RecruitingNot ApplicableNCT06192511

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients


Sponsor

Erin Rothwell

Enrollment

5,980 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria3

  • 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

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Interventions

BEHAVIORALEducational 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.


Locations(2)

University of Utah Hospital and Clinics

Salt Lake City, Utah, United States

University of Utah, Department of Obstetrics & Gynecology

Salt Lake City, Utah, United States

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NCT06192511


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