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

• Conditions: Health Care Utilization

• Registration Number: NCT05045222
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-16
• Study Start: 2021-10-29
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24
• Primary Completion: 2031-07-31
• Study Completion: 2032-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100000

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States