Clinical trial NCT02676245: Parent Education and Choice About Newborn Screening and Bloodspot Retention
Official title: Parent Education and Choice About Newborn Screening and Bloodspot Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Screening
Keywords: Prenatal Education
Residual Specimens
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Intermountain Health Care, Inc.
name: Albert Einstein College of Medicine
name: University of California, San Francisco
name: National Human Genome Research Institute (NHGRI)
First posted: 2016-02-08
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.

Detailed description: It is widely recognized that new parents receive insufficient information about newborn screening (NBS) and little or no information regarding the retention of residual newborn screening samples. Our current research (R01 HD058854) clearly demonstrates that parents are supportive of NBS and the research use of residual specimens, but they want information before the child is born and want an informed choice regarding the retention and use of residual samples. Previous research has outlined the basic elements of what parents want to know about NBS generally. However, given that many states are adopting an "opt-out" approach for residual samples, it is unclear what basic information parents want to know to enable an informed choice about this practice. While it is recognized that retention and use of residual NBS samples is a valuable research resource, there are prevalent concerns in the NBS community that discussion of this will lead some parents to decline NBS altogether. Some authorities have suggested that discussions of NBS and residual sample retention be conducted separately to reduce the risk that parents will confuse the issues and decline NBS altogether.

To address this the project has the following specific aims:

Specific Aim 1) To determine what pregnant women, young mothers, and their partners want to know regarding the retention and use of residual bloodspot samples

Specific Aim 2) To create multimedia educational tools to be used in the prenatal care environment that will provide basic information about NBS and the core information determined through Specific Aim 1 about residual sample retention and use.

Specific Aim 3) To determine the impact of the prenatal education intervention on parental knowledge, attitudes, and decisions regarding NBS services and the retention and use of residual samples in diverse populations of English and Spanish speaking pregnant women.

Specific Aim 4) To examine the normative/ethical implications of the results of SA3 for the conduct of state NBS programs. Recommendations on the content and timing of parental NBS education will be developed.

Eligibility criteria: Inclusion Criteria:

* Adult (\> 18 years) women
* Uncomplicated pregnancy
* English and Spanish speaking
* Partners of pregnant women who have give birth.

Exclusion Criteria:

* Women younger than 18 years
* Complicated pregnancy

Primary outcomes:
measure: Factual knowledge about newborn screening as assessed through a survey instrument designed for the project
timeFrame: 2-4 weeks after due date
measure: Factual knowledge about newborn blood spots retention and use as assessed through a survey instrument designed for the project
timeFrame: 2-4 weeks after due date
Secondary outcomes:
measure: Knowledge of partners of the pregnant women regarding newborn screening based on a survey instrument designed for the study
timeFrame: 2-4 weeks after due date
measure: Knowledge of partners of the pregnant women regarding newborn dried blood spots retention and use based on a survey instrument designed for the study
timeFrame: 2-4 weeks after due date
measure: An attitude assessment regarding support for newborn screening programs
timeFrame: 2-4 weeks after due date
measure: An attitude assessment regarding support for retention and use of newborn residual dried blood spots
timeFrame: 2-4 weeks after due date
measure: The clinical choices made by participants regarding participation in newborn screening
timeFrame: 2-4 weeks after due date
measure: The clinical choices made by participants regarding participation in the retention and use of dried blood spots
timeFrame: 2-4 weeks after due date
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Jeffrey R Botkin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botkin JR, Rothwell E, Anderson RA, Goldenberg A, Kuppermann M, Dolan SM, Rose NC, Stark L. What parents want to know about the storage and use of residual newborn bloodspots. Am J Med Genet A. 2014 Nov;164A(11):2739-44. doi: 10.1002/ajmg.a.36694. Epub 2014 Aug 4.
citation: Botkin JR, Rothwell E, Anderson RA, Rose NC, Dolan SM, Kuppermann M, Stark LA, Goldenberg A, Wong B. Prenatal Education of Parents About Newborn Screening and Residual Dried Blood Spots: A Randomized Clinical Trial. JAMA Pediatr. 2016 Jun 1;170(6):543-9. doi: 10.1001/jamapediatrics.2015.4850.