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| Sponsor: | Mathematica Policy Research, Inc. |
|---|---|
| Collaborator: |
Centers for Medicare and Medicaid Services |
| Information provided by: | Mathematica Policy Research, Inc. |
| ClinicalTrials.gov Identifier: | NCT00627029 |
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: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Evaluation of Programs of Coordinated Care and Disease Management |
| 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 |
|---|---|
|
Intervention: Experimental
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.
|
|
Control: No Intervention
Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Carle Foundation and Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CorSolutions/Matria Healthcare | |
| Rosemont, Illinois, United States, 60018 | |
| 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 | |
| Charlestown/Erickson Retirement Communities | |
| Catonsville, Maryland, United States, 21228 | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| 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 | |
| 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
| Responsible Party: | Mathematica Policy Research, Inc. ( Randall Brown, Ph.D., Vice President, Director of Health Research ) |
| Study ID Numbers: | MPR 8756, CMS 500-95-0047(09 |
| Study First Received: | February 15, 2008 |
| Last Updated: | October 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00627029 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Care coordination Disease management Medicare |
Fee-for-service Random assignment Elderly |
|
Myocardial Ischemia Depressive Disorder, Major Arteriosclerosis Brain Diseases Neurodegenerative Diseases Cerebrovascular Disorders Lung Diseases, Obstructive Respiratory Tract Diseases Mental Disorders Psychotic Disorders Cardiovascular Diseases Dementia Schizophrenia and Disorders with Psychotic Features Arterial Occlusive Diseases Heart Failure |
Depression Heart Diseases Alzheimer Disease Nervous System Diseases Vascular Diseases Central Nervous System Diseases Depressive Disorder Behavioral Symptoms Coronary Disease Delirium, Dementia, Amnestic, Cognitive Disorders Lung Diseases Mood Disorders Tauopathies Coronary Artery Disease Pulmonary Disease, Chronic Obstructive |