Educational Tools for Neonatal Screening Consent

(MICI Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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 hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.

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 data supports the effectiveness of the treatment Educational Website and Video, Electronic Consent Education Process, Michigan BioTrust Consent Process?

Research shows that using educational videos and interactive multimedia can improve understanding and confidence in informed consent processes, as seen in studies involving trauma surgery and biobanking. These methods help people better understand the information they need to make informed decisions. ^{1 2 3 4 5}

Is the educational tool for neonatal screening consent safe for use in humans?

The studies reviewed focus on improving understanding and satisfaction with consent processes using videos and electronic tools, but they do not report any safety concerns related to these educational methods. ^{5 6 7 8 9}

How does the treatment in the 'Educational Tools for Neonatal Screening Consent' trial differ from other treatments for neonatal screening consent?

This treatment is unique because it uses video and interactive app tools to improve informed consent for neonatal screening, which enhances understanding and satisfaction compared to traditional brochure-based methods. ^{6 8 10 11 12}

Research Team

Erin Rothwell, MD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

I am over 18 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

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]

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 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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Enhancing Parent Consent for School-Based Primary and Reproductive Health Care Among Vulnerable Youth. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial. [2019]

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

Using improvement science methods to increase accuracy of surgical consents. [2014]

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

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

6. England 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. [2020]

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

A feasibility trial of a video intervention to improve informed consent for parents of children with leukemia. [2021]

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

Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of eConsent: Systematic Review. [2023]

10. Australia pubmed.ncbi.nlm.nih.gov

Implementation of written consent for newborn screening in Victoria, Australia. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Good practice in consent. [2016]

12. Germany pubmed.ncbi.nlm.nih.gov

Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations. [2021]