Clinical trial NCT02719938: Triggered Palliative Care for Advanced Dementia
Official title: Triggered Palliative Care for Advanced Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: National Institute on Aging (NIA)
First posted: 2016-03-25
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of dementia from Alzheimer's or other underlying cause
* Global Deterioration Scale (GDS) Stage 5, 6 or 7
* acute illness hospitalization

Exclusion Criteria:

* No English-speaking family decision-maker
* Primary physician expects study to be too stressful for family caregiver

Primary outcomes:
measure: Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)
timeFrame: From time of hospital discharge up to 60 days
Secondary outcomes:
measure: Patient Comfort End of Life in Dementia (CAD-EOLD)
timeFrame: 60 days
measure: Caregiver Strain
timeFrame: Interview at 60 days after hospitalization
measure: Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up
timeFrame: From time of hospital discharge up to 60 days
measure: Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)
timeFrame: From time of hospital discharge up to 60 days
measure: Number of Palliative Care Domains in Treatment Plan
timeFrame: From time of hospital discharge up to 60 days
measure: Number of Participants With Burdensome Treatments
timeFrame: From time of hospital discharge up to 60 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura Hanson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.