Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence

Study Overview
=================
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.

Official Title
-----------------
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence

Conditions
-----------------
Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Multiple Chronic Conditions

Intervention / Treatment
-----------------
* Other: Patient-reported outcome measure
* Other: Comprehensive Medication Review
* Other: Pharmacist communication


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Coordinated care Oncology Model<br>The Pharmacist Coordinated care Oncology Model includes patient self-reported symptoms and medication adherence, comprehensive medication review(s) and intentional communication between oncology and community pharmacists. | Other: Patient-reported outcome measure<br>* 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.<br>Other: Comprehensive Medication Review<br>* 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.<br>Other: Pharmacist communication<br>* Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral anticancer agent adherence by proportion of days covered (PDC) | 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. | Up to 6 months post-initiation | 
| Chronic disease medication adherence | PDCs for medications for select chronic diseases will be calculated for the 6 months before and after oral anticancer agent initiation | 6 months pre- and post-initiation of the oral anticancer agent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome measure completion | 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. | Approximately 42 days after oral anticancer agent initiation | 
| Comprehensive Medication Review (CMR) completion | Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist | Approximately 50 days after oral anticancer agent initiation | 
| Oncology pharmacist review of patient-reported outcome measure | 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. | Approximately 44 days after oral anticancer agent initiation | 
| Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist | 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. | Approximately 43 days after oral anticancer agent initiation | 
| Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist | 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. | Approximately 44 days after oral anticancer agent initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adherence, leukemia, anticancer agents, chronic disease management, pharmacy practice, hematological malignancy