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Evaluation of Programs of Coordinated Care and Disease Management (Coca)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627029
Recruitment Status : Unknown
Verified September 2015 by Mathematica Policy Research, Inc..
Recruitment status was:  Active, not recruiting
First Posted : February 29, 2008
Last Update Posted : October 1, 2015
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Mathematica Policy Research, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Diabetes Coronary Artery Disease Chronic Obstructive Pulmonary Disease Cancer Cerebrovascular Disease Alzheimer's Disease Psychotic Disorder Major Depression Behavioral: Care Coordination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Programs of Coordinated Care and Disease Management
Study Start Date : September 2000
Actual Primary Completion Date : August 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicare

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.
Behavioral: Care Coordination
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.

No Intervention: Control
Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers

Primary Outcome Measures :
  1. Medicare program expenditures [ Time Frame: Eight years ]

Secondary Outcome Measures :
  1. Claims-based and patient-reported quality of care [ Time Frame: Eight years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00627029

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United States, Arizona
Hospice of the Valley MediCaring Project
Phoenix, Arizona, United States, 85016
United States, District of Columbia
Georgetown University Medical Center-Mind My Heart Program
Washington, District of Columbia, United States, 20036
United States, Florida
Quality Oncology/Matria Healthcare
Sunrise, Florida, United States, 33323
United States, Illinois
CorSolutions/Matria Healthcare
Rosemont, Illinois, United States, 60018
Carle Foundation and Hospital
Urbana, Illinois, United States, 61801
United States, Iowa
Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
United States, Maine
Medical Care Development
Augusta, Maine, United States, 04330
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Charlestown/Erickson Retirement Communities
Catonsville, Maryland, United States, 21228
United States, Missouri
Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Jersey
QMed, Inc.
Eatontown, New Jersey, United States, 07724
United States, New Mexico
Lovelace Health Systems
Albuquerque, New Mexico, United States, 87102
United States, New York
Jewish Home Lifecare
New York, New York, United States, 10025
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57117
United States, Virginia
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Mathematica Policy Research, Inc.
Centers for Medicare and Medicaid Services
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Study Director: Randall S. Brown, Ph.D. Mathematica Policy Research, Inc.
Study Director: Carol A. Magee, Ph.D. Centers for Medicare & Medicaid Services
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mathematica Policy Research, Inc. Identifier: NCT00627029    
Other Study ID Numbers: MPR 8756
CMS 500-95-0047(09
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Keywords provided by Mathematica Policy Research, Inc.:
Care coordination
Disease management
Random assignment
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Alzheimer Disease
Cerebrovascular Disorders
Heart Failure
Coronary Artery Disease
Mental Disorders
Psychotic Disorders
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Schizophrenia Spectrum and Other Psychotic Disorders