Surveying Parents About Genome Screening of Newborns

Study Overview
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Brief Summary
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A 10 minute baseline survey will be administered to parents of healthy newborn infants while in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25 minute survey 3-24 months later. We will measure parents' attitudes and preferences related to genome screening of newborns. The specific aims of this study are: To investigate whether parents' opinions regarding genome screening of newborns change between the first 48 hours post-partum and 3-24 months post-partum. a. We hypothesize that there will not be significant differences between interest in genome screening results in the 48 hours post-partum compared to 3-24 months post-partum. To determine whether seeing hypothetical genome screening results affects parents' decisions regarding whether they would want genome screening for their newborn. We expect many parents to state initially (in the 48 hours post-partum) that they would elect to have genome screening for their newborn if it were available. In the follow-up survey, half of study participants will receive hypothetical scenarios in which they will need to struggle with the probabilistic and ambiguous nature of the information that could be derived from genome sequencing. We will examine whether this alters their preferences. We will also explore whether parents who receive hypothetical genome screening results scenarios are more likely to alter their preferences than parents who do not receive hypothetical scenarios.

Official Title
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Surveying Parents About Genome Screening of Newborns

Conditions
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Parents of Healthy Newborns

Intervention / Treatment
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* Other: Genetics education at baseline
* Other: Hypothetical genomic scenarios at follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent of a healthy newborn in the BWH Department of Obstetrics English-speaking Exclusion Criteria: Impaired decision-making capacity Newborn with life-threatening health concerns in the 48 hours post-partum
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline1-demographics<br>Baseline survey- demographics only | |
| Other: Baseline1 w/genetics<br>Genetics education, baseline interest in genome screening - 1 | Other: Genetics education at baseline<br> <br> |
| Other: Baseline2-demographics<br>Baseline survey- demographics only | Other: Hypothetical genomic scenarios at follow-up<br> <br> |
| Other: Baseline2 w/genetics<br>Genetics education, baseline interest in genome screening - 2 | Other: Genetics education at baseline<br> <br> Other: Hypothetical genomic scenarios at follow-up<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest in genome screening for newborn if this service were available through a research study | This is a question created by the investigators. It uses a 5-point Likert scale to measure parents' self-reported interest in genome screening for their newborn. | Change between baseline and 3-24 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of refusal of newborn screening | Newborn screening refusals are very rare. When they occur, they are tracked by nurses on the postpartum inpatient unit. At the start of all shifts for study recruitment, the research assistant will ask the nurse-in-charge if any patients refused newborn screening since the previous study recruitment shift. | baseline |