Atrial Fibrillation, Cardiovascular Diseases, Diabetes Mellitus, Heart Failure, Hyperlipidemias, Hypertension, Ischemic Heart Disease, Myocardial Infarction, Stroke, Transient Ischemic Attack
Conditions
Keywords
care coordination, accountable care organization
Brief 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. 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.
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.
Interventions
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.
Sponsors
Weill Medical College of Cornell University
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Emergency Department Visits or Hospital Admissions | Over 12 months (beginning 1 month after the start of care coordination) | Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims. This outcome measure allows more than one event per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Up to 1 year of follow-up | Number of people in each group who accept care management |
| Appropriateness | Up to 1 year of follow-up | Number of participants who requested care management services that were in scope for the care managers' credentials |
| Fidelity | Up to 1 year of follow-up | Number of participants who received care management services, among those who requested care management services. |
| Efficiency | Up to 1 year of follow-up | The total number of care management encounters per group. This measure allows more than one encounter per participant. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa M Kern, MD, MPH
Weill Medical College of Cornell University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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.
Care coordination delivered based on perceived need: 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. | 202 |
| Control Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.
Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services. | 198 |
| Total | 400 |
Baseline characteristics
| Characteristic | Total | Control | Intervention |
|---|---|---|---|
| Age, Continuous | 75.8 years STANDARD_DEVIATION 7 | 75.8 years STANDARD_DEVIATION 7 | 76.1 years STANDARD_DEVIATION 7.1 |
| Co-morbidities Acute myocardial infarction | 3 Participants | 3 Participants | 0 Participants |
| Co-morbidities Atrial fibrillation | 47 Participants | 28 Participants | 19 Participants |
| Co-morbidities Chronic kidney disease (not end-stage) | 69 Participants | 34 Participants | 35 Participants |
| Co-morbidities Chronic obstructive pulmonary disease and bronchiectasis | 56 Participants | 37 Participants | 19 Participants |
| Co-morbidities Colorectal cancer | 13 Participants | 4 Participants | 9 Participants |
| Co-morbidities Depression | 87 Participants | 44 Participants | 43 Participants |
| Co-morbidities Diabetes | 124 Participants | 60 Participants | 64 Participants |
| Co-morbidities Endometrial cancer | 8 Participants | 6 Participants | 2 Participants |
| Co-morbidities End-stage renal disease | 4 Participants | 3 Participants | 1 Participants |
| Co-morbidities Female or male breast cancer | 50 Participants | 25 Participants | 25 Participants |
| Co-morbidities Heart failure | 59 Participants | 30 Participants | 29 Participants |
| Co-morbidities Hyperlipidemia | 321 Participants | 159 Participants | 162 Participants |
| Co-morbidities Hypertension | 297 Participants | 143 Participants | 154 Participants |
| Co-morbidities Ischemic heart disease | 153 Participants | 82 Participants | 71 Participants |
| Co-morbidities Lung cancer | 11 Participants | 4 Participants | 7 Participants |
| Co-morbidities Prostate cancer | 26 Participants | 13 Participants | 13 Participants |
| Co-morbidities Stroke / transient ischemic attack | 16 Participants | 9 Participants | 7 Participants |
| Enrollment type 65 years and older, and dually eligible for Medicaid | 136 Participants | 67 Participants | 69 Participants |
| Enrollment type 65 years and older, not dually eligible for Medicaid | 263 Participants | 131 Participants | 132 Participants |
| Enrollment type Disability | 0 Participants | 0 Participants | 0 Participants |
| Enrollment type End-stage renal disease | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-white | 116 Participants | 57 Participants | 59 Participants |
| Race/Ethnicity, Customized White | 284 Participants | 141 Participants | 143 Participants |
| Sex: Female, Male Female | 287 Participants | 146 Participants | 141 Participants |
| Sex: Female, Male Male | 113 Participants | 52 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 202 | 1 / 198 |
| other Total, other adverse events | 0 / 202 | 0 / 198 |
| serious Total, serious adverse events | 44 / 202 | 47 / 198 |
Outcome results
Primary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Emergency Department Visits or Hospital Admissions | 0.25 events per 100 person-days alive |
| Control | Number of Emergency Department Visits or Hospital Admissions | 0.21 events per 100 person-days alive |
Secondary
Acceptability
Number of people in each group who accept care management
Time frame: Up to 1 year of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Acceptability | 13 Participants |
| Control | Acceptability | 17 Participants |
Secondary
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
Population: This outcome is restricted to those who accepted care management.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Appropriateness | 13 Participants |
| Control | Appropriateness | 17 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Efficiency | 52 Encounters |
| Control | Efficiency | 45 Encounters |
Secondary
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
Population: This measure is restricted to those who requested care management services.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Fidelity | 13 Participants |
| Control | Fidelity | 17 Participants |