Effect of Standardized Consent for Urogynecological Procedures on Patient Satisfaction
Completed · Not applicable
Conditions studied: Urinary Incontinence, Pelvic Organ Prolapse
In brief
The investigators aim is to augment the current process for surgical consent for patients undergoing urogynecological procedures by incorporating visual media. We propose that visual media will be an effective and efficient addition to the standard of care in urogynecological consents and will improve patient understanding and satisfaction. Our randomized controlled trial will investigate the effect of standardizing the consent for three urogynecologic procedures (vaginal hysterectomy, robotic sacrocolpopexy, and sub-urethral sling) using visual media, on patients' understanding of, and satisfaction with, their procedure. Our primary outcome will be patient's knowledge score at the end of the pre-operative clinic visit, and secondary outcomes include patients' satisfaction, subjective understanding of their procedure, immediate pre-operative and post-operative knowledge, and number of post-operative encounters. Participants will be followed up to their post-operative clinic visit.
Key facts
- Study ID
- NCT02313701
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 64
- Starts
- 2014-12-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2018-12-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Undergoing vaginal hysterectomy, robotic sacrocolpopexy, or sub-urethral sling
- English speaking
- Written, informed consent
You may not qualify if…
- None
Where it is running
- BIDMC — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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