Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07587073

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

StratiHealth

Los Angeles, California, 90001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive CalAIM Care Bundle

Behavioral

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.

Usual CalAIM Service Delivery

Other

Standard local delivery of CalAIM-related services without the added structured bundle, monitoring cadence, and transition optimization workflow used in the intervention arm.

Primary outcomes

  1. 30-day all-cause acute inpatient readmission rate

    Time frame: 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.

Secondary outcomes

  1. Emergency department utilization

    Time frame: 6 months after index discharge

    Number of ED visits per participant

  2. Successful ambulatory follow-up

    Time frame: 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

  3. Medication reconciliation completion

    Time frame: 7 days after index discharge

    Proportion with documented medication reconciliation after discharge

  4. Community tenure

    Time frame: 6 months

    Days alive and residing in community-based or home-like settings without return to institutional care

  5. Residential stability

    Time frame: 6 months

    Proportion maintaining stable residential placement, assisted living diversion, or successful community transition without unplanned displacement

  6. Total cost of care

    Time frame: 6 months

    Per member per month total cost of care from plan-paid claims and encounter data

  7. Patient-reported quality of life

    Time frame: baseline to 6 months

    Change in PROMIS Global Health or similar validated measure

  8. Member experience

    Time frame: 30 days and 6 months

    Care transition and care coordination experience score using a standardized survey

Sponsors and collaborators

Lead sponsor

StratiHealth

Industry

Registry information

Official study title

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

Acronym: COMPASS-CalAIM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.