Clinical trial NCT04977141: Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT
Official title: Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Prolapse, Urogenital
Keywords: decisional conflict
pelvic organ prolapse
decision making
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Fellows Pelvic Research Network (sponsor)
name: Northwestern University
name: University of New Mexico
name: University of California, Irvine
name: University of South Florida
name: Emory University
name: University of Alabama at Birmingham
name: Johns Hopkins University
First posted: 2021-07-26
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New patients with symptoms of pelvic organ prolapse.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Describe patient and clinical factors associated with increased scores on the Decisional Conflict Scale
timeFrame: immediately on enrollment.
measure: Identify variables correlated with discrepancies between patient-perceived and provider-perceived goals and treatment options
timeFrame: immediately on enrollment.
measure: Explore variations in first-line treatments offered and/or selected for pelvic organ prolapse when stratified by race, ethnicity, and socioeconomic status.
timeFrame: immediately on enrollment.
measure: Describe a possible correlation between race, ethnicity, and socioeconomic differences with scores on the Patient Autonomy Preferences Index and Patient Control Preferences Scale
timeFrame: immediately on enrollment.
measure: Describe the association between race, ethnicity, and socioeconomic differences and scores on the Patient Satisfaction with Decision Scale
timeFrame: immediately on enrollment.
measure: Investigate the relationship between Decisional Conflict Scale scores, Patient Satisfaction with Decision Making scores, and decisional instability 1 year after a new-patient visit.
timeFrame: 1 year
measure: Investigate a correlation between Decisional Conflict Scale scores and zip-code
timeFrame: immediately on enrollment.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Julia K Shinnick, MD
role: PRINCIPAL_INVESTIGATOR
References: