Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study

The University of Texas System (UT)

Status: Completed

Conditions: Understanding of Consent in Clinical Research; Implementation of Video-Consent in Clinical Research

Treatments: Other: ViDEO explaining study; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06446492

HSC-MS-22-0563 (sub-study)

Details and patient eligibility

About

This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the ViDES study, which investigates the effectiveness of Vitamin D supplementation in extremely preterm infants (the ViDES study is separately registered as NCT05459298).

Enrollment: 83 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parents/legal guardians of extremely preterm infants (<28 weeks gestational age or <1000 g birth weight) admitted to the Neonatal Intensive Care Unit at Children's Memorial Hermann hospital that qualify for the ViDES study (ViDES study is separately registered as NCT05459298)

Exclusion criteria

• Parents/legal guardians deaf or blind
• Parents/legal guardians unable to consent for the VIDES study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Video-enhanced approach to consent

Experimental group

Description:

The research team will introduce themselves and ask the parents to watch an informational video explaining the ViDES study on an iPad while they stay in the room with the parents. After viewing the video, the team will answer any questions and provide written consent and enough time to decide whether to participate in the study. The research team will also provide a QR code that grants parents/guardians access to the video on their own device at any time. This allows them to pause, rewind, and revisit the information.

Treatment:

Other: ViDEO explaining study

Usual care approach to consent

Active Comparator group

Description:

The research team will present a detailed explanation of the ViDES study, answer questions, provide written consent, and provide enough time to decide on participation or not in the study.

Treatment:

Other: Usual Care