Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErin Rothwell
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult (> 18 years)
English, Spanish or Arabic speaking
Just gave birth and currently a patient in the Mother & Baby Unit in the hospital
Disqualifiers
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
Design model
Sequential
Treatments tested in this trial
Educational Website and Video
BehavioralThe 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.
Treatment groups
5,980 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Administered immediately after the intervention and at 4 week follow-up2
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
Time frame
Administered at the 4-week follow-up3
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)
Time frame
Administered immediately after the intervention and at 4 week follow-up4
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
Time frame
Obtained from the state 6 months after the end of data collectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erin Rothwell
Lead sponsor
University of Utah
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov