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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04948866
Collaborator
National Institute on Aging (NIA) (NIH)
424
4
2
37.2
106
2.9

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
  • Behavioral: ADRD-PC Program
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

Study Type:
Interventional
Anticipated Enrollment :
424 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

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

  1. 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

  1. 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

  2. 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

  3. 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

  4. Access to hospice [60 days post hospital discharge]

    % of people with ADRD who access hospice services

  5. Access to community-based palliative care [60 days post hospital discharge]

    % of people with ADRD who access community-based palliative care services

  6. Transition to nursing home level of care [60 days post hospital discharge]

    % of people with ADRD who transition to nursing home care

  7. Documented discussion of dementia prognosis [60 days post hospital discharge]

    % of caregivers with documented discussion of dementia prognosis during the index hospitalization

  8. 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

  9. Shared decision-making - hospitalization [60 days post hospital discharge]

    % of caregivers reporting shared decision-making about future hospitalization

  10. 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

  11. Caregiver distress [60 days post hospital discharge]

    Family Distress in Advanced Dementia scale - range 1-5 with higher scores indicating more distress

  12. Caregiver burden [60 days post hospital discharge]

    Zarit Burden scale, short form - range 0-24, higher scores more burden

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT04948866
Other Study ID Numbers:
  • 20-2764
  • R01AG065394
First Posted:
Jul 2, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022