Cardiovascular DiseasesNCT05820295
Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination
A study testing Care coordination delivered based on perceived need in people with Cardiovascular Diseases and Myocardial Infarction, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular Diseases, Myocardial Infarction, Atrial Fibrillation
- What is being tested?
- Care coordination delivered based on perceived need
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to 11 Jul 2024
- Phase
- Interventional
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
- Medicare beneficiaries 65 years and older,
- Attributed to the NewYork Quality Care accountable care organization,
- Are community-dwelling,
- Have cardiovascular disease or 1 or more cardiovascular risk factors, and
- Had highly fragmented ambulatory care in the prior year (defined as a reversed Bice-Boxerman Index greater than or equal to 0.85)
Who cannot join
- Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims)
- Enrolled in home hospice
- Dementia (as measured in claims using the Bynum Standard 1-year definition)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, 10065
About this study
This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. The hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.
Read the detailed description
This project will use a pragmatic clinical trial embedded in an accountable care organization (ACO) to determine the comparative effectiveness of two different approaches for selecting older adults at risk for cardiovascular outcomes to receive support from care coordinators: (1) an approach that assigns older adults to care coordinators based on self-reported difficulty with care coordination, or (2) usual care, which generally assigns older adults to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with cardiovascular disease (CVD) or 1 or more CVD risk factors who have been attributed to the NewYork Quality Care ACO and who have fragmented care. The investigators will randomize the participants into two groups. This study is highly pragmatic, and the intervention is sustainable and scalable. Moreover, the proposed approach has the potential to improve care delivery and outcomes for older adults at risk for cardiovascular outcomes.
- Conditions
- Cardiovascular Diseases, Myocardial Infarction, Atrial Fibrillation, Diabetes Mellitus, Heart Failure, Hyperlipidemias
- Being tested
- Care coordination delivered based on perceived need, Care coordination delivered based on usual care (e.g. discharge from hospital)
- Keywords
- care coordination, accountable care organization
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Atrial Fibrillation, Diabetes Mellitus, Heart Failure, Hyperlipidemias, Hypertension, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care coordination delivered based on perceived needBehavioural
If patients in intervention group report on the survey that they experience difficulty coordinating care among their providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.
Care coordination delivered based on usual care (e.g. discharge from hospital)Behavioural
If a patient is discharged from a hospital, the patient will be selected for care management services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will assign care coordinators to individuals based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Receives: Behavioral: Care coordination delivered based on perceived need |
| Control | Active comparator | Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Receives: Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Visits or Hospital Admissions
Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims. This outcome measure allows more than one event per participant.
Measured: Over 12 months (beginning 1 month after the start of care coordination)
Secondary outcomes (4)
Acceptability
Number of people in each group who accept care management
Measured: Up to 1 year of follow-up
Appropriateness
Number of participants who requested care management services that were in scope for the care managers' credentials
Measured: Up to 1 year of follow-up
Fidelity
Number of participants who received care management services, among those who requested care management services.
Measured: Up to 1 year of follow-up
Efficiency
The total number of care management encounters per group. This measure allows more than one encounter per participant.
Measured: Up to 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start17 May 2023
- Primary completion31 May 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Lisa M Kern, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820295
- Sponsor's protocol ID
- 22-09025263
- Other IDs
- 1K18HS029255-01
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2023
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kern LM, Aucapina JE, Banerjee S, Ringel JB, Tobin JN, Fisseha S, Meiri H, Han J, Wu K, Bialor J, Sterling MR, Stange KC, Safford MM, Casale PN. Care Coordination and Hospitalization in Older Adults With or at Risk for Cardiovascular Disease: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e269110. doi: 10.1001/jamanetworkopen.2026.9110.
PubMed 42048081