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| ID | Type | Description | Link |
|---|---|---|---|
| R56AG067045-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with advanced dementia and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for 6 months.
Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
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 |
|---|---|---|---|
| Home Palliative Care | Experimental | Randomized to Intervention Arm |
|
| Control Arm | No Intervention | Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses. |
| 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 |
|---|---|---|
| Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | Number of Patients who completed the SM-EOLD Assessment Scale: Symptom Management at the End of Life for Dementia - Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Completed the McGill Quality of Life Assessment | Number of Patients who completed the McGill Quality of Life Assessment McGill Quality of Life instrument is assessment in the domains of physical symptoms, emotional well-being, social interactions, and an overall global rating. Alzheimer's Disease Scale: Quality of Life - Likert scale, 13 items, each 1-4. Total scale from 13- 52. Higher values are more positive scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Goldstein, MD | Icahn School of Medicine at Mount Sinai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Beth Israel | New York | New York | 10003 | United States | ||
| Mount Sinai West |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38777615 | Background | Estrada LV, Gelfman L, Zhang M, Espino C, Goldstein N. Challenges and solutions of conducting dementia clinical trials: A palliative care at home pilot for persons with dementia. J Am Geriatr Soc. 2024 Aug;72(8):2544-2551. doi: 10.1111/jgs.18966. Epub 2024 May 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Palliative Care - Patients | Home Palliative Care: Patients will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. |
| FG001 | Usual Care - Control Arm - Patients | Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses. |
| FG002 | Home Palliative Care - Caregiver | Caregivers of patients cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. |
| FG003 | Usual Care - Caregiver | Usual Care - Caregivers of patients will be cared for by the physician who treats their dementia and other illnesses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home Palliative Care - Patients | Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. |
| BG001 | Usual Care - Control Arm - Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Per the planned analyses, totals were calculated separately for participants in the caregiver and patient groups |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Completed the Symptom Management at the End of Life for Dementia Scale (SM-EOLD) | Number of Patients who completed the SM-EOLD Assessment Scale: Symptom Management at the End of Life for Dementia - Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home Palliative Care - Patients | Home Palliative Care: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nathan Goldstein | Icahn School of Medicine at Mount Sinai | 212-844-1712 | Nathan.goldstein@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2020 | Jul 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2020 | Oct 2, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2022 | Jul 5, 2024 | ICF_002.pdf |
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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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Patient - caregiver pairs
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Single blind control
| Baseline, 3 months, 6 months |
| Number of Complete of Advance Directives | The Study Team will examine the patient's chart for completion of advanced directives Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no). | 6 months |
| Preference Consistent Care | The Study Team will examine if the care patients receive is concordant with the care they wanted to receive. Scale: Simple chart review of whether care received matches stated preferences (yes/no) | 6 months |
| Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | Number of Caregivers who completed the Caregiver Zaria 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) Scale: Zarit Burden Inventory - Likert scale 0-4,total score = 0-88, higher score is more burden | Baseline, 3 months, 6 months |
| Number of Caregivers Who Completed the FAMCARE-10 Assessment | Number of Caregivers who completed the FAMCARE-10 Assessment 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. Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction | Baseline, 3 months, 6 months |
| Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | Number of Caregivers who completed the Patient Health Questionnaire (PHQ-9) 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). Scale: Patient Health Questionnaire - 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months] | Baseline, 3 months, 6 months |
| Mean Change in Number of Hospital Admissions | Healthcare Utilization measured from the data warehouse as well as using the Resource Use Instrument (RUI) collected through interviews with patients. assessed by hospital admissions | Baseline and 6 months |
| Hospital Length of Stay | Patient healthcare utilization as assessed by hospital length of stay over the past 6 months | 6 months |
| New York |
| New York |
| 10019 |
| United States |
| Mount Sinai St. Luke's | New York | New York | 10025 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses. |
| BG002 | Home Palliative Care - Caregivers | Caregivers of patients cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. |
| BG003 | Usual Care - Caregivers | Usual Care - Caregivers of patients will be cared for by the physician who treats their dementia and other illnesses. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Number of Participants who lives alone | Count of Participants | Participants |
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| Highest Education obtained | Count of Participants | Participants |
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| Marital Status | Data collected for caregivers only. | Count of Participants | Participants |
|
|
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| Secondary | Number of Patients Who Completed the McGill Quality of Life Assessment | Number of Patients who completed the McGill Quality of Life Assessment McGill Quality of Life instrument is assessment in the domains of physical symptoms, emotional well-being, social interactions, and an overall global rating. Alzheimer's Disease Scale: Quality of Life - Likert scale, 13 items, each 1-4. Total scale from 13- 52. Higher values are more positive scores. | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Number of Complete of Advance Directives | The Study Team will examine the patient's chart for completion of advanced directives Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no). | Not Posted | 6 months | Participants |
| Secondary | Preference Consistent Care | The Study Team will examine if the care patients receive is concordant with the care they wanted to receive. Scale: Simple chart review of whether care received matches stated preferences (yes/no) | Not Posted | 6 months | Participants |
| Secondary | Number of Caregivers Who Completed the Caregiver Zaria Burden Inventory | Number of Caregivers who completed the Caregiver Zaria 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) Scale: Zarit Burden Inventory - Likert scale 0-4,total score = 0-88, higher score is more burden | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Number of Caregivers Who Completed the FAMCARE-10 Assessment | Number of Caregivers who completed the FAMCARE-10 Assessment 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. Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Number of Caregivers Who Completed the Patient Health Questionnaire (PHQ-9) | Number of Caregivers who completed the Patient Health Questionnaire (PHQ-9) 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). Scale: Patient Health Questionnaire - 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months] | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Mean Change in Number of Hospital Admissions | Healthcare Utilization measured from the data warehouse as well as using the Resource Use Instrument (RUI) collected through interviews with patients. assessed by hospital admissions | Posted | Mean | Standard Deviation | admissions | Baseline and 6 months |
|
|
|
| Secondary | Hospital Length of Stay | Patient healthcare utilization as assessed by hospital length of stay over the past 6 months | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care - Control Arm - Patients | Usual Care - Patients will be cared for by the physician who treats their dementia and other illnesses. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Home Palliative Care - Caregivers | Caregivers of patients cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Usual Care - Caregivers | Usual Care - Caregivers of patients will be cared for by the physician who treats their dementia and other illnesses. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001523 | Mental Disorders |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| High school diploma/GED or greater |
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| Missing |
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| Single |
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| Missing |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
|