Recruiting

ACCT, CCP, C4P

Sponsor:

University of Chicago

Code:

NCT04489693

Conditions

Comprehensive Care

Quality of Care

Medicare

Cost of Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ambulatory Care Coordinator Team (ACCT)

Comprehensive Care Physician Program (CCP)

Comprehensive Care Community & Culture Program (C4P)

Study Details

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

Study ID

NCT04489693

Start date

Mar 6, 2019

Status verified date

Apr, 2025

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

- None

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Ambulatory Care Coordinator Team (ACCT)

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.

active comparator: Comprehensive Care Physician (CCP)

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.

active comparator: Comprehensive Care, Community & Culture Program (C4P)

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.

Interventions

Ambulatory Care Coordinator Team (ACCT)

See arm description

Comprehensive Care Physician Program (CCP)

see arm description

Comprehensive Care Community & Culture Program (C4P)

see arm description

Primary outcome measure

  • Quarterly hospitalization rate [ Time Frame: Through study completion, with a range of 1 to 4.5 years ]

Central Contacts and Locations

Locations

David Meltzer

Recruiting

Chicago, Illinois, United States, 60637

Contacts

David Meltzer, MD, PhD

773-702-0836dmeltzer@medicine.bsd.uchicago.edu

Emily Perish, MPP

773-702-3726dmeltzer@medicine.bsd.uchicago.edu

Principal Investigator:

David Meltzer, MD,PhD

More Information

Sponsor

University of Chicago

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-04-09.