Video-Assisted Informed Consent for Neonatal Lumbar Puncture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-11-15

Brief Summary

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The purpose of this study is to explore the effectiveness of video-assisted neonatal lumbar puncture consent processes against a conventional consent discussion to inform parents about pediatric lumbar puncture in the pediatric ED. We hypothesize that having a visual aid in addition to the verbal information presented in the consent process will lead to increased parent comprehension, decision-making, and satisfaction with the consent process. Furthermore, the findings from this study may have broader implications for improving the informed consent process for other medical procedures and interventions in pediatric settings.

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Detailed Description

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A neonatal lumbar puncture (LP), also known as a spinal tap, is a critical diagnostic procedure for detecting and managing serious infections such as meningitis in newborns. Ensuring that parents and caregivers fully understand the procedure, its risks, and its benefits is an essential aspect of the informed consent process. Traditionally, healthcare providers have relied on verbal and written methods to communicate this information to parents, aiming to facilitate comprehension and obtain consent for the procedure. However, there is growing evidence that these traditional methods may not always be sufficient in providing parents with a comprehensive understanding of the procedure, which could potentially impact the decision-making process and overall satisfaction with the care provided. After conventional consent discussions, parents are still often not aware of what the procedure will entail, the risks, how long the procedure will take, and what outcomes to expect. Language barriers can also contribute to misunderstandings during the consent process, even with the assistance of translation services.

Despite the importance of obtaining informed consent for neonatal LPs, there is a notable lack of research on the effectiveness of alternative methods for communicating this information, such as video-assisted consent. Video-based interventions have been shown to improve patient understanding and satisfaction in other medical contexts and may provide a more engaging and easily accessible means of conveying complex information related to the neonatal lumbar puncture procedure. Integrating video-assisted consent into the process could potentially enhance parent comprehension, decision-making, and satisfaction with the consent process.

The purpose of this study is to explore the effectiveness of video-assisted neonatal lumbar puncture consent processes against a conventional consent discussion to inform parents about pediatric lumbar puncture in the pediatric ED. We hypothesize that having a visual aid in addition to the verbal information presented in the consent process will lead to increased parent comprehension, decision-making, and satisfaction with the consent process. Furthermore, the findings from this study may have broader implications for improving the informed consent process for other medical procedures and interventions in pediatric settings.

A video-assisted informed consent intervention will be implemented in the Dell Children's Medical Center (DCMC) Emergency Department (ED). Parents whose children are recommended for LP will be randomly selected to receive either standard informed consent procedures or video-assisted informed consent. We plan to enroll 100 participants. The intervention group (n=50) will receive procedure information via a video and the control group (n=50) will receive standard procedure explanation. The 2-minute video (available in English or Spanish) will use animation to explain the neonatal LP procedure, benefits, and risks.

All participants will complete brief knowledge surveys after the intervention and will be asked to provide feedback on their satisfaction with the informed consent process. Pediatric emergency medicine physicians at Dell Children's collaborated to create the knowledge surveys using the Delphi method. The primary outcome to be assessed is the efficacy of the video intervention on parents' comprehension compared to the conventional discussion. Secondary outcomes will focus on parental satisfaction with the informed consent process and the rate of consent refusal.

Conditions

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Lumbar Puncture Pediatrics Emergency Department Patient Informed Consent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Video assisted consent

The intervention group (n=50) will receive procedure information via a video explanation. The 2-minute video (available in English or Spanish) will use animation to explain the neonatal LP procedure, benefits, and risks.

Group Type EXPERIMENTAL

Video assisted informed consent

Intervention Type OTHER

The 2-minute video (available in English or Spanish) will use animation to explain the neonatal LP procedure, benefits, and risks.

Standard consent

The control group (n=50) will receive standard procedure explanation.

Group Type ACTIVE_COMPARATOR

Standard consent

Intervention Type OTHER

The standard consent group will receive usual procedure description and consent.

Interventions

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