Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Implementation Science Clinical Trial

— MICI  

Official title:

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192511
• Other study ID #: 00153608
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: January 30, 2028

Study information

• Verified date: June 2024
• Source: University of Utah
• Contact: Erin Johnson, PhD
• Phone: 801-587-8578
• Email: erin.p.johnson[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5980
• Est. completion date: January 30, 2028
• Est. primary completion date: June 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implementation Science
• Informed Consent
• Neonatal Screening

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	University of Utah, Department of Obstetrics & Gynecology	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Erin Rothwell	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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