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NOT YET RECRUITING
NCT07806643

Facilitating the Implementation of Population-wide Genomic Screening

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

This is a multi-site hybrid implementation-effectiveness trial that uses a stepped-wedge cluster randomized design to evaluate the impact of the FOCUS toolkit, a multicomponent implementation guide, on improving the implementation of population-wide genomic screening (PGS) programs across diverse healthcare settings. The trial will assess program-level outcomes using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) and explore mechanisms of change and implementation process progression. The study involves program-level and individual-level data collection and will not alter clinical care or treatment decisions of individuals made by participating sites.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

8

Start Date

2027-01

Completion Date

2028-10

Last Updated

2026-09-08

Healthy Volunteers

Yes

Interventions

OTHER

FOCUS Toolkit Training

The FOCUS toolkit is a multicomponent implementation guide on improving the implementation of population-wide genomic screening programs across diverse healthcare settings.

Locations (7)

University of North Carolina

Chapel Hill, North Carolina, United States

Moses Cone Hospital

Greensboro, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States

WellSpan York Hospital

York, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Memorial Hermann-Texas Medical Center

Houston, Texas, United States