Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications

Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Lymphocytic Leukemia; Chronic Myeloid Leukemia; Multiple Chronic Conditions
• Intervention / Treatment: Other: Patient Reported Outcome Measure (PROM); Other: Comprehensive Medication Review (CMR); Other: Communications between oncology and primary care pharmacists

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Pharmacist Coordinated care Oncology Model (PCOM); 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.

Other: Patient Reported Outcome Measure (PROM); 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.; Other: Comprehensive Medication Review (CMR); 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.; Other: Communications between oncology and primary care pharmacists; Throughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months following OAA initiation
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.	Up to 6 months following OAA initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to day 42 (+/-3) after OAA initiation
Percent of patients with completed Comprehensive Medication Reviews (CMRs)	Completed CMR includes initial and follow-up CMR with primary care pharmacist.	Day 50 (+/-3) after OAA initiation
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.	Day 22 (+/-3) after OAA initiation
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.	Up to day 44 (+/-3) after OAA initiation
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.	Up to day 43 (+/-3) after OAA initiation
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.	Up to day 44 (+/-3) after OAA initiation

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Karen Farris, PhD, University of Michigan College of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): July 14, 2022
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia, Lymphoid; Leukemia, B-Cell; Leukemia, Myeloid; Chronic Disease; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Multiple Chronic Conditions
• Other Study ID Numbers: UMCC 2020.053; HUM00178781 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No