Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening (MICI)

Erin Rothwell

Status: Enrolling

Conditions: Implementation Science; Informed Consent; Neonatal Screening

Treatments: Behavioral: Educational Website and Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06192511

00153608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,980 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5,980 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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.

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Educational Website and Video