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OpenTrials
Completed

NCT Number: NCT04977141

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

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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Prolapse, Urogenital

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decisional Conflict Scale

Other

Decisional Conflict Scale

Primary outcomes

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

    Time frame: immediately on enrollment.

Secondary outcomes

  1. Describe patient and clinical factors associated with increased scores on the Decisional Conflict Scale

    Time frame: 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

  2. Identify variables correlated with discrepancies between patient-perceived and provider-perceived goals and treatment options

    Time frame: 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).

  3. Explore variations in first-line treatments offered and/or selected for pelvic organ prolapse when stratified by race, ethnicity, and socioeconomic status.

    Time frame: immediately on enrollment.

    Chart review of patient's medical history, exam findings, self-reported demographic background to investigate correlation with treatment patterns

  4. Describe a possible correlation between race, ethnicity, and socioeconomic differences with scores on the Patient Autonomy Preferences Index and Patient Control Preferences Scale

    Time frame: immediately on enrollment.

    Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scales.

  5. Describe the association between race, ethnicity, and socioeconomic differences and scores on the Patient Satisfaction with Decision Scale

    Time frame: immediately on enrollment.

    Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scale.

  6. Investigate the relationship between Decisional Conflict Scale scores, Patient Satisfaction with Decision Making scores, and decisional instability 1 year after a new-patient visit.

    Time frame: 1 year

    Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scales.

  7. Investigate a correlation between Decisional Conflict Scale scores and zip-code

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Collaborators

  • Emory University
  • Fellows Pelvic Research Network (sponsor)
  • Johns Hopkins University
  • Northwestern University
  • University of Alabama at Birmingham
  • University of California, Irvine
  • University of New Mexico
  • University of South Florida

Registry information

Acronym: RESPECT

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jul 26, 2021
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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