Enhanced Consent and Preparedness for Surgery Trial

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence, Urge Incontinence, Pelvic Organ Prolapse

In brief

To develop an audiovisual decision aid (AVDA) to improve the informed consent process. The investigators aim to examine the impact of a comprehensible AVDA that is written below the 8th grade reading level. The AVDA would be used for surgical consent compared to traditional verbal consent. Additionally, the investigators plan to determine whether this effect varies across the measured levels of health literacy of our patients.

Key facts

Study ID

NCT03988569

Run by

Loyola University

People needed

158

Starts

2019-07-01

Expected to finish

2024-02-22

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients electing for surgical intervention of pelvic organ prolapse, stress urinary incontinence, urgency urinary incontinence by treating physicians in the Female Pelvic Medicine \& Reconstructive Surgery.

You may not qualify if…

• Patients ≤ 18 years old
• Non-English speaking patients
• Patients with video or audio impairments who are unable to view the AVDA

Where it is running

• Loyola Medical Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.