Parent Education and Choice About Newborn Screening and Bloodspot Retention

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

Detailed Description
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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.

Official Title
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Parent Education and Choice About Newborn Screening and Bloodspot Retention

Conditions
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Neonatal Screening

Intervention / Treatment
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* Behavioral: Viewing Newborn Screening movie
* Behavioral: Viewing Residual Dried Blood Spot movie


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viewing NBS + DBS Educational Movies<br>Group A: pregnant women who will view the NBS and residual specimen movies and printed materials during one visit between 30 and 40 weeks gestation. | Behavioral: Viewing Newborn Screening movie<br>* NBS Movie and printed brochure were viewed by the participants<br>Behavioral: Viewing Residual Dried Blood Spot movie<br>* DBS Movie and and printed brochure were viewed by the participants<br>|
| Experimental: Viewing NBS Educational Movie only<br>Group B: pregnant women who will view the NBS movie only and printed materials at one visit between 30 and 40 weeks. The movies will be presented on a tablet PC. | Behavioral: Viewing Newborn Screening movie<br>* NBS Movie and printed brochure were viewed by the participants<br>|
| No Intervention: No Educational Interventions<br>Control Group: pregnant women who will receive no experimental intervention during pregnancy or the postpartum period but will receive whatever information is routinely provided by their OB clinic and/or delivery center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factual knowledge about newborn screening as assessed through a survey instrument designed for the project | Knowledge of key items about newborn screening that were conveyed in the educational interventions | 2-4 weeks after due date | 
| Factual knowledge about newborn blood spots retention and use as assessed through a survey instrument designed for the project | Knowledge of key items about newborn dried blood spots that were conveyed in the educational interventions | 2-4 weeks after due date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of partners of the pregnant women regarding newborn screening based on a survey instrument designed for the study | Knowledge of newborn screening | 2-4 weeks after due date | 
| Knowledge of partners of the pregnant women regarding newborn dried blood spots retention and use based on a survey instrument designed for the study | Knowledge of newborn dried blood spots | 2-4 weeks after due date | 
| An attitude assessment regarding support for newborn screening programs | Attitudes regarding support for newborn screening | 2-4 weeks after due date | 
| An attitude assessment regarding support for retention and use of newborn residual dried blood spots | Attitudes regarding support for newborn dried blood spots | 2-4 weeks after due date | 
| The clinical choices made by participants regarding participation in newborn screening | Parents choice about newborn screening | 2-4 weeks after due date | 
| The clinical choices made by participants regarding participation in the retention and use of dried blood spots | Parents choice about dried bloodspot retention | 2-4 weeks after due date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal Education, Residual Specimens