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

2. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

8

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
FOCUS Toolkit
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Mitarbeiter

National Human Genome Research Institute (NHGRI)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

2. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. September 2026

Zuerst gepostet (Tatsächlich)

8. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • IRB00143953
  • R01HG013851-03 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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