VIGOR: Virtual Genome Center for Infant Health

Conditions

• Genetic Predisposition to Disease
• Genetics Disease
• Genetics/Birth Defects

Eligibility Criteria

Sex

ALL

Age

0 Days - 99 Years

Healthy Volunteers

Not accepted

Study Details

This study will provide rigorous evaluation of implementing a virtual genome center into community clinical settings without highly specialized resources, thereby offering generalizable insights as to how best to implement genomic medicine at scale and for other age groups. This intervention has great potential to address disparities in genomic medicine among low-income and underrepresented minority (URM) populations and will enhance capacity for providers and health systems to utilize highly specialized genomic techniques in their communities. The goal of this study is to achieve equitable access to state-of-the-art genomic medical care to sick newborns in community centers that predominately care for low-income and racial/ethnic minority populations through the creation of a virtual genome center (VIGOR). VIGOR will provide a venue for physician and family education, genomic expert consultation, reanalysis of unsolved sequencing data, and access to cutting edge therapeutic innovation, thereby facilitating institutionalization of genomic best practices in community settings, and not just highly specialized referral centers.

Key Dates

Start date

Mar 22, 2022

Status verified

Jan 2026

Primary completion

Nov 30, 2026

Completion

Mar 1, 2027

Study Design

Enrollment

750 participants (estimated)

Arms

• Arm: Neonates and Parents/Caregivers
  Providers caring for newborns that meet eligibility criteria will approach parents to assess interest. The VIGOR study staff will remotely contact parents to complete consent for genomic sequencing (GS). We will also invite 1 additional primary caregiver (e.g. father, co-mother etc.) to participate even if that caregiver is not biologically related to the child. We will administer surveys at baseline enrollment to assess sociodemographics, obstetrical history, family genetic history \& mental health; within 1 week of disclosure of findings to assess satisfaction \& mental health; \& at 3 \& 6 months to further assess mental health \& newborn clinical outcomes. We will approach a subset of the families for qualitative interviews to assess satisfaction with VIGOR \& receipt of GS results with their physician in more detail.
• Arm: Clinicians
  Following focus groups at each of the participating sites to assess the feasibility \& needs of each site, the care teams will receive basic training in genomics and how to disclose GS results with VIGOR support. Study orientation will be completed as part of the training. Focus groups will be conducted within 1 year post implementation \& again between year 4 \& the completion of the study, to assess feasibility \& appropriateness of VIGOR. We will administer brief surveys to the care providers before \& after receipt of genomic education to assess their baseline knowledge \& comfort with genomic medicine in newborns. Surveys will be repeated within a week of disclosure to families regarding feedback on the process \& satisfaction with VIGOR. After approximately 3-5 disclosure events, study staff will approach the clinical care team members to participate in a qualitative interview to assess their perspectives in more depth.

Primary Outcome Measure

Implementation of VIGOR [ Time Frame: 4 year ]

Central Contacts

• Timothy Yu, MD, PhD
  617-919-7499
  [email protected]
• Vanessa J Young, MS, BA, RN
  617-355-8330
  [email protected]

Locations (10)

Find similar trials in Mobile, AL

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