Comprehensive Care Models for Medicare Patients

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to assist Medicare patients at risk of frequent hospital visits. It aims to determine if different care models can reduce hospitalizations and improve overall health and satisfaction. Participants will receive one of three types of care: a team of doctors and care coordinators (Ambulatory Care Coordinator Team, or ACCT), a single comprehensive care physician (Comprehensive Care Physician Program, or CCP), or a comprehensive care plan that includes social support and community activities (Comprehensive Care Community & Culture Program, or C4P). This trial is suitable for individuals with Medicare Part A and Part B who have been hospitalized at least once in the past two years or are currently in an emergency department. As an unphased trial, this study provides a unique opportunity to explore innovative care models that could enhance healthcare experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these care models are safe for Medicare patients?

Research has shown that the Ambulatory Care Coordinator Team (ACCT) can improve patient safety. This team, composed of nurses and social workers, manages the complex needs of high-risk patients. By providing quick and personalized care, they enhance safety outcomes.

In the Comprehensive Care Physician Program (CCP), studies have found that patients often feel more satisfied and experience better mental health. Hospital visits decrease, indicating that the program is effective, safe, and well-received by patients.

The Comprehensive Care, Community & Culture Program (C4P) focuses on social needs along with medical care. While specific safety data for C4P is not detailed, it builds on the successful CCP model, which has shown positive safety results. By also focusing on social needs and arts and culture, C4P aims to further engage patients, potentially boosting their overall well-being and safety.

Overall, these programs enhance patient care and safety through comprehensive and coordinated methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these comprehensive care models for Medicare patients because they offer personalized and coordinated care that differs significantly from traditional approaches. The Ambulatory Care Coordinator Team (ACCT) focuses on managing high-risk patients through a team of nurses and social workers, providing tailored support to reduce hospital visits. The Comprehensive Care Physician (CCP) model ensures continuity by assigning a single physician for both outpatient and inpatient care, enhancing the doctor-patient relationship. Meanwhile, the Comprehensive Care, Community & Culture Program (C4P) not only offers consistent physician care but also addresses social needs and provides access to community resources and cultural activities, which can improve overall well-being. These innovative models aim to improve patient outcomes by addressing both medical and social determinants of health.

What evidence suggests that this trial's treatments could be effective for reducing hospitalizations in socioeconomically disadvantaged Medicare patients?

In this trial, participants will be randomized into one of three care models. Research has shown that the Ambulatory Care Coordinator Team (ACCT), one of the models being tested, can help reduce hospital stays and improve patient care. Studies indicate that when teams, including nurses and social workers, better coordinate care, clinical outcomes improve. Evidence from the Comprehensive Care Physician Program (CCP) suggests it results in 15-22% fewer hospitalizations compared to regular care, with patients also reporting higher satisfaction. The Comprehensive Care, Community & Culture Program (C4P), the third model under study, adds social support and community activities, which boosts patient involvement and further reduces hospital visits. Overall, these care models show promise in improving health outcomes for those at high risk of hospitalization. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for socioeconomically disadvantaged Medicare patients who have been hospitalized once in the past 2 years or are currently in the emergency department. It's designed to see if different care approaches can reduce hospital visits.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three care models: ACCT, CCP, or C4P, and receive care coordination and support services

1 year

Follow-up

Participants are monitored for hospitalization rates, patient activation, engagement, satisfaction, and health outcomes

1 year

Extension

Optional continuation of care coordination and support services for participants who wish to continue beyond the initial study period

Up to 4.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Ambulatory Care Coordinator Team (ACCT)
• Comprehensive Care Community & Culture Program (C4P)
• Comprehensive Care Physician Program (CCP)

Trial Overview The study compares three care models: ACCT with team-based coordination, CCP with consistent care from one physician, and C4P which adds social support and cultural programs to CCP. The impact on health, satisfaction, and goal attainment will be measured.

How Is the Trial Designed?

Group I: Ambulatory Care Coordinator Team (ACCT) Active Control 1 Intervention

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.

Group II: Comprehensive Care Physician (CCP) Active Control 1 Intervention

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.

Group III: Comprehensive Care, Community & Culture Program (C4P) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Implementing a proactive telehealth follow-up system for geriatric patients at the Tennessee Valley Healthcare System led to a significant reduction in 30-day all-cause readmissions, decreasing from 21% to 13% during the intervention period.

The use of Plan, Do, Study, Act (PDSA) cycles and data sharing among care teams improved care coordination and accountability, contributing to better management of high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The GeriPACT Initiative to Prevent All-Cause 30-Day Readmission in High Risk Elderly. Powers, JS., Abraham, L., Parker, R., et al.[2021]

Care coordination programs for high-risk Medicaid patients can improve outcomes, but there are significant unmet needs related to trauma, mental health, and executive function challenges that require additional support.

Focus groups revealed that while provider communication is generally positive, enhancing peer-to-peer support and addressing specific patient needs can further improve the effectiveness of care coordination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient perspective: utilizing focus groups to inform care coordination for high-risk medicaid populations. Sheff, A., Park, ER., Neagle, M., et al.[2018]

The Johns Hopkins Community Health Partnership (J-CHiP) effectively improved care coordination for high-risk patients by implementing redesigned acute care delivery and seamless transitions of care, targeting adults discharged from hospitals and those receiving primary care in the community.

Key interventions included risk screening, multidisciplinary care planning, and collaboration with skilled nursing facilities, which collectively enhanced patient engagement and strengthened partnerships with community organizations, ultimately aiming to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive program to improve coordination of care in an urban academic health care system. Hsiao, YL., Bass, EB., Wu, AW., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-2-2019-36255

Comprehensive Care Models for Medicare Patients What data supports the effectiveness of the treatment Ambulatory Care Coordinator Team (ACCT), Comprehensive Care Community & Culture Program (C4P) ...

2. cms.gov cms.gov/priorities/innovation/innovation-models/team-model

TEAM (Transforming Episode Accountability Model) Solution: TEAM aims to improve the patient experience from surgery through recovery by supporting the coordination and transition of care ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841852/

Ambulatory Care Coordination Data Gathering and Use - PMC Care coordination is a crucial component of healthcare systems. However, little is known about data needs and uses in ambulatory care coordination practice.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8642573/

Patient-Reported Care Coordination is Associated with Better ... Prior studies using aggregated data suggest that better care coordination is associated with higher performance on measures of clinical care process.

5. cms.gov cms.gov/priorities/innovation/innovation-models/asm

ASM (Ambulatory Specialty Model) Outcomes: ASM will reduce avoidable hospitalizations and unnecessary procedures, improve patient experience and outcomes, and lower costs to ...

6. psnet.ahrq.gov psnet.ahrq.gov/perspective/patient-safety-ambulatory-care-setting

Patient Safety in the Ambulatory Care Setting | PSNet We highlight recent work in diagnostic safety, which continues to be a subject of importance and a major challenge in ambulatory care.

7. nature.com nature.com/articles/s44401-025-00020-9

Care coordination and patient safety outcome: a graph- ... This study highlights how care coordination can be modeled at scale using EHRs and can affect patient care safety outcomes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7207252/

A “Behind-the-Scenes” Look at Interprofessional Care ... This paper describes how interactions among interprofessional team members enabled individualized, rapid responses to the complex needs of vulnerable patients.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3951040/

Self-Reported Activities and Outcomes of Ambulatory Care ... This research study supports what ambulatory care RNs say they are doing: daily, diverse, and complex patient care activities that influence multiple relevant ...

10. jointcommissionjournal.com jointcommissionjournal.com/article/S1553-7250(20)30213-0/fulltext

What Safety Events Are Reported For Ambulatory Care? ... Health care staff document patient safety events using incident reporting systems, which are compiled within Patient Safety Organization databases.