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Enhanced Consent and Preparedness for Surgery Trial

NCT03988569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence
  • Urge Incontinence
  • Pelvic Organ Prolapse

Interventions

OTHER

audiovisual decision aid

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

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Marian G Acevedo-Alvarez, MD · Loyola Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-12-20
Completion
2024-02-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988569 on ClinicalTrials.gov