protocolSection identificationModule nctId: NCT06278883, orgStudyIdInfo id: Pro00115007, secondaryIdInfos id: R01HG011794, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HG011794, briefTitle: Genomic Medicine Risk Assessment Care for Everyone - Implementation Phase, acronym: GRACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: National Human Genome Research Institute (NHGRI), descriptionModule briefSummary: 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., conditionsModule conditions: Cardiovascular Diseases, conditions: Cancer, conditions: Liver Diseases, conditions: Hyperthermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Everyone who consents is enrolled in the risk assessment pipeline., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: Disease Risk Assessment, outcomesModule primaryOutcomes measure: Reach of genomic risk assessment, primaryOutcomes measure: Utility of genomic risk assessment, primaryOutcomes measure: Uptake of genetic counseling risk recommendations by the participant, primaryOutcomes measure: Uptake of genetic testing recommendations by the provider, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UF Health Callahan, city: Callahan, state: Florida, zip: 32011, country: United States, geoPoint lat: 30.56218, lon: -81.83066, locations facility: UF Health Murray Hill, city: Jacksonville, state: Florida, zip: 32205, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: UF Health Normandy, city: Jacksonville, state: Florida, zip: 32221, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: UF Health Kernan Square, city: Jacksonville, state: Florida, zip: 32246, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: UF Health Augustine Oaks, city: Jacksonville, state: Florida, zip: 32258, country: United States, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False