ADRD-PC: Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 at 4 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina, University of Colorado, Massachusetts General Hospital (Harvard University), and Indiana 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 Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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.
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Colorado Denver | Denver | Colorado | United States | 80045 |
2 | Indiana University | Indianapolis | Indiana | United States | 46202 |
3 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02215 |
4 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Laura C Hanson, MD, MPH, University of North Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-2764
- R01AG065394