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

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ClinicalTrials.gov Identifier: NCT01929005
Recruitment Status : Recruiting
First Posted : August 27, 2013
Last Update Posted : January 25, 2017
Sponsor:
Collaborators:
University HealthSystem Consortium
University of Illinois at Chicago
Rush University Medical Center
Northwestern University
NorthShore University HealthSystem
Information provided by (Responsible Party):
University of Chicago

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Medicare Patients High Risk of Hospitalizations Other: Comprehensive Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrated Inpatient/Outpatient Care for Patients at High Risk of Hospitalization
Actual Study Start Date : November 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicare

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.
Other: Comprehensive Care
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.




Primary Outcome Measures :
  1. 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

  2. Total Cost of Care [ Time Frame: Cumulative costs after enrollment up to 3 years ]
    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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. Doctor-patient relationship [ Time Frame: Every 3 months after enrollment up to 3 years ]
    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.

  4. Mortality [ Time Frame: Cumulative after enrollment up to 3 years ]
    Mortality will be assessed by report of key contacts and confirmed using death records.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929005


Contacts
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Contact: Ainoa Coltri, MA 773-702-5956 acoltri@medicine.bsd.uchicago.edu
Contact: Gregory Ruhnke, MD 773-834-8350 gruhnke@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ainoa Coltri, MA    773-702-5956    acoltri@medicine.bsd.uchicago.edu   
Principal Investigator: David Meltzer, MD, PhD         
Sponsors and Collaborators
University of Chicago
University HealthSystem Consortium
University of Illinois at Chicago
Rush University Medical Center
Northwestern University
NorthShore University HealthSystem
Investigators
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Principal Investigator: David Meltzer, MD, PhD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01929005    
Other Study ID Numbers: IRB12-1440
FP050658-01-PR ( Other Grant/Funding Number: Centers for Medicare and Medicaid Services )
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
Comprehensive care
Medicare
Cost-sharing
Quality of care