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Trial record 27 of 1104 for:    pharmacogenomics OR pharmacogenetics

Pharmacogenetic Testing Among Home Health Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378220
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : August 29, 2018
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Harding University
Information provided by (Responsible Party):
Genelex Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
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
Intervention Genetic: Pharmacogenetic testing
Enrollment 110
Recruitment Details Study was conducted at a hospital-based HHA in Searcy, Arkansas. The study population was derived from patient referrals to home health upon hospital discharge. Of 655 patients assessed for eligibility, 412 did not meet the inclusion criteria and 133 patients declined to participate.
Pre-assignment Details Exclusion criteria were the same for tested and untested groups and included patients previously tested for CYP 450, history of organ transplant, current malabsorption, treatment of invasive solid tumors or hematologic malignancies in the last year, end stage renal disease or current dialysis.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Period Title: Overall Study
Started [1] 53 57
Completed 47 56
Not Completed 6 1
Reason Not Completed
Death             6             1
[1]
Patients were enrolled from Feb 2015 to Dec 2015 with follow-up ending in Feb 2016.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested") Total
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Total of all reporting groups
Overall Number of Baseline Participants 53 57 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 57 participants 110 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  26.4%
6
  10.5%
20
  18.2%
>=65 years
39
  73.6%
51
  89.5%
90
  81.8%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 57 participants 110 participants
74.6  (11.9) 76.5  (9.4) 75.6  (10.7)
[1]
Measure Description: Baseline data was extracted from patient charts & manually entered into the study database.Study pharmacist reviewed DDIs, DGIs, and cumulative drug and/or gene interactions in the tested group using the YouScript generated reports and CDST to provide drug therapy recommendations to clinicians, after which prescriptions were altered at clinician discretion. Patients in the untested group were screened for DDIs using standard drug information resources (Lexicomp) with recommendations acted on according to clinician judgment. Time to change therapy was similar to those in the tested group.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 57 participants 110 participants
Female
36
  67.9%
32
  56.1%
68
  61.8%
Male
17
  32.1%
25
  43.9%
42
  38.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 57 participants 110 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.9%
0
   0.0%
1
   0.9%
White
52
  98.1%
57
 100.0%
109
  99.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 57 participants 110 participants
53 57 110
OASIS Metrics   [1] 
Mean (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 53 participants 57 participants 110 participants
OVERALL OASIS SCORE
1.63
(0 to 3)
1.64
(0 to 3)
1.63
(0 to 3)
AVERAGE PHARMACOGENETIC RISK
34.3
(0 to 73)
33.2
(0 to 63)
33.75
(0 to 73)
[1]
Measure Description:

OASIS (Outcome and Assessment Information Set) Score represents an outcome measure in home health at an individual patient level to plan care, measure quality, and calculate reimbursement. On an overall scale of 0 to 3, a lower number represents a better outcome.

Average Pharmacogenetic Risk score estimates individual patient risk of having at least one significant adverse drug event due to genetic variation. Total range is 0 to 100, representing percentage, where a larger number indicates a higher risk.

1.Primary Outcome
Title Number of Re-hospitalizations at 30 and 60 Days
Hide Description The primary outcomes included the number of re-hospitalizations at 30 and 60 days.
Time Frame 30 days, 60 days post discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Primary outcomes included the number of re-hospitalizations between the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Re-hospitalizations
Re-hospitalizations at 30 Days
0.38
(0 to 2)
0.25
(0 to 3)
Re-hospitalizations at 60 Days
0.7
(0 to 3)
0.33
(0 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Controls ("Not Tested"), Intervention ("Tested")
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments P-value for 30 days measure.
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.32 to 1.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Controls ("Not Tested"), Intervention ("Tested")
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-Value for 60 days measure
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.27 to 0.82
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcomes assessed the number of emergency department visits between the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: ED visits
ED Visits at 30 Days
0.40
(0 to 2)
0.25
(0 to 2)
ED Visits at 60 Days
0.66
(0 to 4)
0.39
(0 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Controls ("Not Tested"), Intervention ("Tested")
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments P-Value for 30 days measure
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.31 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Controls ("Not Tested"), Intervention ("Tested")
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.34 to 0.99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to 1st Re-hospitalization
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
We compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Measure Type: Number
Unit of Measure: Percentage of participants
Cumulative Percentage Events at 30 Days 29 19
Cumulative Percentage Events at 60 Days 43 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Controls ("Not Tested"), Intervention ("Tested")
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.31 to 1.12
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to 1st Emergency Department Visit
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Measure Type: Number
Unit of Measure: Percentage of participants
Cumulative Percentage Events at 30 Days 30 23
Cumulative Percentage Events at 60 Days 49 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Controls ("Not Tested"), Intervention ("Tested")
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.33 to 1.10
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcomes assessed the overall status according to OASIS M1034 of the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Scores on a scale
OASIS M1034 at 30 Days
1.00
(0 to 2)
1.11
(0 to 3)
OASIS M1034 at 60 Days
0.76
(0 to 3)
0.71
(0 to 3)
6.Secondary Outcome
Title Pain as Measured by OASIS Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcomes assessed frequency of pain according to OASIS M1242 of the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Scores on a scale
OASIS M1242 at 30 Days
1.02
(0 to 4)
1.16
(0 to 4)
OASIS M1242 at 60 Days
1.19
(0 to 4)
1.49
(0 to 4)
7.Secondary Outcome
Title Confusion as Measured by OASIS Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcomes assessed frequency of confusion according to OASIS M1710 of the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Scores on a scale
OASIS M1710 at 30 Days
0.49
(0 to 4)
0.66
(0 to 3)
OASIS M1710 at 60 Days
0.79
(0 to 4)
0.61
(0 to 4)
8.Secondary Outcome
Title Anxiety as Measured by OASIS Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcomes assessed frequency of anxiety according to OASIS M1720 of the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Scores on a scale
OASIS M1720 at 30 Days
0.51
(0 to 3)
0.41
(0 to 2)
OASIS M1720 at 60 Days
0.67
(0 to 3)
0.55
(0 to 2)
9.Secondary Outcome
Title Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcomes assessed feelings of depression according to PHQ-2 of the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Scores on a scale
OASIS PHQ-2 at 30 Days
0.06
(0 to 1)
0.16
(0 to 2)
OASIS PHQ-2 at 60 Days
0.59
(0 to 3)
0.35
(0 to 2)
10.Secondary Outcome
Title Disruptive Behavior as Measured by OASIS Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcomes assessed frequency of disruptive behavior according to OASIS M1745 of the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Scores on a scale
OASIS M1745 at 30 Days
0.06
(0 to 1)
0.05
(0 to 1)
OASIS M1745 at 60 Days
0.45
(0 to 5)
0.14
(0 to 3)
11.Secondary Outcome
Title Activities of Daily Living as Measured by OASIS Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcomes assessed frequency of ADL and IADL according to OASIS M2110 of the tested group and the untested group at 30 and 60 days post-discharge.
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Scores on a scale
OASIS M2110 at 30 Days
2.72
(1 to 5)
2.30
(1 to 5)
OASIS M2110 at 60 Days
2.86
(1 to 5)
2.76
(1 to 5)
12.Secondary Outcome
Title Number of Falls as Measured by Tabulation
Hide Description To assess whether YouScript® testing decreases falls
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 53 57
Mean (Full Range)
Unit of Measure: Falls
0.09
(0 to 1)
0.11
(0 to 1)
13.Secondary Outcome
Title Number of Pharmacist-accepted of Recommendations as Measured by Tabulation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the "tested" group accepted by the study pharmacist and passed to clinicians.
Arm/Group Title Intervention ("Tested")
Hide Arm/Group Description:

Patients in the “tested” group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: recommendations
Number of YouScript® Recommendations Made 124
Number of YouScript® Recommendations Accepted 124
14.Secondary Outcome
Title Number of Clinician-accepted of Recommendations as Measured by Tabulation
Hide Description To assess the proportion of study pharmacist recommendations acted on by clinicians.
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the "tested" group acted on by clinicians.
Arm/Group Title Intervention ("Tested")
Hide Arm/Group Description:

Patients in the “tested” group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: recommendations
Number of Recommendations Passed to Clinicians 124
Number of Recommendations Followed 96
Number of Recommendations Not Followed 6
Number of Unknown Status Recommendations 22
Time Frame We compared primary and exploratory composite outcomes (re-hospitalizations, ED visits and mortality) between the tested group and the untested group at 30 and 60 days post-discharge. The adverse events were not recorded.
Adverse Event Reporting Description The adverse events were not tracked and was not an outcome of our study. However, we compared differences in the distribution of CYP 450 metabolic phenotypes, and differences in the severity of drug-drug interactions (DDI) (binary and cumulative), drug-gene interactions (DGI), or drug-drug-gene interactions (DDGI) between this home health trial and another published study population.
 
Arm/Group Title Controls ("Not Tested") Intervention ("Tested")
Hide Arm/Group 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, drug-gene, and drug-drug-gene interactions using YouScript® to provide drug therapy recommendations to prescribers.

Pharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System

All-Cause Mortality
Controls ("Not Tested") Intervention ("Tested")
Affected / at Risk (%) Affected / at Risk (%)
Total   6/53 (11.32%)   1/57 (1.75%) 
Show Serious Adverse Events Hide Serious Adverse Events
Controls ("Not Tested") Intervention ("Tested")
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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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lindsay Elliott
Organization: Harding University College of Pharmacy / Unity Health – White County Medical Center, Searcy, Arkansas, USA
Phone: 5012794800
EMail: lselliott@harding.edu
Layout table for additonal information
Responsible Party: Genelex Corporation
ClinicalTrials.gov Identifier: NCT02378220     History of Changes
Other Study ID Numbers: 2015-003
First Submitted: February 24, 2015
First Posted: March 4, 2015
Results First Submitted: February 27, 2017
Results First Posted: August 29, 2018
Last Update Posted: September 20, 2019