Video Decision Aid in Latina Women With Pelvic Organ Prolapse

NCT ID: NCT02850835

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Video Decision Aid

This group will be shown a video decision aid along with their standard of care.

Group Type EXPERIMENTAL

Video Decision Aid

Intervention Type OTHER

A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.

Standard Care

This group will not see the video decision aid and will only receive standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Video Decision Aid

A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.

Intervention Type OTHER

Other Intervention Names

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VDA

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Teodoro Ignacio Montoya

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Teodoro I Montoya, M.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

References

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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):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.

Reference Type BACKGROUND
PMID: 19935030 (View on PubMed)

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. doi: 10.1097/01.AOG.0000245784.31082.ed.

Reference Type BACKGROUND
PMID: 17138771 (View on PubMed)

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. doi: 10.1067/mob.2002.123819.

Reference Type BACKGROUND
PMID: 12066091 (View on PubMed)

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. doi: 10.1016/j.ajog.2006.01.060.

Reference Type BACKGROUND
PMID: 16647928 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 7240708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23597598 (View on PubMed)

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. doi: 10.1136/bmj.319.7212.731.

Reference Type BACKGROUND
PMID: 10487995 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31008776 (View on PubMed)

Other Identifiers

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E16059

Identifier Type: -

Identifier Source: org_study_id

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