Status:
COMPLETED
YouScript IMPACT Registry
Lead Sponsor:
Genelex Corporation
Collaborating Sponsors:
University of Utah
Conditions:
Adverse Drug Events
Adverse Drug Reactions
Eligibility:
All Genders
65+ years
Brief Summary
This multicenter observational study aims to investigate the benefits of providing pharmacogenetic testing with the YouScript Personalized Prescribing System which includes a clinical decision support...
Detailed Description
BACKGROUND AND RATIONALE: Genelex Corporation is a leader in comprehensive medication management based on the YouScript clinical decision support tool and DNA drug sensitivity testing. Controlling pr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA: Prospectively enrolled study participants (i.e. "tested" patients) must fulfill all of the following criteria to be eligible for enrollment into the study:
- Age 65 or older
- Willing and able to provide informed consent for study participation either directly or by a legally authorized representative (LAR)
- Undergoing testing through the YouScript Personalized Prescribing System as recommended during the course of routine care, and ordering all of the following tests: CYP2D6, CYP2C19, CYP2C9, VKORC1, CYP3A4, CYP3A5
- Currently taking at least 3 prescription medications (any route of administration)
- Initiated treatment with, or changed the dose of, at least 1 of the following oral forms of medication (excluding medications taken PRN) within the previous 120 days (generic name given with major U.S. brand name given in parentheses). These medications are subject to significant drug---gene interactions as defined by FDA boxed warning, FDA cautionary labeling, clinical literature or a YouScript algorithm---predicted significant effect:
- Amitriptyline (Elavil), Aripiprazole (Abilify), Atomoxetine (Strattera), Carvedilol (Coreg), Celecoxib (Celebrex), Citalopram (Celexa), Clobazam (Onfi), Clomipramine (Anafranil), Clopidogrel (Plavix), Clozapine (Clozaril), Codeine \[Tylenol #3 (combo)\], Desipramine (Norpramin), Dextromethorphan (Delsym), Diazepam (Valium), Doxepin (Sinequan), Escitalopram (Lexapro), Esomeprazole (Nexium), Fesoterodine (Toviaz), Flecainide (Tambocor), Fluoxetine (Prozac), Flurbiprofen (Ansaid), Fluvoxamine (Luvox), Haloperidol (Haldol), Hydrocodone (Zohydro), Ibuprofen (Motrin), Iloperidone (Fanapt), Imipramine (Tofranil), Indomethacin (Indocin), Meloxicam (Mobic), Metoprolol (Toprol-XL), Mexiletine (Mexitil), Nortriptyline (Pamelor), Omeprazole (Prilosec), Oxycodone (Oxycontin), Paroxetine (Paxil), Perphenazine (Trilafon), Phenobarbital (Luminal), Phenytoin (Dilantin), Pimozide (Orap), Piroxicam (Feldene), Proguanil \[(Malarone (combo)\], Propafenone (Rythmol), Propranolol (Inderal), Risperidone (Risperdal), Sertraline (Zoloft), Tetrabenazine (Xenazine), Thioridazine (Mellaril), Timolol (Apotimol), Tolterodine (Detrol), Torsemide (Demadex), Tramadol (Ultram), Trimipramine (Surmontil), Venlafaxine (Effexor), Voriconazole (Vfend), Vortioxetine (Brintellix)
- For a list of the inclusion criteria adapted to the "untested" patients (retrospective cohort), see the protocol.
- EXCLUSION CRITERIA: Patients (prospective and retrospective) meeting any of the following criteria will not be eligible for enrollment/inclusion in the study (ICD9 codes are included for retrospective database patients):
- Previous CYP testing (CPT codes 81225, 81226, 81227)
- History of organ transplant (199.2; 238.77; 414.06; 414.07; 996.80---996.89; E878.0; V42.0---V42.7; V42.81---V42.84; V42.89; V42.9; V45.87; V49.83; V58.44)
- Patient currently receiving intravenous antibiotics
- Currently taking immunosuppressants (azathioprine, cyclosporine, monoclonal antibodies, corticosteroids)
- Current malabsorption syndrome (579.0), including the following: Intestinal malabsorption (579.8, 579.9), Postoperative malabsorption (579.3), Short bowel syndrome (579.3)
- Current hospitalization
- Treatment of invasive solid tumors or hematologic malignancies in the last year, excluding in situ cancers or non-melanoma skin cancer (basal cell carcinoma)
- Currently malnourished, as determined by treating provider
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT02191358
Start Date
October 1 2014
End Date
August 1 2015
Last Update
March 1 2017
Active Locations (7)
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1
Dr. Michael Dao
Garden Grove, California, United States, 92844
2
Kaiser Permanente Colorado
Denver, Colorado, United States, 80011
3
Gill Heart Institute
Lexington, Kentucky, United States, 40508
4
IRC Clinics
Towson, Maryland, United States, 21204