NCT00627029

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18,277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

14.9 years

First QC Date

February 15, 2008

Last Update Submit

September 29, 2015

Conditions

Keywords

Care coordinationDisease managementMedicareFee-for-serviceRandom assignmentElderly

Outcome Measures

Primary Outcomes (1)

  • Medicare program expenditures

    Eight years

Secondary Outcomes (1)

  • Claims-based and patient-reported quality of care

    Eight years

Study Arms (2)

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

Control

NO INTERVENTION

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

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospice of the Valley MediCaring Project

Phoenix, Arizona, 85016, United States

Location

Georgetown University Medical Center-Mind My Heart Program

Washington D.C., District of Columbia, 20036, United States

Location

Quality Oncology/Matria Healthcare

Sunrise, Florida, 33323, United States

Location

CorSolutions/Matria Healthcare

Rosemont, Illinois, 60018, United States

Location

Carle Foundation and Hospital

Urbana, Illinois, 61801, United States

Location

Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Medical Care Development

Augusta, Maine, 04330, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Charlestown/Erickson Retirement Communities

Catonsville, Maryland, 21228, United States

Location

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

St Louis, Missouri, 63110, United States

Location

QMed, Inc.

Eatontown, New Jersey, 07724, United States

Location

Lovelace Health Systems

Albuquerque, New Mexico, 87102, United States

Location

Jewish Home Lifecare

New York, New York, 10025, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57117, United States

Location

CenVaNet

Richmond, Virginia, 23220, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Heart FailureDiabetes MellitusCoronary Artery DiseasePulmonary Disease, Chronic ObstructiveNeoplasmsCerebrovascular DisordersAlzheimer DiseasePsychotic DisordersDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersDepressive DisorderMood Disorders

Study Officials

  • Randall S. Brown, Ph.D.

    Mathematica Policy Research, Inc.

    STUDY DIRECTOR
  • Carol A. Magee, Ph.D.

    Centers for Medicare & Medicaid Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 29, 2008

Study Start

September 1, 2000

Primary Completion

August 1, 2015

Study Completion

December 1, 2016

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations