Video Decision Aid in Latina Women With Pelvic Organ Prolapse
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video Decision Aid
Sponsored by
About this trial
This is an interventional health services research trial for Pelvic Organ Prolapse focused on measuring Decision Aid, Pelvic Organ Prolapse (POP)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Video Decision Aid
Standard Care
Arm Description
This group will be shown a video decision aid along with their standard of care.
This group will not see the video decision aid and will only receive standard of care.
Outcomes
Primary Outcome Measures
Change from baseline decisional conflict score at 6 months.
Decisional Conflict Scale will be used
Secondary Outcome Measures
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
Change from baseline satisfaction with selected treatment at 6 months.
Satisfaction with Decision Scale-(PFD) will be used
Full Information
NCT ID
NCT02850835
First Posted
July 7, 2016
Last Updated
April 24, 2019
Sponsor
Texas Tech University Health Sciences Center, El Paso
1. Study Identification
Unique Protocol Identification Number
NCT02850835
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Decision Aid, Pelvic Organ Prolapse (POP)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video Decision Aid
Arm Type
Experimental
Arm Description
This group will be shown a video decision aid along with their standard of care.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
This group will not see the video decision aid and will only receive standard of care.
Intervention Type
Other
Intervention Name(s)
Video Decision Aid
Other Intervention Name(s)
VDA
Intervention Description
A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.
Primary Outcome Measure Information:
Title
Change from baseline decisional conflict score at 6 months.
Description
Decisional Conflict Scale will be used
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline knowledge of condition score at 6 months.
Description
12-item questionnaire of female pelvic anatomy and pelvic organ prolapse concepts will be used
Time Frame
6 months
Title
Change from baseline satisfaction with selected treatment at 6 months.
Description
Satisfaction with Decision Scale-(PFD) will be used
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teodoro I Montoya, M.D.
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19935030
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):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
Results Reference
background
PubMed Identifier
17138771
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. doi: 10.1097/01.AOG.0000245784.31082.ed.
Results Reference
background
PubMed Identifier
12066091
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. doi: 10.1067/mob.2002.123819.
Results Reference
background
PubMed Identifier
16647928
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. doi: 10.1016/j.ajog.2006.01.060.
Results Reference
background
PubMed Identifier
7240708
Citation
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.
Results Reference
background
PubMed Identifier
23597598
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.
Results Reference
background
PubMed Identifier
10487995
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. doi: 10.1136/bmj.319.7212.731.
Results Reference
background
PubMed Identifier
31008776
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.
Results Reference
derived
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Video Decision Aid in Latina Women With Pelvic Organ Prolapse
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