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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Comprehensive 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.
• Другое Usual 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.

Первичные конечные точки

• 30-day all-cause acute inpatient readmission rate [Срок оценки: 30 days after index discharge]

Вторичные конечные точки (8)

• Emergency department utilization [Срок оценки: 6 months after index discharge]
• Successful ambulatory follow-up [Срок оценки: 30 days after index discharge]
• Medication reconciliation completion [Срок оценки: 7 days after index discharge]
• Community tenure [Срок оценки: 6 months]
• Residential stability [Срок оценки: 6 months]
• Total cost of care [Срок оценки: 6 months]
• Patient-reported quality of life [Срок оценки: baseline to 6 months]
• Member experience [Срок оценки: 30 days and 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• StratiHealth — Los Angeles

Публикации

• Finkelstein A, Zhou A, Taubman S, Doyle J. Health Care Hotspotting - A Randomized, Controlled Trial. N Engl J Med. 2020 Jan 9;382(2):152-162. doi: 10.1056/NEJMsa1906848. PMID 31914242
• Gottlieb LM, Wing H, Adler NE. A Systematic Review of Interventions on Patients' Social and Economic Needs. Am J Prev Med. 2017 Nov;53(5):719-729. doi: 10.1016/j.amepre.2017.05.011. Epub 2017 Jul 5. PMID 28688725
• Lachaud J, Mejia-Lancheros C, Durbin A, Nisenbaum R, Wang R, O'Campo P, Stergiopoulos V, Hwang SW. The Effect of a Housing First Intervention on Acute Health Care Utilization among Homeless Adults with Mental Illness: Long-term Outcomes of the At Home/Chez-Soi Randomized Pragmatic Trial. J Urban Health. 2021 Aug;98(4):505-515. doi: 10.1007/s11524-021-00550-1. Epub 2021 Jun 28. PMID 34181180
• Raven MC, Niedzwiecki MJ, Kushel M. A randomized trial of permanent supportive housing for chronically homeless persons with high use of publicly funded services. Health Serv Res. 2020 Oct;55 Suppl 2(Suppl 2):797-806. doi: 10.1111/1475-6773.13553. PMID 32976633
• Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public Health. 2017 Oct;107(10):1660-1667. doi: 10.2105/AJPH.2017.303985. Epub 2017 Aug 17. PMID 28817334
• Vasan A, Morgan JW, Mitra N, Xu C, Long JA, Asch DA, Kangovi S. Effects of a standardized community health worker intervention on hospitalization among disadvantaged patients with multiple chronic conditions: A pooled analysis of three clinical trials. Health Serv Res. 2020 Oct;55 Suppl 2(Suppl 2):894-901. doi: 10.1111/1475-6773.13321. Epub 2020 Jul 8. PMID 32643163
• Kangovi S, Mitra N, Norton L, Harte R, Zhao X, Carter T, Grande D, Long JA. Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1635-1643. doi: 10.1001/jamainternmed.2018.4630. PMID 30422224
• Edwards ST, Peterson K, Chan B, Anderson J, Helfand M. Effectiveness of Intensive Primary Care Interventions: A Systematic Review. J Gen Intern Med. 2017 Dec;32(12):1377-1386. doi: 10.1007/s11606-017-4174-z. Epub 2017 Sep 18. PMID 28924747

Идентификаторы

NCT: NCT07587073 · COFGR202601120331071364 · STRATI-CalAIM-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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