NCT02719938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 8, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

March 21, 2016

Results QC Date

October 29, 2018

Last Update Submit

January 7, 2019

Conditions

Alzheimer DiseaseDementia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Patient Comfort End of Life in Dementia (CAD-EOLD)

    60 days

  • Caregiver Strain

    Interview at 60 days after hospitalization

  • 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

  • Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)

    From time of hospital discharge up to 60 days

  • Number of Palliative Care Domains in Treatment Plan

    From time of hospital discharge up to 60 days

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Specialty Palliative Care

Control

NO INTERVENTION

Usual care.

Interventions

Specialty Palliative CareBEHAVIORAL

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 30342242DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Laura C. Hanson, MD, MPH
Organization
University of North Carolina at Chapel Hill
lhanson@med.unc.edu
919-843-4096

Study Officials

  • Laura Hanson, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

March 1, 2016

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

January 8, 2019

Results First Posted

January 8, 2019

Record last verified: 2018-01

Locations

US(1)