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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Alzheimer's Disease and Related Disorders (dementia) are a group of serious life limiting illness that cause significant challenges to our public health system, with significant illness burden for both the person with dementia and the caregiver. At the end of life, over 230,000 persons with dementia annually are cared for in hospice, yet hospice agencies are ill prepared to care for this population and often resort to inappropriate pharmacologic measures such as antipsychotics that reduce quality of life rather than improve it. This study will therefore through its two phases refine and then implement, using a pragmatic stepped wedge trial design, the Dementia Symptom Management at Home Program Hospice Edition, with the goal improving quality of care for the person with dementia and their caregiver, reducing antipsychotic use, and increasing bereaved caregiver satisfaction in the hospice setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Demential Patients | Experimental |
| |
| Hospice IDT Members | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dementia symptom management at home hospice edition | Behavioral | Quality assurance performance improvement program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Hospice IDT Members Who Complete Required Education and Training | Percentage of Hospice IDT Members who Complete Required Education and Training | 2 Months |
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Inclusion Criteria:
Clinicians:
Exclusion Criteria:
Persons with Dementia:
Clinicians:
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| Name | Affiliation | Role |
|---|---|---|
| Abraham Brody, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33377138 | Derived | Lin SY, Schneider CE, Bristol AA, Clancy M, Sprague SA, Aldridge M, Cortes T, Goldfeld KS, Kutner JS, Mitchell SL, Shega JW, Wu B, Zhu CW, Brody AA. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. Gerontologist. 2022 Feb 9;62(2):304-314. doi: 10.1093/geront/gnaa220. | |
| 32416231 |
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All of the individual participant data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hospice IDT Members | Hospice Interdisciplinary Team (IDT) |
| FG001 | Advanced Demential Patients | Dementia symptom management at home hospice edition: quality assurance performance improvement program |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hospice IDT MembersHospice Clinicians (RNs, Social Workers, Ch | Hospice Clinicians (RNs, Social Workers, Chaplains) who are given training |
| BG001 | Advanced Demential Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Hospice IDT Members Who Complete Required Education and Training | Percentage of Hospice IDT Members who Complete Required Education and Training | Posted | Number | percentage of participants | 2 Months |
|
|
1 month
All qualifying adverse events were pulled from all eligible patients' electronic health records. Adverse events were only reported on the Advanced Dementia Patients arm.
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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 | Advanced Demential Patients | Dementia symptom management at home hospice edition: quality assurance performance improvement program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abraham Brody, PhD, RN, FAAN | NYU Langone Health | 212-992-7341 | Abraham.Brody@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2019 | Jun 30, 2020 | Prot_SAP_000.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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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education and Training | Behavioral | Education and training |
|
| Schneider CE, Bristol A, Ford A, Lin SY, Palmieri J, Meier MR, Brody AA; HAS-QOL Trial Investigators. The Impact of Aliviado Dementia Care-Hospice Edition Training Program on Hospice Staff's Dementia Symptom Knowledge. J Pain Symptom Manage. 2020 Aug;60(2):e7-e13. doi: 10.1016/j.jpainsymman.2020.05.010. Epub 2020 May 15. |
Dementia symptom management at home hospice edition: quality assurance performance improvement program
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 5 |
| 11 |
| 5 |
| 11 |
| 0 |
| 11 |
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| D001523 | Mental Disorders |