Recruiting

Observational Study

Sponsor:

Erin Rothwell

Code:

NCT06192511

Conditions

Implementation Science

Informed Consent

Neonatal Screening

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational Website and Video

Study Details

Brief summary:

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.

Conditions

Implementation Science

Informed Consent

Neonatal Screening

Study ID

NCT06192511

Start date

May 15, 2024

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult (> 18 years)
  • English, Spanish or Arabic speaking
  • Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital

Exclusion Criteria:

  • Parents of infants who are born pre-term (< 37 weeks gestation)
  • Parents of infants in the Neonatal Intensive Care Unit
  • Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth

Study Design

Enrollment

5980 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

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.

experimental: 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.

Interventions

Educational Website and Video

The website offers users the opportunity to choose to watch a 4-minute video or read relevant information about Newborn Screening and the Michigan BioTrust. If they choose to read, the website is designed to present information in an engaging manner, while providing optional voiceover. The video uses a mixture of live action shots and animation, all with voiceover. All materials are available in English, Spanish and Arabic.

Primary outcome measure

  • Consent and biobanking knowledge scores [ Time Frame: Administered immediately after the intervention and at 4 week follow-up ]
  • Decisional regret [ Time Frame: Administered at the 4-week follow-up ]
  • Decisional Conflict [ Time Frame: Administered immediately after the intervention and at 4 week follow-up ]
  • Consenting rates [ Time Frame: Obtained from the state 6 months after the end of data collection ]
  • Biobanking rates [ Time Frame: Obtained from the state 6 months after the end of data collection ]

Central Contacts and Locations

Locations

University of Utah Hospital and Clinics

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Erin Rothwell, MD

University of Utah, Department of Obstetrics & Gynecology

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Erin Rothwell, M.D.

More Information

Sponsor

Erin Rothwell

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • newborn screening
  • informed consent
  • biobanking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Erin Rothwell on 2026-07-31.