Educational Tools for Neonatal Screening Consent

(MICI Trial)

Recruiting at 2 trial locations

Overseen By Erin Johnson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erin Rothwell

Disqualifiers: Pre-term birth, NICU, adoption, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

5980 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help new mothers understand and consent to the use of leftover blood samples from their babies for research, known as the Michigan BioTrust. The study compares current education methods—a brief talk and brochure—with a new electronic format that includes an educational website and video. The goal is to determine if the new tools make the consent process clearer and more effective for both mothers and hospital staff. Women who have just given birth and speak English, Spanish, or Arabic may qualify if they are still in the Mother & Baby Unit and their newborn is not in intensive care or up for adoption. As an unphased trial, this study offers participants the opportunity to contribute to improving consent processes for future parents.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this electronic consent education process is safe for neonatal screening consent?

Research has shown that educational tools like websites and videos for informed consent are safe and effective. One study tested a process called dynamic consent with an educational website and found it helped participants understand their choices without harm. Another project used a video to explain newborn screening and found it improved knowledge without negative effects.

These educational tools are simple and easy to use. They provide clear information to help people make informed decisions, focusing on improving understanding rather than causing stress or confusion. Overall, the tools have been well-received, with no reports of negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how digital tools can enhance understanding and consent in neonatal screening. Unlike the standard approach, which includes a brief verbal explanation and a brochure, the new method offers an engaging website and a concise video. These digital resources aim to provide more comprehensive and accessible information, potentially leading to better-informed decision-making by parents. By presenting information in multiple languages and through different media, the trial hopes to determine if these tools improve comprehension and satisfaction with the consent process.

What evidence suggests that this educational process is effective for neonatal screening consent?

Research has shown that tools like videos and websites can clarify and engage patients in the consent process. In this trial, participants in the intervention arm will receive standard care along with access to an educational website and a 4-minute video about the Michigan BioTrust. One study found that using a video improved understanding of the process without reducing support for newborn screening. Another study discovered that electronic consent tools help people make informed decisions about using leftover blood samples for research. These tools simplify complex information, making it easier to understand and remember. Overall, educational videos and websites show promise in improving how consent is obtained and understood. ^{1 2 4 6 7}

Who Is on the Research Team?

Erin Rothwell, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English, Spanish or Arabic and have just given birth at one of the four participating hospitals in Michigan. They should be patients in the Mother & Baby Unit and willing to provide feedback on a new consent process for using leftover blood samples from newborn screening.

Inclusion Criteria

I am over 18 years old.

Just gave birth and currently a patient in the Mother & Baby Unit in the hospital

Exclusion Criteria

Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth

Parents of infants who are born pre-term (< 37 weeks gestation)

Parents of infants in the Neonatal Intensive Care Unit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-implementation Data Collection

Participants complete surveys about the BioTrust consent process before the new education process is implemented

1 day

1 visit (in-person)

Implementation and Intervention

Hospital staff provide access to a website with detailed information and a video about the Michigan BioTrust; participants complete surveys immediately after

1 day

1 visit (in-person)

Follow-up

Participants are monitored for decisional regret, decisional conflict, and knowledge scores at 4 weeks post-intervention

4 weeks

1 visit (virtual)

Post-implementation Data Collection

Hospital consenting and biobanking rates are obtained from state data 6 months after the end of data collection

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Website and Video

Trial Overview The study is testing an electronic consent education tool that includes an educational website and video. It aims to improve how parents understand and agree to allow their newborn's residual dried bloodspots to be used for research after screening tests.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention group will receive standard of care in addition to the opportunity to access a website with engaging information about the Michigan BioTrust and a 4-minute video. Materials will be provided in English, Spanish, or Arabic.

Group II: Standard of Care Active Control 1 Intervention

Standard education provided about the Michigan BioTrust includes a brief verbal description from hospital staff and a brochure. Materials will be provided in English, Spanish, or Arabic.

Who Is Running the Clinical Trial?

Erin Rothwell

Lead Sponsor

Trials

2

Recruited

7,100+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A randomized controlled trial in three Michigan hospitals showed that using video and interactive tablet app consent processes resulted in higher knowledge and satisfaction scores compared to standard brochure-based consent for bloodspot research from newborn screening.

The study highlights the need for further research to determine the optimal amount of information necessary for informed consent and to explore effective implementation strategies for these consent methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial. Rothwell, E., Johnson, E., Wong, B., et al.[2021]

A 20-minute video intervention significantly improved parental understanding of informed consent for pediatric leukemia clinical trials, with 92% of parents finding it helpful in understanding information from their child's physician.

Parents who viewed the video asked more questions during informed consent conferences compared to a historical control group, indicating that the intervention may enhance parental engagement and communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility trial of a video intervention to improve informed consent for parents of children with leukemia. Hazen, RA., Eder, M., Drotar, D., et al.[2021]

The introduction of a two-stage written consent process for newborn screening in Victoria allowed parents to separately consent to screening and the secondary use of samples for research, enhancing transparency and parental choice.

Despite a slight increase in refusals for screening, overall participation remained above 99%, indicating that informed consent can be implemented without negatively impacting the uptake of newborn screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of written consent for newborn screening in Victoria, Australia. Charles, T., Pitt, J., Halliday, J., et al.[2019]

A systematic review of 35 studies involving 13,281 participants found that electronic consent (eConsent) significantly improved patient comprehension, acceptability, and usability of the consenting process compared to traditional paper-based methods.

While eConsent resulted in longer cycle times, indicating greater patient engagement, it also suggested a potential reduction in administrative workload for site staff, highlighting its efficiency in addressing data quality concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of eConsent: Systematic Review. Cohen, E., Byrom, B., Becher, A., et al.[2023]

A quality-improvement initiative successfully increased parental consent for students aged 13 to 18+ to access a school-based health clinic, raising the consent rate from 35% to 72% through various strategies.

The initiative highlighted the challenges in obtaining consent but emphasized the importance of improving students' access to essential health-care services, particularly in a Hispanic immigrant community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Parent Consent for School-Based Primary and Reproductive Health Care Among Vulnerable Youth. Smith, PB., Abacan, AA., Chacko, MR.[2021]

Informed parental consent is crucial in neonatal care, emphasizing respect for parental autonomy and involving key elements like information sharing, understanding assessment, and the freedom to choose.

Challenges in obtaining consent during the newborn period include parental distress and competence, particularly in special cases like emergency treatments, screening, and decisions about intensive care, highlighting the need for consistent training and practices across European neonatal units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good practice in consent. Cooke, RW.[2016]

A study involving interviews with 68 stakeholders (32 parents, 19 healthcare professionals, and 17 policy makers) revealed that consent-related terminology in newborn bloodspot screening is understood differently among groups, which can impact decision-making and information sharing.

To improve the consent process, the study suggests that clear, descriptive explanations of consent procedures are necessary, along with support systems to educate parents and assist healthcare professionals in effectively communicating information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is in a Name? Parent, Professional and Policy-Maker Conceptions of Consent-Related Language in the Context of Newborn Screening. Nicholls, SG., Etchegary, H., Tessier, L., 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]

In a study involving 142 trauma patients, those who received video-assisted informed consent had significantly higher knowledge scores (72.57) compared to those who read a document (61.67), indicating that video education enhances understanding of surgical procedures.

Patients who watched the educational video also reported greater satisfaction with the informed consent process, suggesting that this method not only improves comprehension but also positively impacts patient experience in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial. Lin, YK., Chen, CW., Lee, WC., et al.[2019]

A quality improvement initiative at a pediatric medical center successfully increased the accuracy of informed surgical consents, with safety errors decreasing from 95.4% to 99.7% over a year, indicating enhanced communication and safety protocols.

The initiative involved reviewing 54,082 consent forms and implementing strategies like education and real-time feedback, demonstrating that systematic safety checks can effectively prevent errors in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using improvement science methods to increase accuracy of surgical consents. Mercurio, P., Shaffer Ellis, A., Schoettker, PJ., et al.[2014]

A video and app were developed to help obtain consent for using newborn blood spots for biobanking, which is important for future research on treatable diseases.

Focus groups revealed that participants preferred the video format and were generally unaware that their newborn's blood spots could be used for research, highlighting the need for better information on the use of biospecimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations. Frost, CJ., Johnson, EP., Witte, B., et al.[2021]

The use of an interactive multimedia educational platform (EngagedMD) significantly improved patient comprehension during the initiation of ovulation induction-intrauterine insemination (OI-IUI) and in vitro fertilization (IVF) treatments, particularly for IVF patients, who maintained higher comprehension scores throughout their treatment cycle.

Despite the enhanced understanding provided by the multimedia platform, it did not significantly reduce anxiety levels in patients undergoing fertility treatments, indicating that while education is beneficial, additional psychological support may be needed for younger patients, especially those undergoing IVF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of an interactive multimedia educational platform on patient comprehension and anxiety during fertility treatment: a randomized controlled trial. Bernard, AL., Barbour, AK., Meernik, C., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-implementation-science-2024-6fb05

Educational Tools for Neonatal Screening Consent What data supports the effectiveness of the treatment Educational Website and Video, Electronic Consent Education Process, Michigan BioTrust Consent Process?

2. michigan.gov michigan.gov/mdhhs/adult-child-serv/childrenfamilies/hereditary/biotrust/michigan-biotrust-for-health-consent-options

Michigan BioTrust for Health - Consent Options This form allows parents to choose if their child's left-over blood spots can be used in medical and public health research studies.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7486234/

Comparison of Video, App and Standard Consent ... Results demonstrated efficacy and acceptability of using an educational video ... consent process, and did not negatively impact support for the newborn screening ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06192511?intr=%22informed%20consent%22&aggFilters=status:not%20rec&rank=6

Implementing a Novel Consent Process for Biospecimen ... The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03141307

The Effect of Electronic Informed Consent Information (EICI ... A state-of-the-art electronic informed consent information (EICI) tool for use in the clinical setting about the retention and use of residual biospecimens.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4289420/

Testing an Online, Dynamic Consent Portal for Large ... We created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing the DBS.

7. mdpi.com mdpi.com/2409-515X/8/2/34

Use of Online Newborn Screening Educational Resources ... This video is an animated road map of the newborn screening process ... Consent Decisions and Knowledge of the Michigan BioTrust, 2012–2015.