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| Name | Class |
|---|---|
| Fellows Pelvic Research Network (sponsor) | UNKNOWN |
| Northwestern University | OTHER |
| University of New Mexico | OTHER |
| University of California, Irvine |
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This study is trying to see if people from different backgrounds have different feelings when making treatment decisions about prolapse.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Under-represented minority | Non-English speaking and/or non-White |
| |
| Non-under-represented minority | English-speaking and/or White |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decisional Conflict Scale | Other | Decisional Conflict Scale |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Decisional Conflict Scale scores measuring prolapse treatment-related decisional conflict reported by URMs to non-URMs after new patient consultations with FPMRS providers. | immediately on enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Describe patient and clinical factors associated with increased scores on the Decisional Conflict Scale | 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 | immediately on enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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New patients with symptoms of pelvic organ prolapse.
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| Name | Affiliation | Role |
|---|---|---|
| Julia K Shinnick, MD | Women & Infants Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital | Providence | Rhode Island | 02905 | United States |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| University of South Florida | OTHER |
| Emory University | OTHER |
| University of Alabama at Birmingham | OTHER |
| Johns Hopkins University | OTHER |
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| Identify variables correlated with discrepancies between patient-perceived and provider-perceived goals and treatment options |
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). |
| immediately on enrollment. |
| Explore variations in first-line treatments offered and/or selected for pelvic organ prolapse when stratified by race, ethnicity, and socioeconomic status. | Chart review of patient's medical history, exam findings, self-reported demographic background to investigate correlation with treatment patterns | immediately on enrollment. |
| Describe a possible correlation between race, ethnicity, and socioeconomic differences with scores on the Patient Autonomy Preferences Index and Patient Control Preferences Scale | Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scales. | immediately on enrollment. |
| Describe the association between race, ethnicity, and socioeconomic differences and scores on the Patient Satisfaction with Decision Scale | Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scale. | immediately on enrollment. |
| Investigate the relationship between Decisional Conflict Scale scores, Patient Satisfaction with Decision Making scores, and decisional instability 1 year after a new-patient visit. | Review of patient's self-reported demographic background information to assess to correlation with scores on above-mentioned scales. | 1 year |
| Investigate a correlation between Decisional Conflict Scale scores and zip-code | Review of whether distance driven to a hospital and/or living in a food desert is correlated with a higher Decisional Conflict Scale score. | immediately on enrollment. |