Pelvic Organ Prolapse, Stress Urinary Incontinence, Urge Incontinence
Conditions
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.
Interventions
OTHERaudiovisual decision aid
Will view AVDA and then have opportunity for questions with physician before signing consent forms
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed