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NCT03988569 · ClinicalTrials.gov registry record · NA

Enhanced Consent and Preparedness for Surgery Trial

A NA study, sponsored by Loyola University.

Completed
Registry status
NA
Development phase
158
Enrollment target

NCT03988569: Completed NA study, sponsored by Loyola University.

NCT03988569 is a NA study that has completed, run by Loyola University. The registered enrollment target is 158 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03988569, a NA study, has completed, sponsored by Loyola University.

COMPLETED
Registry status
NA
Development phase
158 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • OTHER audiovisual decision aid

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2019-07-01
Est. Completion 2024-02-22
Phase NA
Loyola University

92 total trials

What the finished NCT03988569 record still lists

NCT03988569 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 1 intervention - of which audiovisual decision aid is the first listed.

NCT03988569 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03988569 about?

NCT03988569 is a clinical study titled "Enhanced Consent and Preparedness for Surgery 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. Additiona...

What is the current status of trial NCT03988569?

This trial is currently completed. It is a NA study. The enrollment target is 158 participants. The study started on 2019-07-01. Estimated completion is 2024-02-22.

What interventions are being tested in trial NCT03988569?

The interventions under investigation include: audiovisual decision aid (OTHER).

Who is sponsoring clinical trial NCT03988569?

This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03988569's enrollment target sits among peer trials

158 654th of 2000 higher than 1,345 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03988569, the US trial registry maintained by the National Library of Medicine. NCT03988569 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.