CompletedNot Applicable

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

United States210 participantsStarted 2021-07-07

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare Decisional Conflict Scale scores measuring prolapse treatment-related decisional conflict reported by URMs to non-URMs after new patient consultations with FPMRS providers.

Timeframe: immediately on enrollment.

Trial details

NCT IDNCT04977141

SponsorWomen and Infants Hospital of Rhode Island

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials