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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG067045 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.
The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.
Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Visits will combine a combination of video-teleconferencing technology and in person visits. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.
Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative care at home | Experimental | Randomized to intervention arm |
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| Augmented control | Active Comparator | Randomized to augmented control (visits to the caregiver from a CHW without training in dementia or palliative care) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Palliative Care | Behavioral | Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Management as measured by the End of Life for Dementia scale | This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator. The Symptom Management at the End of Life in Dementia (SM-EOLD) scale responses range from 0 to 45 with higher scores indicating better symptom management. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospital Admissions | Acute care utilization as measured by the number of hospital admissions | at 12 months |
| Number of Hospital Stays | Acute care utilization as measured by the number of hospital days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura P Gelfman, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichan School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
For individual participant data meta-analysis. Proposals should be directed to christian.espino@mssm.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Subjects assigned to intervention or control arms in a 1:1 ratio
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Single blind control
| at 12 months |
| Patient reported treatment concordance | The Study Team will examine if the care patients receive is concordant with the care they wanted to receive using simple chart review of whether care received matches stated preferences (yes/no). | at 12 months |
| Cost Analysis | Total costs between the arms including inpatient, emergency department, ambulatory services, and home care services will be compared. Costs of the clinical intervention (e.g. clinical personnel, transportation) will be included in the analyses. | at 12 months |
| Caregiver burden per Zarit Burden Inventory | Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point scale range from 0 (never) to 4 (always). Full scale from 22 - 110, higher score indicates a greater burden. | at 6 months |
| Caregiver burden per Zarit Burden Inventory | Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point scale range from 0 (never) to 4 (always). Full scale from 22 - 110, higher score indicates a greater burden. | at 12 months |
| Caregiver satisfaction measured using FAMCARE-10 | FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. Full scale ranges 0-20, with higher scores indicating higher satisfaction. | at 6 months |
| Caregiver satisfaction measured using FAMCARE-10 | FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. Full scale ranges 0-20, with higher scores indicating higher satisfaction. | at 12 months |
| Caregiver depression measured by PHQ-9 Score | PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-27, with higher score indicating more severe symptoms. | at 6 months |
| Caregiver depression measured by PHQ-9 Score | PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-27, with higher score indicating more severe symptoms. | at 12 months |
| D001523 | Mental Disorders |