Video Decision Aid in Latina Women With Pelvic Organ Prolapse

NCT02850835 | Completed

• 1 other identifier: E16059
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Keywords

Decision Aid; Pelvic Organ Prolapse (POP)

Outcome Measures

Primary Outcomes (1)

• Change from baseline decisional conflict score at 6 months.

  Decisional Conflict Scale will be used

  6 months

Secondary Outcomes (2)

• Change from baseline knowledge of condition score at 6 months.

  6 months

• Change from baseline satisfaction with selected treatment at 6 months.

  6 months

Study Arms (2)

Video Decision Aid

EXPERIMENTAL

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

Other: Video Decision Aid

Standard Care

NO INTERVENTION

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

Interventions

Video Decision Aid OTHER

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

Also known as: VDA

Video Decision Aid

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hispanic Women
• Referred for evaluation of pelvic organ prolapse for the first time

You may not qualify if:

• Women previously referred or treated for pelvic organ prolapse
• Women who do not live in El Paso, Texas

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Related Publications (8)

• 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.

  PMID: 19935030 BACKGROUND

• 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.

  PMID: 17138771 BACKGROUND

• 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.

  PMID: 12066091 BACKGROUND

• 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.

  PMID: 16647928 BACKGROUND

• 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.

  PMID: 7240708 BACKGROUND

• 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.

  PMID: 23597598 BACKGROUND

• 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.

  PMID: 10487995 BACKGROUND

• 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.

  PMID: 31008776 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Teodoro I Montoya, M.D.

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: August 1, 2016
• Study Start: July 1, 2016
• Primary Completion: August 17, 2017
• Study Completion: December 31, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share