Pharmacogenetic Testing Among Home Health Patients
Status: | Completed |
---|---|
Conditions: | Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 8/31/2018 |
Start Date: | March 2015 |
End Date: | March 2016 |
A Pilot Prospective, Randomized Controlled Trial Assessing the Clinical Impact of Integrated Pharmacogenetic Testing on Selected OASIS Metrics, Re-hospitalizations and Emergency Department Visits
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.
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.
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.
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.
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.
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