Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Erin Rothwell
Study ID
NCT06192511
Status
Recruiting
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Conditions

  • Implementation Science
  • Informed Consent
  • Neonatal Screening

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Educational Website and Video — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Jun 2025
Primary completion
Nov 15, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
5,980 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

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.

Primary Outcome Measure

Consent and biobanking knowledge scores [ Time Frame: Administered immediately after the intervention and at 4 week follow-up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Utah Hospital and ClinicsSalt Lake CityUtah84132
Erin Johnson, PhD
[email protected]
801-587-0975
Erin Rothwell, MD (PRINCIPAL_INVESTIGATOR)
University of Utah, Department of Obstetrics & GynecologySalt Lake CityUtah84132
Erin Johnson, PhD
[email protected]
Erin Rothwell, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Utah Hospital and Clinics· Salt Lake City, UTUniversity of Utah, Department of Obstetrics & Gynecology· Salt Lake City, UT

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