Video-Consent for Informed Decision-Making

Overseen By Maria del Mar Romero López, MD, MS, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Deaf, Blind, Unable to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether watching a video can help parents make better decisions about joining a study on Vitamin D for very premature babies. The goal is to determine if the video clarifies details and eases decision-making compared to discussions with the research team. Participants will either follow the usual consent process or watch a video explaining the study, with an opportunity to ask questions afterward. Parents of extremely premature infants (born before 28 weeks or weighing less than 1000 grams) in the NICU may be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could improve decision-making tools for parents in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this video-enhanced consent method is safe for improving decision-making?

Research has shown that using videos to explain medical studies is safe for participants. In previous studies, video-based consent tools helped people better understand and feel more confident about joining a study. People generally respond well to these videos, experiencing no negative effects from watching them.

Evidence of harm from using videos in the consent process is minimal. Most reports highlight how videos assist people in making better decisions about joining a study. These tools aim to clarify information and help people feel more comfortable with their choices.

Overall, using video for informed consent is considered safe. It provides people with the necessary information without any known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to the informed consent process using video technology. Unlike the traditional method where information is explained verbally and through written documents, this video-enhanced technique provides a consistent, engaging, and easily accessible way for participants to understand study details. This method also allows participants to review the information at their own pace, using a QR code to revisit the video as needed. By enhancing comprehension and convenience, this approach has the potential to improve decision-making and increase participant confidence in the consent process.

What evidence suggests that video-enhanced consent is effective for informed decision-making?

This trial will compare two approaches to informed consent: a usual care approach and a video-enhanced approach. Studies have shown that videos explaining medical studies improve understanding. Research indicates that participants who watch these videos often know more about study details than those who only read about them. One study found that people preferred video consent because it made the information clearer and more engaging. Videos allow viewers to pause and replay parts, helping them learn at their own pace. Overall, videos can aid in making informed decisions about joining a study. ^{1 6 7 8 9}

Who Is on the Research Team?

Maria del Mar Romero López, MD

Principal Investigator

The University of Texas Health Science Center at Houston (UTHealth Houston)

Are You a Good Fit for This Trial?

This trial is for parents of extremely preterm infants who are considering enrolling their child in the ViDES study, which looks at Vitamin D supplementation. Parents must be deciding on participation and able to give informed consent.

Inclusion Criteria

My extremely preterm infant is in the NICU and qualifies for the ViDES study.

Exclusion Criteria

My parent or legal guardian is deaf or blind.

My legal guardians cannot consent for me to join the ViDES study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Consent

Participants undergo either a usual care approach or a video-enhanced approach to consent, including watching an informational video and receiving a QR code for video access

1 day

1 visit (in-person)

Assessment

Participants' understanding, satisfaction, and opinions are assessed via questionnaires

Within 48 hours of the intervention

Follow-up

Participants are monitored for any additional feedback or questions post-consent

1 week

What Are the Treatments Tested in This Trial?

Interventions

• ViDEO explaining study

Trial Overview The trial compares two ways of getting consent: one uses a video to explain the study (video-enhanced consent), while the usual care group receives standard information without a video. The goal is to see if videos help parents make better decisions.

How Is the Trial Designed?

Group I: Video-enhanced approach to consent Experimental Treatment 1 Intervention

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.

Group II: Usual care approach to consent Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Patients who watched educational videos before their endoscopy reported significantly higher satisfaction regarding pre-procedural information compared to those who only received standard information leaflets, indicating that videos can enhance the consent process.

The use of educational videos also led to a significantly lower cancellation rate (4%) compared to the control group (20%), suggesting that these videos may improve patient engagement and commitment to the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Information Videos to Improve Patient Satisfaction in Endoscopy: A Prospective Service Improvement Project. Broder, E., Davies, A., Alrubaiy, L.[2022]

A pilot study involving 61 participants tested video clips embedded in mock-informed consent documents, showing that 78.7% preferred the video-assisted format over traditional paper consent.

While the videos significantly improved participants' perceived understanding of research procedures, comprehension scores did not differ significantly between the video and paper formats, indicating that while videos are helpful, further testing is needed for more complex protocols and individuals with lower literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a video-assisted informed consent process. Sonne, SC., Andrews, JO., Gentilin, SM., et al.[2021]

A multimedia informed consent video and website were developed over 15 months by a diverse team to improve comprehension of research procedures for parents and adolescents participating in an asthma clinical trial.

The video incorporates five cognitive strategies—Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization—to enhance understanding, suggesting that integrating cognitive principles into consent processes could lead to better comprehension and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive approach for design of a multimedia informed consent video and website in pediatric research. Antal, H., Bunnell, HT., McCahan, SM., et al.[2018]

In a study of 113 patients undergoing informed consent consultations for refractive excimer laser treatment, adding a video to the consultation did not change patient knowledge, satisfaction, or anxiety levels compared to traditional consultations.

However, the video-assisted consultations significantly reduced the total consultation time by nearly 5 minutes, suggesting that this method could improve efficiency without compromising patient understanding or comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of video-presented information about excimer laser treatment on ametropic patients' knowledge and satisfaction with the informed consent process. Baenninger, PB., Faes, L., Kaufmann, C., et al.[2019]

Patients who watched a videotape explaining the risks, benefits, and alternatives of ankle fracture surgery showed a 40.1% higher comprehension on an immediate questionnaire compared to those who received verbal information.

The videotape method was particularly beneficial for patients with lower educational levels, who scored 67.8% better on the initial questionnaire after watching the video, highlighting its effectiveness in improving understanding for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed consent for ankle fracture surgery: patient comprehension of verbal and videotaped information. Rossi, M., McClellan, R., Chou, L., et al.[2021]

The addition of a multimedia information resource to standard printed patient information did not significantly improve recruitment rates for a trial involving patients with mild COPD, with recruitment rates of 9.6% versus 10.8% for standard materials alone.

There was no observed impact on participant response rates or retention in the trial at 6 and 12 months, suggesting that simply providing multimedia resources may not enhance patient engagement or understanding in the context of clinical trial recruitment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled 'study within a trial' (SWAT) of a multimedia information resource. Jolly, K., Sidhu, M., Bower, P., et al.[2020]

Interactive elements in multimedia consent materials significantly enhance participants' understanding and confidence regarding biobank consent compared to traditional face-to-face methods, as shown in a study with 200 patients.

While both interactivity and multimedia improved understanding, only interactivity increased confidence in understanding, indicating that these two aspects should be considered separately in future research on electronic consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive multimedia consent for biobanking: a randomized trial. Simon, CM., Klein, DW., Schartz, HA.[2022]

Parents who received information about research risks and benefits in tables or pictographs had significantly better understanding compared to those who received standard text, indicating that visual formats can enhance comprehension.

This study, involving 408 parents of children undergoing elective surgery, highlights that using clear visual aids can improve understanding of complex information, especially for those with lower literacy and numeracy skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presenting research risks and benefits to parents: does format matter? Tait, AR., Voepel-Lewis, T., Zikmund-Fisher, BJ., et al.[2022]

Patients who received information about intravenous fluorescein angiography (IVFA) through a narrated white board animation (nWBA) scored higher on a knowledge quiz (84%) compared to those who received standard physician-patient interaction (73%), indicating better comprehension of the procedure.

A majority of participants (73%) preferred the nWBA method over the traditional consent process, suggesting that multimedia tools could enhance patient understanding and satisfaction in the informed consent process for medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing a narrated white board animation as part of the consent process for intravenous fluorescein angiography: a randomized educational study. Mednick, Z., Irrcher, I., Hopman, WM., et al.[2017]

In a study of 80 cataract surgery patients, those who received video assistance during the informed consent process reported significantly higher satisfaction (86% vs. 65%) and completed the consent process in less time (5.6 minutes vs. 12.3 minutes) compared to those who only received traditional verbal advisement.

Both groups demonstrated similar levels of comprehension regarding the consent information, indicating that the video did not negatively impact understanding, but rather enhanced the overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. Zhang, Y., Ruan, X., Tang, H., et al.[2022]

A study involving 2618 adults tested seven different consent methods for a low-risk comparative effectiveness research study, finding that all methods resulted in high understanding and positive attitudes towards the consent process.

Streamlined consent methods, particularly one that included a video, were as acceptable as traditional signed consent, achieving similar levels of understanding and respect in the doctor-patient interaction, although some participants mistakenly thought a signature was necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients' and public attitudes. Kass, NE., Faden, RR., Morain, SR., et al.[2022]

Citations

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Acceptability and effectiveness of a study information video ... The video consent method has the potential to enhance the informed consent process to becoming person-centred and context-sensitive and should ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12582470/

Video consent is preferred over written informed consent in ... The goal of this study was to determine the difference in participant understanding, satisfaction, timing and, preference between video ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06446492?term=AREA%5BBasicSearch%5D(study)&rank=10

Impact of Video-Enhanced Consent on Informed Decision ... This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0011384025000310

The effects of written versus video aids on informed ... The aim of this study was to compare the effectiveness of written and video patient decision aids in improving the informed consent process across different ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11289049/

Video consent significantly improves patient knowledge of ... Informed consent is essential in ensuring patients' understanding of their medical condition, treatment, and potential risks.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772572323001164

Improving the Consent Process With an Informed ... We conducted a quality improvement study to assess how a preprocedure consent video 2 days prior to an outpatient colonoscopy impacts patient satisfaction.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12225439/

Digitalizing informed consent in healthcare: a scoping review This scoping review explores the digitalization of the consent process, focusing on the types of technologies used, their role in the consent process, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480422007284

A Video-Based Consent Tool: Development and Effect of ... We sought to examine the impact of a high-quality video-based consent tool and the effect of risk–benefit framing on patient willingness to participate in a ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9942032/

Electronic informed consent: effects on enrolment, practical ... The purpose of this review is to investigate the effect of using e-IC on enrolment, practical and economic benefits, challenges, and drawbacks