Evaluation of Programs of Coordinated Care and Disease Management (Coca)
Primary Purpose
Congestive Heart Failure, Diabetes, Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Coordination
Sponsored by
About this trial
This is an interventional health services research trial for Congestive Heart Failure focused on measuring Care coordination, Disease management, Medicare, Fee-for-service, Random assignment, Elderly
Eligibility 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)
Sites / Locations
- Hospice of the Valley MediCaring Project
- Georgetown University Medical Center-Mind My Heart Program
- Quality Oncology/Matria Healthcare
- CorSolutions/Matria Healthcare
- Carle Foundation and Hospital
- Mercy Medical Center - North Iowa
- Medical Care Development
- University of Maryland Medical Center
- Charlestown/Erickson Retirement Communities
- Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital
- QMed, Inc.
- Lovelace Health Systems
- Jewish Home Lifecare
- Avera McKennan Hospital and University Health Center
- CenVaNet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers
Outcomes
Primary Outcome Measures
Medicare program expenditures
Secondary Outcome Measures
Claims-based and patient-reported quality of care
Full Information
NCT ID
NCT00627029
First Posted
February 15, 2008
Last Updated
September 29, 2015
Sponsor
Mathematica Policy Research, Inc.
Collaborators
Centers for Medicare and Medicaid Services
1. Study Identification
Unique Protocol Identification Number
NCT00627029
Brief Title
Evaluation of Programs of Coordinated Care and Disease Management
Acronym
Coca
Official Title
Evaluation of Programs of Coordinated Care and Disease Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2000 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mathematica Policy Research, Inc.
Collaborators
Centers for Medicare and Medicaid Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Diabetes, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease, Cancer, Cerebrovascular Disease, Alzheimer's Disease, Psychotic Disorder, Major Depression
Keywords
Care coordination, Disease management, Medicare, Fee-for-service, Random assignment, Elderly
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers
Intervention Type
Behavioral
Intervention Name(s)
Care Coordination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medicare program expenditures
Time Frame
Eight years
Secondary Outcome Measure Information:
Title
Claims-based and patient-reported quality of care
Time Frame
Eight years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall S. Brown, Ph.D.
Organizational Affiliation
Mathematica Policy Research, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carol A. Magee, Ph.D.
Organizational Affiliation
Centers for Medicare & Medicaid Services
Official's Role
Study Director
Facility Information:
Facility Name
Hospice of the Valley MediCaring Project
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Georgetown University Medical Center-Mind My Heart Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Quality Oncology/Matria Healthcare
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33323
Country
United States
Facility Name
CorSolutions/Matria Healthcare
City
Rosemont
State/Province
Illinois
ZIP/Postal Code
60018
Country
United States
Facility Name
Carle Foundation and Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Mercy Medical Center - North Iowa
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
Medical Care Development
City
Augusta
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Charlestown/Erickson Retirement Communities
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
QMed, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Lovelace Health Systems
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Jewish Home Lifecare
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Avera McKennan Hospital and University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
CenVaNet
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19211468
Citation
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.
Results Reference
derived
Links:
URL
http://www.cms.hhs.gov/reports/downloads/Brown.pdf
Description
The Evaluation of the Medicare Coordinated Care Demonstration: Findings for the First Two Years
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Evaluation of Programs of Coordinated Care and Disease Management
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