Clinical trial NCT02850835: Video Decision Aid in Latina Women With Pelvic Organ Prolapse
Official title: Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Decision Aid
Pelvic Organ Prolapse (POP)
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 33
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change from baseline decisional conflict score at 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline knowledge of condition score at 6 months.
timeFrame: 6 months
measure: Change from baseline satisfaction with selected treatment at 6 months.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Teodoro I Montoya, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Montoya TI, Rondeau NU, Maldonado PA, Mallett VT. Decision Aid Video for Treatment Selection in Latinas With Symptomatic Pelvic Organ Prolapse: A Randomized Pilot Study. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):39-45. doi: 10.1097/SPV.0000000000000727.