A Randomized Controlled, Type 1 Hybrid Effectiveness-implementation Trial Study to Compare the Effectiveness of a Patient-Reported Outcomes (PRO)-Driven Culturally Grounded Supportive Care Navigation in Reducing Healthcare Disparities Among Hispanic/Latinx Patients Receiving Anticancer Therapies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- ED visits, hospitalizations, and urgent care visits
研究概览
简要总结
This is a randomized controlled, type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness of a patient-reported outcomes (PRO)-driven culturally grounded supportive care navigation in reducing healthcare disparities among Hispanic/Latinx patients receiving anticancer therapies. The objectives of this study are: (1) to compare the effectiveness of an ePRO-driven culturally grounded supportive care navigation versus usual care (control) in Hispanic/Latinx patients undergoing anticancer treatment; and (2) to elicit perspectives from Hispanic/Latinx patients, healthcare providers, and community partners on how an ePRO-driven culturally grounded supportive care navigation can address health disparities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •At least 18 years old
- •Hispanic/LatinX origin
- •Newly diagnosed cancer patients
- •Receiving anticancer treatment (may include combinations of intravenous or oral chemotherapy, targeted therapies, and/or immunotherapies)
排除标准
- •Being physically and/or mentally incapable of providing written consent
研究组 & 干预措施
Usual care
Patient-Reported Outcomes (PRO)-driven supportive care navigation
干预措施: Patient-Reported Outcomes (PRO)-driven supportive care navigation (Other)
结局指标
主要结局
ED visits, hospitalizations, and urgent care visits
时间窗: baseline and 3 months post-baseline
Detailed information regarding ED visits, hospitalization, and urgent care visits from the first 3 months of anticancer treatment (after joining the study) will be obtained using EMR, and the UCI Health Data Warehouse.
Emergency department visits, hospitalizations, and urgent care visits
时间窗: baseline and 3 months post-baseline
Detailed information regarding emergency department visits, hospitalization, and urgent care visits from the first 3 months of anticancer treatment (after joining the study) will be obtained using electronic medical records, and the UCI Health Data Warehouse.
次要结局
- Symptom severity(baseline and 3 months post-baseline)
- Health-related quality of life(baseline and 3 months post-baseline)
- Health literacy(baseline and 3 months post-baseline)
研究者
Alexandre Chan
Professor of Clinical Pharmacy
University of California, Irvine