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

NCT01014884 | Terminated

• 1 other identifier: 7714
• Study Type: interventional
• Target: 2,150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Diabetes; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Determine the impact of multidisciplinary team interventions in reducing the rate of non-elective hospitalizations over a 12 month period compared to usual care

  12 months

Secondary Outcomes (8)

• 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.

  12 months

• Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)

  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)]

  12 months

• Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)

  12 months

• Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care

  12 months

Study Arms (2)

Control Group

OTHER

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

OTHER

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; Other: Multidisciplinary team bimonthly visits either in person or via telephone.

Interventions

Multidisciplinary team interventions OTHER

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.

Intervention group

Multidisciplinary team bimonthly visits either in person or via telephone. OTHER

Intervention group

Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager OTHER

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medco Health Solutions, Inc.: lead
• Coventry Health Care, Inc.: collaborator

Study Sites (2)

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Diabetes Mellitus; Osteoporosis

Condition Hierarchy (Ancestors)

Heart Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Julia O McEachern, MHS, PA-C

  Medco Health Solutions, Inc.

  PRINCIPAL INVESTIGATOR

• Stephen L Cavalieri, MD

  Coventry Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 21, 2010

Record last verified: 2010-01

Locations

US (2)