NCT03988569

Enhanced Consent and Preparedness for Surgery Trial

Enhanced Consent and Preparedness for Surgery (ECAPS) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

To address the limitations of consent, interventions have been developed to improve the quality of information provided to patients including written pamphlets, videos, and websites. Such interventions have been called decision aids. Decision aids may promote informed consent through greater knowledge and consistency of personal values or attitudes with an enacted choice. Providing adequate information increases satisfaction, more rapid symptom resolution, reduced emotional distress, reduced use of analgesia, and possibly shorter hospital admissions. Cochrane reviews have established that audiovisual decision aids enhance informed surgical consent, yet little data exists about the benefits of such aids in Female Pelvic Medicine and Reconstructive Surgery (FPMRS)4.

Conditions

• Stress Urinary Incontinence
• Urge Incontinence
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	audiovisual decision aid	Will view AVDA and then have opportunity for questions with physician before signing consent forms

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-12-20
• Completion: 2024-02-22
• First posted: 2019-06-17
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States