Enhanced Consent and Preparedness for Surgery Trial

Not Applicable

Completed

• Conditions: Urge Incontinence; Pelvic Organ Prolapse; Stress Urinary Incontinence
• Interventions: Other: audiovisual decision aid

• Registration Number: NCT03988569
• Lead Sponsor: Loyola University

Brief 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.

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Study Start: 2019-07-01
• Primary Completion: 2023-12-20
• Study Completion: 2024-02-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 158

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	audiovisual decision aid	Will view audiovisual decision aid (AVDA) and then have opportunity for questions with physician before signing consent forms

Primary Outcome Measures

Name	Time	Method
Preparedness for surgery	Day 0	To compare the odds of higher agreement between patients assigned to receive enhanced audiovisual aided consent versus standard consent on the question "Overall, I feel prepared for my upcoming surgery". This item is asked on day of consent and patients respond using a six-point Likert scale ranging from 0 (Strongly disagree) to 5 (Strongly agree).

Trial Locations

Locations (1)

Loyola Medical Center; 🇺🇸 Maywood, Illinois, United States