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Comprehensive CareNCT04489693

Comprehensive Care Community and Culture Study

A study testing Ambulatory Care Coordinator Team (ACCT), Comprehensive Care Physician Program (CCP) and Comprehensive Care Community & Culture Program (C4P) in people with Comprehensive Care and Quality of Care, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Comprehensive Care, Quality of Care, Medicare
What is being tested?
Ambulatory Care Coordinator Team (ACCT), Comprehensive Care Physician Program (CCP) and Comprehensive Care Community & Culture Program (C4P)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
1 siteUnited States
Study dates
6 Mar 2019to 31 Jul 2029
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

  • 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

Who cannot join

  • None

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, 1 recruiting
  • David Meltzer

    Chicago, Illinois, 60637

    David Meltzer, MD, PhD, 773-702-0836, dmeltzer@medicine.bsd.uchicago.edu

    Emily Perish, MPP, 773-702-3726 ext. Meltzer, dmeltzer@medicine.bsd.uchicago.edu

    Recruiting

Other trials in United States

About this study

Official title: Care in the Comprehensive Care Physician (CCP) Program vs. Care in the Comprehensive Care Community and Culture Program (C4P) vs. Care in the Traditional Care

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.

Read the detailed description

Health disparities and the health of communities are influenced both by the health care system and by the social context in which people live. Accordingly, interventions that seek to meaningfully reduce disparities should consider patients' medical and social needs. The fragmentation of medical care is one aspect of the health care system that adversely affects health, perhaps particularly for socioeconomically disadvantaged individuals with more limited resources to bridge gaps in care. Indeed, while many care coordination programs have been developed, evidence supporting their effectiveness is quite limited and especially for vulnerable populations. This study will fill important gaps in evidence concerning the effects of 3 diverse care coordination models on hospitalization rates for a socioeconomically disadvantaged population at increased risk of hospitalization that is served by the University of Chicago Medicine (UCM). Secondary outcomes include patient activation and engagement with care, satisfaction with care, general health and mental health and personal goal attainment.

The first model is an example of a commonly implemented class of care coordination models that relies primarily on the use of care coordinators. The specific care coordinator (CC) model that is being studied - the Partners HealthCare Care Management Program (PHCMP) - was initially developed and studied by Partners HealthCare. In PHCMP, "high-risk" patients (defined primarily as ≥2 hospitalizations in the year before enrollment) have access to nurse care coordinators who seek to help manage the patient's care across the continuum. UCM's Medicare Shared Savings Plan Accountable Care Organization has recently implemented a model based on PHCMP that it calls the Ambulatory Care Coordination Team (ACCT). In ACCT, nurses and social workers provide proactive care coordination to "high-risk" patients. CC and ACCT are representative of common care coordination models implemented nationally. The fact that these models typically involve hiring additional staff and increase the number of hand-offs may explain why programs such as these have often failed to produce desired improvements in health outcomes or decreases in utilization.

The second model is a novel care delivery program called the Comprehensive Care Physician (CCP) program. The CCP model seeks to more effectively integrate inpatient and outpatient care for patients at increased risk of hospitalization by offering them care from the same physician in the inpatient and the outpatient settings so that these patients can benefit from the advantages of continuity in the doctor patient relationship. Since 2012, the investigators have developed and tested this model at UCM in a randomized trial funded by the Center for Medicare and Medicaid Innovation comparing CCP to standard care (SC) in which patients receive inpatient and outpatient care from different doctors and do not have access to care coordinators. The investigators enrolled 2,000 patients in this study, of whom ~90% are African American, with a median income of ~$20,000 per year and 1-year mortality rate of 15-20%. The results are striking: care ratings on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) measures correspond to the 95th percentile nationally for CCP patients vs. the 80th for SC, about 30% of CCP patients have a 1 point improvement in self-rated mental health status (e.g., from good to very good) compared to SC patients, hospitalizations are 20% lower over 1 year follow-up and 26% lower for CCP patients who experienced ≥2 hospitalizations in the year before enrollment. We think the efficacy of this model comes from the deep connection that the CCP team develops with patients, understanding thise patients as individuals and recognizing and beginning to address the deeper social determinants of their health.

The third model, the Comprehensive Care, Community and Culture Program (C4P), builds on the CCP program to better engage patients in their care. C4P was motivated by the finding that ~30% of patients who enrolled in the CCP program did not engage with it despite having expressed interest in the program and that a wide range of social factors might be barriers to their engagement. To better address social determinants of health, C4P builds on CCP by adding 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. Preliminary findings from a pilot of C4P indicate that unmet social needs are diverse, highly concentrated in a small number of patients and linked to each other, presenting barriers to addressing these needs. However, unmet needs were also found to cluster in ways that suggested actionable strategies to address needs more effectively. Early results suggest that C4P increases patient activation and engagement in care compared to CCP and SC.

While we have rigorously compared CCP to SC and performed a pilot study of C4P, CCP and SC at UCM, we have not compared CCP or C4P to the more commonly-used CC model, nor have we performed an adequately powered study comparing CCP and C4P. The rigorous findings comparing these models that we will generate are sorely needed by patients and health systems to inform choices about care coordination models, and particularly for socioeconomically disadvantaged individuals.

This study has 2 specific aims:

Aim 1: To compare the effect of 3 models of care on hospitalization (primary outcome) and patient activation, engagement in care, satisfaction, health outcomes and goal attainment over 1 year for patients at increased risk of hospitalization: 1) a care coordinator (CC) model in which patients receive inpatient and outpatient care from different physicians with access to care coordinator services for patients identified as at high risk of hospitalization, 2) the Comprehensive Care Physician (CCP) program in which patients at increased risk of hospitalization can receive inpatient and outpatient care from the same physician and 3) the Comprehensive Care, Community and Culture Program(C4P), which enhances CCP care with systematic screening for unmet social needs, access to a community health worker and access to programming to better engage patients and address their unmet social needs.

Aim 2: To determine whether the effects of the 3 models differ based on the number of hospitalizations that a patient has experienced in the year before entering these models of care.

Study Description: This study is a randomized clinical trial that compares 3 approaches to care for patients at increased risk of hospitalization: 1) ACCT in which patients receive inpatient and outpatient care from different doctors with the option to receive care from UCM physicians and care coordination from nurses and social workers who manage their care with the larger clinical team, 2) CCP in which patients receive care from the same UCM physician in the inpatient and outpatient settings and 3) C4P in which patients receive care from a CCP in addition to systematic screening of unmet social needs and access to a community health worker and community based arts and culture programming. Patients are insured by Medicare or Medicare and Medicaid, be at increased risk of hospitalization based on a history of prior hospitalization or emergency department use and be recruited from mixed, but predominantly low-income communities on Chicago's South Side. A total of 3,000 patients will be recruited, with 1,000 patients in the ACCT, CCP and C4P arms. The primary outcome is hospitalization because of its importance to both patients and health systems. Our primary measure of hospitalization is the number of hospitalizations over 1 year measured in Medicare claims data. Other outcomes are patient activation and engagement in care (measured using the Patient Activation Measure and the rate of completion of primary care visits), satisfaction with care (measured using HCAHPS scores), self-rated general and mental health status, and goal attainment.

Being tested
Ambulatory Care Coordinator Team (ACCT), Comprehensive Care Physician Program (CCP), Comprehensive Care Community & Culture Program (C4P)

What participants receive

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

  • Ambulatory Care Coordinator Team (ACCT)Behavioural

    See arm description

  • Comprehensive Care Physician Program (CCP)Behavioural

    see arm description

  • Comprehensive Care Community & Culture Program (C4P)Behavioural

    see arm description

Study groups in NCT04489693
Study groupRoleWhat they receive
Ambulatory Care Coordinator Team (ACCT)Active comparatorPatients 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.
Receives: Behavioral: Ambulatory Care Coordinator Team (ACCT)
Comprehensive Care Physician (CCP)Active comparatorPatients 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.
Receives: Behavioral: Comprehensive Care Physician Program (CCP)
Comprehensive Care, Community & Culture Program (C4P)Active comparatorPatients 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.
Receives: Behavioral: Comprehensive Care Community & Culture Program (C4P)

What is being measured

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

  1. Quarterly hospitalization rate

    Number of hospitalizations per quarter

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

Secondary outcomes (6)
  1. Quarterly hospitalization rate from all sources

    Combines Medicare, Illinois State Department of Public Health (IDPH) hospitalization data, patient self report

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

  2. Patient experience

    Self reported Consumer assessment of Health Care Providers and Systems Survey (CAHPS) overall satisfaction with provider

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

  3. Health Outcomes General Health

    Patient-Reported Outcomes Measurement Information System (PROMIS) GLOBAL General Health Measure Single Item--In general, would you say your/patients health is: Excellent/very good/good/fair/poor/don't know/refused

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

  4. Health Outcomes Mental Health

    PROMIS GLOBAL Mental Health MeasurePROMIS GLOBAL General Health Measure Single Item--In general, how would you rate (your/PATIENT'S) mental health, including (your/PATIENT) mood and (your/PATIENT'S)ability to think: Excellent/very good/good/fair/poor/don't know/refused

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

  5. Patient Activation Measure (PAM)

    Patient Activation Measure (PAM) developed by Hibbard et al. Hibbard, J. H., Mahoney, E. R., Stockard, J., \& Tusler, M. (2005). Development and Testing of a Short Form of the Patient Activation Measure. Health Services Research, 40(6 Pt 1), 1918-1930. http://doi.org/10.1111/j.1475-6773.2005.00438.x

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

  6. Goal Attainment

    Goal Attainment Scale weighted by The Schedule for the Evaluation of Individual Quality of Life (SEIQoL): A Direct Weighting procedure for Quality of Life Domains (SEIQoL-DW)-O'Boyle CA, McGee HM, Hickey A, Joyce CRB, Browne J, O'Malley K, et al. The Schedule for the Evaluation of Individual Quality of Life (SEIQoL): A Direct Weighting procedure for Quality of Life Domains (SEIQoL-DW) Administration Manual. Dublin: Royal College of Surgeons in Ireland. 1993;1-13.

    Hickey AM, Bury G, O'Boyle CA, Bradley F, O'Kelly FD, Shannon W. A new short form individual quality of life measure (SEIQoL-DW): application in a cohort of individuals with HIV/AIDS. British Medical Journal. 1996;313(7048):29-33 Wettergren L, Kettis-Lindblad A, Sprangers M, Ring L. The use, feasibility and psychometric properties of an individualised quality-of-life instrument: a systematic review of the SEIQoL-DW. Qual Life Res. 2009;18:737-46.

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

Timeline

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

  1. First posted28 Jul 2020
  2. Study start6 Mar 2019
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2029 (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
This Compares the CCP ,C4P and Traditional Care Coordination Models
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489693
Sponsor's protocol ID
IRB-16-0391
Status last verified
Apr 2025
First submitted
21 Jul 2020
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no plan at present

Publications

  • 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.

    PubMed 41145263

Questions about this trial

What is this clinical trial studying?

A study testing Ambulatory Care Coordinator Team (ACCT), Comprehensive Care Physician Program (CCP) and Comprehensive Care Community & Culture Program (C4P) in people with Comprehensive Care and Quality of Care, run by University of Chicago 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quarterly hospitalization rate (time frame: Through study completion, with a range of 1 to 4.5 years). 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 NCT04489693, which also lists 1 linked publication.

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 9 Apr 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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