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

NCT04595851 | Terminated

• 2 other identifiers: UMCC 2020.053HUM00178781
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; Multiple Chronic Conditions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percent of patients with two completed Patient Reported Outcome Measures (PROMs)

  Up to day 42 (+/-3) after OAA initiation

• Percent of patients with completed Comprehensive Medication Reviews (CMRs)

  Day 50 (+/-3) after OAA initiation

• Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result

  Day 22 (+/-3) after OAA initiation

• Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM

  Up to day 44 (+/-3) after OAA initiation

• Percent of CMRs where note was routed to oncology pharmacist

  Up to day 43 (+/-3) after OAA initiation

Study Arms (1)

Pharmacist Coordinated care Oncology Model (PCOM)

OTHER

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); Other: Comprehensive Medication Review (CMR); Other: Communications between oncology and primary care pharmacists

Interventions

Patient Reported Outcome Measure (PROM) OTHER

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.

Pharmacist Coordinated care Oncology Model (PCOM)

Comprehensive Medication Review (CMR) OTHER

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.

Pharmacist Coordinated care Oncology Model (PCOM)

Communications between oncology and primary care pharmacists OTHER

Throughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record.

Pharmacist Coordinated care Oncology Model (PCOM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cannot speak English
• Concurrent diagnosis of type 1 diabetes
• Concurrent diagnosis of human immunodeficiency virus

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Chronic Conditions

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Karen Farris, PhD

  University of Michigan College of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 22, 2020
• Study Start: March 26, 2021
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)