Triggered Palliative Care for Advanced Dementia

University of North Carolina (UNC)

Status: Completed

Conditions: Alzheimer Disease; Dementia

Treatments: Behavioral: Specialty Palliative Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02719938

R21AG052140 (U.S. NIH Grant/Contract)

Pilot & Exploratory Project (Other Identifier)

15-1350

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Specialty Palliative Care

Experimental group

Description:

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.

Treatment:

Behavioral: Specialty Palliative Care

Control

No Intervention group

Description:

Usual care.