Risk Assessment for Health Risks

(GRACE Trial)

No longer recruiting at 7 trial locations

Overseen By Kathryn Carpenter, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Previous genetic counseling, hereditary panel testing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve healthcare in low-resource areas by using genomic medicine, a type of personalized medicine based on genes, to assess health risks. The goal is to help people and doctors use genetic information to make better health decisions, leading to healthier lives and lower medical costs. Participants will use a web-based platform to enter family health information and, depending on the results, may receive genetic testing. Individuals who receive medical care at one of the five participating clinics, speak English, and are willing to use the internet might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform healthcare in underserved communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on risk assessment and genetic testing, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this genomic medicine risk assessment is safe?

Research has shown that using genetic information to assess health risks is generally safe for participants. This method examines genes and family health history to predict possible diseases. While specific data on negative effects is lacking, the process primarily involves risk assessment rather than direct medical treatment. Consequently, the likelihood of physical side effects is lower compared to taking medications. Additionally, this method is not linked to a specific trial phase, which suggests ongoing exploration, but this does not directly impact safety. Participants typically fill out surveys and share family health details, which are simple and non-invasive activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Genomic Medicine Risk Assessment Care because it offers a personalized approach to evaluating health risks, which differs significantly from traditional methods like family history assessments and standard screenings. This innovative method uses genomic information to predict an individual's risk for various health conditions, offering a more precise and personalized risk profile. By identifying potential health issues before they develop, this approach could lead to earlier interventions and more tailored healthcare strategies, ultimately improving patient outcomes.

What evidence suggests that the GRACE intervention is effective for genomic risk assessment?

Research shows that genetic information can help identify health risks, enabling preventive measures. In this trial, participants will receive a Genomic Medicine Risk Assessment as part of the intervention. One study of 1,889 primary care patients revealed that 76.4% were advised of a higher risk for certain conditions, highlighting how genetic testing can spot potential health issues. Another study found that genetic screening provided useful results to 1 in 30 people, demonstrating its value. This method could improve health by identifying risks early and guiding personalized care. ^{1 2 5 6 7}

Who Is on the Research Team?

Lori Orlando, MD

Principal Investigator

Duke University

Alexander S Parker, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

The GRACE trial is for patients with conditions like hyperthermia, liver disease, cardiovascular disease, cancer, or risk of heat stroke. It's also for their healthcare providers and family members who might have genetic risks. Participants should be willing to use a web-based platform to enter health history and may need to undergo genetic testing if advised.

Inclusion Criteria

Able to read and communicate in English

Able to provide written and verbal informed consent

Willing to use the Internet

Exclusion Criteria

I have undergone genetic counseling or hereditary cancer testing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey and enter family health history information into MeTree

2 weeks

1 visit (virtual)

Risk Assessment and Counseling

Participants undergo risk assessment using MeTree and receive genetic counseling based on their risk category

4-6 weeks

2 visits (virtual)

Genetic Testing

Participants identified as needing genetic testing receive a saliva collection test kit or mobile phlebotomy for genetic testing

4 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for outcomes and complete surveys about their experience with genetic counseling and testing

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Genomic Medicine Risk Assessment Care for Everyone

Trial Overview GRACE aims to develop a framework for genomic medicine risk assessment that can work even in low-resource settings. The study will test how well this approach helps people understand their health risks based on genetics and improve patient outcomes through better-informed guidelines.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Risk assessment pipeline

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Published Research Related to This Trial

Stakeholders showed varying levels of confidence in the clinical validity of genomic tests, with higher confidence in epidermal growth factor receptor mutation and Lynch syndrome testing compared to Oncotype DX, which decreased after discussion.

Most stakeholders were open to the clinical use of all three tests but emphasized the need for further research and a shared decision-making approach to ensure effective implementation in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder assessment of the evidence for cancer genomic tests: insights from three case studies. Deverka, PA., Schully, SD., Ishibe, N., et al.[2022]

Access to genomic health care in the U.S. is limited for underserved populations due to barriers such as lack of access to knowledgeable providers, low genetic literacy, and insufficient evidence on gene variants in diverse groups.

To address these disparities, it is crucial to foster engagement between underserved communities, healthcare providers, and policymakers to raise awareness and develop solutions for better access to genomic health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advocacy and actions to address disparities in access to genomic health care: A report on a National Academies workshop. Williams, JK., Bonham, VL., Wicklund, C., et al.[2022]

Pharmacogenomics can help predict adverse drug reactions (ADRs) by identifying genetic variations that affect how individuals respond to medications, addressing a significant issue in drug safety.

The review highlights successful examples of pharmacogenomics influencing clinical practice and discusses future areas where it could improve drug safety, while also acknowledging the challenges in implementing these tests in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging era of pharmacogenomics: current successes, future potential, and challenges. Lee, JW., Aminkeng, F., Bhavsar, AP., et al.[2021]

In a study involving 1,889 primary care patients across 19 clinics, 76.4% received increased risk recommendations for various medical conditions, highlighting the potential for systematic risk assessment to identify individuals needing more intensive health management.

The implementation of the MeTree risk assessment tool demonstrated that a significant portion of the primary care population, particularly 46% for hereditary and familial disease risks, could benefit from enhanced screening and prevention strategies, suggesting a promising avenue for improving public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At the intersection of precision medicine and population health: an implementation-effectiveness study of family health history based systematic risk assessment in primary care. Orlando, LA., Wu, RR., Myers, RA., et al.[2021]

An Internet-based health risk assessment called Heart Aware was analyzed with data from 16,879 community-dwelling adults, revealing that there was only marginal agreement between self-reported and clinically measured coronary heart disease (CHD) risk factors, indicating a need for better awareness and understanding of these factors.

The study found that as overall CHD risk increased, the agreement for high-density lipoprotein cholesterol (HDL-C) worsened, while low-density lipoprotein cholesterol (LDL-C) showed slightly improved agreement, suggesting that targeted interventions are necessary to enhance knowledge and perceptions of these specific cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can an Internet-based health risk assessment highlight problems of heart disease risk factor awareness? A cross-sectional analysis. Dickerson, JB., McNeal, CJ., Tsai, G., et al.[2022]

A secure web portal was developed to communicate personalized genetic risk information to 3,177 Finnish individuals, allowing them to understand their genetic and absolute risk for future diseases.

The method utilizes polygenic risk scores, enabling individuals to take an active role in managing their health while providing healthcare professionals with a preventive tool for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web Portal for Communicating Polygenic Risk Score Results for Health Care Use-The P5 Study. Marjonen, H., Marttila, M., Paajanen, T., et al.[2021]

Human genomic sequencing can provide valuable insights for diagnosis, prognosis, and treatment across various medical fields, but its widespread use is limited by a lack of evidence showing improved patient outcomes in those without specific testing indications.

The paper reviews clinical outcome studies in genomic medicine, highlighting the challenges of generating robust evidence to support the integration of next-generation sequencing into standard patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building evidence and measuring clinical outcomes for genomic medicine. Peterson, JF., Roden, DM., Orlando, LA., et al.[2020]

Genetic research is uncovering specific genes that influence how safely and effectively patients respond to medications, which can help prevent adverse drug reactions.

Primary care physicians are being targeted with advertisements for genetic tests that identify these variations, highlighting the need for a careful evaluation of these tests to ensure they are used optimally in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating pharmacogenetic tests: a case example. Freund, CL., Gregory, DF., Clayton, EW.[2019]

Family health history is a traditional method for gathering important genetic and environmental data to predict disease risk, but its effectiveness is inconsistent due to gaps in knowledge and data accuracy among patients and providers.

Advancements in sequencing technologies offer a promising alternative for risk assessment, allowing for comprehensive genetic testing that could enhance precision medicine, though there are still challenges in implementing these tests effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The enduring importance of family health history in the era of genomic medicine and risk assessment. Haga, SB., Orlando, LA.[2021]

Serious adverse drug reactions are a leading cause of death in the USA and contribute significantly to healthcare costs, highlighting the need for better risk management in drug prescriptions.

Pharmacogenomic testing, which identifies genetic factors that affect drug response, is becoming increasingly important, with regulatory agencies pushing for mandatory testing for certain medications to prevent adverse reactions and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomics of adverse drug reactions: practical applications and perspectives. Becquemont, L.[2013]

Genetic testing carries potential patient safety risks at every stage, from ordering to analysis and follow-up, primarily due to a lack of physician knowledge and the rapid evolution of genetic technology.

To mitigate these risks, experts recommend enhancing physician education, providing access to genetic specialists, and improving communication through better test reports and electronic decision support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in genomic medicine: an exploratory study. Korngiebel, DM., Fullerton, SM., Burke, W.[2023]

Health risk assessments are valuable tools for promoting health and preventing diseases by collecting detailed family health history, which helps identify risks for both common and rare conditions.

Despite their potential benefits, the US healthcare system has been slow to adopt health risk assessments, and several concerns, such as provider and patient impact and data validity, need to be addressed for wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of health risk assessments with family health history: barriers and benefits. Wu, RR., Orlando, LA.[2019]

Genomic medicine can significantly enhance preventive healthcare by providing risk information for common conditions, allowing for tailored health plans based on individual genetic profiles.

Genetic counselors are essential in this process, as they possess the expertise needed to communicate genomic health risks and help integrate this information into personalized preventive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prospect of genome-guided preventive medicine: a need and opportunity for genetic counselors. O'Daniel, JM.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06278883

Genomic Medicine Risk Assessment Care for Everyone The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and ...

2. reporter.nih.gov reporter.nih.gov/search/tiY0xgAvaUuTi3O74xWbDQ/project-details/9968425

Building and Deploying a Genomic-Medicine Risk ... In this proposal we will define and deploy this new care delivery model as the “Genomic medicine Risk Assessment Care for Everyone” (GRACE). To this end we ...

3. withpower.com withpower.com/trial/phase-hyperthermia-1-2024-874b1

Risk Assessment for Health Risks · Info for Participants In a study involving 1,889 primary care patients across 19 clinics, 76.4% received increased risk recommendations for various medical conditions, highlighting ...

4. school.wakehealth.edu school.wakehealth.edu/research/labs/precision-health-research-lab

Precision Health Research Lab - Wake Forest School of ... Genomic medicine Risk Assessment Care for Everyone (GRACE): Family health history (FHH), a critical component of genomic medicine that is essential for both ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831645

Genomic Screening at a Single Health System Meaning In this study, genomic screening identified potentially actionable results in 1 in 30 individuals, demonstrating its utility in ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06278883/genomic-medicine-risk-assessment-care-for-everyone-implementation-phase

Genomic Medicine Risk Assessment Care for Everyone The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" project will define, deploy and evaluate a new care delivery model.

7. genome.gov genome.gov/Funded-Programs-Projects/eMERGE-Genomics-Risk-Assessment-and-Management-Network

eMERGE Genomics Risk Assessment and Management ... The eMERGE network aims to implement genomic medicine risk assessment in 20,000 individuals, measuring its impact on clinical outcomes, not a ...