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

September 29, 2015 updated by: Mathematica Policy Research, Inc.

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

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

Interventional

Enrollment (Actual)

18277

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Hospice of the Valley MediCaring Project
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • Georgetown University Medical Center-Mind My Heart Program
    • Florida
      • Sunrise, Florida, United States, 33323
        • Quality Oncology/Matria Healthcare
    • Illinois
      • Rosemont, Illinois, United States, 60018
        • CorSolutions/Matria Healthcare
      • Urbana, Illinois, United States, 61801
        • Carle Foundation and Hospital
    • Iowa
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
    • Maine
      • Augusta, Maine, United States, 04330
        • Medical Care Development
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Catonsville, Maryland, United States, 21228
        • Charlestown/Erickson Retirement Communities
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • QMed, Inc.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Lovelace Health Systems
    • New York
      • New York, New York, United States, 10025
        • Jewish Home Lifecare
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Avera McKennan Hospital and University Health Center
    • Virginia
      • Richmond, Virginia, United States, 23220
        • CenVaNet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

August 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

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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