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Comprehensive Enhanced Care Management Under CalAIM for High-Risk Medi-Cal Members (COMPASS-CalAIM)

2026年5月8日 更新者:StratiHealth

A Pragmatic Cluster-Randomized Evaluation of Enhanced Care Management With Community Supports, Transitional Care, and Residential Care Coordination for High-Risk Medi-Cal Members Under CalAIM in California

This pragmatic, cluster-randomized trial will evaluate whether a comprehensive CalAIM-aligned care model consisting of Enhanced Care Management, selected Community Supports, Transitional Care Services, and residential care coordination improves population health outcomes among high-risk Medi-Cal managed care members in California compared with usual CalAIM service delivery. The intervention is intended to improve continuity of care after discharge, reduce potentially avoidable utilization, increase successful linkage to outpatient and social supports, and improve community tenure and patient-reported outcomes.

研究概览

详细说明

California Advancing and Innovating Medi-Cal (CalAIM) initiative emphasizes person-centered care, integration across medical and social services, and support for members with complex clinical and social needs. Within this framework, Enhanced Care Management provides high-touch community-based care management, while Population Health Management requires Transitional Care Services to support members through discharge and follow-up. Community Supports may include medically appropriate substitute services such as recuperative care, short-term post-hospitalization housing, and supports related to nursing facility transition or diversion to assisted living and other community settings (Source: Department of Health Care Service (DHCS) Population Health Management (PHM) Policy Guide, DHCS Transitional Care Services (TCS) for Medi-Cal Members with Long-Term Services and Supports (LTSS) Resource, DHCS Community Supports Fact Sheet).

The study will prospectively compare two implementation approaches at the cluster level. Clusters assigned to the intervention will deliver a structured, comprehensive care bundle, including an assigned Enhanced Care Management (ECM) care manager, a discharge-transition workflow, medication-reconciliation support, timely ambulatory follow-up, community-support referral and activation, and residential stabilization or transition coordination, where indicated. Control clusters will continue usual CalAIM operations without the enhanced standardized bundle. The hypothesis is that comprehensive integration of these elements will reduce 30-day readmissions and emergency department utilization while improving community stability and total cost of care.

研究类型

介入性

注册 (估计的)

1200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90001
        • StratiHealth

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult Medi-Cal managed care member in California.
  • Identified as high-risk for poor outcomes based on plan stratification or qualifying CalAIM criteria.
  • Eligible for ECM and at least one of the following: Transitional Care Services, Community Supports related to post-acute recovery, housing/residential stabilization, or nursing facility transition/diversion.
  • Recent discharge or active transition from hospital, emergency department, skilled nursing facility, post-acute facility, recuperative care, assisted living, residential behavioral health setting, or other qualifying level-of-care transition.
  • Able to provide informed consent, or eligible for waiver/alteration of consent if approved for cluster-level pragmatic implementation research.

Exclusion Criteria:

  • Enrollment in hospice or expected survival less than 6 months at the time of the index episode.
  • Long-term custodial institutional placement without an anticipated community transition plan.
  • Current incarceration or detention is preventing intervention delivery.
  • Previous enrollment in this study during the same observation window.
  • Any condition that, in the investigator's judgment, makes participation infeasible or data interpretation unreliable.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Arm A: Comprehensive ECM + Community Supports + Transitional/Residential Care Bundle
A standardized service bundle composed of Enhanced Care Management, selected Community Supports, Transitional Care Services, and residential care coordination designed to improve continuity, utilization, and community tenure.
A standardized service bundle composed of Enhanced Care Management, selected Community Supports, Transitional Care Services, and residential care coordination designed to improve continuity, utilization, and community tenure.
其他:Arm B: Usual CalAIM Services
Participants in control clusters will receive routine services available through existing CalAIM operations, including any standard ECM, PHM, discharge planning, and Community Supports workflows already in place, without the enhanced bundled implementation protocol.
Standard local delivery of CalAIM-related services without the added structured bundle, monitoring cadence, and transition optimization workflow used in the intervention arm.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
30-day all-cause acute inpatient readmission rate
大体时间:30 days after index discharge
Proportion of enrolled participants experiencing an unplanned all-cause inpatient readmission within 30 days after index discharge or index transition episode.
30 days after index discharge

次要结果测量

结果测量
措施说明
大体时间
Emergency department utilization
大体时间:6 months after index discharge
Number of ED visits per participant
6 months after index discharge
Successful ambulatory follow-up
大体时间:30 days after index discharge
Proportion with completed primary care or appropriate ambulatory follow-up within 7 days for high-risk transition episodes and within 30 days overall
30 days after index discharge
Medication reconciliation completion
大体时间:7 days after index discharge
Proportion with documented medication reconciliation after discharge
7 days after index discharge
Community tenure
大体时间:6 months
Days alive and residing in community-based or home-like settings without return to institutional care
6 months
Residential stability
大体时间:6 months
Proportion maintaining stable residential placement, assisted living diversion, or successful community transition without unplanned displacement
6 months
Total cost of care
大体时间:6 months
Per member per month total cost of care from plan-paid claims and encounter data
6 months
Patient-reported quality of life
大体时间:baseline to 6 months
Change in PROMIS Global Health or similar validated measure
baseline to 6 months
Member experience
大体时间:30 days and 6 months
Care transition and care coordination experience score using a standardized survey
30 days and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 学习椅:Vernon R Pertelle、StratiHealth

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年9月30日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年5月14日

上次提交的符合 QC 标准的更新

2026年5月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • COFGR202601120331071364
  • STRATI-CalAIM-01 (其他赠款/资助编号:StratiHealth Services LLC)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

De-identified aggregate study findings will be disseminated in publications and presentations. Participant-level data may be made available only pursuant to data use agreements, HIPAA compliance requirements, Medi-Cal data restrictions, and institutional approvals.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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