An interventional study of Care coordination delivered based on perceived need and Care coordination delivered based on usual care (e.g. discharge from hospital) in Cardiovascular Diseases, Myocardial Infarction and Atrial Fibrillation, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Health services research
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 400 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Care coordination delivered based on perceived need
Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.
Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital)
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.
If a patient is discharged from a hospital, the patient will be selected for care management services.
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.
Time frame: Over 12 months (beginning 1 month after the start of care coordination)
Acceptability
Number of people in each group who accept care management
Time frame: 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
Time frame: Up to 1 year of follow-up
Fidelity
Number of participants who received care management services, among those who requested care management services.
Time frame: 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.
Time frame: Up to 1 year of follow-up
| Milestone | Intervention | Control |
|---|---|---|
| Started | 202 | 198 |
| Completed | 202 | 198 |
| Not completed | 0 | 0 |
Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims. This outcome measure allows more than one event per participant.
| events per 100 person-days alive | Intervention | Control |
|---|---|---|
| Number of Emergency Department Visits or Hospital Admissions | 0.25 (0.21 to 0.31) | 0.21 (0.17 to 0.27) |
Number of people in each group who accept care management
| Participants | Intervention | Control |
|---|---|---|
| Acceptability | 13 | 17 |
Number of participants who requested care management services that were in scope for the care managers' credentials
| Participants | Intervention | Control |
|---|---|---|
| Appropriateness | 13 | 17 |
Number of participants who received care management services, among those who requested care management services.
| Participants | Intervention | Control |
|---|---|---|
| Fidelity | 13 | 17 |
The total number of care management encounters per group. This measure allows more than one encounter per participant.
| Encounters | Intervention | Control |
|---|---|---|
| Efficiency | 52 | 45 |
Collected over Up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 4/202 (2%) | 44/202 (21.8%) | 0/202 (0%) |
| Control | 1/198 (0.5%) | 47/198 (23.7%) | 0/198 (0%) |
| Event | Intervention | Control |
|---|---|---|
| All-cause emergency department visitsGeneral disorders | 34/202 | 35/198 |
| All-cause hospitalizationGeneral disorders | 22/202 | 21/198 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 76.1 ± 7.1 | 75.8 ± 7.0 | 75.8 ± 7.0 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 141 | 146 | 287 |
| Male | 61 | 52 | 113 |
| Race/Ethnicity, Customized(Participants) | Intervention | Control | Total |
|---|---|---|---|
| White | 143 | 141 | 284 |
| Non-white | 59 | 57 | 116 |
| Enrollment type(Participants) | Intervention | Control | Total |
|---|---|---|---|
| 65 years and older, and dually eligible for Medicaid | 69 | 67 | 136 |
| 65 years and older, not dually eligible for Medicaid | 132 | 131 | 263 |
| End-stage renal disease | 1 | 0 | 1 |
| Disability | 0 | 0 | 0 |
| Co-morbidities(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Acute myocardial infarction | 0 | 3 | 3 |
| Atrial fibrillation | 19 | 28 | 47 |
| Chronic kidney disease (not end-stage) | 35 | 34 | 69 |
| Chronic obstructive pulmonary disease and bronchiectasis | 19 | 37 | 56 |
| Colorectal cancer | 9 | 4 | 13 |
| Depression | 43 | 44 | 87 |
| Diabetes | 64 | 60 | 124 |
| Endometrial cancer | 2 | 6 | 8 |
| End-stage renal disease | 1 | 3 | 4 |
| Female or male breast cancer | 25 | 25 | 50 |
| Heart failure | 29 | 30 | 59 |
| Hyperlipidemia | 162 | 159 | 321 |
| Hypertension | 154 | 143 | 297 |
| Ischemic heart disease | 71 | 82 | 153 |
| Lung cancer | 7 | 4 | 11 |
| Prostate cancer | 13 | 13 | 26 |
| Stroke / transient ischemic attack | 7 | 9 | 16 |
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Weill Medical College of Cornell University