Dementia
Conditions
Keywords
care coordination, accountable care organization
Brief summary
Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all the people involved. However, care coordinators' time is limited, and there is uncertainty about which patients should be selected to receive their help. This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to PLWD.
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 PLWD to receive support from care coordinators: (1) an approach that assigns PLWD to care coordinators based on care partners' self-reported difficulty with care coordination, or (2) usual care, which generally assigns PLWD to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with dementia 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 PLWD.
Interventions
If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' 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
National Institute on Aging (NIA)
Brown University
Weill Medical College of Cornell University
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 old who: * Are attributed to the NewYork Quality Care accountable care organization by Medicare, * Have dementia (as measured in claims using the Bynum standard 1-year definition), * Reside in the community, and * Had fragmented ambulatory care in the previous 12 months (defined as a reversed Bice-Boxerman Index greater than or equal to the median score for this population, using Medicare claims)
Exclusion criteria
* Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims), or * Enrolled in home hospice
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Up to 1 year | The number of people who accepted care management in each group |
| Appropriateness | Up to 1 year | The number of people with problems in scope for care coordinators, out of all people who received care management |
| Fidelity | Up to 1 year | The number of people who actually received care coordination services, out of all of those who agreed to receive it |
| Efficiency | Up to 1 year | The number of care coordinator encounters in each group. This measure allows more than one encounter per person. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention The intervention group will assign care coordinators to PLWD 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 proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' 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. | 193 |
| 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. | 192 |
| Total | 385 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 82.8 years STANDARD_DEVIATION 6.9 | 82.6 years STANDARD_DEVIATION 6.9 | 82.3 years STANDARD_DEVIATION 7 |
| Co-morbidities Acute myocardial infarction | 10 Participants | 17 Participants | 7 Participants |
| Co-morbidities Atrial fibrillation | 32 Participants | 50 Participants | 18 Participants |
| Co-morbidities Chronic kidney disease (any stage other than ESRD) | 50 Participants | 101 Participants | 51 Participants |
| Co-morbidities Chronic obstructive pulmonary disease or bronchiectasis | 28 Participants | 56 Participants | 28 Participants |
| Co-morbidities Colorectal cancer | 15 Participants | 21 Participants | 6 Participants |
| Co-morbidities Depression | 65 Participants | 122 Participants | 57 Participants |
| Co-morbidities Diabetes | 39 Participants | 77 Participants | 38 Participants |
| Co-morbidities Endometrial cancer | 4 Participants | 7 Participants | 3 Participants |
| Co-morbidities End-stage renal disease (ESRD) | 3 Participants | 6 Participants | 3 Participants |
| Co-morbidities Female or male breast cancer | 18 Participants | 33 Participants | 15 Participants |
| Co-morbidities Heart failure | 63 Participants | 114 Participants | 51 Participants |
| Co-morbidities Hyperlipidemia | 123 Participants | 246 Participants | 123 Participants |
| Co-morbidities Hypertension | 130 Participants | 252 Participants | 122 Participants |
| Co-morbidities Ischemic heart disease | 86 Participants | 167 Participants | 81 Participants |
| Co-morbidities Lung cancer | 6 Participants | 8 Participants | 2 Participants |
| Co-morbidities Prostate cancer | 13 Participants | 30 Participants | 17 Participants |
| Co-morbidities Stroke / transient ischemic attack | 10 Participants | 20 Participants | 10 Participants |
| Medicare enrollment type Aged duals | 48 Participants | 81 Participants | 33 Participants |
| Medicare enrollment type Aged non-duals | 141 Participants | 299 Participants | 158 Participants |
| Medicare enrollment type Disabled | 0 Participants | 0 Participants | 0 Participants |
| Medicare enrollment type End-stage renal disease | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-White | 39 Participants | 78 Participants | 39 Participants |
| Race/Ethnicity, Customized White | 154 Participants | 307 Participants | 153 Participants |
| Sex: Female, Male Female | 109 Participants | 217 Participants | 108 Participants |
| Sex: Female, Male Male | 84 Participants | 168 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 32 / 193 | 37 / 192 |
| other Total, other adverse events | 47 / 193 | 57 / 192 |
| serious Total, serious adverse events | 52 / 193 | 45 / 192 |
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
Time frame: Over 12 months (beginning 1 month after the start of care coordination)
Population: Intention-to-treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Emergency Department Visits or Hospital Admissions | 0.33 events per 100 person-days alive |
| Control | Number of Emergency Department Visits or Hospital Admissions | 0.35 events per 100 person-days alive |
Secondary
Acceptability
The number of people who accepted care management in each group
Time frame: Up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Acceptability | 19 Participants |
| Control | Acceptability | 14 Participants |
p-value: 0.3795% CI: [-0.03, 0.08]Chi-squared
Secondary
Appropriateness
The number of people with problems in scope for care coordinators, out of all people who received care management
Time frame: Up to 1 year
Population: The only participants who were analyzed in this measure were those who received care management services (as shown in Secondary Outcome #1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Appropriateness | 19 Participants |
| Control | Appropriateness | 14 Participants |
Secondary
Efficiency
The number of care coordinator encounters in each group. This measure allows more than one encounter per person.
Time frame: Up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Efficiency | 77 Encounters |
| Control | Efficiency | 54 Encounters |
Secondary
Fidelity
The number of people who actually received care coordination services, out of all of those who agreed to receive it
Time frame: Up to 1 year
Population: The only people analyzed for this measure were people who agreed to receive care management (as shown in Secondary Outcome #1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Fidelity | 19 Participants |
| Control | Fidelity | 14 Participants |