Back to resultsCoventry Outcomes Study of Seniors (COSS): A Comparative Effectiveness Study to Evaluate the Effect of a Multidisciplinary Team's Intervention on the Incidence of Nonelective Hospitalizations in a Medicare Population (COSS)
Primary Purpose
Heart Failure, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multidisciplinary team interventions
Multidisciplinary team bimonthly visits either in person or via telephone.
Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager
Sponsored by
About this trial
This is an interventional trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Inouye Risk Score >3 calculated on Coventry Claims
- Medicare Advantage beneficiaries age > 65 years
- Continuous eligibility > 12 months prior to study
- Ability to be contacted via telephone
- Subject is willing and able to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
Exclusion Criteria:
- Active cancer treatment (i.e. chemotherapy or radiation) in the past 6 months
- Living anywhere other than a community setting [i.e. Skilled nursing facility (SNF)]
- Just-In-Time (JIT) Members
- Members with a geographic location > 60 from either St. Louis or Kansas City, MO.
- Solid organ transplant recipients
- Active enrollment in another clinical research study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control Group
Intervention group
Arm Description
The control group will receive usual care as provided by your Health Plan.
Additional visits will be conducted by a member of the multidisciplinary team (case manager/nurse, social worker and/or pharmacist that will be either face to face or by telephone.
Outcomes
Primary Outcome Measures
Determine the impact of multidisciplinary team interventions in reducing the rate of non-elective hospitalizations over a 12 month period compared to usual care
Secondary Outcome Measures
Determine the impact of multidisciplinary team interventions on the rate of emergency room visits not resulting in hospitalization in a 24 hour period or less.
Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)
Determine the impact of MDT interventions versus usual care on inpatient costs associated with non-elective hospital events [rehabilitation, physician, incurred but not reported (IBNR)]
Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)
Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care
Determine the impact of multidisciplinary team interventions versus usual care on rate of non-elective hospitalizations by chronic condition
Determine the impact of multidisciplinary team interventions versus usual care on non-elective hospital readmissions at 30, 60, and 90 days following the first non-elective hospitalization event
Determine the impact of multidisciplinary team interventions versus usual care on the length of stay (LOS) of each non-elective hospitalization
Full Information
NCT ID
NCT01014884
First Posted
November 12, 2009
Last Updated
January 20, 2010
Sponsor
Medco Health Solutions, Inc.
Collaborators
Coventry Health Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01014884
Brief Title
Coventry Outcomes Study of Seniors (COSS): A Comparative Effectiveness Study to Evaluate the Effect of a Multidisciplinary Team's Intervention on the Incidence of Nonelective Hospitalizations in a Medicare Population
Acronym
COSS
Official Title
Coventry Outcomes Study of Seniors: A Dual-arm, Controlled, Randomized, Comparative Effectiveness Study to Evaluate the Effect of a Multidisciplinary Team's Intervention Versus Usual Care on the Incidence of Nonelective Hospitalizations in a Medicare Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Why Stopped
Terminated by Sponsor
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medco Health Solutions, Inc.
Collaborators
Coventry Health Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are studying the impact of the interventions of a multidisciplinary team (MDT) - consisting of a Coventry case manager, social worker, and medical director, alongside a Medco specialist pharmacist - on the hospitalization rates of high risk seniors with chronic conditions, compared with a usual care approach. The study will also examine the impact on quality of life, medication adherence, medical costs, hospital readmission rates, and a variety of other important measures. The outcome of COSS may support a means to further enhance and develop a comprehensive care model program by leveraging the partnership between a health plan and a pharmacy benefit manager.
Detailed Description
The multidisciplinary team will provide face-to-face visits in a home setting with interventions that focus on five key areas: care transitions, self-management, care coordination, pharmacy and prevention, all designed to support high-risk Medicare members and their relationship with their primary care providers. If the study proves to reduce hospitalizations in the senior population, it could provide important guidance for future efforts to reduce the cost and improve the quality of care for seniors with chronic conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease, Diabetes, Osteoporosis
7. Study Design
Study Phase
Not Applicable
Enrollment
2150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Description
The control group will receive usual care as provided by your Health Plan.
Arm Title
Intervention group
Arm Type
Other
Arm Description
Additional visits will be conducted by a member of the multidisciplinary team (case manager/nurse, social worker and/or pharmacist that will be either face to face or by telephone.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary team interventions
Intervention Description
The multidisciplinary team will determine which intervention should be applied to the participant in the intervention group based on their health risk assessment responses as well as medication review and visual inspection of the home.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary team bimonthly visits either in person or via telephone.
Intervention Type
Other
Intervention Name(s)
Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager
Primary Outcome Measure Information:
Title
Determine the impact of multidisciplinary team interventions in reducing the rate of non-elective hospitalizations over a 12 month period compared to usual care
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Determine the impact of multidisciplinary team interventions on the rate of emergency room visits not resulting in hospitalization in a 24 hour period or less.
Time Frame
12 months
Title
Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)
Time Frame
12 months
Title
Determine the impact of MDT interventions versus usual care on inpatient costs associated with non-elective hospital events [rehabilitation, physician, incurred but not reported (IBNR)]
Time Frame
12 months
Title
Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)
Time Frame
12 months
Title
Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care
Time Frame
12 months
Title
Determine the impact of multidisciplinary team interventions versus usual care on rate of non-elective hospitalizations by chronic condition
Time Frame
12 months
Title
Determine the impact of multidisciplinary team interventions versus usual care on non-elective hospital readmissions at 30, 60, and 90 days following the first non-elective hospitalization event
Time Frame
12
Title
Determine the impact of multidisciplinary team interventions versus usual care on the length of stay (LOS) of each non-elective hospitalization
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inouye Risk Score >3 calculated on Coventry Claims
Medicare Advantage beneficiaries age > 65 years
Continuous eligibility > 12 months prior to study
Ability to be contacted via telephone
Subject is willing and able to provide informed consent
Willing to comply with all study procedures and be available for the duration of the study
Exclusion Criteria:
Active cancer treatment (i.e. chemotherapy or radiation) in the past 6 months
Living anywhere other than a community setting [i.e. Skilled nursing facility (SNF)]
Just-In-Time (JIT) Members
Members with a geographic location > 60 from either St. Louis or Kansas City, MO.
Solid organ transplant recipients
Active enrollment in another clinical research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia O McEachern, MHS, PA-C
Organizational Affiliation
Medco Health Solutions, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen L Cavalieri, MD
Organizational Affiliation
Coventry Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
City
Kansas City
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Coventry Outcomes Study of Seniors (COSS): A Comparative Effectiveness Study to Evaluate the Effect of a Multidisciplinary Team's Intervention on the Incidence of Nonelective Hospitalizations in a Medicare Population
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