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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia Alzheimers; Dementia Severe; Dementia Frontal
• Intervention / Treatment: Behavioral: ADRD-PC Program

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 884
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Condition: ADRD-PC Program; Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.; Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.; Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.	Behavioral: ADRD-PC Program; Included in arm/group descriptions
Active Comparator: Control Condition; Patient-family caregiver dyads randomized to the control arm will receive educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patient will receive usual hospital and post-acute care.	Behavioral: ADRD-PC Program; Included in arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Hospital Transfers (Patients)	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.	60 days post index hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Treatment (Patients)	Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment	60 days post hospital discharge
Symptom Control for Physical Symptoms (Patients)	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.	60 days post hospital discharge
Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)	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.	60 days post hospital discharge
Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)	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.	60 days post hospital discharge
Access to Hospice (Patients)	Percent of people with ADRD who access hospice services.	60 days post hospital discharge
Access to Community-based Palliative Care (Patients)	Percent of people with ADRD who access community-based palliative care services	60 days post hospital discharge
Transition to Nursing Home Level of Care (Patients)	Percent of people with ADRD who transition to nursing home care	60 days post hospital discharge
Documented Discussion of Dementia Prognosis (Patients)	Percent of patients with documented discussion of dementia prognosis in their medical record.	60 days post hospital discharge
Documented Discussion of Goals of Care (Patients)	Percent of patients with documented discussion of overall goals of care.	60 days post hospital discharge
Shared Decision-making - Hospitalization (Patients)	Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.	60 days post hospital discharge
Shared Decision-making - Burdensome Treatment (Patients)	Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.	60 days post hospital discharge
Caregiver Distress Score (Caregivers)	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.	60 days post hospital discharge
Caregiver Burden (Caregiver)	Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden.	60 days post hospital discharge

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Laura C Hanson, MD, MPH, University of North Carolina

Publications and helpful links

General Publications

• Toles M, Kistler C, Lin FC, Lynch M, Wessell K, Mitchell SL, Hanson LC. Palliative care for persons with late-stage Alzheimer's and related dementias and their caregivers: protocol for a randomized clinical trial. Trials. 2023 Sep 25;24(1):606. doi: 10.1186/s13063-023-07614-4.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Leukoencephalopathies; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Mixed Dementias; Alzheimer Disease; Dementia; Dementia, Vascular; Lewy Body Disease
• Other Study ID Numbers: 20-2764; R01AG065394 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. In addition, every attempt will be made to publish results in peer-reviewed journals. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Data may be requested to achieve aims in an approved proposal by contacting the Palliative Care Research Collaborative Group Data Repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No