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

Health Care Utilization Clinical Trial

— ECOST  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05045222
• Other study ID #: 20-010400
• Status: Enrolling by invitation
• Start date: October 29, 2021
• Est. completion date: July 31, 2032

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100000
• Est. completion date: July 31, 2032
• Est. primary completion date: July 31, 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Care Utilization

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Disease incidence measured by disease count per 100 participants.	Number of disease incidences per 100 participants.	12 months
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Disease incidence from subgroups.	Number of disease incidences per 100 hundred participants categorized by subgroups: minority races, 65 years and older, etc.	12 months
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Mayo Clinic Clinical Trials