Clinical trial NCT04948866: Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Official title: Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Dementia, Vascular
Dementia With Lewy Bodies
Dementia Frontal
Dementia, Mixed
Dementia Alzheimers
Alzheimer Disease
Dementia Severe
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-02
Enrollment: 442
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Transfers
timeFrame: 60 days post hospital discharge
Secondary outcomes:
measure: Symptom treatment
timeFrame: 60 days post hospital discharge
measure: Symptom control for physical symptoms
timeFrame: 60 days post hospital discharge
measure: Symptom control for neuropsychiatric symptoms
timeFrame: 60 days post hospital discharge
measure: Access to hospice
timeFrame: 60 days post hospital discharge
measure: Access to community-based palliative care
timeFrame: 60 days post hospital discharge
measure: Transition to nursing home level of care
timeFrame: 60 days post hospital discharge
measure: Documented discussion of dementia prognosis
timeFrame: 60 days post hospital discharge
measure: Documented discussion of goals of care
timeFrame: 60 days post hospital discharge
measure: Shared decision-making - hospitalization
timeFrame: 60 days post hospital discharge
measure: Shared decision-making - burdensome treatment
timeFrame: 60 days post hospital discharge
measure: Caregiver distress
timeFrame: 60 days post hospital discharge
measure: Caregiver burden
timeFrame: 60 days post hospital discharge
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Laura C Hanson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: