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

2. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

8

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
FOCUS Toolkit
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of People Participating in PGS Program
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Month 4
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 4
Proportion of Eligible Individuals Tested
Tidsramme: Month 10
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 10
Proportion of Eligible Individuals Tested
Tidsramme: Month 16
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Month 16
Proportion of Positive Genomic Screening Results
Tidsramme: Month 4
Number of individuals with positive results after genomic screening
Month 4
Proportion of Positive Genomic Screening Results
Tidsramme: Month 10
Number of individuals with positive results after genomic screening
Month 10
Proportion of Positive Genomic Screening Results
Tidsramme: Month 16
Number of individuals with positive results after genomic screening
Month 16
Proportion of Negative Genomic Screening Results
Tidsramme: Month 4
Number of individuals with negative results after genomic screening
Month 4
Proportion of Negative Genomic Screening Results
Tidsramme: Month 10
Number of individuals with negative results after genomic screening
Month 10
Proportion of Negative Genomic Screening Results
Tidsramme: Month 16
Number of individuals with negative results after genomic screening
Month 16
Proportion of VUS Genomic Screening Results
Tidsramme: Month 4
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 4
Proportion of VUS Genomic Screening Results
Tidsramme: Month 10
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 10
Proportion of VUS Genomic Screening Results
Tidsramme: Month 16
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Month 16
Number of Sites Participating in PGS
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Month 19
Maintenance will be assessed by the number of individuals with positive results that completed high-risk management
Month 19
Program Sustainability Assessment
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wake Forest University Health Sciences

Samarbeidspartnere

National Human Genome Research Institute (NHGRI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. oktober 2028

Studiet fullført (Antatt)

1. oktober 2028

Datoer for studieregistrering

Først innsendt

2. september 2026

Først innsendt som oppfylte QC-kriteriene

2. september 2026

Først lagt ut (Faktiske)

8. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB00143953
  • R01HG013851-03 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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