Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5980 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Implementation Science Informed Consent Neonatal Screening

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Standard of Care

Standard education provided about the Michigan BioTrust includes a brief verbal description from hospital staff and a brochure. Materials will be provided in English, Spanish, or Arabic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

The intervention group will receive standard of care in addition to the opportunity to access a website with engaging information about the Michigan BioTrust and a 4-minute video. Materials will be provided in English, Spanish, or Arabic.

Group Type EXPERIMENTAL

Educational Website and Video

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes