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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia Frontal, Dementia, Mixed, Dementia Alzheimers, Alzheimer Disease, Dementia Severe

Intervention / Treatment
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* Behavioral: ADRD-PC Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition: ADRD-PC Program<br>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<br>* Included in arm/group descriptions<br>|
| Active Comparator: Control Condition<br>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<br>* Included in arm/group descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Transfers | Number of emergency room visits + hospital admissions within 60 days after discharge from index hospitalization | 60 days post hospital discharge | 

Secondary Outcome Measures

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