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临床试验/NCT04663100
NCT04663100招募中不适用

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

University of Tennessee2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Oral anticancer agent adherence by proportion of days covered (PDC)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Cannot communicate in English
  • Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus

结局指标

主要结局

Oral anticancer agent adherence by proportion of days covered (PDC)

时间窗: 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

时间窗: 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

次要结局

  • Oncology pharmacist review of patient-reported outcome measure(Approximately 44 days after oral anticancer agent initiation)
  • Percent of Comprehensive Medication Reviews (CMRs) where note was routed to oncology pharmacist(Approximately 43 days after oral anticancer agent initiation)
  • Patient-reported outcome measure completion(Approximately 42 days after oral anticancer agent initiation)
  • Comprehensive Medication Review (CMR) completion(Approximately 50 days after oral anticancer agent initiation)
  • Proportion of Comprehensive Medication Reviews (CMRs) reviewed by the oncology pharmacist(Approximately 44 days after oral anticancer agent initiation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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