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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment ViDEO explaining study?

Research shows that using videos in the consent process can improve patient satisfaction and reduce the time needed to complete the consent process, as seen in studies involving cataract surgery and endoscopy. These findings suggest that video-consent can make the decision-making process clearer and more efficient for patients. ^{1 2 3 4 5}

Is the video-consent process safe for participants?

The research on video-consent processes focuses on improving understanding of study procedures, and there is no indication of safety concerns for participants using this method. ^{6 7 8 9 10}

How does the Video-Consent treatment differ from other consent processes?

The Video-Consent treatment uses video clips to explain research procedures, making the consent process easier to understand compared to traditional paper-based methods. This approach is unique because it incorporates multimedia elements to enhance participant comprehension and engagement. ^{4 6 7 8 11}

Research Team

Maria del Mar Romero López, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Using Information Videos to Improve Patient Satisfaction in Endoscopy: A Prospective Service Improvement Project. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Informed consent for ankle fracture surgery: patient comprehension of verbal and videotaped information. [2021]

4. England 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. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a video-assisted informed consent process. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Interactive multimedia consent for biobanking: a randomized trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A cognitive approach for design of a multimedia informed consent video and website in pediatric research. [2018]

9. England 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Presenting research risks and benefits to parents: does format matter? [2022]

11. England 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. [2020]