Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry

Study Overview
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Brief Summary
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The purpose of this research is to learn more about the impact of genetic testing on healthcare costs, clinical care, and quality of life.

Official Title
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ECOST = Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry

Conditions
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Health Care Utilization

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tapestry patients who have received genetic results, regardless of positive or negative testing results. Age of 18 and older. Patients with an established Mayo Clinic provider prior to their enrollment in Tapestry. Exclusion Criteria: Individuals less than 18 years old. Patients without capacity to consent (i.e., needing legal authorized representatives). Prisoners. Subjects eligible for chart review, without a Minnesota Research Authorization on record.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life measured through adjusted years. | Measuring quality of life through adjusted years due to learning Tapestry test results. | Every 12 months for 5 years after enrollment. | 
| Disease incidence measured by disease count per 100 participants. | Number of disease incidences per 100 participants. | 12 months | 
| Change in utilization measured by total number of office visits, hospital stays, ER visits, and length of visits. | Composite of: Number of Office-based visits. Number of Hospital stays and length of visits. Number of ER visits. | Every 12 months for 5 years after enrollment. | 
| Change in costs measured by disease related and all-cost related costs. | Cost Composite of: Disease-related costs. Disease-related costs by utilization category. All-cause costs. All-cause costs by utilization category. | Every 12 months for 5 years after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life measured through adjusted years from subgroups. | Measuring quality of life through adjusted years due to learning Tapestry test results categorized by subgroups: minority races, 65 years and older, etc. | Every 12 months for 5 years after enrollment. | 
| Change in quality of life measured through adjusted years from different scenarios. | Measuring quality of life through adjusted years due to learning Tapestry test results categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc. | Every 12 months for 5 years after enrollment. | 
| Disease incidence from subgroups. | Number of disease incidences per 100 hundred participants categorized by subgroups: minority races, 65 years and older, etc. | 12 months | 
| Disease incidence from different scenarios.. | Number of disease incidences per 100 hundred participants categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc. | 12 months | 
| Change in utilization from subgroups. | Composite of: Number of Office-based visits. Number of Hospital stays and length of visits. Number of ER visits. All categorized by subgroups: minority races, 65 years and older, etc. | Every 12 months for 5 years after enrollment. | 
| Change in utilization from different scenarios. | Composite of: Number of Office-based visits. Number of Hospital stays and length of visits. Number of ER visits. All categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc. | Every 12 months for 5 years after enrollment. | 
| Change in costs from subgroups. | All-cause costs. All-cause costs by utilization category. All categorized by subgroups: minority races, 65 years and older, etc. | Every 12 months for 5 years after enrollment. | 
| Change in costs from different scenarios. | All-cause costs. All-cause costs by utilization category. All categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc. | Every 12 months for 5 years after enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tapestry, Quality of life - adjusted life years, ECOST