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

Heart Failure Clinical Trial

— COSS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01014884
• Other study ID #: 7714
• Status: Terminated
• Phase: N/A
• First received: November 12, 2009
• Last updated: January 20, 2010
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2010
• Source: Medco Health Solutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2150
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease
• Diabetes
• Heart Failure
• Lung Diseases, Obstructive
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medco Health Solutions, Inc.	Coventry Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)		12 months	No
Secondary	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	No
Secondary	Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)		12 months	No
Secondary	Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care		12 months	No
Secondary	Determine the impact of multidisciplinary team interventions versus usual care on rate of non-elective hospitalizations by chronic condition		12 months	No
Secondary	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		12	Yes
Secondary	Determine the impact of multidisciplinary team interventions versus usual care on the length of stay (LOS) of each non-elective hospitalization		12 months	No