Pharmacogenetic Testing Among Home Health Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing. In this open-label trial, a pharmacist will make medication therapy recommendations using YouScript® Personalized Prescribing System for patients who receive genetic testing and standard drug information resources per usual for patients who do not undergo pharmacogenetic testing.

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Detailed Description

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Both groups will be followed for 60 days. The number of re-hospitalizations and emergency department (ED) visits will be recorded as well as time to first re-hospitalization and time to first ED visit. Select Outcome and Assessment Information Set (OASIS) metrics (e.g. M1034, M1242, M1710, M1720, M1745, M2110) and Patient Health Questionnaire (PHQ)-2 will be evaluated and documented at time of admission to home health, at 30 days, and at 60 days for improvement in overall status, pain, confusion, anxiety, depression, disruptive behavior, and the need for assistance with activities of daily living (ADLs) and instrumental activities of daily living (IADLs). The number of falls will be collected as well as the proportion of YouScript® recommendations accepted by study pharmacist and passed on to clinicians and the proportion of recommendations accepted by clinicians.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Controls ("not tested")

Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention ("tested")

Patients in the "tested" group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug interactions (DDI), drug-gene interactions (DGI), and drug-drug-gene interactions (DDGI) using YouScript® to provide drug therapy recommendations to prescribers.

Group Type ACTIVE_COMPARATOR

Pharmacogenetic testing

Intervention Type GENETIC

Pharmacogenetic testing via YouScript® Personalized Prescribing System

Interventions

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Pharmacogenetic testing

Pharmacogenetic testing via YouScript® Personalized Prescribing System

Intervention Type GENETIC

Other Intervention Names

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YouScript® Personalized Prescribing System

Eligibility Criteria

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Inclusion Criteria

* Age 50 or older.
* Willing and able to provide informed consent for study participation either directly or by a legally authorized representative (LAR).
* Presently taking or beginning treatment with at least one of the following oral forms of medication (excluding medications taken PRN) (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 , 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), Warfarin (Coumadin).

Exclusion Criteria

* Previous CYP testing (CPT codes 81225, 81226, 81227, 81355, 81401)
* 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)
* Current malabsorption syndrome (579.0), including the following: Intestinal malabsorption (579.8, 579.9), Postoperative malabsorption (579.3), or Short bowel syndrome (579.3)
* Treatment of invasive solid tumors or hematologic malignancies in the last year, excluding in situ cancers or non-melanoma skin cancer (basal cell carcinoma)
* End Stage Renal Disease (ESRD)
* Persistent acute renal failure: complete loss of kidney function \>4 weeks (requiring dialysis)
* Renal failure by: Glomerular filtration rater (GFR): SCr \> 3 times baseline or GFR decreased 75% or SCr ≥4 mg/dL; acute rise ≥0.5 mg/dL; OR Urine Output (UO): UO \< 0.3 mL/kg/h 24 h (oliguria) or anuria 12 h.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No