Study Results
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View full resultsBasic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2016-03-31
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Control
Usual care.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Global Deterioration Scale (GDS) Stage 5, 6 or 7
* acute illness hospitalization
Exclusion Criteria
* Primary physician expects study to be too stressful for family caregiver
65 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
National Institute on Aging (NIA)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Laura Hanson, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pilot & Exploratory Project
Identifier Type: OTHER
Identifier Source: secondary_id
15-1350
Identifier Type: -
Identifier Source: org_study_id
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