Enhanced Consent and Preparedness for Surgery Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhanced Consent and Preparedness for Surgery (ECAPS) Trial

Conditions
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Stress Urinary Incontinence, Urge Incontinence, Pelvic Organ Prolapse

Intervention / Treatment
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* Other: audiovisual decision aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the proposed study is to test the null hypothesis that there is no difference in surgical preparedness between women who receive a standard surgical consent for pelvic reconstructive surgery (control) and those who receive a standard surgical consent that is enhanced with an audiovisual decision aid (treatment) for the same surgery. Equivalently, the null hypothesis is that the odds ratio is 1.00.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Will view audiovisual decision aid (AVDA) and then have opportunity for questions with physician before signing consent forms | Other: audiovisual decision aid<br>* Will view AVDA and then have opportunity for questions with physician before signing consent forms<br>|
| No Intervention: Control Group<br>Will undergo standard verbal informed consent with physician before signing consent forms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparedness for surgery | 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). | Day 0 |