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Medicare PatientsCCPNCT01929005

Comprehensive Care Physician: Integrated Inpatient and Outpatient Care for Patients at High Risk of Hospitalization

A study testing Comprehensive Care in people with Medicare Patients and High Risk of Hospitalizations, run by University of Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The investigators propose an innovative new model of care in which patients identified to be at high risk of hospitalization are offered care by a physician who will direct their care both in the hospital and in clinic but is able to do so because they see patients only at high risk of hospitalization. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Comprehensive Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,008 participants
Where
1 siteUnited States
Study dates
Nov 2012to Dec 2028
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

  • Medicare recipients and were hospitalized at least one time in the past year

Who cannot join

  • Non-Medicare recipients and/or were not hospitalized in the past year

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Integrated Inpatient/Outpatient Care for Patients at High Risk of Hospitalization

The investigators propose an innovative new model of care in which patients identified to be at high risk of hospitalization are offered care by a physician who will direct their care both in the hospital and in clinic but is able to do so because they see patients only at high risk of hospitalization. This allows these physicians to have a panel of patients that is small enough that they can provide them with continuing ambulatory care but sick enough for those physicians to have enough of their patients hospitalized at any time to justify having the physician spend several hours each morning seeing those patients in the hospital, making the model economically viable and clinically valuable for the patient. The investigators estimate that each of the 5 physicians the investigators propose to establish in this model will serve a panel of about 200 patients in steady state with an average of 10 days of expected hospitalization and $75,000 each in Medicare spending per year, totaling $75 million annually. The investigators estimate that a 1% reduction in costs for these patients will be more than enough to cover the ongoing costs of the model the investigators propose; this is because the investigators' program reorganizes care rather than adding new forms of care.

Read the detailed description

The investigators' project has 5 aims:

Aim 1: To implement an innovative Comprehensive Care Physician (CCP) Model of multi-disciplinary team-based care at the University of Chicago Medical Center (UCMC) in which care for patients at high risk of hospitalization is led by CCPs who focus their practices on patients at high risk of hospitalization so that they can personally care for these patients both in clinic and in the hospital, with savings to Medicare shared with the AMC.

As noted above and supported by theory and data below, the key justification for this goal is based on the value of the doctor-patient relationship. Building on 15 years experience developing our hospitalist program (IRB protocol 9967) from 2 to 30 clinicians, the investigators provide detailed plans to efficiently implement the investigators' model to improve care within 6 months. To incentivize and assess cost-savings, the investigators propose:

Aim 2: Among patients who meet clinical eligibility criteria for the CCP model and express willingness to receive care in the model, to assess the utilization and quality of health care, health outcomes, and cost of care of patients randomly assigned to be offered CCP care compared to patients randomly assigned not to be offered CCP care.

Evaluation is important in the investigators' project both to ensure that the investigators meet the triple-aim and because assessment of cost savings is needed to implement the shared savings model that the investigators think is important to incentivize cost savings. The investigators recognize that the use of randomization to assess out-comes cannot be the basis for a long-term payment model in Medicare but select this approach to evaluation because the investigators think it will provide the most accurate estimate of the effects of the program. Assuming capitated payments to Accountable Care Organizations (ACOs) become a major payment approach for Medicare, cost savings from CCPs would create sustainable incentives for their use. CCPs might also work well in ACOs because selection of high risk patients into a CCP program might not be a concern if those patient came from within the ACO's covered population. Sustained incentives to use CCPs could also exist if high-risk persons selected into ACOs with CCPs, but risk adjustment was adequate. Shared savings programs with adequate risk adjustment would produce similar incentives. To address dissemination and risk adjustment, the investigators propose:

Aim 3: To use data collected by UHC from 4 Chicago-area AMCs with linked Medicare data to support evaluation and potential local and national dissemination of the CCP model

UHC (previously University HealthSystem Consortium) includes over 100 AMCs nation-wide and has exceptional data on hospital resource use to support risk-adjustment. UHC also houses laboratory and Medicare data to enhance risk-adjustment and outcomes assessment. The investigators will use this data to inform potential local dissemination and testing of our model by helping the other participating Chicago-area AMCs identify the segments of their patient populations that are frequently admitted enough to be suitable for the CCP model. If the model is successful at UCMC, and perhaps in later local dissemination and evaluation, UHC's national scope creates opportunities for dissemination of the investigators' work to almost all US AMCs. The risk-adjustment data will also allow us to evaluate alternative strategies to assess program savings to estimate shared savings that do not require randomization. Thus the investigators propose:

Aim 4: To compare the results obtained in Aim 2 to three alternative assessment strategies that: 1) compare patients in UCMC treated in the CCP model to patients in UCMC who meet CCP clinical eligibility criteria but receive usual care, 2) compare patients in UCMC who meet CCP clinical eligibility criteria to historical patients in UCMC who met CCP clinical eligibility criteria, 3) compare patients in UCMC eligible for the CCP model to current patients in 4 other Chicago-area AMCs who meet CCP clinical eligibility criteria.

The investigators propose to evaluate these alternative approaches for selection of a control group because the investigators think they might be feasible approaches to estimate savings in a shared-savings model and because they differ in potential threats to validity (e.g., 1 must address patient selection into the intervention and 2 must address time trends in costs), outcomes assessment (patient outcomes will be harder to assess in 2 and 3), and generalizability (1 requires local patients treated outside the model and 2 requires historical data, which becomes less relevant over time). All models will be adjusted with the CMS-Hierarchical Condition Category (HCC) risk adjustment model for our base analysis but the investigators will also explore other approaches to risk adjustment, such as using prior year total Medicare expenditures and patient-reported variables as risk adjusters. The investigators propose to use our randomized control group for our shared savings incentive, but to work with CMMI in our cooperative agreement to assess how these control groups and approaches to risk adjustment could be used in shared savings incentives. Patient-reported outcomes will be assessed from enrolled subjects. Finally, since workforce development is key to implementing and disseminating this model, the investigators propose:

Aim 5: To develop skills of a multidisciplinary team of providers to execute the CCP model, and expose medical students, residents and fellows, and other health professions trainees to the model.

Because the investigators are an AMC with a rich pipeline of health professions trainees and excellent record of training national leaders, the investigators are excellently situated to train clinicians in the investigators' model who have the potential to help disseminate its core principles both locally and nationally.

Being tested
Comprehensive Care
Keywords
Comprehensive care, Medicare, Cost-sharing, Quality of care

What participants receive

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

  • Comprehensive CareOther

    Patients will receive comprehensive medical care from their CCP in clinic and the hospital. For most patients, the ambulatory care provided by the CCP will be in our onsite medicine clinic, but for some patients with subspecialty needs the CCP may be a specialist who will care for the patient in a nearby ambulatory setting (e.g., nursing home, dialysis facility). The CCPs will also supervise the nurses, pharmacists, social workers, and others who are part of the multi-disciplinary care team. Daytime inpatient care will be provided by CCPs in conjunction with our inpatient advanced practice nurses (APNs). These APNs now work with our hospitalists, so they are experienced providing hospital care.

Study groups in NCT01929005
Study groupRoleWhat they receive
Standard of CareNo interventionIf patients are randomized to standard of care, they are not assigned to a Comprehensive Care Physician. They are asked to continue receiving their care as they normally would.
Comprehensive CareExperimentalPatients randomized to the Comprehensive Care group are assigned to a Comprehensive Care physician and are asked to see their assigned CCP for their primary care. The patients will receive their care by the CCP in the outpatient clinic and also if they were to be hospitalized.
Receives: Other: Comprehensive Care

What is being measured

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

  1. Patient Satisfaction

    patient satisfaction measured by Consumer Assessment of Health Plans (CAHPs) instrument

    Measured: Every 3 months after patient enrollment up to 3 years

  2. Total Cost of Care

    Total cost of care will be measured using Medicare claims data obtained from RESDAC to examine all care that charged to Medicare, including use of acute care hospitals, physician services, SNF, home health, hospice, etc., and Part D. We will also seek to link to data from Illinois Medicaid for our dual eligibles.

    Measured: Cumulative costs after enrollment up to 3 years

Secondary outcomes (4)
  1. Patient outcomes

    Patient outcomes will be measured by quarterly assessment by phone of health status using the SF-12, limitations of activities of daily living (ADLs) and instrumental ADLs (IADLs) and patient satisfaction (e.g., Consumer Assessment of Health Plans (CAHPs) instrument).

    Measured: Every 3 months after enrollment up to 3 years

  2. Care utilization

    Following Donabedian's framework, we will first assess the extent to which care is structured with integrity to the CCP model using a primary measure of what fraction of a patient's clinic and hospital encounters are provided by their CCP. Care utilization will be measured using Medicare claims data obtained from RESDAC to examine all care that charged to Medicare, including use of acute care hospitals, physician services, SNF, home health, hospice, etc., and Part D. We are experienced working with these raw claim files for research. We will also link to data from Illinois Medicaid for our dual eligibles. For utilization in the hospital (e.g., ICU days or ICU days in terminal hospitalization), we will use UHC data.

    Measured: Cumulative utilization from patient enrollment up to 3 years

  3. Doctor-patient relationship

    Given the central role of the quality of the doctor-patient relationship on our conceptual model of care, we will administer the Primary Care Assessment Survey (discussed above) quarterly.

    Measured: Every 3 months after enrollment up to 3 years

  4. Mortality

    Mortality will be assessed by report of key contacts and confirmed using death records.

    Measured: Cumulative after enrollment up to 3 years

Timeline

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

  1. First posted27 Aug 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionJan 2026 (estimated)
  4. Study completionDec 2028 (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
Masking
None (open label)
Enrolment
2,008 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01929005
Sponsor's protocol ID
IRB12-1440
Other IDs
FP050658-01-PR
Acronym
CCP
Status last verified
Dec 2025
First submitted
29 Jun 2013
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive Care in people with Medicare Patients and High Risk of Hospitalizations, 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 1 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Satisfaction (time frame: Every 3 months after patient enrollment up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Dec 2025.

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