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Completed

NCT Number: NCT02719938

Triggered Palliative Care for Advanced Dementia

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specialty Palliative Care

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2016
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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