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Trial record 12 of 12 for:    pimozide

YouScript IMPACT Registry (IMPACT)

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ClinicalTrials.gov Identifier: NCT02191358
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Genelex Corporation

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.

Condition or disease
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

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: YouScript IMPACT (Improving Medication Protocols and Abating Cost of Treatment) Registry
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Group/Cohort
"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.



Primary Outcome Measures :
  1. Healthcare Resource Utilization [ Time Frame: 120 days ]
    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.


Secondary Outcome Measures :
  1. Clinical decision-making [ Time Frame: 120 days ]
    A secondary objective is to assess the impact of the YouScript Personalized Prescribing System on clinical decision-making, including risk modification through dosage adjustment. This will involve comparing changes in drug regimen/dose, as well as reasons for any changes and healthcare provider survey/question regarding the role and usefulness of YouScript in clinical decision making/or medication change for the tested group versus the untested group.

  2. Adverse Drug Events [ Time Frame: 120 days ]
    A secondary objective is to assess the impact of the YouScript Personalized Prescribing System on the number of adverse drug events experienced by patients. This will involve comparing the number of adverse events experienced by patients along with severity and relatedness for the tested group versus the untested group.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191358


Locations
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United States, California
Dr. Michael Dao
Garden Grove, California, United States, 92844
United States, Colorado
Kaiser Permanente Colorado
Denver, Colorado, United States, 80011
United States, Kentucky
Gill Heart Institute
Lexington, Kentucky, United States, 40508
United States, Maryland
IRC Clinics
Towson, Maryland, United States, 21204
United States, Massachusetts
Internal Medicine & Cardiology Associates
Fall River, Massachusetts, United States, 02720
Prima CARE
Fall River, Massachusetts, United States, 02720
United States, Virginia
Carilion Clinic
Christiansburg, Virginia, United States, 24073
Sponsors and Collaborators
Genelex Corporation
University of Utah
Investigators
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Principal Investigator: Diana Brixner, PhD, RPh University of Utah

Additional Information:
Publications of Results:
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Responsible Party: Genelex Corporation
ClinicalTrials.gov Identifier: NCT02191358     History of Changes
Other Study ID Numbers: Genelex 2014-01
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: September 2015
Keywords provided by Genelex Corporation:
Pimozide
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
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders