Clinical Trial: Video Decision Aid in Latina Women With Pelvic Organ Prolapse

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women

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 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. 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.
Sponsor: Texas Tech University Health Sciences Center, El Paso

Current Primary Outcome: Change from baseline decisional conflict score at 6 months. [ Time Frame: 6 months ]

Decisional Conflict Scale will be used


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline knowledge of condition score at 6 months. [ Time Frame: 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. [ Time Frame: 6 months ]
    Satisfaction with Decision Scale-(PFD) will be used


Original Secondary Outcome: Same as current

Information By: Texas Tech University Health Sciences Center, El Paso

Dates:
Date Received: July 7, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: April 14, 2017
Last Verified: April 2017