Back to resultsPharmacogenetic Testing Among Home Health Patients
Primary Purpose
Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacogenetic testing
Sponsored by
About this trial
This is an interventional other trial for Adverse Drug Events focused on measuring Home Care Agencies, Home Health Care Agencies, Home Health Care Nursing, Home Health Nurses, CYP 2D6, CYP 2C9, CYP 2C19, CYP 3A4, CYP 3A5
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.
Sites / Locations
- White County Medical Center Home Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Controls ("not tested")
Intervention ("tested")
Arm Description
Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)
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.
Outcomes
Primary Outcome Measures
Number of Re-hospitalizations at 30 and 60 Days
The primary outcomes included the number of re-hospitalizations at 30 and 60 days.
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.
Secondary Outcome Measures
Time to 1st Re-hospitalization
To assess time to first re-hospitalization, we compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects re-hospitalized before or at 30 and 60 days.
Time to 1st Emergency Department Visit
To assess time to first emergency department visit, we compared the exploratory time-to-event outcomes (time to 1st ED visit) between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects who visited the emergency department before or at 30 and 60 days.
Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale
We assessed the impact of genetic testing on overall status according to OASIS M1034 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1034, one data point in the OASIS system, measures overall patient status on a scale of 0 to 3, with a lower score indicating better overall status.
Pain as Measured by OASIS Scale
We assessed the impact of genetic testing on patient pain frequency according to OASIS M1242 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1242, one data point in the OASIS system, measures patient pain frequency on a scale of 0 to 4, with a lower score indicating less frequent pain.
Confusion as Measured by OASIS Scale
We assessed the impact of genetic testing on frequency of confusion according to OASIS M1710 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1710, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 4, with a lower score indicating less frequent confusion.
Anxiety as Measured by OASIS Scale
We assessed the impact of genetic testing on frequency of anxiety according to OASIS M1720 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1720, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 3, with a lower score indicating less frequent confusion.
Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale
We assessed the impact of genetic testing on frequency of depressive mood according to PHQ-2 at 30 and 60 days post discharge. PHQ-2 evaluates patient depression by assessing two factors: frequency of little interest or pleasure in doing things and frequency of feeling down, depressed, or hopeless. This outcome measure assessed the second factor, frequency of feeling down or depressed. The scale for this factor ranges from 0 to 3, with a lower score represented less frequent depressive feelings.
Disruptive Behavior as Measured by OASIS Scale
We assessed the impact of genetic testing on frequency of disruptive behavior according to OASIS M1745 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1745, one data point in the OASIS system, measures frequency of disruptive behavior by patient on a scale of 0 to 5, with a lower score indicating less frequent disruptive behavior.
Activities of Daily Living as Measured by OASIS Scale
We assessed the impact of genetic testing on the frequency of activities of daily living (ADL) and instrumental activities of daily living (IADL) assistance according to OASIS M2110 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M2110, one data point in the OASIS system, measures frequency of receiving ADL/IADL assistance on a scale of 0 to 5, with a lower score indicating less frequent assistance.
Number of Falls as Measured by Tabulation
To assess whether YouScript® testing decreases falls
Number of Pharmacist-accepted of Recommendations as Measured by Tabulation
To assess the proportion of YouScript® Personalized Prescribing System recommendations accepted by the study pharmacist and passed on to clinicians.
Number of Clinician-accepted of Recommendations as Measured by Tabulation
To assess the proportion of study pharmacist recommendations acted on by clinicians.
Full Information
NCT ID
NCT02378220
First Posted
February 24, 2015
Last Updated
September 18, 2019
Sponsor
Genelex Corporation
Collaborators
Harding University
1. Study Identification
Unique Protocol Identification Number
NCT02378220
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genelex Corporation
Collaborators
Harding University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controls ("not tested")
Arm Type
No Intervention
Arm Description
Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)
Arm Title
Intervention ("tested")
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
Pharmacogenetic testing
Other Intervention Name(s)
YouScript® Personalized Prescribing System
Intervention Description
Pharmacogenetic testing via YouScript® Personalized Prescribing System
Primary Outcome Measure Information:
Title
Number of Re-hospitalizations at 30 and 60 Days
Description
The primary outcomes included the number of re-hospitalizations at 30 and 60 days.
Time Frame
30 days, 60 days post discharge
Title
The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.
Description
Assessed the number of Emergency Department visits at 30 and 60 days post discharge with pharmacogenetic testing and YouScript® Personalized Prescribing system.
Time Frame
30 days, 60 days post discharge
Secondary Outcome Measure Information:
Title
Time to 1st Re-hospitalization
Description
To assess time to first re-hospitalization, we compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects re-hospitalized before or at 30 and 60 days.
Time Frame
30 days, 60 days
Title
Time to 1st Emergency Department Visit
Description
To assess time to first emergency department visit, we compared the exploratory time-to-event outcomes (time to 1st ED visit) between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects who visited the emergency department before or at 30 and 60 days.
Time Frame
30 days, 60 days
Title
Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale
Description
We assessed the impact of genetic testing on overall status according to OASIS M1034 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1034, one data point in the OASIS system, measures overall patient status on a scale of 0 to 3, with a lower score indicating better overall status.
Time Frame
30 days, 60 days post discharge
Title
Pain as Measured by OASIS Scale
Description
We assessed the impact of genetic testing on patient pain frequency according to OASIS M1242 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1242, one data point in the OASIS system, measures patient pain frequency on a scale of 0 to 4, with a lower score indicating less frequent pain.
Time Frame
30 days, 60 days post discharge
Title
Confusion as Measured by OASIS Scale
Description
We assessed the impact of genetic testing on frequency of confusion according to OASIS M1710 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1710, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 4, with a lower score indicating less frequent confusion.
Time Frame
30 days, 60 days post discharge
Title
Anxiety as Measured by OASIS Scale
Description
We assessed the impact of genetic testing on frequency of anxiety according to OASIS M1720 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1720, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 3, with a lower score indicating less frequent confusion.
Time Frame
30 days, 60 days post discharge
Title
Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale
Description
We assessed the impact of genetic testing on frequency of depressive mood according to PHQ-2 at 30 and 60 days post discharge. PHQ-2 evaluates patient depression by assessing two factors: frequency of little interest or pleasure in doing things and frequency of feeling down, depressed, or hopeless. This outcome measure assessed the second factor, frequency of feeling down or depressed. The scale for this factor ranges from 0 to 3, with a lower score represented less frequent depressive feelings.
Time Frame
30 days, 60 days post discharge
Title
Disruptive Behavior as Measured by OASIS Scale
Description
We assessed the impact of genetic testing on frequency of disruptive behavior according to OASIS M1745 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1745, one data point in the OASIS system, measures frequency of disruptive behavior by patient on a scale of 0 to 5, with a lower score indicating less frequent disruptive behavior.
Time Frame
30 days, 60 days post discharge
Title
Activities of Daily Living as Measured by OASIS Scale
Description
We assessed the impact of genetic testing on the frequency of activities of daily living (ADL) and instrumental activities of daily living (IADL) assistance according to OASIS M2110 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M2110, one data point in the OASIS system, measures frequency of receiving ADL/IADL assistance on a scale of 0 to 5, with a lower score indicating less frequent assistance.
Time Frame
30 days, 60 days post discharge
Title
Number of Falls as Measured by Tabulation
Description
To assess whether YouScript® testing decreases falls
Time Frame
60 days
Title
Number of Pharmacist-accepted of Recommendations as Measured by Tabulation
Description
To assess the proportion of YouScript® Personalized Prescribing System recommendations accepted by the study pharmacist and passed on to clinicians.
Time Frame
60 days
Title
Number of Clinician-accepted of Recommendations as Measured by Tabulation
Description
To assess the proportion of study pharmacist recommendations acted on by clinicians.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Elliott, PharmD
Organizational Affiliation
Harding University
Official's Role
Principal Investigator
Facility Information:
Facility Name
White County Medical Center Home Health
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28151991
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.
Results Reference
result
Links:
URL
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170905
Description
Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial
URL
http://healthitanalytics.com/news/genomics-clinical-decision-support-combo-cuts-ed-visits-by-42
Description
Genomics, Clinical Decision Support Combo Cuts ED Visits by 42%
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Pharmacogenetic Testing Among Home Health Patients
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