Pharmacogenetic Testing Among Home Health Patients

• Sponsor: Genelex Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02378220
• Collaborator: Harding University (Other)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 9.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Genetic: Pharmacogenetic testing	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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 Start Date: Mar 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Controls ("not tested") Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)
Active Comparator: Intervention ("tested") 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; Pharmacogenetic testing via YouScript® Personalized Prescribing System; Other Names: YouScript® Personalized Prescribing System

Outcome Measures

Primary Outcome Measures

1. Number of Re-hospitalizations at 30 and 60 Days [30 days, 60 days post discharge]

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

2. The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. [30 days, 60 days post discharge]

   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

1. Time to 1st Re-hospitalization [30 days, 60 days]

   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.

2. Time to 1st Emergency Department Visit [30 days, 60 days]

   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.

3. Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale [30 days, 60 days post discharge]

   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.

4. Pain as Measured by OASIS Scale [30 days, 60 days post discharge]

   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.

5. Confusion as Measured by OASIS Scale [30 days, 60 days post discharge]

   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.

6. Anxiety as Measured by OASIS Scale [30 days, 60 days post discharge]

   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.

7. Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale [30 days, 60 days post discharge]

   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.

8. Disruptive Behavior as Measured by OASIS Scale [30 days, 60 days post discharge]

   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.

9. Activities of Daily Living as Measured by OASIS Scale [30 days, 60 days post discharge]

   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.

10. Number of Falls as Measured by Tabulation [60 days]

    To assess whether YouScript® testing decreases falls

11. Number of Pharmacist-accepted of Recommendations as Measured by Tabulation [60 days]

    To assess the proportion of YouScript® Personalized Prescribing System recommendations accepted by the study pharmacist and passed on to clinicians.

12. Number of Clinician-accepted of Recommendations as Measured by Tabulation [60 days]

    To assess the proportion of study pharmacist recommendations acted on by clinicians.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	White County Medical Center Home Health	Searcy	Arkansas	United States	72143

Sponsors and Collaborators

• Genelex Corporation
• Harding University

Investigators

• Principal Investigator: Lindsay Elliott, PharmD, Harding University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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%

Publications

None provided.

• Responsible Party: Genelex Corporation
• ClinicalTrials.gov Identifier: NCT02378220
• Other Study ID Numbers: 2015-003
• First Posted: Mar 4, 2015
• Last Update Posted: Sep 20, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Genelex Corporation: Home Care Agencies; Home Health Care Agencies; Home Health Care Nursing; Home Health Nurses; CYP 2D6; CYP 2C9; CYP 2C19; CYP 3A4; CYP 3A5
• Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions

Study Results

Participant Flow

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 Detail	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")
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	53	57
COMPLETED	47	56
NOT COMPLETED	6	1

Baseline Characteristics

Arm/Group Title	Controls ("Not Tested")	Intervention ("Tested")	Total
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 Participants	53	57	110
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.6 (11.9)	76.5 (9.4)	75.6 (10.7)
Sex: Female, Male (Count of Participants)
Female	36 67.9%	32 56.1%	68 61.8%
Male	17 32.1%	25 43.9%	42 38.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 1.9%	0 0%	1 0.9%
White	52 98.1%	57 100%	109 99.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	53 100%	57 100%	110 100%
OASIS Metrics (Scores on a scale) [Mean (Full Range) ]
OVERALL OASIS SCORE	1.63	1.64	1.63
AVERAGE PHARMACOGENETIC RISK	34.3	33.2	33.75

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
Re-hospitalizations at 30 Days	0.38	0.25
Re-hospitalizations at 60 Days	0.7	0.33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Controls ("Not Tested"), Intervention ("Tested")
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments	P-value for 30 days measure.
	Method	Regression, Poisson
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95%; 0.32 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Controls ("Not Tested"), Intervention ("Tested")
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	P-Value for 60 days measure
	Method	Regression, Poisson
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; 0.27 to 0.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
ED Visits at 30 Days	0.40	0.25
ED Visits at 60 Days	0.66	0.39

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Controls ("Not Tested"), Intervention ("Tested")
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments	P-Value for 30 days measure
	Method	Regression, Poisson
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; 0.31 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Controls ("Not Tested"), Intervention ("Tested")
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments
	Method	Regression, Poisson
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95%; 0.34 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
Cumulative Percentage Events at 30 Days	29 54.7%	19 33.3%
Cumulative Percentage Events at 60 Days	43 81.1%	28 49.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Controls ("Not Tested"), Intervention ("Tested")
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; 0.31 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
Cumulative Percentage Events at 30 Days	30 56.6%	23 40.4%
Cumulative Percentage Events at 60 Days	49 92.5%	32 56.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Controls ("Not Tested"), Intervention ("Tested")
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.33 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
OASIS M1034 at 30 Days	1.00	1.11
OASIS M1034 at 60 Days	0.76	0.71

6. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
OASIS M1242 at 30 Days	1.02	1.16
OASIS M1242 at 60 Days	1.19	1.49

7. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
OASIS M1710 at 30 Days	0.49	0.66
OASIS M1710 at 60 Days	0.79	0.61

8. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
OASIS M1720 at 30 Days	0.51	0.41
OASIS M1720 at 60 Days	0.67	0.55

9. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
OASIS PHQ-2 at 30 Days	0.06	0.16
OASIS PHQ-2 at 60 Days	0.59	0.35

10. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
OASIS M1745 at 30 Days	0.06	0.05
OASIS M1745 at 60 Days	0.45	0.14

11. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	53	57
OASIS M2110 at 30 Days	2.72	2.30
OASIS M2110 at 60 Days	2.86	2.76

12. Secondary Outcome

Title	Number of Falls as Measured by Tabulation
Description	To assess whether YouScript® testing decreases falls
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Controls ("Not Tested")	Intervention ("Tested")
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
Measure Participants	53	57
Mean (Full Range) [Falls]	0.09	0.11

13. Secondary Outcome

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

Outcome Measure Data

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")
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
Measure Participants	57
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
Description	To assess the proportion of study pharmacist recommendations acted on by clinicians.
Time Frame	60 days

Outcome Measure Data

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")
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
Measure Participants	57
Number of Recommendations Passed to Clinicians	124
Number of Recommendations Followed	96
Number of Recommendations Not Followed	6
Number of Unknown Status Recommendations	22

Adverse Events

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")
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	6/53 (11.3%)		1/57 (1.8%)
Serious Adverse Events
	Controls ("Not Tested")		Intervention ("Tested")
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Controls ("Not Tested")		Intervention ("Tested")
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

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.