Deploying a Genomic-medicine Risk Assessment Model for Diverse Primary Care Populations and Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 8
- 主要终点
- Reach of genomic risk assessment
研究概览
简要总结
The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The three primary aims are:
Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.
Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.
Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.
Three sets of participants will be engaged: patients (n=750), providers (n=25), and family members of "probands" (i.e., patients that have a genetic change that increases risk, n~500).
Patient participants will be asked to complete a baseline survey, enter their family health history information into MeTree (a family health history web-based platform) and complete a survey about their experience using the platform. Subsequent study procedures will depend on: 1) the results of their MeTree risk evaluation, 2) their acceptance/declination of genetic testing (for those categorized as needing testing by MeTree), and 3) the results of the test (for those accepting testing).
Provider participants will be providers who are the primary care physicians treating one or more patients enrolled in the patient participant group. Providers will be notified on a patient by patient basis once the patient participant under their care has complete the risk assessment process and the risk report is available from MeTree. At study completion, provider participants will be asked to complete a survey about their demographics, practice, and experiences with the study.
Blood relatives of the probands who are identified by the proband as open to engaging with the study will be contacted and offered genetic counseling and genetic testing.
详细描述
The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" project will define, deploy and evaluate a new care delivery model. Specifically, the GRACE project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The central hypothesis is that combining a Family Health History (FHH) -driven risk assessment tool (in this case MeTree), family engagement, and a genetic testing delivery system, will create a solution that engages and increases the proportion of diverse patients who are identified as at increased risk, who undergo testing, and, when appropriate, who initiate cascade genetic testing among relatives. The three primary aims are:
Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.
Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.
Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.
This trial is a cluster step wedge design, meaning that while the trial will ultimately be implemented in five family medicine clinics at the University of Florida Health System, it will be implemented in only one clinic at a time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Receiving primary medical care in one of the 5 participating clinics
- •Age 18 years or older
- •Able to read and communicate in English
- •Able to provide written and verbal informed consent
- •Willing to use the Internet
排除标准
- •Anyone not meeting inclusion criteria
- •Previous genetic counseling and/or previous hereditary panel testing
研究组 & 干预措施
Intervention
Risk assessment pipeline
干预措施: Disease Risk Assessment (Behavioral)
结局指标
主要结局
Reach of genomic risk assessment
时间窗: at study completion, expected 1 year from study start
The number of participants completing MeTree relative to the number of participants who consented to the study.
Utility of genomic risk assessment
时间窗: at study completion, expected 1 year from study start
The number of participants newly identified as at increased risk for familial and/or heritable conditions warranting genetic counseling and/or genetic testing.
Uptake of genetic counseling risk recommendations by the participant
时间窗: at study completion, expected 1 year from study start
The number of participants who complete genetic counseling/the number of participants who are recommended for genetic counseling.
Uptake of genetic testing recommendations by the provider
时间窗: at study completion, expected 1 year from study start
The number of participants who undergo genetic testing relative to the number of participants recommended for genetic testing (i.e., have a hereditary risk CDS outcome).
次要结局
未报告次要终点