Wake Forest University Health Sciences
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.
To help facilitate growth of population-wide genomic screening (PGS) programs and enhance recruitment and retention of representative populations into genomic initiatives, this study propose to identify best practices for PGS implementation and develop and test a freely available, online multicomponent implementation guide (FOCUS toolkit). This project will establish a gold standard approach for integrating PGS and offer the field generalizable methods and knowledge about PGS implementation. Specifically, using a stakeholder-engaged Implementation Mapping approach we will: 1) conduct a qualita…
Inclusion Criteria: * Operate an active or population genomic screening (PGS) program. * Agree to utilize the FOCUS Toolkit throughout the trial and engage staff in its use and fidelity tracking. * Ability to understand and willingness to sign a data use agreement and comply with study procedures for the entire length of the study. * Ability to provide program-level data (Reach, Effectiveness, Adoption, Implementation, Maintenance) quarterly. * Confirmation of implementing or sustaining stage, as determined by the investigator. * Capacity to participate in stakeholder surveys and interviews a…
The FOCUS toolkit is a multicomponent implementation guide on improving the implementation of population-wide genomic screening programs across diverse healthcare settings.