Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT03988569
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2019-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Consent and Preparedness for Surgery Trial
Sponsor:
Loyola University
Organization:
Study Overview
Official Title:
Enhanced Consent and Preparedness for Surgery (ECAPS) Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECAPS
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: