Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Website and Video.
- Who it may be relevant to
- Registry conditions: Implementation Science, Informed Consent, Neonatal Screening. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
Overview
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.
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.
Primary outcome measures
- Consent and biobanking knowledge scores [Time frame: Administered immediately after the intervention and at 4 week follow-up]
- Decisional regret [Time frame: Administered at the 4-week follow-up]
- Decisional Conflict [Time frame: Administered immediately after the intervention and at 4 week follow-up]
- Consenting rates [Time frame: Obtained from the state 6 months after the end of data collection]
- Biobanking rates [Time frame: Obtained from the state 6 months after the end of data collection]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 2 centers
- University of Utah Hospital and Clinics — Salt Lake City
- University of Utah, Department of Obstetrics & Gynecology — Salt Lake City
Identifiers
NCT: NCT06192511 · 00153608