Trial Outcomes & Findings for Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers (NCT NCT04948866)
NCT ID: NCT04948866
Last Updated: 2025-12-16
Results Overview
Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
884 participants
Primary outcome timeframe
60 days post index hospital discharge
Results posted on
2025-12-16
Participant Flow
Participant milestones
| Measure |
Intervention Condition: ADRD-PC Program
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Overall Study
STARTED
|
442
|
442
|
|
Overall Study
Patients Started
|
221
|
221
|
|
Overall Study
Caregivers Started
|
221
|
221
|
|
Overall Study
COMPLETED
|
372
|
376
|
|
Overall Study
NOT COMPLETED
|
70
|
66
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data are reported separately for Patients and Caregivers.
Baseline characteristics by cohort
| Measure |
Intervention Condition: ADRD-PC Program
n=442 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=442 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
Total
n=884 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Patients
|
82.8 years
STANDARD_DEVIATION 8.03 • n=221 Participants • Data are reported separately for Patients and Caregivers.
|
82.5 years
STANDARD_DEVIATION 7.78 • n=221 Participants • Data are reported separately for Patients and Caregivers.
|
82.6 years
STANDARD_DEVIATION 7.89 • n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Age, Continuous
Caregivers
|
58.2 years
STANDARD_DEVIATION 12.9 • n=221 Participants • Data are reported separately for Patients and Caregivers.
|
59.5 years
STANDARD_DEVIATION 12.2 • n=221 Participants • Data are reported separately for Patients and Caregivers.
|
58.9 years
STANDARD_DEVIATION 12.5 • n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Sex: Female, Male
Patients · Female
|
135 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
137 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
272 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Sex: Female, Male
Patients · Male
|
86 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
84 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
170 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Sex: Female, Male
Caregivers · Female
|
152 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
154 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
306 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Sex: Female, Male
Caregivers · Male
|
69 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
67 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
136 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Ethnicity (NIH/OMB)
Patients · Hispanic or Latino
|
13 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
21 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
34 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Ethnicity (NIH/OMB)
Patients · Not Hispanic or Latino
|
208 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
200 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
408 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Ethnicity (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
16 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
18 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
34 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
205 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
203 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
408 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Patients · American Indian or Alaska Native
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Patients · Asian
|
6 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
2 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
8 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Patients · Black or African American
|
57 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
55 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
112 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Patients · White
|
148 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
146 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
294 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Patients · More than one race
|
1 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
4 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
5 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Patients · Unknown or Not Reported
|
9 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
14 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
23 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
1 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
1 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Caregivers · Asian
|
3 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
3 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
6 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
0 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
53 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
57 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
110 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Caregivers · White
|
149 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
144 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
293 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
2 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
3 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
5 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
13 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
14 Participants
n=221 Participants • Data are reported separately for Patients and Caregivers.
|
27 Participants
n=442 Participants • Data are reported separately for Patients and Caregivers.
|
|
Region of Enrollment
United States · Patients
|
221 Participants
n=442 Participants
|
221 Participants
n=442 Participants
|
442 Participants
n=884 Participants
|
|
Region of Enrollment
United States · Caregivers
|
221 Participants
n=442 Participants
|
221 Participants
n=442 Participants
|
442 Participants
n=884 Participants
|
PRIMARY outcome
Timeframe: 60 days post index hospital dischargeNumber of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Incidence of Hospital Transfers (Patients)
|
0.99 events per person day at risk
|
1.12 events per person day at risk
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePalliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Symptom Treatment (Patients)
|
8.06 score on a scale
Standard Deviation 2.14
|
6.49 score on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePopulation: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
Symptom Management at the End of Life in Dementia (SM-EOLD) - Likert scale, 9 items each scored 0-5, range of 0-45 with higher scores indicating greater symptoms.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=194 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=197 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Symptom Control for Physical Symptoms (Patients)
|
21.0 score on a scale
Standard Deviation 9.08
|
21.8 score on a scale
Standard Deviation 9.25
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePopulation: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity Score - 12 items, each symptom reported as present is rated from 1 (mild) to 3 (severe). The range in this subscale is 0-36 with higher scores indicating worse symptom control.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=192 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=199 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)
|
21.6 score on a scale
Standard Deviation 5.83
|
21.8 score on a scale
Standard Deviation 5.87
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePopulation: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress - 12 items, if the symptom was reported as present the caregiver rated the level of distress they experienced related tot he patient's symptom from 0 (not distressing) to 5 (extremely distressing). This subscale ranges from 0-60, with higher scores indicating more caregiver distress.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=192 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=199 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)
|
24.9 score on a scale
Standard Deviation 13.7
|
27.7 score on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePercent of people with ADRD who access hospice services.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Access to Hospice (Patients)
|
17.2 percentage of participants
|
17.6 percentage of participants
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePercent of people with ADRD who access community-based palliative care services
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Access to Community-based Palliative Care (Patients)
|
12.7 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePercent of people with ADRD who transition to nursing home care
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Transition to Nursing Home Level of Care (Patients)
|
35.7 percentage of participants
|
36.7 percentage of participants
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePercent of patients with documented discussion of dementia prognosis in their medical record.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Documented Discussion of Dementia Prognosis (Patients)
|
80.1 percentage of participants
|
14.9 percentage of participants
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePercent of patients with documented discussion of overall goals of care.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Documented Discussion of Goals of Care (Patients)
|
86.9 percentage of participants
|
44.8 percentage of participants
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePercent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Shared Decision-making - Hospitalization (Patients)
|
21.7 percentage of participants
|
25.8 percentage of participants
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePercent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=221 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=221 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Shared Decision-making - Burdensome Treatment (Patients)
|
38.5 percentage of participants
|
42.1 percentage of participants
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePopulation: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
Family Distress in Advanced Dementia scale - 21 item Likert scale (1=Never to 5=Always) ranges from 21 to 105 with higher scores indicating more distress.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=198 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=200 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Caregiver Distress Score (Caregivers)
|
48.5 score on a scale
Standard Deviation 14.0
|
52.3 score on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 60 days post hospital dischargePopulation: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden.
Outcome measures
| Measure |
Intervention Condition: ADRD-PC Program
n=198 Participants
Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition
n=199 Participants
Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|
|
Caregiver Burden (Caregiver)
|
7.52 score on a scale
Standard Deviation 5.44
|
7.44 score on a scale
Standard Deviation 5.19
|
Adverse Events
Intervention Condition: ADRD-PC Program (Patients)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 41 deaths
Intervention Condition: ADRD-PC Program (Caregivers)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Control Condition (Patients)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 40 deaths
Control Condition (Caregivers)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Condition: ADRD-PC Program (Patients)
n=221 participants at risk
Patients randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Intervention Condition: ADRD-PC Program (Caregivers)
n=221 participants at risk
Caregivers randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
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.
|
Control Condition (Patients)
n=221 participants at risk
Patients randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
Control Condition (Caregivers)
n=221 participants at risk
Caregivers randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.
|
|---|---|---|---|---|
|
Psychiatric disorders
Emotional Distress
|
0.00%
0/221 • Adverse events were collected from when participants entered the study to 60 days post hospital discharge.
Due to the severity of illness present in the study population, adverse events including mortality and caregiver emotional distress were expected but adjudicated as unrelated to study participation.
|
10.9%
24/221 • Number of events 32 • Adverse events were collected from when participants entered the study to 60 days post hospital discharge.
Due to the severity of illness present in the study population, adverse events including mortality and caregiver emotional distress were expected but adjudicated as unrelated to study participation.
|
0.00%
0/221 • Adverse events were collected from when participants entered the study to 60 days post hospital discharge.
Due to the severity of illness present in the study population, adverse events including mortality and caregiver emotional distress were expected but adjudicated as unrelated to study participation.
|
18.1%
40/221 • Number of events 52 • Adverse events were collected from when participants entered the study to 60 days post hospital discharge.
Due to the severity of illness present in the study population, adverse events including mortality and caregiver emotional distress were expected but adjudicated as unrelated to study participation.
|
Additional Information
Kathryn Wessell, MPH
University of North Carolina at Chapel Hill
Phone: 919-966-2939
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place