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Clinical Trials/NCT02719938
NCT02719938
Completed
Not Applicable

Triggered Palliative Care for Advanced Dementia

University of North Carolina, Chapel Hill1 site in 1 country62 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University of North Carolina, Chapel Hill
Enrollment
62
Locations
1
Primary Endpoint
Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
October 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)

Time Frame: From time of hospital discharge up to 60 days

Includes emergency department visits and hospital admissions during measure interval

Secondary Outcomes

  • Patient Comfort End of Life in Dementia (CAD-EOLD)(60 days)
  • Number of Participants With Burdensome Treatments(From time of hospital discharge up to 60 days)
  • Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up(From time of hospital discharge up to 60 days)
  • Caregiver Strain(Interview at 60 days after hospitalization)
  • Number of Palliative Care Domains in Treatment Plan(From time of hospital discharge up to 60 days)
  • Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)(From time of hospital discharge up to 60 days)

Study Sites (1)

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