Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
Erin Rothwell
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.
Description
The research team will compare a prospective observational control group enrolled during pre-implementation data collection within a hospital (n=2,990) to the implemented consent process group enrolled at the same hospital after implementation (2,990). Implementation will consist of hospital staff providing patients with access to a website with detailed written descriptions and a video about the Michigan BioTrust. The current standard of care, that will be maintained in addition to the new website, involves providing the patient with a brochure and descriptive information from hospital staff…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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
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 ClinicsSalt Lake City, Utah
- University of Utah, Department of Obstetrics & GynecologySalt Lake City, Utah