Facilitating the Implementation of Population-wide Genomic Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 7
- 主要终点
- Number of People Participating in PGS Program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
FOCUS Toolkit
干预措施: FOCUS Toolkit Training (Other)
结局指标
主要结局
Number of People Participating in PGS Program
时间窗: 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
Number of People Participating in PGS Program
时间窗: 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
Number of People Participating in PGS Program
时间窗: 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
Proportion of Eligible Individuals Tested
时间窗: Month 4
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Proportion of Eligible Individuals Tested
时间窗: Month 10
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Proportion of Eligible Individuals Tested
时间窗: Month 16
Effectiveness is measured as the proportion of eligible individuals tested compared to those consented
Proportion of Positive Genomic Screening Results
时间窗: Month 4
Number of individuals with positive results after genomic screening
Proportion of Positive Genomic Screening Results
时间窗: Month 10
Number of individuals with positive results after genomic screening
Proportion of Positive Genomic Screening Results
时间窗: Month 16
Number of individuals with positive results after genomic screening
Proportion of Negative Genomic Screening Results
时间窗: Month 4
Number of individuals with negative results after genomic screening
Proportion of Negative Genomic Screening Results
时间窗: Month 10
Number of individuals with negative results after genomic screening
Proportion of Negative Genomic Screening Results
时间窗: Month 16
Number of individuals with negative results after genomic screening
Proportion of VUS Genomic Screening Results
时间窗: Month 4
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Proportion of VUS Genomic Screening Results
时间窗: Month 10
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Proportion of VUS Genomic Screening Results
时间窗: Month 16
Number of individuals with variant of uncertain significance (VUS) after genomic screening
Number of Sites Participating in PGS
时间窗: 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
Acceptability of Intervention Measure (AIM)
时间窗: 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.
Intervention Appropriateness Measure (IAM)
时间窗: 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.
Feasibility of Intervention Measure (FIM)
时间窗: 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.
Number of Individuals that Completed High-Risk Management
时间窗: Month 19
Maintenance will be assessed by the number of individuals with positive results that completed high-risk management
Program Sustainability Assessment
时间窗: 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.
次要结局
未报告次要终点