NCT Number: NCT06192511
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of Utah Hospital and Clinics, Salt Lake City, Utah, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Administered immediately after the intervention and at 4 week follow-up
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)
Time frame: Administered at the 4-week follow-up
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
Time frame: Administered immediately after the intervention and at 4 week follow-up
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)
Time frame: Obtained from the state 6 months after the end of data collection
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
Time frame: Obtained from the state 6 months after the end of data collection
The research team will summarize the percentage who opt to participate in biobanking before and after implementation using state level data
Contact information is provided by the study sponsor or research team.
Erin Johnson, PhD
CONTACT
Valerie Joseph
CONTACT
Erin Rothwell
Other
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
Acronym: MICI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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