Enhanced Consent and Preparedness for Surgery (ECAPS) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- Loyola University
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Preparedness for surgery
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Marian G. Acevedo Alvarez
Assistant Professor
Loyola University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Preparedness for surgery
Time Frame: 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).