CompletedNot Applicable

YouScript IMPACT Registry

United States800 participantsStarted 2014-10

Plain-language 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 tool and individualized pharmacist recommendations to elderly polypharmacy patients who are most at risk of adverse drug events. The YouScript system is unique in identifying drug-gene, and drug-drug-gene interactions that are missed by existing systems, and represent over 35% of significant interaction warnings. Data analysis will assess the impact of recommendations for medication changes on clinical decision making, patient outcomes, and healthcare resource utilization to determine which medications, specialties, or patient segments derive the greatest benefit from this intervention. Data gathered from patients enrolled in this study will be compared to patients matched on key characteristics from Inovalon's MORE2 healthcare database.

Who can participate

Age range65 Years

SexALL

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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 …

What they're measuring

Healthcare Resource Utilization

Timeframe: 120 days

Trial details

NCT IDNCT02191358

SponsorGenelex Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-08