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
Conditions
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
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.
Interventions
GENETICPharmacogenetic testing
Pharmacogenetic testing via YouScript® Personalized Prescribing System
Sponsors
Harding University
Genelex Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Number of Falls as Measured by Tabulation | 60 days | To assess whether YouScript® testing decreases falls |
| 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. |
| Number of Clinician-accepted of Recommendations as Measured by Tabulation | 60 days | To assess the proportion of study pharmacist recommendations acted on by clinicians. |
Countries
United States
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 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.
Participants by arm
| Arm | Count |
|---|---|
| Controls (Not Tested) Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online) | 53 |
| Intervention (Tested) 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 | 57 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 1 |
Baseline characteristics
| Characteristic | Controls (Not Tested) | Intervention (Tested) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 51 Participants | 90 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 6 Participants | 20 Participants |
| Age, Continuous | 74.6 years STANDARD_DEVIATION 11.9 | 76.5 years STANDARD_DEVIATION 9.4 | 75.6 years STANDARD_DEVIATION 10.7 |
| OASIS Metrics AVERAGE PHARMACOGENETIC RISK | 34.3 Scores on a scale | 33.2 Scores on a scale | 33.75 Scores on a scale |
| OASIS Metrics OVERALL OASIS SCORE | 1.63 Scores on a scale | 1.64 Scores on a scale | 1.63 Scores on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 57 Participants | 109 Participants |
| Region of Enrollment United States | 53 participants | 57 participants | 110 participants |
| Sex: Female, Male Female | 36 Participants | 32 Participants | 68 Participants |
| Sex: Female, Male Male | 17 Participants | 25 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 53 | 1 / 57 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Re-hospitalizations at 30 and 60 Days
The primary outcomes included the number of re-hospitalizations at 30 and 60 days.
Time frame: 30 days, 60 days post discharge
Population: Primary outcomes included the number of re-hospitalizations between the tested group and the untested group at 30 and 60 days post-discharge.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Number of Re-hospitalizations at 30 and 60 Days | Re-hospitalizations at 30 Days | 0.38 Re-hospitalizations |
| Controls (Not Tested) | Number of Re-hospitalizations at 30 and 60 Days | Re-hospitalizations at 60 Days | 0.7 Re-hospitalizations |
| Intervention (Tested) | Number of Re-hospitalizations at 30 and 60 Days | Re-hospitalizations at 30 Days | 0.25 Re-hospitalizations |
| Intervention (Tested) | Number of Re-hospitalizations at 30 and 60 Days | Re-hospitalizations at 60 Days | 0.33 Re-hospitalizations |
p-value: 0.2195% CI: [0.32, 1.28]Regression, Poisson
p-value: 0.00795% CI: [0.27, 0.82]Regression, Poisson
Primary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. | ED Visits at 30 Days | 0.40 ED visits |
| Controls (Not Tested) | The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. | ED Visits at 60 Days | 0.66 ED visits |
| Intervention (Tested) | The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. | ED Visits at 30 Days | 0.25 ED visits |
| Intervention (Tested) | The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days. | ED Visits at 60 Days | 0.39 ED visits |
p-value: 0.1695% CI: [0.31, 1.21]Regression, Poisson
p-value: 0.04595% CI: [0.34, 0.99]Regression, Poisson
Secondary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Activities of Daily Living as Measured by OASIS Scale | OASIS M2110 at 30 Days | 2.72 Scores on a scale |
| Controls (Not Tested) | Activities of Daily Living as Measured by OASIS Scale | OASIS M2110 at 60 Days | 2.86 Scores on a scale |
| Intervention (Tested) | Activities of Daily Living as Measured by OASIS Scale | OASIS M2110 at 30 Days | 2.30 Scores on a scale |
| Intervention (Tested) | Activities of Daily Living as Measured by OASIS Scale | OASIS M2110 at 60 Days | 2.76 Scores on a scale |
Secondary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Anxiety as Measured by OASIS Scale | OASIS M1720 at 30 Days | 0.51 Scores on a scale |
| Controls (Not Tested) | Anxiety as Measured by OASIS Scale | OASIS M1720 at 60 Days | 0.67 Scores on a scale |
| Intervention (Tested) | Anxiety as Measured by OASIS Scale | OASIS M1720 at 30 Days | 0.41 Scores on a scale |
| Intervention (Tested) | Anxiety as Measured by OASIS Scale | OASIS M1720 at 60 Days | 0.55 Scores on a scale |
Secondary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Confusion as Measured by OASIS Scale | OASIS M1710 at 30 Days | 0.49 Scores on a scale |
| Controls (Not Tested) | Confusion as Measured by OASIS Scale | OASIS M1710 at 60 Days | 0.79 Scores on a scale |
| Intervention (Tested) | Confusion as Measured by OASIS Scale | OASIS M1710 at 30 Days | 0.66 Scores on a scale |
| Intervention (Tested) | Confusion as Measured by OASIS Scale | OASIS M1710 at 60 Days | 0.61 Scores on a scale |
Secondary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale | OASIS PHQ-2 at 30 Days | 0.06 Scores on a scale |
| Controls (Not Tested) | Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale | OASIS PHQ-2 at 60 Days | 0.59 Scores on a scale |
| Intervention (Tested) | Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale | OASIS PHQ-2 at 30 Days | 0.16 Scores on a scale |
| Intervention (Tested) | Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale | OASIS PHQ-2 at 60 Days | 0.35 Scores on a scale |
Secondary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Disruptive Behavior as Measured by OASIS Scale | OASIS M1745 at 30 Days | 0.06 Scores on a scale |
| Controls (Not Tested) | Disruptive Behavior as Measured by OASIS Scale | OASIS M1745 at 60 Days | 0.45 Scores on a scale |
| Intervention (Tested) | Disruptive Behavior as Measured by OASIS Scale | OASIS M1745 at 30 Days | 0.05 Scores on a scale |
| Intervention (Tested) | Disruptive Behavior as Measured by OASIS Scale | OASIS M1745 at 60 Days | 0.14 Scores on a scale |
Secondary
Number of Clinician-accepted of Recommendations as Measured by Tabulation
To assess the proportion of study pharmacist recommendations acted on by clinicians.
Time frame: 60 days
Population: This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the tested group acted on by clinicians.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Controls (Not Tested) | Number of Clinician-accepted of Recommendations as Measured by Tabulation | Number of Recommendations Passed to Clinicians | 124 recommendations |
| Controls (Not Tested) | Number of Clinician-accepted of Recommendations as Measured by Tabulation | Number of Recommendations Followed | 96 recommendations |
| Controls (Not Tested) | Number of Clinician-accepted of Recommendations as Measured by Tabulation | Number of Recommendations Not Followed | 6 recommendations |
| Controls (Not Tested) | Number of Clinician-accepted of Recommendations as Measured by Tabulation | Number of Unknown Status Recommendations | 22 recommendations |
Secondary
Number of Falls as Measured by Tabulation
To assess whether YouScript® testing decreases falls
Time frame: 60 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Controls (Not Tested) | Number of Falls as Measured by Tabulation | 0.09 Falls |
| Intervention (Tested) | Number of Falls as Measured by Tabulation | 0.11 Falls |
Secondary
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.
Time frame: 60 days
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Controls (Not Tested) | Number of Pharmacist-accepted of Recommendations as Measured by Tabulation | Number of YouScript® Recommendations Made | 124 recommendations |
| Controls (Not Tested) | Number of Pharmacist-accepted of Recommendations as Measured by Tabulation | Number of YouScript® Recommendations Accepted | 124 recommendations |
Secondary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale | OASIS M1034 at 30 Days | 1.00 Scores on a scale |
| Controls (Not Tested) | Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale | OASIS M1034 at 60 Days | 0.76 Scores on a scale |
| Intervention (Tested) | Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale | OASIS M1034 at 30 Days | 1.11 Scores on a scale |
| Intervention (Tested) | Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale | OASIS M1034 at 60 Days | 0.71 Scores on a scale |
Secondary
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.
Time frame: 30 days, 60 days post discharge
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Controls (Not Tested) | Pain as Measured by OASIS Scale | OASIS M1242 at 60 Days | 1.19 Scores on a scale |
| Controls (Not Tested) | Pain as Measured by OASIS Scale | OASIS M1242 at 30 Days | 1.02 Scores on a scale |
| Intervention (Tested) | Pain as Measured by OASIS Scale | OASIS M1242 at 30 Days | 1.16 Scores on a scale |
| Intervention (Tested) | Pain as Measured by OASIS Scale | OASIS M1242 at 60 Days | 1.49 Scores on a scale |
Secondary
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.
Time frame: 30 days, 60 days
Population: Compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Controls (Not Tested) | Time to 1st Emergency Department Visit | Cumulative Percentage Events at 30 Days | 30 Percentage of participants |
| Controls (Not Tested) | Time to 1st Emergency Department Visit | Cumulative Percentage Events at 60 Days | 49 Percentage of participants |
| Intervention (Tested) | Time to 1st Emergency Department Visit | Cumulative Percentage Events at 30 Days | 23 Percentage of participants |
| Intervention (Tested) | Time to 1st Emergency Department Visit | Cumulative Percentage Events at 60 Days | 32 Percentage of participants |
p-value: 0.0995% CI: [0.33, 1.1]Log Rank
Secondary
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 frame: 30 days, 60 days
Population: We compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Controls (Not Tested) | Time to 1st Re-hospitalization | Cumulative Percentage Events at 30 Days | 29 Percentage of participants |
| Controls (Not Tested) | Time to 1st Re-hospitalization | Cumulative Percentage Events at 60 Days | 43 Percentage of participants |
| Intervention (Tested) | Time to 1st Re-hospitalization | Cumulative Percentage Events at 30 Days | 19 Percentage of participants |
| Intervention (Tested) | Time to 1st Re-hospitalization | Cumulative Percentage Events at 60 Days | 28 Percentage of participants |
p-value: 0.195% CI: [0.31, 1.12]Log Rank