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RECRUITING
NCT06192511
NA

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Sponsor: Erin Rothwell

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5980

Start Date

2024-05-15

Completion Date

2028-04-30

Last Updated

2025-06-19

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

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