Video Decision Aid in Latina Women With Pelvic Organ Prolapse

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Video Decision Aid

• Registration Number: NCT02850835
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief Summary

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP in a border region university-affiliated medical clinic, will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment.

Detailed Description

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Counseling Latina women suffering from POP is often complex due to a variety of factors, including language barriers, limited patient understanding of anatomy and disease etiology and confusion regarding surgical versus nonsurgical treatment options. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment, empowering these women as active participants in their healthcare instead of relying on provider input alone.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Primary Completion: 2017-08-17
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Hispanic Women
• Referred for evaluation of pelvic organ prolapse for the first time

Exclusion Criteria

• Women previously referred or treated for pelvic organ prolapse
• Women who do not live in El Paso, Texas

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Decision Aid	Video Decision Aid	This group will be shown a video decision aid along with their standard of care.

Primary Outcome Measures

Name	Time	Method
Change from baseline decisional conflict score at 6 months.	6 months	Decisional Conflict Scale will be used

Secondary Outcome Measures

Name	Time	Method
Change from baseline knowledge of condition score at 6 months.	6 months	12-item questionnaire of female pelvic anatomy and pelvic organ prolapse concepts will be used
Change from baseline satisfaction with selected treatment at 6 months.	6 months	Satisfaction with Decision Scale-(PFD) will be used