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Behavioral Intervention

Palliative Care Program for Alzheimer's Disease (ADRD-PC Trial)

N/A

Waitlist Available

Led By Laura C Hanson, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

People with ADRD aged 55 or older and hospitalized with a physician-confirmed diagnosis of ADRD and staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher

Be older than 18 years old

Must not have

Dyads will be excluded if the patient currently receives palliative care or hospice

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days post hospital discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a program of dementia-specific palliative care, standardized caregiver education, and transitional care can reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and improve caregiver outcomes of communication, shared decision-making and distress.

Who is the study for?

This trial is for persons aged 55 or older with late-stage Alzheimer's/dementia (GDS stages 5-7) and their family caregivers who can make healthcare decisions. Caregivers must be adults, legally authorized to represent the patient, support them, and complete interviews in English or Spanish. Those already receiving palliative care or hospice are excluded.

What is being tested?

The ADRD Palliative Care (ADRD-PC) program is being tested to see if it reduces hospital transfers, improves symptom management, augments supportive services for patients with dementia, and helps caregivers with communication and decision-making.

What are the potential side effects?

Since this trial focuses on a care program rather than medication, traditional side effects are not applicable. However, there may be emotional impacts due to changes in caregiving routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 55 or older with advanced dementia and have been hospitalized.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently in palliative care or hospice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days post hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days post hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days post hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Transfers

Secondary study objectives

Access to community-based palliative care

Access to hospice

Caregiver burden

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Condition: ADRD-PC ProgramExperimental Treatment1 Intervention

1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams. 2. 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. 3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.

Group II: Control ConditionActive Control1 Intervention

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.

0 / 2Eligibility criteria met