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

Pelvic Organ Prolapse Clinical Trial

— RESPECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977141
• Other study ID #: 1674479
• Status: Recruiting
• Start date: July 7, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2021
• Source: Women and Infants Hospital of Rhode Island
• Contact: Julia K Shinnick, MD
• Phone: (401) 274 1122
• Email: jshinnick[@]wihri.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Decisional Conflict Scale
Decisional Conflict Scale

Locations

Country	Name	City	State
United States	Women & Infants Hospital	Providence	Rhode Island

Sponsors (9)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.