Outcome | Level | Mode of data collection | Timing of data collection |
Implementation outcomes | |||
Appropriateness | Neonatal providers | Virtual focus groups | Preimplementation and postimplementation of VIGOR at participating sites |
Feasibility | Neonatal providers | Virtual focus groups | Preimplementation and postimplementation of VIGOR at participating sites |
Penetration | Infant | Tracking rapid ES report, CIR and disclosure | Throughout enrolment period |
Service outcomes | |||
Equity | Infant | Tracking rapid ES report, CIR and disclosure, as well as chart abstraction | Throughout enrolment period |
Client outcomes | |||
Function (provider) Comfort with genomic medicine | Neonatal providers | Survey | Pregenomic and postgenomic education survey |
Function (family) Mental health | Family | Survey | At enrolment and 3, 6 and 12 months after results disclosure |
Symptomatology Neonatal clinical outcomes | Infant | Chart abstraction | At NICU discharge/transfer and 12 months after results disclosure |
Survey | 3, 6 and 12 months after results disclosure | ||
Satisfaction (provider) With disclosure process and the VIGOR study | Neonatal provider | Survey | After each results disclosure |
Qualitative interviews | After 3–5 disclosure events | ||
Virtual focus groups | Postimplementation of VIGOR at participating sites | ||
Satisfaction (family) With disclosure process and participation in VIGOR | Family | Survey | Within 2 weeks of results disclosure |
Qualitative interviews (with subset) | Within 2 months of results disclosure |
CIR, clinical interpretive report; ES, exome sequencing; NICU, neonatal intensive care unit; VIGOR, VIrtual GenOme CenteR.