What this study is
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.
What's being tested
- Educational Website and Video
Intervention · 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
- Official title
- Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
- Sponsor
- Erin Rothwell
- Conditions
- Implementation Science · Informed Consent · Neonatal Screening
- Enrolling
- 5,980 people
- Starts
- 2024-05-15
- Est. completion
- 2028-04-30
- Design
- Open-label, non-randomized, sequential groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Adult (> 18 years)
- English, Spanish or Arabic speaking
- Just gave birth and currently a patient in the Mother & Baby Unit in the hospital
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openContact for every open site
- Erin Rothwell, MD · Principal investigator
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
- Erin Johnson, PhD · Contact801-587-0975erin.p.johnson@hsc.utah.edu
RecruitingUniversity of Utah, Department of Obstetrics & Gynecology
Salt Lake City, Utah, United States
- Erin Johnson, PhD · Contacterin.p.johnson@hsc.utah.edu
Recruiting
Study team
Sponsor
Erin Rothwell
Study ID 00153608
Principal investigator
Erin Rothwell, MD
University of Utah
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.