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Facilitating the Implementation of Population-wide Genomic Screening (FOCUS)

2 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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 qualitative needs assessment among ten PGS programs (FOCUS design sites) at various implementation stages (emerging, implementing, sustaining) guided by the Consolidated Framework for Implementation Research, 2) develop and produce the FOCUS toolkit consisting of implementation strategies, materials, and protocols, and 3) evaluate the impact of the FOCUS toolkit on Reach, Effectiveness, Implementation, Adoption, Maintenance outcomes for PGS in 12 PGS sites (FOCUS test sites) using a stepped wedge cluster randomized trial design. These findings will: 1) provide a standardized approach and evaluation framework for programs seeking to strategically implement and expand population-based approaches for identifying individuals and families at high risk of serious, yet preventable disease, 2) provide generalizable methods and knowledge about PGS, and 3) support efforts to bring the promise of precision health to all.

Studietype

Observationeel

Inschrijving (Geschat)

8

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • University of North Carolina
        • Contact:
      • Greensboro, North Carolina, Verenigde Staten, 27401
      • Winston-Salem, North Carolina, Verenigde Staten, 27157
        • Atrium Health Wake Forest Baptist
        • Contact:
    • Pennsylvania
      • Bethlehem, Pennsylvania, Verenigde Staten, 18015
      • York, Pennsylvania, Verenigde Staten, 17403
        • WellSpan York Hospital
        • Contact:
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Baylor College of Medicine
        • Contact:
      • Houston, Texas, Verenigde Staten, 77030

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

This study will include specific sites population genomic screening (PGS) rather than individual participants.

Beschrijving

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 at study conclusion.
  • Ability to read and understand the English language.

Exclusion Criteria:

  • They lack infrastructure to collect and share required data.
  • They cannot commit to toolkit use or quarterly reporting.
  • They are unable to comply with study timelines

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
FOCUS Toolkit
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of People Participating in PGS Program
Tijdsspanne: Month 4
Reach is measured as the total number of people who have consented to participate in the population-based genomic screening (PGS) program. Data will be collected from PGS program data collection form
Month 4
Number of People Participating in PGS Program
Tijdsspanne: Month 10
Reach is measured as the total number of people who have consented to participate in the population-based genomic screening (PGS) program. Data will be collected from PGS program data collection form
Month 10
Number of People Participating in PGS Program
Tijdsspanne: Month 16
Reach is measured as the total number of people who have consented to participate in the population-based genomic screening (PGS) program. Data will be collected from PGS program data collection form
Month 16
Proportion of Eligible Individuals Tested
Tijdsspanne: Month 4
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 4
Proportion of Eligible Individuals Tested
Tijdsspanne: Month 10
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 10
Proportion of Eligible Individuals Tested
Tijdsspanne: Month 16
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 16
Proportion of Positive Genomic Screening Results
Tijdsspanne: Month 4
Number of individuals with positive results after genomic screening
Month 4
Proportion of Positive Genomic Screening Results
Tijdsspanne: Month 10
Number of individuals with positive results after genomic screening
Month 10
Proportion of Positive Genomic Screening Results
Tijdsspanne: Month 16
Number of individuals with positive results after genomic screening
Month 16
Proportion of Negative Genomic Screening Results
Tijdsspanne: Month 4
Number of individuals with negative results after genomic screening
Month 4
Proportion of Negative Genomic Screening Results
Tijdsspanne: Month 10
Number of individuals with negative results after genomic screening
Month 10
Proportion of Negative Genomic Screening Results
Tijdsspanne: Month 16
Number of individuals with negative results after genomic screening
Month 16
Proportion of VUS Genomic Screening Results
Tijdsspanne: Month 4
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 4
Proportion of VUS Genomic Screening Results
Tijdsspanne: Month 10
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 10
Proportion of VUS Genomic Screening Results
Tijdsspanne: Month 16
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 16
Number of Sites Participating in PGS
Tijdsspanne: Month 19
Adoption is defined as the uptake of population-based genomic screening (PGS) at each site, measured by the number of sites participating in PGS relative to those eligible. Measured through stakeholder surveys
Month 19
Acceptability of Intervention Measure (AIM)
Tijdsspanne: Month 19
Implementation will be assessed using the Acceptability of Intervention Measure survey includes 4 items with the total score range 4-20. Higher scores indicate higher level of acceptability.
Month 19
Intervention Appropriateness Measure (IAM)
Tijdsspanne: Month 19
Implementation will be assessed using the Intervention Appropriateness Measure survey includes 4 items with a total score range 4-20. Higher scores indicate higher level of appropriateness.
Month 19
Feasibility of Intervention Measure (FIM)
Tijdsspanne: Month 19
Implementation will be assessed using the Feasibility of Intervention Measure survey includes 4 items with a total score range 4-20. Higher scores indicate higher level of feasibility.
Month 19
Number of Individuals that Completed High-Risk Management
Tijdsspanne: Month 19
Maintenance will be assessed by the number of individuals with positive results that completed high-risk management
Month 19
Program Sustainability Assessment
Tijdsspanne: Month 19
Maintenance will be assessed by using the Program Sustainability Assessment survey has 40 items with a total score range of 40-280. Higher scores indicate greater sustainability capacity.
Month 19

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Medewerkers

National Human Genome Research Institute (NHGRI)

Onderzoekers

  • Hoofdonderzoeker: Caitlin Allen, PhD, Atrium Health Wake Forest Baptist

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 oktober 2028

Studie voltooiing (Geschat)

1 oktober 2028

Studieregistratiedata

Eerst ingediend

2 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 september 2026

Eerst geplaatst (Werkelijk)

8 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • IRB00143953
  • R01HG013851-03 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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