Clinical trial NCT02378220: Pharmacogenetic Testing Among Home Health Patients
Official title: A Pilot Prospective, Randomized Controlled Trial Assessing the Clinical Impact of Integrated Pharmacogenetic Testing on Selected OASIS Metrics, Re-hospitalizations and Emergency Department Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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: Home Care Agencies
Home Health Care Agencies
Home Health Care Nursing
Home Health Nurses
CYP 2D6
CYP 2C9
CYP 2C19
CYP 3A4
CYP 3A5
Lead sponsor: Genelex Corporation
Sponsor class: INDUSTRY
Collaborators: name: Harding University
First posted: 2015-03-04
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Number of Re-hospitalizations at 30 and 60 Days
timeFrame: 30 days, 60 days post discharge
measure: The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.
timeFrame: 30 days, 60 days post discharge
Secondary outcomes:
measure: Time to 1st Re-hospitalization
timeFrame: 30 days, 60 days
measure: Time to 1st Emergency Department Visit
timeFrame: 30 days, 60 days
measure: Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale
timeFrame: 30 days, 60 days post discharge
measure: Pain as Measured by OASIS Scale
timeFrame: 30 days, 60 days post discharge
measure: Confusion as Measured by OASIS Scale
timeFrame: 30 days, 60 days post discharge
measure: Anxiety as Measured by OASIS Scale
timeFrame: 30 days, 60 days post discharge
measure: Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale
timeFrame: 30 days, 60 days post discharge
measure: Disruptive Behavior as Measured by OASIS Scale
timeFrame: 30 days, 60 days post discharge
measure: Activities of Daily Living as Measured by OASIS Scale
timeFrame: 30 days, 60 days post discharge
measure: Number of Falls as Measured by Tabulation
timeFrame: 60 days
measure: Number of Pharmacist-accepted of Recommendations as Measured by Tabulation
timeFrame: 60 days
measure: Number of Clinician-accepted of Recommendations as Measured by Tabulation
timeFrame: 60 days
Other outcomes:
Locations:
city: Searcy
country: United States
facility: White County Medical Center Home Health
state: Arkansas
Study officials:
affiliation: Harding University
name: Lindsay Elliott, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott LS, Henderson JC, Neradilek MB, Moyer NA, Ashcraft KC, Thirumaran RK. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial. PLoS One. 2017 Feb 2;12(2):e0170905. doi: 10.1371/journal.pone.0170905. eCollection 2017.