Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

NCT06192511 | Recruiting

• 1 other identifier: 00153608
• Study Type: interventional
• Target: 5,980
• Locations: 1 country
• Sites: 2

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.

Conditions

Implementation Science; Informed Consent; Neonatal Screening

Keywords

newborn screening; informed consent; biobanking

Outcome Measures

Primary Outcomes (5)

• Consent and biobanking knowledge scores

  Knowledge will be measured with with 23 questions specific to the setting of NIPS testing, and including the multidimensional measure of informed choice (MMIC). Scored will range from 0 (no knowledge) to 23 (extremely high knowledge)

  Administered immediately after the intervention and at 4 week follow-up

• Decisional regret

  The Residual Decisional Regret measure assesses a person's feelings of regret after making a decision. Scores range from 1 to 5 with lower scores indicating better outcomes

  Administered at the 4-week follow-up

• Decisional Conflict

  The Decisional Conflict survey will determine participant uncertainty in the decision process. DCS score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

  Administered immediately after the intervention and at 4 week follow-up

• Consenting rates

  From the state the research team will obtain whole hospital consenting rates (people who make a decision, whether it's yes or no) for the 6-month time period before and after the Implementation

  Obtained from the state 6 months after the end of data collection

• Biobanking rates

  The research team will summarize the percentage who opt to participate in biobanking before and after implementation using state level data

  Obtained from the state 6 months after the end of data collection

Study Arms (2)

Standard of Care

NO INTERVENTION

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

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.

Behavioral: Educational Website and Video

Interventions

Educational Website and Video 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\> 18 years)
• English, Spanish or Arabic speaking
• Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Erin Rothwell: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Utah, Department of Obstetrics & Gynecology

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Erin Rothwell, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Johnson, PhD

CONTACT

801-587-8578; erin.p.johnson@hsc.utah.edu

Valerie Joseph

CONTACT

801-587-2249; valerie.joseph@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 5, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)