Clinical trial NCT04595851: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Myeloid Leukemia
Chronic Lymphocytic Leukemia
Multiple Chronic Conditions
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2020-10-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)
timeFrame: Up to 6 months following OAA initiation
measure: PDC for chronic condition medications
timeFrame: Up to 6 months following OAA initiation
Secondary outcomes:
measure: Percent of patients with two completed Patient Reported Outcome Measures (PROMs)
timeFrame: Up to day 42 (+/-3) after OAA initiation
measure: Percent of patients with completed Comprehensive Medication Reviews (CMRs)
timeFrame: Day 50 (+/-3) after OAA initiation
measure: Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result
timeFrame: Day 22 (+/-3) after OAA initiation
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
measure: Percent of CMRs where note was routed to oncology pharmacist
timeFrame: Up to day 43 (+/-3) after OAA initiation
measure: Percent of CMR notes that oncology pharmacist reviewed
timeFrame: Up to day 44 (+/-3) after OAA initiation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan College of Pharmacy
name: Karen Farris, PhD
role: PRINCIPAL_INVESTIGATOR
References: