Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04071951
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2019-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacist Intervention to Reduce Post-Hospitalization Utilization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pevnickj@cshs.org', 'phone': '310.423.4683', 'title': 'Joshua Pevnick', 'organization': 'Cedars-Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time of randomization (near hospital admission) up to 90 days after hospital discharge', 'eventGroups': [{'id': 'EG000', 'title': 'Pharmacist Arm', 'description': 'Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling\n\nPharmacist-led Hospital Discharge Care Intervention: Pharmacists will address medication reconciliation, medication adherence, and polypharmacy issues as appropriate. Pharmacists will rely most on their prior training, but study investigators will also encourage the use of documentation templates with reminders, Beers list, deprescribing, motivational interviewing, the Medication Adherence and Literacy tool, and post-discharge phone calls.\n\nPharmacists will assess patient needs and customize accordingly. All patients will receive one discharge counseling visit and one post-discharge phone call, but pharmacists will find that some patients need further phone calls, interventions, referrals, or other interactions. Some or all of the pharmacist activities may take place over the phone.', 'otherNumAtRisk': 3239, 'deathsNumAtRisk': 3239, 'otherNumAffected': 0, 'seriousNumAtRisk': 3239, 'deathsNumAffected': 330, 'seriousNumAffected': 1485}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.', 'otherNumAtRisk': 3239, 'deathsNumAtRisk': 3239, 'otherNumAffected': 0, 'seriousNumAtRisk': 3239, 'deathsNumAffected': 334, 'seriousNumAffected': 1438}], 'seriousEvents': [{'term': '90-day post-discharge utilization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3239, 'numAffected': 1155}, {'groupId': 'EG001', 'numAtRisk': 3239, 'numAffected': 1104}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '30-day post-discharge utilization (same hospital)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3239, 'numAffected': 662}, {'groupId': 'EG001', 'numAtRisk': 3239, 'numAffected': 666}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Including Hospitals at Least Statewide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2288', 'groupId': 'OG000'}, {'value': '2314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacist Arm', 'description': 'Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling\n\nPharmacist-led Hospital Discharge Care Intervention: Pharmacists will address medication reconciliation, medication adherence, and polypharmacy issues as appropriate. Pharmacists will rely most on their prior training, but study investigators will also encourage the use of documentation templates with reminders, Beers list, deprescribing, motivational interviewing, the Medication Adherence and Literacy tool, and post-discharge phone calls.\n\nPharmacists will assess patient needs and customize accordingly. All patients will receive one discharge counseling visit and one post-discharge phone call, but pharmacists will find that some patients need further phone calls, interventions, referrals, or other interactions. Some or all of the pharmacist activities may take place over the phone.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '595', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)', 'description': 'A patient is readmitted to a hospital (including observation) or has an ED visit within 30 days of discharge (including all hospitals at least statewide), excluding foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'note that to obtain outside hospital data, analysis was restricted to 4602 patients with fee-for-service Medicare (for whom all-hospital claims data was available)'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital)', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge, excluding foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Receipt of Different Intervention Components', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge. This outcome measure will analyze the outcome by whether patients received the intervention components (admission medication reconciliation, medication regimen review, actions to improve adherence, side effect management, drug level monitoring, discharge medication reconciliation, patient/caregiver education, motivational interviewing, post-discharge follow-up phone call, medication access, communication with PCP, communication with communication pharmacy, other). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Whether Patient Has a Diagnosis of Congestive Heart Failure at Admission', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has a diagnosis of congestive heart failure at admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital), Stratified by Whether Patient Has Three or More High Risk Medications (Anticoagulants, Antiplatelets, Insulin, Oral Hypoglycemics) Prior to Admission', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has three or more high risk medications (anticoagulants, antiplatelets, insulin, oral hypoglycemics) prior to admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital), Stratified by Whether Patient Has 10 or More Medications Prior to Admission', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has 10 or more medications prior to admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Study Site', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by study site. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Patient Medication Adherence and Literacy', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient medication adherence and literacy (as assessed by study pharmacists, in addition to using limited English proficiency as a proxy for low medication literacy). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Quintiles of Patient Socioeconomic Status (Estimated Via Median Income of Home Census Tract)', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient socioeconomic status (estimated via median income of home census tract). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of New BZR Discharge Prescriptions Among Patients Not Taking BZRs Prior to Admission', 'timeFrame': 'Patients not taking BZRs prior to admission', 'description': 'A dichotomous variable for a new discharge prescription of BZRs among patients not taking BZRs prior to admission.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of Increased BZR Dose Prescription Among Patients Taking BZRs Prior to Admission', 'timeFrame': 'Patients taking BZRs prior to admission', 'description': 'A dichotomous variable for an increased dose prescription among patients taking BZRs prior to admission.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of Post-hospitalization Fall-related Injuries as Healthcare Utilization (Hospitalization, ED Visits, Urgent Care Visits, or Office Visits)', 'timeFrame': 'Fall-related injuries within 30 days of discharge of the index admission', 'description': 'The investigators define post-hospitalization fall-related injuries as healthcare utilization (hospitalization, ED visits, urgent care visits, or office visits) due to fall-related injuries within 30 days of discharge of the index admission. The investigators will link Medicare claims data to trial data to track this outcome at the individual patient level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified by Patient Age Groups', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient age groups. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified According to Time Periods That Had Changes in the Intervention and Control Arms', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified according to time periods that had changes in the intervention and control arms. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate of 30 Day Post Hospitalization in ED Visits (Same Hospital) Restricted to Medication-related Utilization', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge restricted to medication-related utilization. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate of 7 Day Post-discharge Hospitalization Medication-related Post-discharge Utilization.', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 7 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 7 days of discharge by hospitalization medication-related post-discharge utilization. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30-day Post-discharge Hospital Utilization With ED Visits, Observation Stays, and Inpatient Readmissions Counted Separately (Including Hospitals at Least Statewide).', 'timeFrame': 'Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)', 'description': 'A patient is readmitted to a hospital under inpatient or observation status or has an ED visit within 30 days of discharge (including hospitals at least statewide). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': '30-day, All-cause Mortality After Hospital Discharge', 'timeFrame': 'Death occurring within 30 days after hospital discharge', 'description': 'All-cause mortality rate and survival analysis through Day 30 after hospital discharge.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate (%) of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Among Patients Who Were Enrolled and Received the Intervention, Compared to Patients Who Were Eligible Yet Not Enrolled During the Study Period.', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pharmacist Arm', 'description': 'Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling\n\nPharmacist-led Hospital Discharge Care Intervention: Pharmacists will address medication reconciliation, medication adherence, and polypharmacy issues as appropriate. Pharmacists will rely most on their prior training, but study investigators will also encourage the use of documentation templates with reminders, Beers list, deprescribing, motivational interviewing, the Medication Adherence and Literacy tool, and post-discharge phone calls.\n\nPharmacists will assess patient needs and customize accordingly. All patients will receive one discharge counseling visit and one post-discharge phone call, but pharmacists will find that some patients need further phone calls, interventions, referrals, or other interactions. Some or all of the pharmacist activities may take place over the phone.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3239'}, {'groupId': 'FG001', 'numSubjects': '3239'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3213'}, {'groupId': 'FG001', 'numSubjects': '3215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3213', 'groupId': 'BG000'}, {'value': '3215', 'groupId': 'BG001'}, {'value': '6428', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pharmacist Arm', 'description': 'Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling\n\nPharmacist-led Hospital Discharge Care Intervention: Pharmacists will address medication reconciliation, medication adherence, and polypharmacy issues as appropriate. Pharmacists will rely most on their prior training, but study investigators will also encourage the use of documentation templates with reminders, Beers list, deprescribing, motivational interviewing, the Medication Adherence and Literacy tool, and post-discharge phone calls.\n\nPharmacists will assess patient needs and customize accordingly. All patients will receive one discharge counseling visit and one post-discharge phone call, but pharmacists will find that some patients need further phone calls, interventions, referrals, or other interactions. Some or all of the pharmacist activities may take place over the phone.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.5', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '75.6', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '75.5', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1586', 'groupId': 'BG000'}, {'value': '1577', 'groupId': 'BG001'}, {'value': '3163', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1627', 'groupId': 'BG000'}, {'value': '1638', 'groupId': 'BG001'}, {'value': '3265', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '257', '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': '479', 'groupId': 'BG000'}, {'value': '475', 'groupId': 'BG001'}, {'value': '954', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2303', 'groupId': 'BG000'}, {'value': '2367', 'groupId': 'BG001'}, {'value': '4670', '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': '286', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study Site', 'classes': [{'categories': [{'title': 'Cedars-Sinai Medical Center', 'measurements': [{'value': '1299', 'groupId': 'BG000'}, {'value': '1300', 'groupId': 'BG001'}, {'value': '2599', 'groupId': 'BG002'}]}, {'title': "Brigham and Women's Hospital", 'measurements': [{'value': '1914', 'groupId': 'BG000'}, {'value': '1915', 'groupId': 'BG001'}, {'value': '3829', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-25', 'size': 467543, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-27T23:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6478}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2019-08-26', 'resultsFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-27', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Including Hospitals at Least Statewide)', 'timeFrame': 'Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)', 'description': 'A patient is readmitted to a hospital (including observation) or has an ED visit within 30 days of discharge (including all hospitals at least statewide), excluding foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations'}], 'secondaryOutcomes': [{'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital)', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge, excluding foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Receipt of Different Intervention Components', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge. This outcome measure will analyze the outcome by whether patients received the intervention components (admission medication reconciliation, medication regimen review, actions to improve adherence, side effect management, drug level monitoring, discharge medication reconciliation, patient/caregiver education, motivational interviewing, post-discharge follow-up phone call, medication access, communication with PCP, communication with communication pharmacy, other). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Whether Patient Has a Diagnosis of Congestive Heart Failure at Admission', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has a diagnosis of congestive heart failure at admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital), Stratified by Whether Patient Has Three or More High Risk Medications (Anticoagulants, Antiplatelets, Insulin, Oral Hypoglycemics) Prior to Admission', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has three or more high risk medications (anticoagulants, antiplatelets, insulin, oral hypoglycemics) prior to admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital), Stratified by Whether Patient Has 10 or More Medications Prior to Admission', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has 10 or more medications prior to admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Study Site', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by study site. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Patient Medication Adherence and Literacy', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient medication adherence and literacy (as assessed by study pharmacists, in addition to using limited English proficiency as a proxy for low medication literacy). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Quintiles of Patient Socioeconomic Status (Estimated Via Median Income of Home Census Tract)', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient socioeconomic status (estimated via median income of home census tract). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of New BZR Discharge Prescriptions Among Patients Not Taking BZRs Prior to Admission', 'timeFrame': 'Patients not taking BZRs prior to admission', 'description': 'A dichotomous variable for a new discharge prescription of BZRs among patients not taking BZRs prior to admission.'}, {'measure': 'Rate (%) of Increased BZR Dose Prescription Among Patients Taking BZRs Prior to Admission', 'timeFrame': 'Patients taking BZRs prior to admission', 'description': 'A dichotomous variable for an increased dose prescription among patients taking BZRs prior to admission.'}, {'measure': 'Rate (%) of Post-hospitalization Fall-related Injuries as Healthcare Utilization (Hospitalization, ED Visits, Urgent Care Visits, or Office Visits)', 'timeFrame': 'Fall-related injuries within 30 days of discharge of the index admission', 'description': 'The investigators define post-hospitalization fall-related injuries as healthcare utilization (hospitalization, ED visits, urgent care visits, or office visits) due to fall-related injuries within 30 days of discharge of the index admission. The investigators will link Medicare claims data to trial data to track this outcome at the individual patient level.'}, {'measure': 'Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified by Patient Age Groups', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient age groups. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified According to Time Periods That Had Changes in the Intervention and Control Arms', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified according to time periods that had changes in the intervention and control arms. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate of 30 Day Post Hospitalization in ED Visits (Same Hospital) Restricted to Medication-related Utilization', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge restricted to medication-related utilization. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate of 7 Day Post-discharge Hospitalization Medication-related Post-discharge Utilization.', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 7 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 7 days of discharge by hospitalization medication-related post-discharge utilization. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': 'Rate (%) of 30-day Post-discharge Hospital Utilization With ED Visits, Observation Stays, and Inpatient Readmissions Counted Separately (Including Hospitals at Least Statewide).', 'timeFrame': 'Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)', 'description': 'A patient is readmitted to a hospital under inpatient or observation status or has an ED visit within 30 days of discharge (including hospitals at least statewide). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}, {'measure': '30-day, All-cause Mortality After Hospital Discharge', 'timeFrame': 'Death occurring within 30 days after hospital discharge', 'description': 'All-cause mortality rate and survival analysis through Day 30 after hospital discharge.'}, {'measure': 'Rate (%) of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Among Patients Who Were Enrolled and Received the Intervention, Compared to Patients Who Were Eligible Yet Not Enrolled During the Study Period.', 'timeFrame': 'Hospitalization to the same hospital or ED visit within 30 days of discharge', 'description': 'A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonadherence, Patient', 'Polypharmacy', 'Readmission']}, 'referencesModule': {'references': [{'pmid': '35151310', 'type': 'DERIVED', 'citation': 'Murry LT, Keller MS, Pevnick JM, Schnipper JL, Kennelty KA; PHARM-DC Group. A qualitative dual-site analysis of the pharmacist discharge care (PHARM-DC) intervention using the CFIR framework. BMC Health Serv Res. 2022 Feb 12;22(1):186. doi: 10.1186/s12913-022-07583-5.'}, {'pmid': '33932574', 'type': 'DERIVED', 'citation': 'Pevnick JM, Keller MS, Kennelty KA, Nuckols TK, Ko EM, Amer K, Anderson L, Armbruster C, Conti N, Fanikos J, Guan J, Knight E, Leang DW, Llamas-Sandoval R, Matta L, Moriarty D, Murry LT, Muske AM, Nguyen AT, Phung E, Rosen O, Rosen SL, Salandanan A, Shane R, Schnipper JL. The Pharmacist Discharge Care (PHARM-DC) study: A multicenter RCT of pharmacist-directed transitional care to reduce post-hospitalization utilization. Contemp Clin Trials. 2021 Jul;106:106419. doi: 10.1016/j.cct.2021.106419. Epub 2021 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized trial testing a peri- and post-discharge pharmacist-led medication management intervention on post-discharge utilization, including both readmissions and emergency department visits within 30 days of discharge. The intervention incorporates evidence addressing three main areas: medication reconciliation, medication adherence, and polypharmacy.\n\nThis study uses a pragmatic trial randomized at the patient level and conducted in two large hospitals to achieve the following aims, each of which has been designed using the RE-AIM framework:\n\nAim 1: To test the effect of PHARM-DC on post-discharge utilization among patients most at risk for post-discharge ADEs: recently discharged older adults taking \\>10 medications or \\>3 high-risk medications using a prospective, randomized, pragmatic multi-site study.\n\nAim 2: To study barriers and facilitators of implementing PHARM-DC using a qualitative study.\n\nAim 3: To analyze the costs of PHARM-DC, including the incremental cost per readmission averted and the net incremental cost from the health system perspective using a time-and-motion study and a cost-effectiveness analysis.', 'detailedDescription': "There are three components to this study: (1) the prospective, randomized, controlled trial (RCT), which includes a pharmacist-led hospital discharge care intervention, (2) the qualitative study, which involves focus groups and interviews, and (3) a cost-effectiveness study, which involves a review of the literature and a time-and-motion study component.For all three studies, there are two sites: CSMC and Brigham and Women's Hospital in Boston. Additionally, Dr. Kennelty of University of Iowa will participate in the qualitative study.1. For the RCT: Eligible patients will be identified through the use of a daily Epic report using inclusion/exclusion criteria. Patients will be randomized by a study coordinator to the intervention arm or control arm. For the control arm, patients will receive usual care, which includes medication reconciliation at hospital admission. For the intervention arm, pharmacy staff will address medication reconciliation at hospital discharge, medication review, and medication adherence. Most intervention activities will occur during the hospital stay or during a post-discharge phone call. We estimate a total number of 4,888 patients per study arm.\n\n2\\. For the qualitative study: This is a qualitative study employing focus groups aimed at understanding implementation barriers and facilitators. Dr. Kennelty and study staff will conduct 3-day site visits to hold focus groups and/or interviews regarding intervention expectations, how the intervention is being implemented, barriers/facilitators to adoption and implementation, and adaptations made during delivery. Towards the end of the trial, Dr. Kennelty and study staff will use phone interviews to determine any changes to the implementation of PHARM-DC that occurred during the RCT, as well as to understand whether and how institutions will address the maintenance of PHARM-DC after the study ends. We estimate that up to 180 people may participate in this qualitative study.\n\n3\\. For the cost-effectiveness study: This is a time-and-motion study aimed at understanding how much time during the day pharmacists spend on activities related to the hospital discharge (and post-discharge) interventions. During the trial, we will use time and motion methodology to understand how much pharmacist time is needed for PHARM-DC. Coupled with data on post-discharge utilization, this will enable us to conduct economic analyses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to a medical ward, AND\n* \\> 55 years AND\n* ≥ 10 prescription medications at admission\n\nOR\n\n• ≥ 3 high-risk medications (anticoagulants, antiplatelets, insulin, oral hypoglycemics) at admission\n\nExclusion Criteria:\n\n* Expected discharge to another state, acute care facility, psychiatric facility, or locked facility (including locked skilled nursing facility, jail, or prison) OR\n* Expected AMA or left hospital against medical advice (AMA) OR\n* Homeless OR\n* On hospice OR\n* Already enrolled into study within the past year OR\n* Patients admitted by admitting or attending Primary Medical Doctors who have a specialty that is not Internal Medicine or Family Medicine OR\n* Expected to receive pharmacist-led peri- and post-discharge medication management regardless of the trial OR\n* Expected post-discharge setting not conducive to the studied medication management intervention (e.g. SNF, rehabilitation facility) OR\n* Patients admitted with a suspected or confirmed diagnosis of COVID-19.'}, 'identificationModule': {'nctId': 'NCT04071951', 'briefTitle': 'Pharmacist Intervention to Reduce Post-Hospitalization Utilization', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Multicenter RCT of Pharmacist-Directed Transitional Care to Reduce Post-Hospitalization Utilization', 'orgStudyIdInfo': {'id': 'Pro00053414'}, 'secondaryIdInfos': [{'id': 'R01AG058911', 'link': 'https://reporter.nih.gov/quickSearch/R01AG058911', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacist Arm', 'description': 'Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling', 'interventionNames': ['Behavioral: Pharmacist-led Hospital Discharge Care Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.'}], 'interventions': [{'name': 'Pharmacist-led Hospital Discharge Care Intervention', 'type': 'BEHAVIORAL', 'description': 'Pharmacists will address medication reconciliation, medication adherence, and polypharmacy issues as appropriate. Pharmacists will rely most on their prior training, but study investigators will also encourage the use of documentation templates with reminders, Beers list, deprescribing, motivational interviewing, the Medication Adherence and Literacy tool, and post-discharge phone calls.\n\nPharmacists will assess patient needs and customize accordingly. All patients will receive one discharge counseling visit and one post-discharge phone call, but pharmacists will find that some patients need further phone calls, interventions, referrals, or other interactions. Some or all of the pharmacist activities may take place over the phone.', 'armGroupLabels': ['Pharmacist Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Joshua Pevnick', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Josh Pevnick', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}