- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07587073
Comprehensive Enhanced Care Management Under CalAIM for High-Risk Medi-Cal Members (COMPASS-CalAIM)
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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
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Los Angeles, California, Spojené státy, 90001
- StratiHealth
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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Jiný: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
30-day all-cause acute inpatient readmission rate
Časové okno: 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.
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30 days after index discharge
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Emergency department utilization
Časové okno: 6 months after index discharge
|
Number of ED visits per participant
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6 months after index discharge
|
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Successful ambulatory follow-up
Časové okno: 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
Časové okno: 7 days after index discharge
|
Proportion with documented medication reconciliation after discharge
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7 days after index discharge
|
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Community tenure
Časové okno: 6 months
|
Days alive and residing in community-based or home-like settings without return to institutional care
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6 months
|
|
Residential stability
Časové okno: 6 months
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Vernon R Pertelle, StratiHealth
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- COFGR202601120331071364
- STRATI-CalAIM-01 (Jiné číslo grantu/financování: StratiHealth Services LLC)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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