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NCT03988569 Clinical Trial

Enhanced Consent and Preparedness for Surgery Trial

Pelvic Organ Prolapse Clinical Trial

— ECAPS  

Official title:
Enhanced Consent and Preparedness for Surgery (ECAPS) Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03988569
Other study ID # 212237
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date February 22, 2024

Study information
Verified date March 2024
Source Loyola University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 158
Est. completion date February 22, 2024
Est. primary completion date December 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• audiovisual decision aid
Will view AVDA and then have opportunity for questions with physician before signing consent forms

Locations
Country Name City State
United States Loyola Medical Center Maywood Illinois

Sponsors (1)
Lead Sponsor Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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/ — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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