NCT07587073

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

CalAIMEnhanced Care ManagementCommunity SupportsTransitional Care ServicesResidential CareRecuperative CareShort-Term Post-Hospitalization HousingNursing Facility TransitionMedi-CalPopulation HealthCare CoordinationCalifornia

Outcome Measures

Primary Outcomes (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.

    30 days after index discharge

Secondary Outcomes (8)

  • Emergency department utilization

    6 months after index discharge

  • Successful ambulatory follow-up

    30 days after index discharge

  • Medication reconciliation completion

    7 days after index discharge

  • Community tenure

    6 months

  • Residential stability

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Arm A: Comprehensive ECM + Community Supports + Transitional/Residential Care Bundle

ACTIVE COMPARATOR

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.

Behavioral: Comprehensive CalAIM Care Bundle

Arm B: Usual CalAIM Services

OTHER

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.

Other: Usual CalAIM Service Delivery

Interventions

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.

Arm A: Comprehensive ECM + Community Supports + Transitional/Residential Care Bundle

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

Arm B: Usual CalAIM Services

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StratiHealth

Los Angeles, California, 90001, United States

Location

Related Publications (13)

  • 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.

Related Links

Study Officials

  • Vernon R Pertelle

    StratiHealth

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations