Implementation ScienceMICINCT06192511
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
A study testing Educational Website and Video in people with Implementation Science and Informed Consent, run by Erin Rothwell at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implementation Science, Informed Consent, Neonatal Screening
- What is being tested?
- Educational Website and Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,980 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2024to 30 Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (> 18 years)
- English, Spanish or Arabic speaking
- Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
Erin Johnson, PhD, 801-587-0975, erin.p.johnson@hsc.utah.edu
Erin Rothwell, MD
- Recruiting
University of Utah, Department of Obstetrics & Gynecology
Salt Lake City, Utah, 84132
Erin Johnson, PhD, erin.p.johnson@hsc.utah.edu
Erin Rothwell, M.D.
About this study
Official title: Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
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.
Read the detailed 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.
- Conditions
- Implementation Science, Informed Consent, Neonatal Screening
- Being tested
- Educational Website and Video
- Keywords
- newborn screening, informed consent, biobanking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Website and VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational Website and Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Obtained from the state 6 months after the end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 May 2024
- Primary completion15 Nov 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implementation ScienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erin Rothwell
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Erin Rothwell, University of Utah
- Investigators
- Erin Rothwell, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192511
- Sponsor's protocol ID
- 00153608
- Acronym
- MICI
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No