Facilitating the Implementation of Population-wide Genomic Screening
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT07806643
- Status
- Not Yet Recruiting
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Conditions
- Population Genomic Screening Implementation Best Practices
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Accepted
Interventions
- FOCUS Toolkit Training — OTHERThe FOCUS toolkit is a multicomponent implementation guide on improving the implementation of population-wide genomic screening programs across diverse healthcare settings.
Study Details
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 Dates
- First listed
- Sep 8, 2026
- Start date
- Jan 31, 2027
- Status verified
- Aug 2026
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 8 participants (estimated)
Arms
- Arm: FOCUS Toolkit
Primary Outcome Measure
Number of People Participating in PGS Program [ Time Frame: Month 4 ]
Central Contacts
- Caitlin Allen, PhD614-554-5298
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | |
| Moses Cone Hospital | Greensboro | North Carolina | 27401 | |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | |
| St. Luke's University Hospital | Bethlehem | Pennsylvania | 18015 | |
| WellSpan York Hospital | York | Pennsylvania | 17403 | |
| Baylor College of Medicine | Houston | Texas | 77030 | |
| Memorial Hermann-Texas Medical Center | Houston | Texas | 77030 |