Clinical trial NCT06192511: Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
Official title: Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implementation Science
Informed Consent
Neonatal Screening
Keywords: newborn screening
informed consent
biobanking
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-01-05
Enrollment: 5980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief 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.

Detailed 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 about the Michigan BioTrust.

A research staff member will approach patients and ask if they are willing to answer some surveys about the BioTrust consent process. After agreeing to answer the surveys, the researcher will provide them with a direct link to the research survey. If the participant does not have a phone or tablet with them, the research team member will provide a tablet upon which they can answer the questions on the survey.

All participating women or men will complete a survey 1) in the day following the BioTrust Consent and 2) at roughly 4 weeks later by email, text or telephone.

Hospital employees involved in the implementation will also answer surveys about potential sustainability immediately after completing training and again after several months of implementation.

Eligibility criteria: 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

Primary outcomes:
measure: Consent and biobanking knowledge scores
timeFrame: Administered immediately after the intervention and at 4 week follow-up
measure: Decisional regret
timeFrame: Administered at the 4-week follow-up
measure: Decisional Conflict
timeFrame: Administered immediately after the intervention and at 4 week follow-up
measure: Consenting rates
timeFrame: Obtained from the state 6 months after the end of data collection
measure: Biobanking rates
timeFrame: Obtained from the state 6 months after the end of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah, Department of Obstetrics & Gynecology
state: Utah
Study officials:
affiliation: University of Utah
name: Erin Rothwell, MD
role: PRINCIPAL_INVESTIGATOR
References: