Video Decision Aid in Latina Women With Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850835
• Other study ID #: E16059
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2018
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Video Decision Aid
A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

References & Publications (7)

Andersen R, Lewis SZ, Giachello AL, Aday LA, Chiu G. Access to medical care among the Hispanic population of the southwestern United States. J Health Soc Behav. 1981 Mar;22(1):78-89. — View Citation

Buchsbaum GM, Duecy EE, Kerr LA, Huang LS, Perevich M, Guzick DS. Pelvic organ prolapse in nulliparous women and their parous sisters. Obstet Gynecol. 2006 Dec;108(6):1388-93. — View Citation

Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. — View Citation

Herman JP, Blangero A, Madelain L, Khan A, Harwood MR. Saccade adaptation as a model of flexible and general motor learning. Exp Eye Res. 2013 Sep;114:6-15. doi: 10.1016/j.exer.2013.04.001. Epub 2013 Apr 15. Review. — View Citation

Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006 May;194(5):1455-61. — View Citation

O'Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas H, Holmes-Rovner M, Barry M, Jones J. Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ. 1999 Sep 18;319(7212):731-4. Review. — View Citation

Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-83. doi: 10.1097/AOG.0b013e3181c2ce96. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline decisional conflict score at 6 months.	Decisional Conflict Scale will be used	6 months
Secondary	Change from baseline knowledge of condition score at 6 months.	12-item questionnaire of female pelvic anatomy and pelvic organ prolapse concepts will be used	6 months
Secondary	Change from baseline satisfaction with selected treatment at 6 months.	Satisfaction with Decision Scale-(PFD) will be used	6 months