Clinical trial NCT01014884: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Cardiovascular Disease
Diabetes
Osteoporosis
Lead sponsor: Medco Health Solutions, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Coventry Health Care, Inc.
First posted: 2009-11-17
Enrollment: 2150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no

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.

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 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

Primary outcomes:
measure: Determine the impact of multidisciplinary team interventions in reducing the rate of non-elective hospitalizations over a 12 month period compared to usual care
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)
timeFrame: 12 months
measure: 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)]
timeFrame: 12 months
measure: Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)
timeFrame: 12 months
measure: Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care
timeFrame: 12 months
measure: Determine the impact of multidisciplinary team interventions versus usual care on rate of non-elective hospitalizations by chronic condition
timeFrame: 12 months
measure: 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
timeFrame: 12
measure: Determine the impact of multidisciplinary team interventions versus usual care on the length of stay (LOS) of each non-elective hospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
Study officials:
affiliation: Medco Health Solutions, Inc.
name: Julia O McEachern, MHS, PA-C
role: PRINCIPAL_INVESTIGATOR
affiliation: Coventry Health Care, Inc.
name: Stephen L Cavalieri, MD
role: PRINCIPAL_INVESTIGATOR
References: