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

Primary Purpose

Dementia, Dementia, Vascular, Dementia With Lewy Bodies

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADRD-PC Program
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Denver
  • Emory University
  • Indiana University
  • Massachusetts General Hospital
  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Condition: ADRD-PC Program

Control Condition

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Symptom treatment
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
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
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
% of people with ADRD who access hospice services
Access to community-based palliative care
% of people with ADRD who access community-based palliative care services
Transition to nursing home level of care
% of people with ADRD who transition to nursing home care
Documented discussion of dementia prognosis
% of caregivers with documented discussion of dementia prognosis during the index hospitalization
Documented discussion of goals of care
% of caregivers with documented discussion of overall goals of care during the index hospitalization
Shared decision-making - hospitalization
% of caregivers reporting shared decision-making about future hospitalization
Shared decision-making - burdensome treatment
% of caregivers reporting shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment
Caregiver distress
Family Distress in Advanced Dementia scale - range 1-5 with higher scores indicating more distress
Caregiver burden
Zarit Burden scale, short form - range 0-24, higher scores more burden

Full Information

First Posted
June 23, 2021
Last Updated
April 18, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04948866
Brief Title
Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Acronym
ADRD-PC
Official Title
Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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, 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia Frontal, Dementia, Mixed, Dementia Alzheimers, Alzheimer Disease, Dementia Severe

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
474 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition: ADRD-PC Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ADRD-PC Program
Intervention Description
Included in arm/group descriptions
Primary Outcome Measure Information:
Title
Hospital Transfers
Description
Number of emergency room visits + hospital admissions within 60 days after discharge from index hospitalization
Time Frame
60 days post hospital discharge
Secondary Outcome Measure Information:
Title
Symptom treatment
Description
Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment
Time Frame
60 days post hospital discharge
Title
Symptom control for physical symptoms
Description
Symptom Management at the End of Life in Dementia (SM-EOLD) - scored 0-45 with higher scores indicating better symptom control
Time Frame
60 days post hospital discharge
Title
Symptom control for neuropsychiatric symptoms
Description
Neuropsychiatric Inventory Questionnaire (NPI-Q) - range in two subscales of 0-36 and 0-60, with higher scores indicating worse symptom control
Time Frame
60 days post hospital discharge
Title
Access to hospice
Description
% of people with ADRD who access hospice services
Time Frame
60 days post hospital discharge
Title
Access to community-based palliative care
Description
% of people with ADRD who access community-based palliative care services
Time Frame
60 days post hospital discharge
Title
Transition to nursing home level of care
Description
% of people with ADRD who transition to nursing home care
Time Frame
60 days post hospital discharge
Title
Documented discussion of dementia prognosis
Description
% of caregivers with documented discussion of dementia prognosis during the index hospitalization
Time Frame
60 days post hospital discharge
Title
Documented discussion of goals of care
Description
% of caregivers with documented discussion of overall goals of care during the index hospitalization
Time Frame
60 days post hospital discharge
Title
Shared decision-making - hospitalization
Description
% of caregivers reporting shared decision-making about future hospitalization
Time Frame
60 days post hospital discharge
Title
Shared decision-making - burdensome treatment
Description
% of caregivers reporting shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment
Time Frame
60 days post hospital discharge
Title
Caregiver distress
Description
Family Distress in Advanced Dementia scale - range 1-5 with higher scores indicating more distress
Time Frame
60 days post hospital discharge
Title
Caregiver burden
Description
Zarit Burden scale, short form - range 0-24, higher scores more burden
Time Frame
60 days post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura C Hanson, MD, MPH
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
from 9 months after publication and indefinitely
IPD Sharing Access Criteria
Data may be requested to achieve aims in an approved proposal by contacting the Palliative Care Research Collaborative Group Data Repository.

Learn more about this trial

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

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