NCT03988569

Enhanced Consent and Preparedness for Surgery Trial

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT03988569

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Enhanced Consent and Preparedness for Surgery (ECAPS) Trial

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.

Eligibility

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

Disease(s) and\or Condition(s)

Stress Urinary Incontinence

Urge Incontinence

Pelvic Organ Prolapse

Primary Purpose

HEALTH_SERVICES_RESEARCH

Intervention/Treatment

- Type: OTHER
- Name: audiovisual decision aid
- Description: Will view AVDA and then have opportunity for questions with physician before signing consent forms
- Arm Group Labels: Intervention Group

Sponsor

Loyola University