Enhanced Consent and Preparedness for Surgery Trial

NCT03988569 | Completed

• 1 other identifier: 212237
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Urge Incontinence; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Preparedness for surgery

  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).

  Day 0

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: audiovisual decision aid

Control Group

NO INTERVENTION

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

Interventions

audiovisual decision aid OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients ≤ 18 years old
• Non-English speaking patients
• Patients with video or audio impairments who are unable to view the AVDA

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (4)

• Vos IML, Schermer MHN, Bolt ILLE. Recent insights into decision-making and their implications for informed consent. J Med Ethics. 2018 Nov;44(11):734-738. doi: 10.1136/medethics-2018-104884. Epub 2018 Jul 21.

  PMID: 30032106 BACKGROUND

• Weiss BD, Blanchard JS, McGee DL, Hart G, Warren B, Burgoon M, Smith KJ. Illiteracy among Medicaid recipients and its relationship to health care costs. J Health Care Poor Underserved. 1994;5(2):99-111. doi: 10.1353/hpu.2010.0272.

  PMID: 8043732 BACKGROUND

• Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/

  PMID: 25009856 BACKGROUND

• Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999 Sep;38(1):33-42. doi: 10.1016/s0738-3991(98)00116-5.

  PMID: 14528569 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Marian G Acevedo-Alvarez, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 17, 2019
• Study Start: July 1, 2019
• Primary Completion: December 20, 2023
• Study Completion: February 22, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)