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Triggered Palliative Care for Advanced Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719938
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Behavioral: Specialty Palliative Care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Triggered Palliative Care for Advanced Dementia
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: 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.
No Intervention: Control
Usual care.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Patient Comfort End of Life in Dementia (CAD-EOLD) [ Time Frame: 60 days ]
    Comfort at the End of Life in Dementia (CAD-EOLD) instrument, consisting of 14 Likert-scaled items measuring comfort in the final phase of life with dementia. Scores range from 14-42, with higher scores indicting greater comfort.

  2. Caregiver Strain [ Time Frame: Interview at 60 days after hospitalization ]
    Family Distress in Advanced Dementia instrument, a 21 item questionnaire designed to detect strain in family caregivers in dementia. Caregivers are asked a series of items about emotional distress, preparedness, and relations with healthcare providers scored 1-5, with higher scores indicting greater distress.

  3. Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up [ Time Frame: From time of hospital discharge up to 60 days ]
    Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews.

  4. Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST) [ Time Frame: From time of hospital discharge up to 60 days ]
    Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed

  5. Number of Palliative Care Domains in Treatment Plan [ Time Frame: From time of hospital discharge up to 60 days ]
    Number of palliative care domains addressed in treatment plan, using the Palliative Care Domain score which is scored 0 (not addressed) or 1 (addressed) for each of 10 possible domains of a palliative care treatment plan -- prognosis, overall goals of care, physical symptoms, psychiatric symptoms, spiritual needs, and 5 treatment preferences: resuscitation, artificial feeding, intravenous fluids, antibiotics, and hospitalization. Scores are summed for a total possible score of 0-10, with higher scores indicating greater attention to palliative care needs in the treatment plan.

  6. Number of Participants With Burdensome Treatments [ Time Frame: From time of hospital discharge up to 60 days ]
    Number of participants with burdensome treatments, defined as a count of participants with any use of the following treatments: feeding tube, central intravenous line, surgical procedure, intensive care transfer, ventilator use, cardiopulmonary resuscitation use at any time during the time frame of measurement.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719938


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Laura Hanson, MD, MPH University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Study Protocol and Statistical Analysis Plan  [PDF] July 18, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02719938    
Other Study ID Numbers: 15-1350
R21AG052140 ( U.S. NIH Grant/Contract )
Pilot & Exploratory Project ( Other Identifier: National Palliative Care Research Center )
First Posted: March 25, 2016    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing plan not written
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders