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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07587073
Acronym
COMPASS-CalAIM
Enrollment
1200
Registered
2026-05-14
Start date
2026-10-01
Completion date
2028-12-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Care Transitions, Complex Care, Housing Instability, Population Health Management, Post-Acute Care Utilization, Residential Care Transition

Keywords

CalAIM, Enhanced Care Management, Community Supports, Transitional Care Services, Residential Care, Recuperative Care, Short-Term Post-Hospitalization Housing, Nursing Facility Transition, Medi-Cal, Population Health, Care Coordination, California

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALComprehensive CalAIM 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.

OTHERUsual CalAIM Service Delivery

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

Sponsors

StratiHealth
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Clusters consisting of participating care management entities or discharge-site networks will be randomized 1:1 to either the comprehensive ECM bundle or usual CalAIM services.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30-day all-cause acute inpatient readmission rate30 days after index dischargeProportion of enrolled participants experiencing an unplanned all-cause inpatient readmission within 30 days after index discharge or index transition episode.

Secondary

MeasureTime frameDescription
Emergency department utilization6 months after index dischargeNumber of ED visits per participant
Successful ambulatory follow-up30 days after index dischargeProportion with completed primary care or appropriate ambulatory follow-up within 7 days for high-risk transition episodes and within 30 days overall
Medication reconciliation completion7 days after index dischargeProportion with documented medication reconciliation after discharge
Community tenure6 monthsDays alive and residing in community-based or home-like settings without return to institutional care
Residential stability6 monthsProportion maintaining stable residential placement, assisted living diversion, or successful community transition without unplanned displacement
Total cost of care6 monthsPer member per month total cost of care from plan-paid claims and encounter data
Patient-reported quality of lifebaseline to 6 monthsChange in PROMIS Global Health or similar validated measure
Member experience30 days and 6 monthsCare transition and care coordination experience score using a standardized survey

Countries

United States

Contacts

STUDY_CHAIRVernon R Pertelle

StratiHealth

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026