Clinical trial NCT00627029: Evaluation of Programs of Coordinated Care and Disease Management
Official title: Evaluation of Programs of Coordinated Care and Disease Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
First posted: 2008-02-29
Enrollment: 18277
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Medicare program expenditures
timeFrame: Eight years
Secondary outcomes:
measure: Claims-based and patient-reported quality of care
timeFrame: Eight years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hospice of the Valley MediCaring Project
state: Arizona
city: Washington
country: United States
facility: Georgetown University Medical Center-Mind My Heart Program
state: District of Columbia
city: Sunrise
country: United States
facility: Quality Oncology/Matria Healthcare
state: Florida
city: Rosemont
country: United States
facility: CorSolutions/Matria Healthcare
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation and Hospital
state: Illinois
city: Mason City
country: United States
facility: Mercy Medical Center - North Iowa
state: Iowa
city: Augusta
country: United States
facility: Medical Care Development
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Charlestown/Erickson Retirement Communities
state: Maryland
city: St. Louis
country: United States
facility: Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital
state: Missouri
city: Eatontown
country: United States
facility: QMed, Inc.
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Health Systems
state: New Mexico
city: New York
country: United States
facility: Jewish Home Lifecare
state: New York
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital and University Health Center
state: South Dakota
city: Richmond
country: United States
facility: CenVaNet
state: Virginia
Study officials:
affiliation: Mathematica Policy Research, Inc.
name: Randall S. Brown, Ph.D.
role: STUDY_DIRECTOR
affiliation: Centers for Medicare & Medicaid Services
name: Carol A. Magee, Ph.D.
role: STUDY_DIRECTOR
References:
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.