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
This study has been terminated.
(Terminated by Sponsor)
Sponsor:
Medco Health Solutions, Inc.
Collaborator:
Coventry Health Care, Inc.
Information provided by:
Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT01014884
First received: November 12, 2009
Last updated: January 20, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure Chronic Obstructive Pulmonary Disease Cardiovascular Disease Diabetes Osteoporosis |
Other: Multidisciplinary team interventions Other: Multidisciplinary team bimonthly visits either in person or via telephone. Other: Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Heart Failure
Medicare
Osteoporosis
U.S. FDA Resources
Further study details as provided by Medco Health Solutions, Inc.:
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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Determine the impact of multidisciplinary team interventions versus usual care on rate of non-elective hospitalizations by chronic condition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2150 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control Group
The control group will receive usual care as provided by your Health Plan.
|
Other: Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager |
|
Intervention group
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.
|
Other: Multidisciplinary team interventions
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.
Other: Multidisciplinary team bimonthly visits either in person or via telephone.
|
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014884
Locations
| United States, Missouri | |
| Kansas City, Missouri, United States | |
| St. Louis, Missouri, United States | |
Sponsors and Collaborators
Medco Health Solutions, Inc.
Coventry Health Care, Inc.
Investigators
| Principal Investigator: | Julia O McEachern, MHS, PA-C | Medco Health Solutions, Inc. |
| Principal Investigator: | Stephen L Cavalieri, MD | Coventry Health Care, Inc. |
More Information
No publications provided
| Responsible Party: | Julia O. McEacherm, Research Director, Medco Health Solutions, Inc. |
| ClinicalTrials.gov Identifier: | NCT01014884 History of Changes |
| Other Study ID Numbers: | 7714 |
| Study First Received: | November 12, 2009 |
| Last Updated: | January 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Failure Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Osteoporosis |
Lung Diseases, Obstructive Heart Diseases Respiratory Tract Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013