The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research
Phase: NA
Conditions: Neonatal Screening
Sponsor: University of Utah

 
 
 
2018 
The Effect of Electronic Informed 
Consent Information (EICI) on 
Residual Newborn Specimen 
Research 
NCT03141307 
APPROVAL DATE: 3/6/2018 

Hospital EICI intervention protocol 
3/6/2018 
 
Run-in Phase 
We will conduct a “run-in” of the EICI in each of the participating hospitals with 10 women and 
then will conduct a follow up interview with all of these participants.  
 
Inclusion and Exclusion Criterion 
 
Inclusion criteria for the intervention include: adult (> 18 years) English speaking women who 
are already being approached for participation in the BioTrust.    
 
Exclusion criteria include mothers of infants that are in the NICU and any situation adoption or 
legal guardianship is unknown at the time of birth. 
 
Recruitment 
Our research procedures are designed to mirror the current practice at the individual hospoitals 
as much as possible. Typically, nurses discuss the BioTrust informational brochure shortly after 
moving into the Mother & Baby unit as part of the packet of information related to their stay in 
the unit. Once the baby is 24 hours old, the nursery tech comes to complete newborn screening 
and asks for BioTrust consent at that time.    
 
Our approach will use a full time research assistant (RA) at each hospital. All potential 
participants will receive the brochure as part of standard practice during their welcome to the 
Mother & Baby Unit. At some point after admission to the Unit, the RA will approach the 
patient, briefly describe the study and content of data collected, and seek verbal consent for 
participation in the study. If they consent, the RA will activate the study-provided electronic 
tablet to see the study group assignment; study staff and healthcare providers will be blind to 
the study group assignment until this point. Participants will be randomized into the video 
intervention group (Group A), interactive intervention group (Group B), or standard of care 
group (Group C). The patient will then complete the intervention (Groups A and B) or continue 
the BioTrust discussion with the nurse (Group C).  
 
Intervention Groups A and B 
Following randomization, participants in Groups A or B will be given the electronic tablet with 
the intervention loaded on the screen and provided with instructions. In order to allow 
particpants as much time as necessary to explore the app, the RA will leave the room while the 
patient is working on the tablet and return within an hour to pick up the tablet.  Participants in 
Group A will be asked to watch a 6-minute video about what it means to consent to have the 
NBS bloodspots retained by the Michigan BioTrust. Participants in Group B will be provided 
with the same information in an interactive app form, and will be asked to explore the 
informational sections at their preferred level of depth. After the video ends or participants 

reach the end point of the educational app, they will automatically be directed to complete the 
associated questionnaires. When the RA returns, she will collect the tablet and provide the 
participant with a $25 gift card to Amazon. The next day, the Nursery Tech will visit the 
patient’s room to gather NBS bloodspots and consent for the BioTrust, following the standard 
consent process.  
 
 
Control Group C 
 
Participants who are randomized to Group C will complete the questionnaires immediately 
following the BioTrust discussion with the nurse. The RA will stay in the room while the 
surveys are being completed then provide the participant with a $25 gift card to Amazon. The 
next day, the Nursery Tech will visit the patient’s room to gather NBS bloodspots and consent 
for the BioTrust, following the standard consent process. The RA will review collected consent 
cards to document the patient’s choice to consent or deny.  
 
Survey Tools 
All participating women will complete a survey 1) immediately following the 
intervention/control on the electronic tablet and 2) by telephone 2-4 weeks follow up. 
Participants will receive an additional $25 gift card to Amazon after the follow-up survey. 
Outcome measures include:  
 
knowledge of the elements of consent and key aspects of the biobank  
 
decisional conflict 
 
satisfaction with the consent process and attitudes toward the clinical program the 
samples were collected for and research with these samples 
 
rates of parental permission 
We will also collect demographic information on the participants and contact information for 
contact by telephone 2-4 weeks later. All identifying information will be kept in a secure data 
storage system separate from data used for analyses.  
 
 
Partners 
Research indicates that the partners of pregnant women are typically not approached for consent 
for the retention of specimens in the biorepository.24 Our Process Observations revealed that 
fathers were in the room during the consent process in roughly half of the cases and were vocal 
and involved in the process in two thirds of those situations. Therefore we will not attempt to 
recruit those who are in the hospital although partners will be welcomed to participate in the 
intervention if they are present. The role of partners may be important in decision-making 
about biobanking whether or not they are typically approached. All participants will be asked 
in the 2-4 week follow-up survey about the role of their partner in decision-making about 
specimen biobanking. Additionally, whoever completed the survey in the hospital will be the 
same person to complete the 2-4 week survey, regardless of status as birth mother or partner. 
 

Clinical Site Coordination 
Drs. Rothwell, Botkin  and Johnson along with Ms. Langbo from the Michigan Department of 
Health will provide guidance for the coordination of the clinical sites. Drs. Botkin and Rothwell 
will visit each site prior to implementation of data collection to introduce the project to staff and 
discuss issues sites may have. To ensure success, there will be at least weekly meetings with all 
three site RA and the Research Director, Dr. Johnson. RAs will provide weekly reports of 
activities and recruitment. In addition, we will hold monthly teleconference with the research 
team and the Site PIs to discuss any larger issues and potential adverse events.  Consistency 
among the sites will be monitored with these reports and communication strategies. Research 
team coordination with communication and meetings is based on the successful 
accomplishment of previous research project (R01 HD058854).  
 
Analysis Plan 
Summary statistics for baseline demographics (age, ethnicity, race, income, etc.) will be 
calculated and reported for each intervention group (App or Video) versus Control. We will 
utilize multilevel generalized mixed modeling (via SPSS and R) under an intent-to-treat (ITT) 
approach to compare primary, secondary outcomes, and exploratory outcomes.  
 
Hypothesis Testing: To evaluate the fixed effect of the two different groups upon knowledge 
we will utilize a single level model that includes the fixed effect of group (G).   
 
𝑌𝑌𝑖𝑖= [𝛾𝛾0 + 𝛾𝛾1𝐺𝐺𝑖𝑖] + [𝜁𝜁𝑖𝑖+ 𝜖𝜖𝑖𝑖] 
 
where Y is the composite score for knowledge. G is an indicator for the different groups (App 
or Video, Control). We will set alpha = 0.05. The two group model reduces to a 2 sided, t-test 
approach.