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Complex CareCOMPASS-CalAIMNCT07587073

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

A study testing Comprehensive CalAIM Care Bundle and Usual CalAIM Service Delivery in people with Complex Care and Post-Acute Care Utilization, run by StratiHealth at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Comprehensive CalAIM Care Bundle and Usual CalAIM Service Delivery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • StratiHealth

    Los Angeles, California, 90001

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Comprehensive CalAIM Care Bundle, Usual CalAIM Service Delivery
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive CalAIM Care BundleBehavioural

    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.

  • Usual CalAIM Service DeliveryOther

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

Study groups in NCT07587073
Study groupRoleWhat they receive
Arm A: Comprehensive ECM + Community Supports + Transitional/Residential Care BundleActive comparatorA 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.
Receives: Behavioral: Comprehensive CalAIM Care Bundle
Arm B: Usual CalAIM ServicesOtherParticipants 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.
Receives: Other: Usual CalAIM Service Delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day all-cause acute inpatient readmission rate

    Proportion of enrolled participants experiencing an unplanned all-cause inpatient readmission within 30 days after index discharge or index transition episode.

    Measured: 30 days after index discharge

Secondary outcomes (8)
  1. Emergency department utilization

    Number of ED visits per participant

    Measured: 6 months after index discharge

  2. Successful ambulatory follow-up

    Proportion with completed primary care or appropriate ambulatory follow-up within 7 days for high-risk transition episodes and within 30 days overall

    Measured: 30 days after index discharge

  3. Medication reconciliation completion

    Proportion with documented medication reconciliation after discharge

    Measured: 7 days after index discharge

  4. Community tenure

    Days alive and residing in community-based or home-like settings without return to institutional care

    Measured: 6 months

  5. Residential stability

    Proportion maintaining stable residential placement, assisted living diversion, or successful community transition without unplanned displacement

    Measured: 6 months

  6. Total cost of care

    Per member per month total cost of care from plan-paid claims and encounter data

    Measured: 6 months

  7. Patient-reported quality of life

    Change in PROMIS Global Health or similar validated measure

    Measured: baseline to 6 months

  8. Member experience

    Care transition and care coordination experience score using a standardized survey

    Measured: 30 days and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587073
Sponsor's protocol ID
COFGR202601120331071364
Other IDs
STRATI-CalAIM-01
Acronym
COMPASS-CalAIM
Status last verified
May 2026
First submitted
8 May 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28924747
  • 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.

    PubMed 27872113
  • 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.

    PubMed 27861853
  • 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.

    PubMed 21471497
  • 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.

    PubMed 38032642
  • 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.

    PubMed 15086645

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive CalAIM Care Bundle and Usual CalAIM Service Delivery in people with Complex Care and Post-Acute Care Utilization, run by StratiHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day all-cause acute inpatient readmission rate (time frame: 30 days after index discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07587073, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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