Pelvic Organ ProlapseRESPECTNCT04977141
Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT
An observational study of Pelvic Organ Prolapse and Prolapse, Urogenital, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
This study is trying to see if people from different backgrounds have different feelings when making treatment decisions about prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Prolapse, Urogenital
- What is being tested?
- Decisional Conflict Scale
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2021to 1 May 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: New patients with symptoms of pelvic organ prolapse.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
This study is trying to see if people from different backgrounds have different feelings when making treatment decisions about prolapse.
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Prolapse, Urogenital
- Being tested
- Decisional Conflict Scale
- Keywords
- decisional conflict, pelvic organ prolapse, decision making
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decisional Conflict ScaleOther
Decisional Conflict Scale
| Study group | Role | What they receive |
|---|---|---|
| Under-represented minority | Non-English speaking and/or non-White Receives: Other: Decisional Conflict Scale | |
| Non-under-represented minority | English-speaking and/or White Receives: Other: Decisional Conflict Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Decisional Conflict Scale scores measuring prolapse treatment-related decisional conflict reported by URMs to non-URMs after new patient consultations with FPMRS providers.
Measured: immediately on enrollment.
Secondary outcomes (7)
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
Measured: immediately on enrollment.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately on enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start7 Jul 2021
- Primary completion1 Dec 2022
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Fellows Pelvic Research Network (sponsor), Northwestern University, University of New Mexico, University of California, Irvine, University of South Florida, Emory University, University of Alabama at Birmingham, Johns Hopkins University
- Responsible party
- Principal investigator, Julia Shinnick, Women and Infants Hospital of Rhode Island
- Investigators
- Julia K Shinnick, MD, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977141
- Sponsor's protocol ID
- 1674479
- Acronym
- RESPECT
- Status last verified
- May 2025
- First submitted
- 7 Jul 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT
- ClinicalTrials.gov ID
- NCT04977141
- Acronym / sponsor ID
- RESPECT / 1674479
- Conditions
- Pelvic Organ Prolapse, Prolapse, Urogenital
- Keywords
- decisional conflict, pelvic organ prolapse, decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Fellows Pelvic Research Network (sponsor), Northwestern University, University of New Mexico, University of California, Irvine, University of South Florida, Emory University, University of Alabama at Birmingham, Johns Hopkins University
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Under-represented minority | – | Other: Decisional Conflict ScaleNon-English speaking and/or non-White |
| Non-under-represented minority | – | Other: Decisional Conflict ScaleEnglish-speaking and/or White |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New patients with symptoms of pelvic organ prolapse.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decisional Conflict ScaleDecisional Conflict Scale | Other | Non-under-represented minority, Under-represented minority |
Primary outcome
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.
7 secondary outcomes
Describe patient and clinical factors associated with increased scores on the Decisional Conflict Scale
Time frame: immediately on enrollment.
Identify variables correlated with discrepancies between patient-perceived and provider-perceived goals and treatment options
Time frame: 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.
Time frame: 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
Time frame: immediately on enrollment.
Describe the association between race, ethnicity, and socioeconomic differences and scores on the Patient Satisfaction with Decision Scale
Time frame: 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.
Time frame: 1 year
Investigate a correlation between Decisional Conflict Scale scores and zip-code
Time frame: immediately on enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia K Shinnick, MD principal investigator
Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Prolapse, Urogenital, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: immediately on enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.