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 (COSS)

January 20, 2010 updated by: Medco Health Solutions, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States
      • St. Louis, Missouri, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months
Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)
Time Frame: 12 months
12 months
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
12 months
Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)
Time Frame: 12 months
12 months
Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care
Time Frame: 12 months
12 months
Determine the impact of multidisciplinary team interventions versus usual care on rate of non-elective hospitalizations by chronic condition
Time Frame: 12 months
12 months
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
12
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medco Health Solutions, Inc.

Collaborators

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

November 12, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (ESTIMATE)

November 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2010

Last Update Submitted That Met QC Criteria

January 20, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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