Comparative Development of Data Driven Systems for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) generated with the new system
研究概览
简要总结
This research trial studies an adherence monitoring system in managing myelosuppression in patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation therapy. The development of an adherence monitoring system may help doctors more effectively utilize electronic medical records to manage myelosuppression during standard treatment with temozolomide and radiation therapy in patients with malignant gliomas.
详细描述
PRIMARY OBJECTIVES:
I. To develop an adherence monitoring system within Epic that is functionally equivalent to the previously designed and validated system in the Cancer Center Oncology Research Information System (ORIS) for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.
II. To test the newly designed Epic system by comparing the frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) and non-adherent days generated with the frequency and timing of those generated by ORIS for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.
SECONDARY OBJECTIVES:
I. To develop both systems so that they may be easily adapted in the future to other therapies that require compliance monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who receive concurrent temozolomide and radiation therapy for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study
排除标准
- •Patients participating in clinical trials or other deviations from standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis
结局指标
主要结局
Frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) generated with the new system
时间窗: 42 days
To compare the two systems, the McNemar's tests of paired proportions will be used. For each day, whether or not any flag (laboratory date flags, visit date flags and in-patient status flags) was generated or whether a gap occurred will be characterized. By day, the two systems will be compared to determine if they agree for flags and gap days (separately). Alternative methods will be used (such as conditional logistic regression with a random subject effect) if correlation between days is observed.
Non-adherent days generated with the new system
时间窗: 42 Days
To compare the two systems, the McNemar's tests of paired proportions will be used. For each day, whether or not any flag (laboratory date flags, visit date flags and in-patient status flags) was generated or whether a gap occurred will be characterized. By day, the two systems will be compared to determine if they agree for flags and gap days (separately). Alternative methods will be used (such as conditional logistic regression with a random subject effect) if correlation between days is observed.
Development of a new adherence monitoring system within Epic that is functionally equivalent to the previously designed and validated system in the Cancer Center ORIS
时间窗: 42 days
To compare the two systems, the McNemar's tests of paired proportions will be used to compare the output of the established software system to the new system built into the EMR reporting structure.
次要结局
- Expansion of both systems to other therapies that require compliance monitoring(42 days)