To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).
The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through Indiana University. The study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. All genetic test results will be returned to participants through a genetic counseling visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
1,982
Counseling provided to participant by site clinician/physician/genetic counselor.
Counseling provided to participant by centralized genetic counseling group at Indiana University.
Barrow Neurological Institute
Phoenix, Arizona, United States
University of California San Diego (UCSD)
La Jolla, California, United States
University of Miami
Fort Lauderdale, Florida, United States
Feasibility of genetic testing and counseling
The total number of participants who receive genetic testing and counseling.
Time frame: up to 24 weeks
Impact Evaluation
The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling.
Time frame: up to 6 months
Satisfaction Comparison
Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score.
Time frame: up to 6 months
Number of participants that enroll in precision medicine trials
Number of participants that enroll in precision medicine trials
Time frame: up to 12 months
Time it takes between first contact to the return of genetic test results
Number of weeks it takes between participant consent to return of genetic test results.
Time frame: up to 12 months
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Cleveland Clinic Florida-Weston
Weston, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Health Partners/Park Nicollet: Struthers Parkinson's Center
Minneapolis, Minnesota, United States
Beth Israel Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
...and 3 more locations