Heart FailureCOSSNCT01014884
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
A study testing Multidisciplinary team interventions, Multidisciplinary team bimonthly visits either in person or via telephone. and Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Medco Health Solutions, Inc. at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease
- What is being tested?
- Multidisciplinary team interventions, Multidisciplinary team bimonthly visits either in person or via telephone. and Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,150 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Kansas City, Missouri
Study site
St Louis, Missouri
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease, Diabetes, Osteoporosis
- Being tested
- Multidisciplinary team interventions, 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
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Diabetes Mellitus, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary team interventionsOther
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.Other
Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit managerOther
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The control group will receive usual care as provided by your Health Plan. Receives: 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. Receives: Other: Multidisciplinary team interventions; Other: Multidisciplinary team bimonthly visits either in person or via telephone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the impact of multidisciplinary team interventions in reducing the rate of non-elective hospitalizations over a 12 month period compared to usual care
Measured: 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.
Measured: 12 months
Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)
Measured: 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)]
Measured: 12 months
Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)
Measured: 12 months
Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care
Measured: 12 months
Determine the impact of multidisciplinary team interventions versus usual care on rate of non-elective hospitalizations by chronic condition
Measured: 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
Measured: 12
Determine the impact of multidisciplinary team interventions versus usual care on the length of stay (LOS) of each non-elective hospitalization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: Terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 2,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medco Health Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coventry Health Care, Inc.
- Investigators
- Julia O McEachern, MHS, PA-C, Principal investigator, Medco Health Solutions, Inc.Stephen L Cavalieri, MD, Principal investigator, Coventry Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014884
- Sponsor's protocol ID
- 7714
- Acronym
- COSS
- Status last verified
- Jan 2010
- First submitted
- 12 Nov 2009
- Last updated
- 21 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01014884
- Acronym / sponsor ID
- COSS / 7714
- Conditions
- Heart Failure, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease, Diabetes, Osteoporosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by Sponsor
- Enrolment
- 2,150 participants (estimated)
- Lead sponsor
- Medco Health Solutions, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Coventry Health Care, Inc.
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit managerThe control group will receive usual care as provided by your Health Plan. |
| Intervention group | Other | Other: Multidisciplinary team interventions, Other: Multidisciplinary team bimonthly visits either in person or via telephone.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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary team interventionsThe 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 | 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 |
Primary outcome
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
8 secondary outcomes
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
Determine the impact of multidisciplinary team interventions versus usual care on health-related quality of life (HR-QOL)
Time frame: 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
Determine the impact of multidisciplinary team interventions versus usual care on total outpatient costs (physician, pharmacy,rehabilitation)
Time frame: 12 months
Determine the impact of multidisciplinary team interventions versus usual care on satisfaction with care
Time frame: 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
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
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
Results and safety
The study was stopped early (reason given: Terminated by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia O McEachern, MHS, PA-C principal investigator
Medco Health Solutions, Inc.
Stephen L Cavalieri, MD principal investigator
Coventry Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary team interventions, Multidisciplinary team bimonthly visits either in person or via telephone. and Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Medco Health Solutions, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated by Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2010.