Enhanced Consent and Preparedness for Surgery Trial (ECAPS)

Enhanced Consent and Preparedness for Surgery (ECAPS) Trial

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence; Urge Incontinence
• Intervention / Treatment: Other: audiovisual decision aid

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Tulke, RN; Phone Number: 708-216-2016; Email: mtulke@luc.edu
• Study Contact Backup: Name: Marian G Acevedo-Alvarez, MD; Phone Number: 708-216-2170; Email: Marian.AcevedoAlvarez@lumc.edu

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Will view audiovisual decision aid (AVDA) and then have opportunity for questions with physician before signing consent forms	Other: audiovisual decision aid; Will view AVDA and then have opportunity for questions with physician before signing consent forms
No Intervention: Control Group; Will undergo standard verbal informed consent with physician before signing consent forms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loyola University
• Investigators: Principal Investigator: Marian G Acevedo-Alvarez, MD, Loyola Medical Center

Publications and helpful links

General Publications

• 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/
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Other Study ID Numbers: 212237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No