Pharmacogenetic Testing Among Home Health Patients

NCT02378220 | Completed Results

• 1 other identifier: 2015-003
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Number of Re-hospitalizations at 30 and 60 Days

  The primary outcomes included the number of re-hospitalizations at 30 and 60 days.

  30 days, 60 days post discharge

• The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.

  Assessed the number of Emergency Department visits at 30 and 60 days post discharge with pharmacogenetic testing and YouScript® Personalized Prescribing system.

  30 days, 60 days post discharge

Secondary Outcomes (12)

• Time to 1st Re-hospitalization

  30 days, 60 days

• Time to 1st Emergency Department Visit

  30 days, 60 days

• Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale

  30 days, 60 days post discharge

• Pain as Measured by OASIS Scale

  30 days, 60 days post discharge

• Confusion as Measured by OASIS Scale

  30 days, 60 days post discharge

Study Arms (2)

Controls ("not tested")

NO INTERVENTION

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

Intervention ("tested")

ACTIVE COMPARATOR

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.

Genetic: Pharmacogenetic testing

Interventions

Pharmacogenetic testing GENETIC

Pharmacogenetic testing via YouScript® Personalized Prescribing System

Also known as: YouScript® Personalized Prescribing System

Intervention ("tested")

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genelex Corporation: lead
• Harding University: collaborator

Study Sites (1)

White County Medical Center Home Health

Searcy, Arkansas, 72143, United States

Location

Related Publications (1)

• 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.

  PMID: 28151991 RESULT

Related Links

• Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial
• PGx Testing Firm Genelex Publishes RCT, Spins Out Analytics Unit in Effort to Improve Adoption
• Genomics, Clinical Decision Support Combo Cuts ED Visits by 42%

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Drug Metabolism, Poor, CYP2D6-Related; Drug Metabolism, Poor, CYP2C19-Related

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Limitations and Caveats

The limitations of this study include small sample size, use of a randomized population within one institution and undetermined impact of the genetic testing on patient-provider interactions.

Results Point of Contact

• Title: Lindsay Elliott
• Organization: Harding University College of Pharmacy / Unity Health - White County Medical Center, Searcy, Arkansas, USA

lselliott@harding.edu

5012794800

Study Officials

• Lindsay Elliott, PharmD

  Harding University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 4, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 20, 2019
• Results First Posted: August 29, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)