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

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.

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).

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

Randomization allocation to study arms is concealed from all study personnel until the point of randomization assignment. In the ADRD-PC Study, the overall PI (Dr. Hanson) and the research staff Clinical Research Coordinators (CRC) collecting data in 30- and 60-day interviews (data source for primary outcome and most secondary outcomes) are masked to study assignment until planned study arm reveal during final analyses. CRCs will conduct 60-day electronic health record (EHR) reviews only after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.

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.

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.

Number of emergency room visits + hospital admissions within 60 days after discharge from index hospitalization

Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment

Symptom Management at the End of Life in Dementia (SM-EOLD) - scored 0-45 with higher scores indicating better symptom control

Neuropsychiatric Inventory Questionnaire (NPI-Q) - range in two subscales of 0-36 and 0-60, with higher scores indicating worse symptom control

% of caregivers reporting shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment

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.

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. In addition, every attempt will be made to publish results in peer-reviewed journals. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Data may be requested to achieve aims in an approved proposal by contacting the Palliative Care Research Collaborative Group Data Repository.