

210 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.