Implementation Science Clinical Trial
— MICIOfficial title:
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
NCT number | NCT06192511 |
Other study ID # | 00153608 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2024 |
Est. completion date | January 30, 2028 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Erin Rothwell | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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 |
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