跳至主要内容
临床试验/NCT07279376
NCT07279376
Enrolling By Invitation
不适用

Harnessing Data Science to Improve HIV Care Continuum Outcomes: A Hybrid Type 2 Trial Evaluating a Machine-Learning Algorithm-Based Implementation Strategy

Hunter College of City University of New York1 个研究点 分布在 1 个国家目标入组 2,600 人开始时间: 2025年11月18日最近更新:

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

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

Active Comparator

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

Other

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

发起方
Hunter College of City University of New York
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarit Golub

Distinguished Professor

Hunter College of City University of New York

研究点 (1)

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