Enhanced Consent and Preparedness for Surgery Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2024-02-22

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.

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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.

Conditions

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Stress Urinary Incontinence Urge Incontinence Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

audiovisual decision aid

Intervention Type OTHER

Will view AVDA and then have opportunity for questions with physician before signing consent forms

Control Group

Will undergo standard verbal informed consent with physician before signing consent forms

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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audiovisual decision aid

Will view AVDA and then have opportunity for questions with physician before signing consent forms

Intervention Type OTHER

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.