Back to resultsPharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications
Primary Purpose
Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Chronic Conditions
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Reported Outcome Measure (PROM)
Comprehensive Medication Review (CMR)
Communications between oncology and primary care pharmacists
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Has primary care physician
- Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
- Initiating an OAA, either for the first time or a change from previous OAA
- 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
- Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.
- Willing and able to sign informed consent.
Exclusion Criteria:
- Cannot speak English
- Concurrent diagnosis of type 1 diabetes
- Concurrent diagnosis of human immunodeficiency virus
Sites / Locations
- University of Michigan Rogel Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pharmacist Coordinated care Oncology Model (PCOM)
Arm 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.
Outcomes
Primary Outcome Measures
Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)
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.
PDC for chronic condition medications
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.
Secondary Outcome Measures
Percent of patients with two completed Patient Reported Outcome Measures (PROMs)
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.
Percent of patients with completed Comprehensive Medication Reviews (CMRs)
Completed CMR includes initial and follow-up CMR with primary care pharmacist.
Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result
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.
Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM
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.
Percent of CMRs where note was routed to oncology pharmacist
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.
Percent of CMR notes that oncology pharmacist reviewed
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.
Full Information
NCT ID
NCT04595851
First Posted
October 13, 2020
Last Updated
November 21, 2022
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT04595851
Brief Title
Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications
Official Title
Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
accrual difficulties
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
July 14, 2022 (Actual)
Study Completion Date
July 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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]).
This 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Chronic Conditions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist Coordinated care Oncology Model (PCOM)
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Patient Reported Outcome Measure (PROM)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Medication Review (CMR)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Communications between oncology and primary care pharmacists
Intervention Description
Throughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record.
Primary Outcome Measure Information:
Title
Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)
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.
Time Frame
Up to 6 months following OAA initiation
Title
PDC for chronic condition medications
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.
Time Frame
Up to 6 months following OAA initiation
Secondary Outcome Measure Information:
Title
Percent of patients with two completed Patient Reported Outcome Measures (PROMs)
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.
Time Frame
Up to day 42 (+/-3) after OAA initiation
Title
Percent of patients with completed Comprehensive Medication Reviews (CMRs)
Description
Completed CMR includes initial and follow-up CMR with primary care pharmacist.
Time Frame
Day 50 (+/-3) after OAA initiation
Title
Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result
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.
Time Frame
Day 22 (+/-3) after OAA initiation
Title
Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM
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.
Time Frame
Up to day 44 (+/-3) after OAA initiation
Title
Percent of CMRs where note was routed to oncology pharmacist
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.
Time Frame
Up to day 43 (+/-3) after OAA initiation
Title
Percent of CMR notes that oncology pharmacist reviewed
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.
Time Frame
Up to day 44 (+/-3) after OAA initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has primary care physician
Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
Initiating an OAA, either for the first time or a change from previous OAA
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
Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.
Willing and able to sign informed consent.
Exclusion Criteria:
Cannot speak English
Concurrent diagnosis of type 1 diabetes
Concurrent diagnosis of human immunodeficiency virus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Farris, PhD
Organizational Affiliation
University of Michigan College of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications
We'll reach out to this number within 24 hrs