Evaluation of Programs of Coordinated Care and Disease Management

Coronary Artery Disease Clinical Trial

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Official title:

Evaluation of Programs of Coordinated Care and Disease Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00627029
• Other study ID #: MPR 8756
• Secondary ID: CMS 500-95-0047(
• Status: Active, not recruiting
• Phase: N/A
• First received: February 15, 2008
• Last updated: September 29, 2015
• Start date: September 2000
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Mathematica Policy Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18277
• Est. completion date: December 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cancer
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Coronary Artery Disease
• Coronary Disease
• Depressive Disorder, Major
• Diabetes
• Heart Failure
• Lung Diseases, Obstructive
• Major Depression
• Mental Disorders
• Myocardial Ischemia
• Psychotic Disorder
• Psychotic Disorders
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Lovelace Health Systems	Albuquerque	New Mexico
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	QMed, Inc.	Eatontown	New Jersey
United States	Mercy Medical Center - North Iowa	Mason City	Iowa
United States	Jewish Home Lifecare	New York	New York
United States	Hospice of the Valley MediCaring Project	Phoenix	Arizona
United States	CenVaNet	Richmond	Virginia
United States	CorSolutions/Matria Healthcare	Rosemont	Illinois
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota
United States	Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital	St. Louis	Missouri
United States	Quality Oncology/Matria Healthcare	Sunrise	Florida
United States	Carle Foundation and Hospital	Urbana	Illinois
United States	Georgetown University Medical Center-Mind My Heart Program	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Mathematica Policy Research, Inc.	Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medicare program expenditures		Eight years	No
Secondary	Claims-based and patient-reported quality of care		Eight years	No

External Links

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