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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
1200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Los Angeles、California、アメリカ、90001
- StratiHealth
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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他の：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.
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Standard local delivery of CalAIM-related services without the added structured bundle, monitoring cadence, and transition optimization workflow used in the intervention arm.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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30-day all-cause acute inpatient readmission rate
時間枠：30 days after index discharge
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Proportion of enrolled participants experiencing an unplanned all-cause inpatient readmission within 30 days after index discharge or index transition episode.
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30 days after index discharge
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Emergency department utilization
時間枠：6 months after index discharge
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Number of ED visits per participant
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6 months after index discharge
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Successful ambulatory follow-up
時間枠：30 days after index discharge
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Proportion with completed primary care or appropriate ambulatory follow-up within 7 days for high-risk transition episodes and within 30 days overall
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30 days after index discharge
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Medication reconciliation completion
時間枠：7 days after index discharge
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Proportion with documented medication reconciliation after discharge
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7 days after index discharge
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Community tenure
時間枠：6 months
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Days alive and residing in community-based or home-like settings without return to institutional care
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6 months
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Residential stability
時間枠：6 months
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Proportion maintaining stable residential placement, assisted living diversion, or successful community transition without unplanned displacement
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6 months
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Total cost of care
時間枠：6 months
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Per member per month total cost of care from plan-paid claims and encounter data
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6 months
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Patient-reported quality of life
時間枠：baseline to 6 months
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Change in PROMIS Global Health or similar validated measure
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baseline to 6 months
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Member experience
時間枠：30 days and 6 months
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Care transition and care coordination experience score using a standardized survey
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30 days and 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Vernon R Pertelle、StratiHealth
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Damery S, Flanagan S, Combes G. Does integrated care reduce hospital activity for patients with chronic diseases? An umbrella review of systematic reviews. BMJ Open. 2016 Nov 21;6(11):e011952. doi: 10.1136/bmjopen-2016-011952.
- Joo JY, Liu MF. Case management effectiveness in reducing hospital use: a systematic review. Int Nurs Rev. 2017 Jun;64(2):296-308. doi: 10.1111/inr.12335. Epub 2016 Nov 11.
- Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011 Apr;30(4):746-54. doi: 10.1377/hlthaff.2011.0041.
- Tyler N, Hodkinson A, Planner C, Angelakis I, Keyworth C, Hall A, Jones PP, Wright OG, Keers R, Blakeman T, Panagioti M. Transitional Care Interventions From Hospital to Community to Reduce Health Care Use and Improve Patient Outcomes: A Systematic Review and Network Meta-Analysis. JAMA Netw Open. 2023 Nov 1;6(11):e2344825. doi: 10.1001/jamanetworkopen.2023.44825.
- Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年9月30日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月8日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月8日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- COFGR202601120331071364
- STRATI-CalAIM-01 (その他の助成金/資金番号：StratiHealth Services LLC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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