Harnessing Data Science to Improve HIV Care Continuum Outcomes: A Hybrid Type 2 Trial Evaluating a Machine-Learning Algorithm-Based Implementation Strategy
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Hunter College of City University of New York
- 入组人数
- 2,600
- 试验地点
- 1
- 主要终点
- Hospitalizations
概览
简要总结
This study tests a strategy for helping Care Management Agencies prioritize patients with HIV (PWH) for outreach and support. Under the new strategy, care managers are given a list of highest-priority patients who have been identified by a computer algorithm as being at high risk of going to the emergency room in the next two weeks. This strategy is compared to traditional (standard of care) care management, in which care managers reach out to patients based on a set schedule and their clinical judgement (but not based on a computerized report). We are looking at whether the use of the computer report helps care managers reach the right patients at the right time, preventing them from having to go to the emergency room.
详细描述
Comprehensive Care Management and Care Coordination (CCM/CC) is a medical case management intervention with demonstrated effectiveness in reducing ED visits and hospitalization for PWH, and improving both health outcomes (viral load, CD4 count) and retention in care. However, despite CCM/CC's effectiveness, there are persistent challenges to its implementation. This project is based on the scientific premise that the effectiveness of the CCM/CC intervention can be greatly improved by utilizing a data-driven implementation strategy that optimizes timely provision of CCM/CC services to the patients who need it most. Our community-based collaborator, Comprehensive Care Management Partners (CCMP) Health Home, has developed and validated a machine-learning algorithm that can reliably predict which of its PWH patients are most likely to visit the ED in the next two weeks. In this project, we will apply this algorithm as a targeted implementation strategy for CCM/CC, focusing service provision on the PWH who need it most, when they need it most. Our core hypothesis (supported by preliminary studies data) is that this "just-in-time" strategy for implementing a care management intervention will overcome both provider-level barriers to the provision of CCM/CC services and patient-level barriers to the receipt of HIV treatment and care. We will conduct a Hybrid 2 implementation-effectiveness trial, guided by the RE-AIM implementation science framework and the behavioral economics theory of Scarcity to collect rigorous data on the impact of this algorithm-driven implementation strategy on the reach, effectiveness, adoption, implementation and maintenance of the CCM/CC intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None (Participant)
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
- •Participants must be members of one of the Care Management Agencies that comprise the Community Care Management Partners (CCMP) Health Home
- •Participants must be living with HIV
排除标准
- •None, other than those listed above.
研究组 & 干预措施
Predictive Emergency Room Alerts (perA)Implementation Strategy
Refers to patients within Care Management Agencies that have been randomized to use the pERA implementation strategy to delivery CCM/CC during that study period.
干预措施: predictive emergency room alerts (pERA) (Other)
Standard of Care Implementation Strategy
Refers to patients in Care Management Agencies that have been randomized to use their standard of care implementation strategy to deliver CCM/CC during that study period.
干预措施: Standard of care (Other)
结局指标
主要结局
Hospitalizations
时间窗: Each 18 month Cluster Period (36 months total)
Number of days of Hospitalization
Viral Suppression
时间窗: Each 18 month cluster period (36 months total)
Number of timepoints at which patient was virally suppressed
ER visits
时间窗: Each 18 month cluster period (36 months total)
Number of ER visits made by patients
CD4 Count
时间窗: Each 18 month Cluster Period (36 months total)
CD4 Level at each data collection timepoint
次要结局
未报告次要终点
研究者
Sarit Golub
Distinguished Professor
Hunter College of City University of New York