- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00627029
Evaluation of Programs of Coordinated Care and Disease Management (Coca)
This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.
In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mathematica Policy Research, Inc. (MPR) evaluated 16 independent demonstration sites that provide coordinated care interventions to Medicare beneficiaries with chronic illnesses. The rationale for the demonstration is the lack of coordination among the multiple providers typically serving Medicare beneficiaries with chronic illnesses, as well as the adverse consequences of the lack of coordination for the beneficiaries and for Medicare costs. The demonstration sites, selected in early 2001, offered programs designed to improve both the care that patients receive and patients' knowledge of, and adherence with, recommended self-care and behavior. The study estimated the effects of each site on patients' well-being and satisfaction, in addition to the site's effects on the use and cost of Medicare covered services. This analysis relied on a patient survey conducted 6 to 12 months after enrollment, and on Medicare claims data and any data available from the demonstration sites that could enhance the study. The study included two rounds of physician surveys. In each site, eligible applicants were randomly assigned to treatment and control groups. An extensive process analysis was conducted to describe the interventions in detail, with the key goal being an assessment of those factors that account for program success and failure. The study included case studies of each site, program profiles, interim site-specific memos, two interim summary reports, two reports to Congress (based on the interim summary reports), and a final summary report. This original study enrolled 18,277 beneficiaries.
In 2008 Congress extended the study for 2 of the sites, Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania, and they will recruit beneficiaries and provide demonstration intervention services through the spring of 2010. Mathematica Policy Research will evaluate the results of this extended demonstration using Medicare claims data and qualitative site visits to the two programs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85016
- Hospice of the Valley MediCaring Project
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District of Columbia
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Washington, District of Columbia, United States, 20036
- Georgetown University Medical Center-Mind My Heart Program
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Florida
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Sunrise, Florida, United States, 33323
- Quality Oncology/Matria Healthcare
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Illinois
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Rosemont, Illinois, United States, 60018
- CorSolutions/Matria Healthcare
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Urbana, Illinois, United States, 61801
- Carle Foundation and Hospital
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Iowa
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Mason City, Iowa, United States, 50401
- Mercy Medical Center - North Iowa
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Maine
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Augusta, Maine, United States, 04330
- Medical Care Development
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Catonsville, Maryland, United States, 21228
- Charlestown/Erickson Retirement Communities
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital
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New Jersey
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Eatontown, New Jersey, United States, 07724
- QMed, Inc.
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Lovelace Health Systems
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New York
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New York, New York, United States, 10025
- Jewish Home Lifecare
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South Dakota
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Sioux Falls, South Dakota, United States, 57117
- Avera McKennan Hospital and University Health Center
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Virginia
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Richmond, Virginia, United States, 23220
- CenVaNet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets clinical and prior health service use criteria of each of the 16 demonstration sites (vary across demonstration programs)
- Resides in catchment area of one of the programs
- Enrolled in Medicare fee-for-service program
- Coverage by both Medicare Parts A and B
- Medicare is primary payer
Exclusion Criteria:
- Does not meet any of the relevant program's exclusion criteria (vary across demonstration programs)
- Not enrolled in a Medicare Advantage plan (Medicare managed care program)
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 |
---|---|
Experimental: Intervention
Care coordination, consisting variously (depending on the demonstration site)--nurse telephonic counseling, nurse in-person home visits, home telemonitoring equipment, and physician education and feedback.
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Depending on the demonstration site, may consist of nurse telephonic counseling and monitoring, nurse in-person or home visits, home telemonitoring equipment, patient educational materials, patient group educations classes, physician education and feedback.
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No Intervention: Control
Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medicare program expenditures
Time Frame: Eight years
|
Eight years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Claims-based and patient-reported quality of care
Time Frame: Eight years
|
Eight years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Randall S. Brown, Ph.D., Mathematica Policy Research, Inc.
- Study Director: Carol A. Magee, Ph.D., Centers for Medicare & Medicaid Services
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Lung Diseases
- Neurocognitive Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Neurodegenerative Diseases
- Coronary Disease
- Dementia
- Tauopathies
- Heart Failure
- Coronary Artery Disease
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Psychotic Disorders
- Mental Disorders
- Alzheimer Disease
- Cerebrovascular Disorders
Other Study ID Numbers
- MPR 8756
- CMS 500-95-0047(09
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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