YouScript IMPACT Registry

NCT02191358 | Completed

• 1 other identifier: Genelex 2014-01
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Adverse Drug Events; Adverse Drug Reactions; Drug Interaction Potentiation; Drug Metabolism, Poor, CYP2D6-RELATED; Drug Metabolism, Poor, CYP2C19-RELATED; Cytochrome P450 Enzyme Deficiency; Cytochrome P450 CYP2D6 Enzyme Deficiency; Cytochrome P450 CYP2C9 Enzyme Deficiency; Cytochrome P450 CYP2C19 Enzyme Deficiency; Cytochrome P450 CYP3A Enzyme Deficiency; Poor Metabolizer Due to Cytochrome P450 CYP2C9 Variant; Poor Metabolizer Due to Cytochrome P450 CYP2C19 Variant; Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant

Keywords

Cytochrome drug interactions; Drug-drug interaction; Drug-gene interaction; Drug-drug-gene interaction; Drug Metabolism; Elderly; Geriatric medicine; Geriatrics; Personalized medicine; Pharmacist; Pharmacogenetics; Pharmacogenomics; Pharmacokinetics; Polymorphism; Polypharmacy; Precision medicine; Seniors; YouScript; CYP2C9; CYP2C19; CYP2D6; CYP3A4; CYP3A5; VKORC1; Amitriptyline; Aripiprazole; Atomoxetine; Carvedilol; Celecoxib; Citalopram; Clobazam; Clomipramine; Clopidogrel; Clozapine; Codeine; Desipramine; Dextromethorphan; Diazepam; Doxepin; Escitalopram; Esomeprazole; Fesoterodine; Flecainide; Fluoxetine; Flurbiprofen; Fluvoxamine; Haloperidol; Hydrocodone; Ibuprofen; Iloperidone; Imipramine; Indomethacin; Meloxicam; Metoprolol; Mexiletine; Nortriptyline; Omeprazole; Oxycodone; Paroxetine; Perphenazine; Phenobarbital; Phenytoin; Pimozide; Piroxicam; Proguanil; Propafenone; Propranolol; Risperidone; Sertraline; Tetrabenazine; Thioridazine; Timolol; Tolterodine; Torsemide; Tramadol; Trimipramine; Venlafaxine; Voriconazole; Vortioxetine

Outcome Measures

Primary Outcomes (1)

• Healthcare Resource Utilization

  The primary objective is to determine the impact of the YouScript Personalized Prescribing System on healthcare resource utilization. This will involve comparing the number of hospitalizations, number of ER visits, number of provider office visits, number of radiographic procedures, and number of surgeries for the tested group versus the untested group.

  120 days

Secondary Outcomes (2)

• Clinical decision-making

  120 days

• Adverse Drug Events

  120 days

Study Arms (2)

"Tested" patients (prospective)

Patients whose providers decide to have them undergo testing via the YouScript Personalized Prescribing System will be recruited for the study. Data will be gathered at baseline and 120 days later. The decision to utilize YouScript and all treatment decisions will be made at the discretion of the provider in accordance with their usual care practice, and will be made prior to the decision to participate in the study.

"Untested" patients (retrospective)

Patients for comparison to the prospectively followed patients will be derived from Inovalon's MORE2 healthcare database. Patients meeting the same enrollment criteria (excluding the YouScript testing) will be matched on key characteristics to the tested patients. Outcomes will be compared between the prospectively enrolled patients undergoing pharmacogenetic testing with the YouScript Personalized Prescribing System at the discretion of their treating physician.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study consists of patients age 65 and older who are currently on or initiating treatment with at least one oral form of medication (excluding medications taken PRN) with a significant drug-gene interaction as defined by black box warning, FDA cautionary labeling, clinical literature or a YouScript algorithm-predicted significant effect. Those meeting eligibility criteria and undergoing YouScript testing according to their provider's usual care practice will be eligible for prospective enrollment into the "tested" group. Those included in Inovalon's MORE2 healthcare database meeting enrollment criteria between January 1, 2013 and June 30, 2013 will be eligible for inclusion in the "untested" group.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genelex Corporation: lead
• University of Utah: collaborator

Study Sites (7)

Dr. Michael Dao

Garden Grove, California, 92844, United States

Location

Kaiser Permanente Colorado

Denver, Colorado, 80011, United States

Location

Gill Heart Institute

Lexington, Kentucky, 40508, United States

Location

IRC Clinics

Towson, Maryland, 21204, United States

Location

Internal Medicine & Cardiology Associates

Fall River, Massachusetts, 02720, United States

Location

Prima CARE

Fall River, Massachusetts, 02720, United States

Location

Carilion Clinic

Christiansburg, Virginia, 24073, United States

Location

Related Publications (1)

• Brixner D, Biltaji E, Bress A, Unni S, Ye X, Mamiya T, Ashcraft K, Biskupiak J. The effect of pharmacogenetic profiling with a clinical decision support tool on healthcare resource utilization and estimated costs in the elderly exposed to polypharmacy. J Med Econ. 2016;19(3):213-28. doi: 10.3111/13696998.2015.1110160. Epub 2015 Nov 11.

  PMID: 26478982 RESULT

Related Links

• Sponsor website
• New research shows YouScript cuts ER visits, hospitalizations
• Genelex Publishes Study Hoping to Improve PGx Panel Test Reimbursement; Medicare Remains Unconvinced
• ER visits decline 71%, hospitalizations 39% in elderly patients evaluated by predictive medication analytics system and DNA testing

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Drug Metabolism, Poor, CYP2D6-Related; Drug Metabolism, Poor, CYP2C19-Related; Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, Type 2

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Diana Brixner, PhD, RPh

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 1, 2017

Record last verified: 2015-09

Locations

US (7)