Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Multiple Chronic Conditions, Multiple Myeloma
Conditions
Keywords
adherence, leukemia, anticancer agents, chronic disease management, pharmacy practice, hematological malignancy
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 or community 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.
Interventions
OTHERPatient-reported outcome measure
Participants will complete a patient-reported outcome measure for their oral anticancer agent at two timepoints over 2 months, to assess patient symptoms and adherence to their oral anticancer agent.
Following the first patient-reported outcome measure, participants will be contacted by the community pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. A follow-up CMR will take place after the second patient-reported outcome measure.
OTHERPharmacist communication
Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.
Sponsors
Vanderbilt University Medical Center
AstraZeneca
University of Tennessee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receiving cancer care at Vanderbilt University Medical Center * Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM) * Initiating an oral anticancer agent, either for the first time or a change from previous oral agent * Diagnosis of 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 communicate in English * Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral anticancer agent adherence by proportion of days covered (PDC) | Up to 6 months post-initiation | PDC is a common medication adherence metric, and assesses the ratio of number of days the patient is supplied with oral anticancer agent, from the time of initiation until 6 months later, to the total number of days during that period. Data from the electronic medical record for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC. |
| Chronic disease medication adherence | 6 months pre- and post-initiation of the oral anticancer agent | PDCs for medications for select chronic diseases will be calculated for the 6 months before and after oral anticancer agent initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oncology pharmacist review of patient-reported outcome measure | Approximately 44 days after oral anticancer agent initiation | The patient-reported outcome measure is scored within one day after it is completed by the subject and is routed to the oncology pharmacist to review the results. The number of measures that are reviewed within 1 day of receipt will be assessed at 2 weeks and at 6 weeks. |
| Patient-reported outcome measure completion | Approximately 42 days after oral anticancer agent initiation | The oncology-specific patient-reported outcome measure is to be completed at 2 and 6 weeks after oral anticancer agent initiation. This measure assesses the percent of patients who complete this tool at both time points. |
| Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist | Approximately 44 days after oral anticancer agent initiation | 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. |
| Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist | Approximately 43 days after oral anticancer agent initiation | The number of CMRs where note was routed to oncology pharmacist out of total number of completed CMRs, assessed at 2 weeks and at 6 weeks. |
| Comprehensive Medication Review (CMR) completion | Approximately 50 days after oral anticancer agent initiation | Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist |
Countries
United States
Contacts
Primary ContactJustin Gatwood, PhD
Backup ContactKatie Gatwood, PharmD
Outcome results
None listed