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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 August 21, 2014