Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Compare Decisional Conflict Scale scores measuring prolapse treatment-related decisional conflict reported by URMs to non-URMs after new patient consultations with FPMRS providers.
研究概览
简要总结
This study is trying to see if people from different backgrounds have different feelings when making treatment decisions about prolapse.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Compare Decisional Conflict Scale scores measuring prolapse treatment-related decisional conflict reported by URMs to non-URMs after new patient consultations with FPMRS providers.
时间窗: immediately on enrollment.
次要结局
- Describe patient and clinical factors associated with increased scores on the Decisional Conflict Scale(immediately on enrollment.)
- Identify variables correlated with discrepancies between patient-perceived and provider-perceived goals and treatment options(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.(immediately on enrollment.)
- Investigate a correlation between Decisional Conflict Scale scores and zip-code(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(immediately on enrollment.)
- Describe the association between race, ethnicity, and socioeconomic differences and scores on the Patient Satisfaction with Decision 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.(1 year)
研究者
Julia Shinnick
MD
Women and Infants Hospital of Rhode Island