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

8 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • Los Angeles, California, Estados Unidos, 90001
        • StratiHealth

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
30-day all-cause acute inpatient readmission rate
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Emergency department utilization
Periodo de tiempo: 6 months after index discharge
Number of ED visits per participant
6 months after index discharge
Successful ambulatory follow-up
Periodo de tiempo: 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
Periodo de tiempo: 7 days after index discharge
Proportion with documented medication reconciliation after discharge
7 days after index discharge
Community tenure
Periodo de tiempo: 6 months
Days alive and residing in community-based or home-like settings without return to institutional care
6 months
Residential stability
Periodo de tiempo: 6 months
Proportion maintaining stable residential placement, assisted living diversion, or successful community transition without unplanned displacement
6 months
Total cost of care
Periodo de tiempo: 6 months
Per member per month total cost of care from plan-paid claims and encounter data
6 months
Patient-reported quality of life
Periodo de tiempo: baseline to 6 months
Change in PROMIS Global Health or similar validated measure
baseline to 6 months
Member experience
Periodo de tiempo: 30 days and 6 months
Care transition and care coordination experience score using a standardized survey
30 days and 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Vernon R Pertelle, StratiHealth

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

30 de septiembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de mayo de 2026

Publicado por primera vez (Actual)

14 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • COFGR202601120331071364
  • STRATI-CalAIM-01 (Otro número de subvención/financiamiento: StratiHealth Services LLC)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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