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Enhanced Consent and Preparedness for Surgery Trial (ECAPS)

Primary Purpose

Stress Urinary Incontinence, Urge Incontinence, Pelvic Organ Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
audiovisual decision aid
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Loyola Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 3, 2019
Last Updated
January 6, 2023
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT03988569
Brief Title
Enhanced Consent and Preparedness for Surgery Trial
Acronym
ECAPS
Official Title
Enhanced Consent and Preparedness for Surgery (ECAPS) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Urge Incontinence, Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Will view audiovisual decision aid (AVDA) and then have opportunity for questions with physician before signing consent forms
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Will undergo standard verbal informed consent with physician before signing consent forms
Intervention Type
Other
Intervention Name(s)
audiovisual decision aid
Intervention Description
Will view AVDA and then have opportunity for questions with physician before signing consent forms
Primary Outcome Measure Information:
Title
Preparedness for surgery
Description
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).
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Tulke, RN
Phone
708-216-2016
Email
mtulke@luc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marian G Acevedo-Alvarez, MD
Phone
708-216-2170
Email
Marian.AcevedoAlvarez@lumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian G Acevedo-Alvarez, MD
Organizational Affiliation
Loyola Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30032106
Citation
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.
Results Reference
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PubMed Identifier
8043732
Citation
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.
Results Reference
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PubMed Identifier
25009856
Citation
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/
Results Reference
background
PubMed Identifier
14528569
Citation
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.
Results Reference
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Enhanced Consent and Preparedness for Surgery Trial

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