Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04595851
Status:
TERMINATED
Last Update Posted:
2022-11-22
First Post:
2020-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D000071069', 'term': 'Multiple Chronic Conditions'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071066', 'term': 'Patient Reported Outcome Measures'}], 'ancestors': [{'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D063868', 'term': 'Patient Outcome Assessment'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'accrual difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)', 'timeFrame': 'Up to 6 months following OAA initiation', 'description': "PDC is a common way to assess a patient's adherence to a medication regimen. PDC is the ratio of number of days the patient is supplied with OAA medication, from the time of OAA initiation until 6 months later, to the total number of days during that period. For OAAs, data from the electronic medical record (EMR) for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC."}, {'measure': 'PDC for chronic condition medications', 'timeFrame': 'Up to 6 months following OAA initiation', 'description': 'PDC is the ratio of the number of days the patient is supplied with chronic condition medications, from the time of OAA initiation until 6 months later, to the total number of days during that period.'}], 'secondaryOutcomes': [{'measure': 'Percent of patients with two completed Patient Reported Outcome Measures (PROMs)', 'timeFrame': 'Up to day 42 (+/-3) after OAA initiation', 'description': 'The Michigan Oncology Quality Consortium (MOQC) OAA PROM, Patient Assessment Tool for Oral Chemotherapy is to be completed at 2 and 6 weeks after OAA initiation. This measure assesses the percent of patients who complete this PROM at both time points.'}, {'measure': 'Percent of patients with completed Comprehensive Medication Reviews (CMRs)', 'timeFrame': 'Day 50 (+/-3) after OAA initiation', 'description': 'Completed CMR includes initial and follow-up CMR with primary care pharmacist.'}, {'measure': 'Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result', 'timeFrame': 'Day 22 (+/-3) after OAA initiation', 'description': 'The PROM is scored within one day after it is completed by the patient. The primary care pharmacist sets a date and time for the initial CMR after receiving the first scored PROM.'}, {'measure': 'Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM', 'timeFrame': 'Up to day 44 (+/-3) after OAA initiation', 'description': 'The PROM is scored within one day after it is completed by the patient and is routed to the oncology pharmacist to review the results. The number of PROMs that are reviewed within 1 day of receipt will be assessed at 2 weeks and at 6 weeks.'}, {'measure': 'Percent of CMRs where note was routed to oncology pharmacist', 'timeFrame': 'Up to day 43 (+/-3) after OAA initiation', 'description': 'The number of CMR where note was routed to oncology pharmacist out of total number of completed CMRs, assessed at 2 weeks and at 6 weeks.'}, {'measure': 'Percent of CMR notes that oncology pharmacist reviewed', 'timeFrame': 'Up to day 44 (+/-3) after OAA initiation', 'description': 'The number of CMR notes reviewed by the oncology pharmacist out of the total number of completed CMRs, assessed at 2 weeks and at 6 weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia', 'Chronic Lymphocytic Leukemia', 'Multiple Chronic Conditions']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care practices (Pharmacists Coordinated care Oncology Model \\[PCOM\\]).\n\nThis is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has primary care physician\n* Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)\n* Initiating an OAA, either for the first time or a change from previous OAA\n* Diagnosis of at least 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease\n* Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.\n* Willing and able to sign informed consent.\n\nExclusion Criteria:\n\n* Cannot speak English\n* Concurrent diagnosis of type 1 diabetes\n* Concurrent diagnosis of human immunodeficiency virus'}, 'identificationModule': {'nctId': 'NCT04595851', 'briefTitle': 'Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)', 'orgStudyIdInfo': {'id': 'UMCC 2020.053'}, 'secondaryIdInfos': [{'id': 'HUM00178781', 'type': 'OTHER', 'domain': 'University of Michigan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pharmacist Coordinated care Oncology Model (PCOM)', 'description': 'The Pharmacist Coordinated care Oncology Model includes patient self-reported symptoms and medication adherence, comprehensive medication review(s) and intentional communication between oncology and primary care pharmacists.', 'interventionNames': ['Other: Patient Reported Outcome Measure (PROM)', 'Other: Comprehensive Medication Review (CMR)', 'Other: Communications between oncology and primary care pharmacists']}], 'interventions': [{'name': 'Patient Reported Outcome Measure (PROM)', 'type': 'OTHER', 'description': 'Participants will complete a PROM (Michigan Oncology Quality Consortium, Patient Assessment Tool for Oral Chemotherapy) for their oral anticancer agent (OAA) at two timepoints over 2 months, to assess patient symptoms and adherence to OAA.', 'armGroupLabels': ['Pharmacist Coordinated care Oncology Model (PCOM)']}, {'name': 'Comprehensive Medication Review (CMR)', 'type': 'OTHER', 'description': 'Following the first PROM, participants will be contacted by the primary care pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. If warranted, a follow-up CMR will take place after the second PROM.', 'armGroupLabels': ['Pharmacist Coordinated care Oncology Model (PCOM)']}, {'name': 'Communications between oncology and primary care pharmacists', 'type': 'OTHER', 'description': 'Throughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record.', 'armGroupLabels': ['Pharmacist Coordinated care Oncology Model (PCOM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Rogel Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Karen Farris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan College of Pharmacy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}