- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929005
Comprehensive Care Physician: Integrated Inpatient and Outpatient Care for Patients at High Risk of Hospitalization (CCP)
Integrated Inpatient/Outpatient Care for Patients at High Risk of Hospitalization
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ainoa Coltri, MA
- Phone Number: 773-702-5956
- Email: acoltri@medicine.bsd.uchicago.edu
Study Contact Backup
- Name: Gregory Ruhnke, MD
- Phone Number: 773-834-8350
- Email: gruhnke@medicine.bsd.uchicago.edu
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medicare recipients and were hospitalized at least one time in the past year
Exclusion Criteria:
- Non-Medicare recipients and/or were not hospitalized in the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
If 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.
|
|
Experimental: Comprehensive Care
Patients 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: Every 3 months after patient enrollment up to 3 years
|
patient satisfaction measured by Consumer Assessment of Health Plans (CAHPs) instrument
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Every 3 months after patient enrollment up to 3 years
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Total Cost of Care
Time Frame: Cumulative costs after enrollment up to 3 years
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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.
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Cumulative costs after enrollment up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient outcomes
Time Frame: Every 3 months after enrollment up to 3 years
|
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).
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Every 3 months after enrollment up to 3 years
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Care utilization
Time Frame: Cumulative utilization from patient enrollment up to 3 years
|
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.
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Cumulative utilization from patient enrollment up to 3 years
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Doctor-patient relationship
Time Frame: Every 3 months after enrollment up to 3 years
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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.
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Every 3 months after enrollment up to 3 years
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Mortality
Time Frame: Cumulative after enrollment up to 3 years
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Mortality will be assessed by report of key contacts and confirmed using death records.
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Cumulative after enrollment up to 3 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider outcomes
Time Frame: Every 6 months beginning at the start of data collection up to 3 years
|
Provider outcomes are also important.
We have surveyed attending physician about job satisfaction for 15 years with multiple domains including satisfaction with ability to provide high quality care, efficient care, relationships with patients, relationships with providers, etc., and will continue these annually for all our attendings and for our CCPs.
However, with only 5 CCPs, qualitative reports will be most valuable so we will interview them quarterly, transcribing comments for formal qualitative analysis.
Given the tiny number of CCPs, all CCPs will be allowed to review resulting manuscripts before submission and redact elements as they feel appropriate, either out of personal interest or belief that a clinical reference might be identified with a specific patient.
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Every 6 months beginning at the start of data collection up to 3 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB12-1440
- FP050658-01-PR (Other Grant/Funding Number: Centers for Medicare and Medicaid Services)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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