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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Mathematica Policy Research, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by:
Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier:
NCT00627029
First received: February 15, 2008
Last updated: October 19, 2009
Last verified: October 2009
  Purpose

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 Intervention
Congestive Heart Failure
Diabetes
Coronary Artery Disease
Chronic Obstructive Pulmonary Disease
Cancer
Cerebrovascular Disease
Alzheimer's Disease
Psychotic Disorder
Major Depression
Behavioral: Care Coordination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of Programs of Coordinated Care and Disease Management

Resource links provided by NLM:


Further study details as provided by Mathematica Policy Research, Inc.:

Primary Outcome Measures:
  • Medicare program expenditures [ Time Frame: Eight years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Claims-based and patient-reported quality of care [ Time Frame: Eight years ] [ Designated as safety issue: No ]

Enrollment: 18277
Study Start Date: September 2000
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627029

Locations
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
CenVaNet
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Mathematica Policy Research, Inc.
Centers for Medicare and Medicaid Services
Investigators
Study Director: Randall S. Brown, Ph.D. Mathematica Policy Research, Inc.
Study Director: Carol A. Magee, Ph.D. Centers for Medicare & Medicaid Services
  More Information

No publications provided by Mathematica Policy Research, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Randall Brown, Ph.D., Vice President, Director of Health Research, Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier: NCT00627029     History of Changes
Other Study ID Numbers: MPR 8756, CMS 500-95-0047(09
Study First Received: February 15, 2008
Last Updated: October 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mathematica Policy Research, Inc.:
Care coordination
Disease management
Medicare
Fee-for-service
Random assignment
Elderly

Additional relevant MeSH terms:
Alzheimer Disease
Cerebrovascular Disorders
Coronary Artery Disease
Coronary Disease
Depression
Depressive Disorder, Major
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Mental Disorders
Myocardial Ischemia
Psychotic Disorders
Pulmonary Disease, Chronic Obstructive
Arterial Occlusive Diseases
Arteriosclerosis
Behavioral Symptoms
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Depressive Disorder
Heart Diseases
Mood Disorders
Nervous System Diseases
Neurodegenerative Diseases
Respiratory Tract Diseases
Schizophrenia and Disorders with Psychotic Features
Tauopathies
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014