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

2026년 9월 2일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

8

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
FOCUS Toolkit
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wake Forest University Health Sciences

협력자

National Human Genome Research Institute (NHGRI)

수사관

  • 수석 연구원: Caitlin Allen, PhD, Atrium Health Wake Forest Baptist

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2028년 10월 1일

연구 완료 (추정된)

2028년 10월 1일

연구 등록 날짜

최초 제출

2026년 9월 2일

QC 기준을 충족하는 최초 제출

2026년 9월 2일

처음 게시됨 (실제)

2026년 9월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 2일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IRB00143953
  • R01HG013851-03 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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