Congestive Heart FailureCocaNCT00627029
Evaluation of Programs of Coordinated Care and Disease Management
A study testing Care Coordination in people with Congestive Heart Failure and Diabetes, run by Mathematica Policy Research, Inc. at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congestive Heart Failure, Diabetes, Coronary Artery Disease
- What is being tested?
- Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,277 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2000to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Lovelace Health Systems
Albuquerque, New Mexico, 87102
Medical Care Development
Augusta, Maine, 04330
University of Maryland Medical Center
Baltimore, Maryland, 21201
Charlestown/Erickson Retirement Communities
Catonsville, Maryland, 21228
QMed, Inc.
Eatontown, New Jersey, 07724
Mercy Medical Center - North Iowa
Mason City, Iowa, 50401
Jewish Home Lifecare
New York, New York, 10025
Hospice of the Valley MediCaring Project
Phoenix, Arizona, 85016
CenVaNet
Richmond, Virginia, 23220
CorSolutions/Matria Healthcare
Rosemont, Illinois, 60018
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57117
Washington University-St.Louis School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110
Quality Oncology/Matria Healthcare
Sunrise, Florida, 33323
Carle Foundation and Hospital
Urbana, Illinois, 61801
Georgetown University Medical Center-Mind My Heart Program
Washington D.C., District of Columbia, 20036
About this study
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.
Read the 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
- Being tested
- Care Coordination
- Keywords
- Care coordination, Disease management, Medicare, Fee-for-service, Random assignment, Elderly
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive, Neoplasms, Cerebrovascular Disorders, Alzheimer Disease, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care CoordinationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Care Coordination |
| Control | No intervention | Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medicare program expenditures
Measured: Eight years
Secondary outcomes (1)
Claims-based and patient-reported quality of care
Measured: Eight years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startSep 2000
- Primary completionAug 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18,277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- Randall S. Brown, Ph.D., Study director, Mathematica Policy Research, Inc.Carol A. Magee, Ph.D., Study director, Centers for Medicare & Medicaid Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627029
- Sponsor's protocol ID
- MPR 8756
- Other IDs
- CMS 500-95-0047(09
- Acronym
- Coca
- Status last verified
- Sep 2015
- First submitted
- 15 Feb 2008
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19211468
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Programs of Coordinated Care and Disease Management
- ClinicalTrials.gov ID
- NCT00627029
- Acronym / sponsor ID
- Coca / MPR 8756
- Conditions
- Congestive Heart Failure, Diabetes, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease, Cancer, Cerebrovascular Disease
- Keywords
- Care coordination, Disease management, Medicare, Fee-for-service, Random assignment, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18,277 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Sep 2000
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Care CoordinationCare coordination, consisting variously (depending on the demonstration site)--nurse telephonic counseling, nurse in-person home visits, home telemonitoring equipment, and physician education and feedback. |
| Control | No intervention | –Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care CoordinationDepending 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. | Behavioural | Intervention |
Primary outcome
Medicare program expenditures
Time frame: Eight years
1 secondary outcome
Claims-based and patient-reported quality of care
Time frame: Eight years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Derived from this study: PubMed 19211468Peikes 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.
- The Evaluation of the Medicare Coordinated Care Demonstration: Findings for the First Two YearsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall S. Brown, Ph.D. study director
Mathematica Policy Research, Inc.
Carol A. Magee, Ph.D. study director
Centers for Medicare & Medicaid Services
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination in people with Congestive Heart Failure and Diabetes, run by Mathematica Policy Research, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medicare program expenditures (time frame: Eight years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.