NCT01929005

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,008

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2012Dec 2028

Study Start

First participant enrolled

November 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

13.2 years

First QC Date

June 29, 2013

Last Update Submit

December 17, 2025

Conditions

Keywords

Comprehensive careMedicareCost-sharingQuality of care

Outcome Measures

Primary Outcomes (2)

  • Patient Satisfaction

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

    Every 3 months after patient enrollment up to 3 years

  • 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.

    Cumulative costs after enrollment up to 3 years

Secondary Outcomes (4)

  • Patient outcomes

    Every 3 months after enrollment up to 3 years

  • Care utilization

    Cumulative utilization from patient enrollment up to 3 years

  • Doctor-patient relationship

    Every 3 months after enrollment up to 3 years

  • Mortality

    Cumulative after enrollment up to 3 years

Other Outcomes (1)

  • Provider outcomes

    Every 6 months beginning at the start of data collection up to 3 years

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Comprehensive Care

EXPERIMENTAL

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

Interventions

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.

Comprehensive Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Comprehensive Health Care

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • David Meltzer, MD, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2013

First Posted

August 27, 2013

Study Start

November 1, 2012

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations