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Clinical Trials/NCT02850835
NCT02850835
Completed
Not Applicable

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

Texas Tech University Health Sciences Center, El Paso0 sites33 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Texas Tech University Health Sciences Center, El Paso
Enrollment
33
Primary Endpoint
Change from baseline decisional conflict score at 6 months.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Texas Tech University Health Sciences Center, El Paso
Responsible Party
Principal Investigator
Principal Investigator

Teodoro Ignacio Montoya

Assistant Professor

Texas Tech University Health Sciences Center, El Paso

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline decisional conflict score at 6 months.

Time Frame: 6 months

Decisional Conflict Scale will be used

Secondary Outcomes

  • Change from baseline knowledge of condition score at 6 months.(6 months)
  • Change from baseline satisfaction with selected treatment at 6 months.(6 months)

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