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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medco Health Solutions, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coventry Health Care, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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