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.

February 15, 2008
February 29, 2008
October 1, 2015
September 2000
August 2015   (Final data collection date for primary outcome measure)
Medicare program expenditures [ Time Frame: Eight years ]
Medicare program expenditures [ Time Frame: Five years ]
Complete list of historical versions of study NCT00627029 on Archive Site
Claims-based and patient-reported quality of care [ Time Frame: Eight years ]
Claims-based and patient-reported quality of care [ Time Frame: Five years ]
Not Provided
Not Provided
Evaluation of Programs of Coordinated Care and Disease Management
Evaluation of Programs of Coordinated Care and Disease Management

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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Congestive Heart Failure
  • Diabetes
  • Coronary Artery Disease
  • Chronic Obstructive Pulmonary Disease
  • Cancer
  • Cerebrovascular Disease
  • Alzheimer's Disease
  • Psychotic Disorder
  • Major Depression
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.
  • 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.
    Intervention: Behavioral: Care Coordination
  • No Intervention: Control
    Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers
Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2016
August 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
MPR 8756
CMS 500-95-0047(09
Not Provided
Not Provided
Mathematica Policy Research, Inc.
Mathematica Policy Research, Inc.
Centers for Medicare and Medicaid Services
Study Director: Randall S. Brown, Ph.D. Mathematica Policy Research, Inc.
Study Director: Carol A. Magee, Ph.D. Centers for Medicare & Medicaid Services
Mathematica Policy Research, Inc.
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP