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NCT Number: NCT04948866

Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers

Millions of Americans have late-stage Alzheimer's and related dementias (ADRD), causing suffering due to loss of awareness of self and family, progressive dependency, physical and neuropsychiatric symptoms, and physical, emotional and financial strain for caregivers. Investigators now propose a multi-site randomized clinical trial of the ADRD Palliative Care (ADRD-PC) program for persons with late-stage ADRD and their family caregivers, triggered during hospitalization. Investigators aim to learn if this program of dementia-specific palliative care, standardized caregiver education, and transitional care is effective to reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and to improve caregiver outcomes of communication, shared decision-making and distress.

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Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Alzheimers Dementia Frontal Dementia Severe Dementia With Lewy Bodies Dementia, Mixed Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Mental Disorders Mixed Dementias Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies Tauopathies Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Denver, Colorado, United States

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About this study

Investigators have designed the ADRD Palliative Care (ADRD-PC) program of dementia-specific palliative and transitional care, and shown its feasibility and potential efficacy. Delivered by interdisciplinary hospital palliative care teams, ADRD-PC addresses 1) prognostic awareness, 2) symptom management, 3) shared decision-making, and 4) transition to community support services.

The research objective is to conduct a multi-site efficacy randomized clinical trial (RCT) of the ADRD-PC program. Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD (Global Deterioration Scale (GDS) 6-7 or GDS 5 with significant co-morbidity) with their family caregivers, and an additional 50 dyads that identify as Hispanic/Latino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina, University of Colorado, Massachusetts General Hospital (Harvard University), Indiana University, and Emory University. The primary hypothesis is that ADRD-PC will reduce hospital transfers (Aim 1). Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment, symptom control, use of community palliative care or hospice, and nursing home transitions (Aim 2); and caregiver outcomes of communication, decision-making and distress (Aim 3).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

People with ADRD Inclusion Criteria:

  • aged 55 or older
  • hospitalized
  • have a physician-confirmed diagnosis of ADRD
  • staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher

Caregiver Inclusion Criteria:

  • the adult (aged 18 or older) legally authorized representative (LAR) for healthcare and have capacity to serve in this role
  • support the person with ADRD
  • can complete interviews in English or Spanish.

Exclusion criteria

Dyads will be excluded if

  • the LAR is not a family caregiver
  • the patient currently receives palliative care or hospice
  • patient or caregiver would be unduly stressed
  • dyad is not successfully randomized.

Treatment and study plan

ADRD-PC Program

Behavioral

Included in arm/group descriptions

Primary outcomes

  1. Incidence of Hospital Transfers (Patients)

    Time frame: 60 days post index hospital discharge

    Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.

Secondary outcomes

  1. Symptom Treatment (Patients)

    Time frame: 60 days post hospital discharge

    Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment

  2. Symptom Control for Physical Symptoms (Patients)

    Time frame: 60 days post hospital discharge

    Symptom Management at the End of Life in Dementia (SM-EOLD) - Likert scale, 9 items each scored 0-5, range of 0-45 with higher scores indicating greater symptoms.

  3. Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)

    Time frame: 60 days post hospital discharge

    Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity Score - 12 items, each symptom reported as present is rated from 1 (mild) to 3 (severe). The range in this subscale is 0-36 with higher scores indicating worse symptom control.

  4. Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)

    Time frame: 60 days post hospital discharge

    Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress - 12 items, if the symptom was reported as present the caregiver rated the level of distress they experienced related tot he patient's symptom from 0 (not distressing) to 5 (extremely distressing). This subscale ranges from 0-60, with higher scores indicating more caregiver distress.

  5. Access to Hospice (Patients)

    Time frame: 60 days post hospital discharge

    Percent of people with ADRD who access hospice services.

  6. Access to Community-based Palliative Care (Patients)

    Time frame: 60 days post hospital discharge

    Percent of people with ADRD who access community-based palliative care services

  7. Transition to Nursing Home Level of Care (Patients)

    Time frame: 60 days post hospital discharge

    Percent of people with ADRD who transition to nursing home care

  8. Documented Discussion of Dementia Prognosis (Patients)

    Time frame: 60 days post hospital discharge

    Percent of patients with documented discussion of dementia prognosis in their medical record.

  9. Documented Discussion of Goals of Care (Patients)

    Time frame: 60 days post hospital discharge

    Percent of patients with documented discussion of overall goals of care.

  10. Shared Decision-making - Hospitalization (Patients)

    Time frame: 60 days post hospital discharge

    Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.

  11. Shared Decision-making - Burdensome Treatment (Patients)

    Time frame: 60 days post hospital discharge

    Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.

  12. Caregiver Distress Score (Caregivers)

    Time frame: 60 days post hospital discharge

    Family Distress in Advanced Dementia scale - 21 item Likert scale (1=Never to 5=Always) ranges from 21 to 105 with higher scores indicating more distress.

  13. Caregiver Burden (Caregiver)

    Time frame: 60 days post hospital discharge

    Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: ADRD-PC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2021
Registry last updated
Dec 16, 2025

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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