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

Not Applicable

Active, not recruiting

• Conditions: Alzheimer Disease; Dementia Frontal; Dementia, Mixed; Dementia Alzheimers; Dementia Severe; Dementia, Vascular; Dementia; Dementia With Lewy Bodies
• Interventions: Behavioral: ADRD-PC Program

• Registration Number: NCT04948866
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-02
• Study Start: 2021-07-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 474

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Condition: ADRD-PC Program	ADRD-PC Program	1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams. 2. 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. 3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.
Control Condition	ADRD-PC Program	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.

Primary Outcome Measures

Name	Time	Method
Hospital Transfers	60 days post hospital discharge	Number of emergency room visits + hospital admissions within 60 days after discharge from index hospitalization

Secondary Outcome Measures

Name	Time	Method
Symptom treatment	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
Symptom control for physical symptoms	60 days post hospital discharge	Symptom Management at the End of Life in Dementia (SM-EOLD) - scored 0-45 with higher scores indicating better symptom control
Symptom control for neuropsychiatric symptoms	60 days post hospital discharge	Neuropsychiatric Inventory Questionnaire (NPI-Q) - range in two subscales of 0-36 and 0-60, with higher scores indicating worse symptom control
Access to hospice	60 days post hospital discharge	% of people with ADRD who access hospice services
Access to community-based palliative care	60 days post hospital discharge	% of people with ADRD who access community-based palliative care services
Transition to nursing home level of care	60 days post hospital discharge	% of people with ADRD who transition to nursing home care
Documented discussion of dementia prognosis	60 days post hospital discharge	% of caregivers with documented discussion of dementia prognosis during the index hospitalization
Documented discussion of goals of care	60 days post hospital discharge	% of caregivers with documented discussion of overall goals of care during the index hospitalization
Shared decision-making - hospitalization	60 days post hospital discharge	% of caregivers reporting shared decision-making about future hospitalization
Shared decision-making - burdensome treatment	60 days post hospital discharge	% of caregivers reporting shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment
Caregiver distress	60 days post hospital discharge	Family Distress in Advanced Dementia scale - range 1-5 with higher scores indicating more distress
Caregiver burden	60 days post hospital discharge	Zarit Burden scale, short form - range 0-24, higher scores more burden

Trial Locations

Locations (5)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States