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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG052140 | U.S. NIH Grant/Contract | View source | |
| Pilot & Exploratory Project | Other Identifier | National Palliative Care Research Center |
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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| National Institute on Aging (NIA) | NIH |
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The objective of this study is to generate preliminary data for a large multi-site randomized clinical trial of a model of palliative care consultation for patients with advanced dementia, and for their family caregivers.
Alzheimer's disease and related dementias affect 5 million Americans at an annual cost of $215 billion. Dementia is a contributing cause for 1 in 3 deaths, and is the only major cause of death with no effective prevention or treatment. Dementia-specific palliative care is needed to address the unique symptoms and treatment decisions relevant to this disease.
Investigators therefore propose to develop and pilot test a model of palliative care consultation for advanced dementia patients, triggered by hospitalization for a serious acute illness. After systematic refinement of operational protocols and tools with stakeholders, they will enroll persons with advanced dementia plus an acute illness associated with high risk of death in the coming year. Patients will be enrolled with their family decision-makers (N=60 dyads) in a randomized feasibility trial. Intervention dyads will receive specialty palliative care consultation during hospital admission, plus post-discharge collaborative care by their outpatient primary care provider and a palliative care nurse practitioner. Control dyads will receive usual care.
The research objective is to generate preliminary data for a large multi-site randomized controlled trial of a model of palliative care consultation for advanced dementia.
Specific aims are:
Aim 1: To develop a best-practice model of palliative care consultation for advanced dementia triggered by hospital admission for serious acute illness.
Aim 2: To conduct a pilot randomized trial of triggered palliative care consultation for advanced dementia (versus usual care) to demonstrate the feasibility of conducting a larger randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specialty Palliative Care | Experimental | Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. |
|
| Control | No Intervention | Usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specialty Palliative Care | Behavioral | Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) | Includes emergency department visits and hospital admissions during measure interval | From time of hospital discharge up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort End of Life in Dementia (CAD-EOLD) | Comfort at the End of Life in Dementia (CAD-EOLD) instrument, consisting of 14 Likert-scaled items measuring comfort in the final phase of life with dementia. Scores range from 14-42, with higher scores indicting greater comfort. | 60 days |
| Caregiver Strain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Hanson, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30342242 | Derived | Hanson LC, Kistler CE, Lavin K, Gabriel SL, Ernecoff NC, Lin FC, Sachs GA, Mitchell SL. Triggered Palliative Care for Late-Stage Dementia: A Pilot Randomized Trial. J Pain Symptom Manage. 2019 Jan;57(1):10-19. doi: 10.1016/j.jpainsymman.2018.10.494. Epub 2018 Oct 18. |
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Data sharing plan not written
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March 2016 to August 2017 enrolled dyads of hospitalized patients with late-stage dementia and family decision-makers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Specialty Palliative Care | Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. |
| FG001 | Control | Usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Specialty Palliative Care | Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. |
| 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 | Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) | Includes emergency department visits and hospital admissions during measure interval | Posted | Number | events per day | From time of hospital discharge up to 60 days |
|
60 days
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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 | Specialty Palliative Care | Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura C. Hanson, MD, MPH | University of North Carolina at Chapel Hill | 919-843-4096 | lhanson@med.unc.edu |
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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 | Jul 18, 2016 | Oct 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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|
Family Distress in Advanced Dementia instrument, a 21 item questionnaire designed to detect strain in family caregivers in dementia. Caregivers are asked a series of items about emotional distress, preparedness, and relations with healthcare providers scored 1-5, with higher scores indicting greater distress. |
| Interview at 60 days after hospitalization |
| Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up | Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews. | From time of hospital discharge up to 60 days |
| Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST) | Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed | From time of hospital discharge up to 60 days |
| Number of Palliative Care Domains in Treatment Plan | Number of palliative care domains addressed in treatment plan, using the Palliative Care Domain score which is scored 0 (not addressed) or 1 (addressed) for each of 10 possible domains of a palliative care treatment plan -- prognosis, overall goals of care, physical symptoms, psychiatric symptoms, spiritual needs, and 5 treatment preferences: resuscitation, artificial feeding, intravenous fluids, antibiotics, and hospitalization. Scores are summed for a total possible score of 0-10, with higher scores indicating greater attention to palliative care needs in the treatment plan. | From time of hospital discharge up to 60 days |
| Number of Participants With Burdensome Treatments | Number of participants with burdensome treatments, defined as a count of participants with any use of the following treatments: feeding tube, central intravenous line, surgical procedure, intensive care transfer, ventilator use, cardiopulmonary resuscitation use at any time during the time frame of measurement. | From time of hospital discharge up to 60 days |
| BG001 | Control | Usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control | Usual care. |
|
|
|
| Secondary | Patient Comfort End of Life in Dementia (CAD-EOLD) | Comfort at the End of Life in Dementia (CAD-EOLD) instrument, consisting of 14 Likert-scaled items measuring comfort in the final phase of life with dementia. Scores range from 14-42, with higher scores indicting greater comfort. | Posted | Mean | Standard Deviation | score on a scale | 60 days |
|
|
|
|
| Secondary | Caregiver Strain | Family Distress in Advanced Dementia instrument, a 21 item questionnaire designed to detect strain in family caregivers in dementia. Caregivers are asked a series of items about emotional distress, preparedness, and relations with healthcare providers scored 1-5, with higher scores indicting greater distress. | Posted | Mean | Standard Deviation | score on a scale | Interview at 60 days after hospitalization |
|
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|
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| Secondary | Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up | Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews. | Posted | Number | percentage of patients | From time of hospital discharge up to 60 days |
|
|
|
|
| Secondary | Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST) | Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed | Posted | Number | percentage of participants | From time of hospital discharge up to 60 days |
|
|
|
|
| Secondary | Number of Palliative Care Domains in Treatment Plan | Number of palliative care domains addressed in treatment plan, using the Palliative Care Domain score which is scored 0 (not addressed) or 1 (addressed) for each of 10 possible domains of a palliative care treatment plan -- prognosis, overall goals of care, physical symptoms, psychiatric symptoms, spiritual needs, and 5 treatment preferences: resuscitation, artificial feeding, intravenous fluids, antibiotics, and hospitalization. Scores are summed for a total possible score of 0-10, with higher scores indicating greater attention to palliative care needs in the treatment plan. | Posted | Mean | Standard Deviation | units on a scale | From time of hospital discharge up to 60 days |
|
|
|
|
| Secondary | Number of Participants With Burdensome Treatments | Number of participants with burdensome treatments, defined as a count of participants with any use of the following treatments: feeding tube, central intravenous line, surgical procedure, intensive care transfer, ventilator use, cardiopulmonary resuscitation use at any time during the time frame of measurement. | Posted | Count of Participants | Participants | From time of hospital discharge up to 60 days |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Usual care. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |