Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-25 @ 2:54 AM
Study NCT ID:
NCT02378220
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacogenetic Testing Among Home Health Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'C563835', 'term': 'Drug Metabolism, Poor, CYP2D6-Related'}, {'id': 'C563703', 'term': 'Drug Metabolism, Poor, CYP2C19-Related'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}], 'ancestors': [{'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lselliott@harding.edu', 'phone': '5012794800', 'title': 'Lindsay Elliott', 'organization': 'Harding University College of Pharmacy / Unity Health - White County Medical Center, Searcy, Arkansas, USA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '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.', '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Re-hospitalizations at 30 and 60 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'Re-hospitalizations at 30 Days', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Re-hospitalizations at 60 Days', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.28', 'pValueComment': 'P-value for 30 days measure.', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.82', 'pValueComment': 'P-Value for 60 days measure', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', 'description': 'The primary outcomes included the number of re-hospitalizations at 30 and 60 days.', 'unitOfMeasure': 'Re-hospitalizations', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary outcomes included the number of re-hospitalizations between the tested group and the untested group at 30 and 60 days post-discharge.'}, {'type': 'PRIMARY', 'title': 'The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'ED Visits at 30 Days', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'ED Visits at 60 Days', 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.39', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.21', 'pValueComment': 'P-Value for 30 days measure', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.99', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', 'description': 'Assessed the number of Emergency Department visits at 30 and 60 days post discharge with pharmacogenetic testing and YouScript® Personalized Prescribing system.', 'unitOfMeasure': 'ED visits', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Time to 1st Re-hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'Cumulative Percentage Events at 30 Days', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Cumulative Percentage Events at 60 Days', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.12', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days, 60 days', '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.'}, {'type': 'SECONDARY', 'title': 'Time to 1st Emergency Department Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'Cumulative Percentage Events at 30 Days', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Cumulative Percentage Events at 60 Days', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days, 60 days', '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.'}, {'type': 'SECONDARY', 'title': 'Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'OASIS M1034 at 30 Days', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'OASIS M1034 at 60 Days', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Pain as Measured by OASIS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'OASIS M1242 at 30 Days', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.16', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'OASIS M1242 at 60 Days', 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.49', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Confusion as Measured by OASIS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'OASIS M1710 at 30 Days', 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'OASIS M1710 at 60 Days', 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Anxiety as Measured by OASIS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'OASIS M1720 at 30 Days', 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'OASIS M1720 at 60 Days', 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.55', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'OASIS PHQ-2 at 30 Days', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'OASIS PHQ-2 at 60 Days', 'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Disruptive Behavior as Measured by OASIS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'OASIS M1745 at 30 Days', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'OASIS M1745 at 60 Days', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Activities of Daily Living as Measured by OASIS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'OASIS M2110 at 30 Days', 'categories': [{'measurements': [{'value': '2.72', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2.30', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'OASIS M2110 at 60 Days', 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2.76', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days, 60 days post discharge', '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Falls as Measured by Tabulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'OG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'To assess whether YouScript® testing decreases falls', 'unitOfMeasure': 'Falls', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Pharmacist-accepted of Recommendations as Measured by Tabulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'Number of YouScript® Recommendations Made', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Number of YouScript® Recommendations Accepted', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'To assess the proportion of YouScript® Personalized Prescribing System recommendations accepted by the study pharmacist and passed on to clinicians.', 'unitOfMeasure': 'recommendations', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Clinician-accepted of Recommendations as Measured by Tabulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'classes': [{'title': 'Number of Recommendations Passed to Clinicians', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Number of Recommendations Followed', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Number of Recommendations Not Followed', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Number of Unknown Status Recommendations', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'To assess the proportion of study pharmacist recommendations acted on by clinicians.', 'unitOfMeasure': 'recommendations', 'reportingStatus': 'POSTED', 'populationDescription': 'This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the "tested" group acted on by clinicians.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'FG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Patients were enrolled from Feb 2015 to Dec 2015 with follow-up ending in Feb 2016.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Controls ("Not Tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'id': 'BG001', 'title': 'Intervention ("Tested")', '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.\n\nPharmacogenetic testing: Pharmacogenetic testing via YouScript® Personalized Prescribing System'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '76.5', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '75.6', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'OASIS Metrics', 'classes': [{'title': 'OVERALL OASIS SCORE', 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.64', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.63', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'AVERAGE PHARMACOGENETIC RISK', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '73'}, {'value': '33.2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '63'}, {'value': '33.75', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', '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.\n\nAverage 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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2015-02-24', 'resultsFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-31', 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Re-hospitalizations at 30 and 60 Days', 'timeFrame': '30 days, 60 days post discharge', 'description': 'The primary outcomes included the number of re-hospitalizations at 30 and 60 days.'}, {'measure': 'The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.', 'timeFrame': '30 days, 60 days post discharge', 'description': 'Assessed the number of Emergency Department visits at 30 and 60 days post discharge with pharmacogenetic testing and YouScript® Personalized Prescribing system.'}], 'secondaryOutcomes': [{'measure': 'Time to 1st Re-hospitalization', 'timeFrame': '30 days, 60 days', '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.'}, {'measure': 'Time to 1st Emergency Department Visit', 'timeFrame': '30 days, 60 days', '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.'}, {'measure': 'Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale', 'timeFrame': '30 days, 60 days post discharge', '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.'}, {'measure': 'Pain as Measured by OASIS Scale', 'timeFrame': '30 days, 60 days post discharge', '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.'}, {'measure': 'Confusion as Measured by OASIS Scale', 'timeFrame': '30 days, 60 days post discharge', '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.'}, {'measure': 'Anxiety as Measured by OASIS Scale', 'timeFrame': '30 days, 60 days post discharge', '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.'}, {'measure': 'Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale', 'timeFrame': '30 days, 60 days post discharge', '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.'}, {'measure': 'Disruptive Behavior as Measured by OASIS Scale', 'timeFrame': '30 days, 60 days post discharge', '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.'}, {'measure': 'Activities of Daily Living as Measured by OASIS Scale', 'timeFrame': '30 days, 60 days post discharge', '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.'}, {'measure': 'Number of Falls as Measured by Tabulation', 'timeFrame': '60 days', 'description': 'To assess whether YouScript® testing decreases falls'}, {'measure': 'Number of Pharmacist-accepted of Recommendations as Measured by Tabulation', 'timeFrame': '60 days', 'description': 'To assess the proportion of YouScript® Personalized Prescribing System recommendations accepted by the study pharmacist and passed on to clinicians.'}, {'measure': 'Number of Clinician-accepted of Recommendations as Measured by Tabulation', 'timeFrame': '60 days', 'description': 'To assess the proportion of study pharmacist recommendations acted on by clinicians.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], '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']}, 'referencesModule': {'references': [{'pmid': '28151991', 'type': 'RESULT', 'citation': 'Elliott LS, Henderson JC, Neradilek MB, Moyer NA, Ashcraft KC, Thirumaran RK. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial. PLoS One. 2017 Feb 2;12(2):e0170905. doi: 10.1371/journal.pone.0170905. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170905', 'label': 'Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial'}, {'url': 'https://www.genomeweb.com/molecular-diagnostics/pgx-testing-firm-genelex-publishes-rct-spins-out-analytics-unit-effort-improve', 'label': 'PGx Testing Firm Genelex Publishes RCT, Spins Out Analytics Unit in Effort to Improve Adoption'}, {'url': 'http://healthitanalytics.com/news/genomics-clinical-decision-support-combo-cuts-ed-visits-by-42', 'label': 'Genomics, Clinical Decision Support Combo Cuts ED Visits by 42%'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 or older.\n* Willing and able to provide informed consent for study participation either directly or by a legally authorized representative (LAR).\n* 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).\n\nExclusion Criteria:\n\n* Previous CYP testing (CPT codes 81225, 81226, 81227, 81355, 81401)\n* 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)\n* Current malabsorption syndrome (579.0), including the following: Intestinal malabsorption (579.8, 579.9), Postoperative malabsorption (579.3), or Short bowel syndrome (579.3)\n* Treatment of invasive solid tumors or hematologic malignancies in the last year, excluding in situ cancers or non-melanoma skin cancer (basal cell carcinoma)\n* End Stage Renal Disease (ESRD)\n* Persistent acute renal failure: complete loss of kidney function \\>4 weeks (requiring dialysis)\n* 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.'}, 'identificationModule': {'nctId': 'NCT02378220', 'briefTitle': 'Pharmacogenetic Testing Among Home Health Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genelex Corporation'}, 'officialTitle': 'A Pilot Prospective, Randomized Controlled Trial Assessing the Clinical Impact of Integrated Pharmacogenetic Testing on Selected OASIS Metrics, Re-hospitalizations and Emergency Department Visits', 'orgStudyIdInfo': {'id': '2015-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Controls ("not tested")', 'description': 'Treatment as usual (e.g. review of potential drug-drug interactions via Lexicomp Online)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention ("tested")', 'description': 'Patients in the "tested" group will receive pharmacogenetic testing via YouScript® Personalized Prescribing System. The study pharmacist will review drug-drug interactions (DDI), drug-gene interactions (DGI), and drug-drug-gene interactions (DDGI) using YouScript® to provide drug therapy recommendations to prescribers.', 'interventionNames': ['Genetic: Pharmacogenetic testing']}], 'interventions': [{'name': 'Pharmacogenetic testing', 'type': 'GENETIC', 'otherNames': ['YouScript® Personalized Prescribing System'], 'description': 'Pharmacogenetic testing via YouScript® Personalized Prescribing System', 'armGroupLabels': ['Intervention ("tested")']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72143', 'city': 'Searcy', 'state': 'Arkansas', 'country': 'United States', 'facility': 'White County Medical Center Home Health', 'geoPoint': {'lat': 35.25064, 'lon': -91.73625}}], 'overallOfficials': [{'name': 'Lindsay Elliott, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harding University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genelex Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Harding University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}