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

Alzheimer Disease Clinical Trial

— ADRD-PC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04948866
• Other study ID #: 20-2764
• Secondary ID: R01AG065394
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 474
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• ADRD-PC Program
Included in arm/group descriptions

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Colorado Denver	Denver	Colorado
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Transfers	Number of emergency room visits + hospital admissions within 60 days after discharge from index hospitalization	60 days post hospital discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	Access to hospice	% of people with ADRD who access hospice services	60 days post hospital discharge
Secondary	Access to community-based palliative care	% of people with ADRD who access community-based palliative care services	60 days post hospital discharge
Secondary	Transition to nursing home level of care	% of people with ADRD who transition to nursing home care	60 days post hospital discharge
Secondary	Documented discussion of dementia prognosis	% of caregivers with documented discussion of dementia prognosis during the index hospitalization	60 days post hospital discharge
Secondary	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
Secondary	Shared decision-making - hospitalization	% of caregivers reporting shared decision-making about future hospitalization	60 days post hospital discharge
Secondary	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
Secondary	Caregiver distress	Family Distress in Advanced Dementia scale - range 1-5 with higher scores indicating more distress	60 days post hospital discharge
Secondary	Caregiver burden	Zarit Burden scale, short form - range 0-24, higher scores more burden	60 days post hospital discharge