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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:
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

November 12, 2009
January 20, 2010
November 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01014884 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Not Provided
Not Provided
  • Heart Failure
  • Chronic Obstructive Pulmonary Disease
  • Cardiovascular Disease
  • Diabetes
  • Osteoporosis
  • 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.
  • Other: Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager
  • Control Group
    The control group will receive usual care as provided by your Health Plan.
    Intervention: 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.
    Interventions:
    • Other: Multidisciplinary team interventions
    • Other: Multidisciplinary team bimonthly visits either in person or via telephone.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2150
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014884
7714
No
Julia O. McEacherm, Research Director, Medco Health Solutions, Inc.
Medco Health Solutions, Inc.
Coventry Health Care, Inc.
Principal Investigator: Julia O McEachern, MHS, PA-C Medco Health Solutions, Inc.
Principal Investigator: Stephen L Cavalieri, MD Coventry Health Care, Inc.
Medco Health Solutions, Inc.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP