Enhanced Consent and Preparedness for Surgery Trial (ECAPS)

Loyola University

Status: Completed

Conditions: Stress Urinary Incontinence; Pelvic Organ Prolapse; Urge Incontinence

Treatments: Other: audiovisual decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT03988569

212237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Other: audiovisual decision aid

Control Group

No Intervention group

Description:

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