Comprehensive Care Community and Culture Study

NCT04489693 | Recruiting

• 1 other identifier: IRB-16-0391
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized trial is evaluating whether socioeconomically disadvantaged Medicare patients at increased risk of hospitalization experience fewer hospitalization if those patients are offered care in: 1) ACCT, where patients receive care from different physicians in the hospital and the clinic settings and have access to nurse and social worker care coordination services, 2) CCP where patients receive care from one physician in the inpatient and outpatient settings or 3) C4P which adds screening of unmet social needs, community health worker support and arts and culture programming to CCP. The study will determine how these programs affect patient activation and engagement in care, satisfaction with care, general health and mental health, and goal attainment.

Conditions

Comprehensive Care; Quality of Care; Medicare; Cost of Care

Outcome Measures

Primary Outcomes (1)

• Quarterly hospitalization rate

  Number of hospitalizations per quarter

  Through study completion, with a range of 1 to 4.5 years

Secondary Outcomes (6)

• Quarterly hospitalization rate from all sources

  Through study completion, with a range of 1 to 4.5 years

• Patient experience

  Through study completion, with a range of 1 to 4.5 years

• Health Outcomes General Health

  Through study completion, with a range of 1 to 4.5 years

• Health Outcomes Mental Health

  Through study completion, with a range of 1 to 4.5 years

• Patient Activation Measure (PAM)

  Through study completion, with a range of 1 to 4.5 years

Study Arms (3)

Ambulatory Care Coordinator Team (ACCT)

ACTIVE COMPARATOR

Patients randomized to ACCT receive care from different doctors in clinic and in the hospital. ACCT patients who have been hospitalized twice, had 4 emergency department (ED) visits in the last year or are referred by their primary care physician are offered ACCT care coordination services (ACCT-CC) from nurses and social workers who manage their care with the larger clinical team. Patients are graduated from ACCT if the ACCT team thinks they are no longer high risk.

Behavioral: Ambulatory Care Coordinator Team (ACCT)

Comprehensive Care Physician (CCP)

ACTIVE COMPARATOR

Patients randomized to the CCP group are assigned to a Comprehensive Care Physician and are asked to see their assigned CCP for their primary care. The patients receive their care from the same CCP in the outpatient clinic and also if they were to be hospitalized.

Behavioral: Comprehensive Care Physician Program (CCP)

Comprehensive Care, Community & Culture Program (C4P)

ACTIVE COMPARATOR

Patients randomized to C4P receive care from a CCP in both the hospital and the clinic as well as the following: 1) systematic screening of 17 domains of unmet social needs, 2) access to a community health worker and 3) access to community-based arts and culture programming.

Behavioral: Comprehensive Care Community & Culture Program (C4P)

Interventions

Ambulatory Care Coordinator Team (ACCT) BEHAVIORAL

See arm description

Ambulatory Care Coordinator Team (ACCT)

Comprehensive Care Physician Program (CCP) BEHAVIORAL

see arm description

Comprehensive Care Physician (CCP)

Comprehensive Care Community & Culture Program (C4P) BEHAVIORAL

see arm description

Comprehensive Care, Community & Culture Program (C4P)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have Medicare Part A and Part B
• Must have been hospitalized once in the past 2 years or be in emergency department at time recruitment is initiated

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Chicago: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

David Meltzer

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (1)

• Gier NM, Maurer RR, Tang JW. Clinician experiences in a DBT-informed consultation group embedded within a US academic primary care clinic: a qualitative study. BMJ Open. 2025 Oct 27;15(10):e100967. doi: 10.1136/bmjopen-2025-100967.

  PMID: 41145263 DERIVED

Study Design

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

Model Details: This Compares the CCP ,C4P and Traditional Care Coordination Models

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 28, 2020
• Study Start: March 6, 2019
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)