N/A
N=110
Pharmacogenetic Testing Among Home Health Patients
Adverse Drug Events · Adverse Drug Reactions · Drug Interaction Potentiation · Drug Metabolism, Poor, CYP2D6-RELATED · Drug Metabolism, Poor, CYP2C19-RELATED
Bottom Line
View on ClinicalTrials.gov: NCT02378220 ↗Enrolled (actual)
110
Serious AEs
—
Results posted
Aug 2018
Primary outcome: Primary: Number of Re-hospitalizations at 30 and 60 Days — 0.38; 0.25; 0.7; 0.33 Re-hospitalizations — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacogenetic testing (Genetic)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Genelex Corporation
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Re-hospitalizations at 30 and 60 Days |
0.38; 0.25; 0.7; 0.33 | 0.21 |
| PRIMARY The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. |
0.40; 0.25; 0.66; 0.39 | 0.16 |
| SECONDARY Time to 1st Re-hospitalization |
29; 19; 43; 28 | 0.10 |
| SECONDARY Time to 1st Emergency Department Visit |
30; 23; 49; 32 | 0.09 |
| SECONDARY Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale |
1.00; 1.11; 0.76; 0.71 | — |
| SECONDARY Pain as Measured by OASIS Scale |
1.02; 1.16; 1.19; 1.49 | — |
| SECONDARY Confusion as Measured by OASIS Scale |
0.49; 0.66; 0.79; 0.61 | — |
| SECONDARY Anxiety as Measured by OASIS Scale |
0.51; 0.41; 0.67; 0.55 | — |
| SECONDARY Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale |
0.06; 0.16; 0.59; 0.35 | — |
| SECONDARY Disruptive Behavior as Measured by OASIS Scale |
0.06; 0.05; 0.45; 0.14 | — |
| SECONDARY Activities of Daily Living as Measured by OASIS Scale |
2.72; 2.30; 2.86; 2.76 | — |
| SECONDARY Number of Falls as Measured by Tabulation |
0.09; 0.11 | — |
| SECONDARY Number of Pharmacist-accepted of Recommendations as Measured by Tabulation |
124; 124 | — |
| SECONDARY Number of Clinician-accepted of Recommendations as Measured by Tabulation |
124; 96; 6; 22 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02378220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.