Evaluation of Programs of Coordinated Care and Disease Management

NCT ID: NCT00627029

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18277 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Congestive Heart Failure; Diabetes; Coronary Artery Disease; Chronic Obstructive Pulmonary Disease; Cancer; Cerebrovascular Disease; Alzheimer's Disease; Psychotic Disorder; Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Care Coordination

Intervention Type: BEHAVIORAL

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.

Control

Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Not enrolled in a Medicare Advantage plan (Medicare managed care program)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

Mathematica Policy Research, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall S. Brown, Ph.D.

Role: STUDY_DIRECTOR

Mathematica Policy Research, Inc.

Carol A. Magee, Ph.D.

Role: STUDY_DIRECTOR

Centers for Medicare & Medicaid Services

Locations

Hospice of the Valley MediCaring Project

Phoenix, Arizona, United States

Georgetown University Medical Center-Mind My Heart Program

Washington D.C., District of Columbia, United States

Quality Oncology/Matria Healthcare

Sunrise, Florida, United States

CorSolutions/Matria Healthcare

Rosemont, Illinois, United States

Carle Foundation and Hospital

Urbana, Illinois, United States

Mercy Medical Center - North Iowa

Mason City, Iowa, United States

Medical Care Development

Augusta, Maine, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Charlestown/Erickson Retirement Communities

Catonsville, Maryland, United States

Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States

QMed, Inc.

Eatontown, New Jersey, United States

Lovelace Health Systems

Albuquerque, New Mexico, United States

Jewish Home Lifecare

New York, New York, United States

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, United States

CenVaNet

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 19211468 (View on PubMed)

Related Links

http://www.cms.hhs.gov/reports/downloads/Brown.pdf

The Evaluation of the Medicare Coordinated Care Demonstration: Findings for the First Two Years

Other Identifiers

CMS 500-95-0047(09

Identifier Type: -

Identifier Source: secondary_id

MPR 8756

Identifier Type: -

Identifier Source: org_study_id