Trial Outcomes & Findings for Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support (NCT NCT03323502)
NCT ID: NCT03323502
Last Updated: 2025-12-11
Results Overview
Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs
COMPLETED
NA
47396 participants
12 months
2025-12-11
Participant Flow
145 nursing homes (NH) in 10 states were screened for eligibility. 142 nursing home (NH) facilities in 8 states met inclusion criteria and were randomized to two arms of the study. Corporate ownership divested from 14 facilities prior to study implementation and were thus excluded from study participation. 128 NHs participated in study implementation and were analyzed.
The analysis sample is residents who were identified to have Alzheimer's disease or related dementia (ADRD) or a Cognitive Function Scale (CFS) score \>=2 and this sample had to be identified after the intervention period through cleaning the resident data received from Centers for Medicare and Medicaid Services (CMS). This is why we had available information for all residents (47396) but only analyzed the sample of ADRD residents (14832). Participant Flow is used to show steps of exclusion.
Unit of analysis: Nursing Home Facilities
Participant milestones
| Measure |
APPROACHES ACP Specialist Program
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
APPROACHES ACP Specialist Program: The APPROACHES Advance Care Planning (ACP) Specialist will work with nursing home leaders (in intervention arm facilities) to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP Specialist Program with patients who have Alzheimer's disease/related dementias and their family caregivers.
|
Control
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Standard of care: Standard of care Advance Care Planning (ACP) procedures
|
|---|---|---|
|
Overall Study
STARTED
|
24148 64
|
23248 64
|
|
Overall Study
COMPLETED
|
7474 64
|
7358 64
|
|
Overall Study
NOT COMPLETED
|
16674 0
|
15890 0
|
Reasons for withdrawal
| Measure |
APPROACHES ACP Specialist Program
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
APPROACHES ACP Specialist Program: The APPROACHES Advance Care Planning (ACP) Specialist will work with nursing home leaders (in intervention arm facilities) to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP Specialist Program with patients who have Alzheimer's disease/related dementias and their family caregivers.
|
Control
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Standard of care: Standard of care Advance Care Planning (ACP) procedures
|
|---|---|---|
|
Overall Study
Resident could not be linked to CMS data
|
594
|
435
|
|
Overall Study
Resident cognitive status could not be determined from CMS data
|
6551
|
6426
|
|
Overall Study
Resident was enrolled in hospice care at study start (exclusion criteria)
|
247
|
260
|
|
Overall Study
Resident did not reside in facility for at least one day of study period (exclusion criteria)
|
896
|
573
|
|
Overall Study
Resident did not have ADRD as defined by study (exclusion criteria)
|
8386
|
8196
|
Baseline Characteristics
Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support
Baseline characteristics by cohort
| Measure |
APPROACHES ACP Specialist Program
n=7474 Participants
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
APPROACHES ACP Specialist Program: The APPROACHES Advance Care Planning (ACP) Specialist will work with nursing home leaders (in intervention arm facilities) to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP Specialist Program with patients who have Alzheimer's disease/related dementias and their family caregivers.
|
Control
n=7358 Participants
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Standard of care: Standard of care Advance Care Planning (ACP) procedures
|
Total
n=14832 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
759 Participants
n=9 Participants
|
681 Participants
n=6 Participants
|
1440 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
6715 Participants
n=9 Participants
|
6677 Participants
n=6 Participants
|
13392 Participants
n=9 Participants
|
|
Age, Continuous
|
78.7 years
STANDARD_DEVIATION 11 • n=9 Participants
|
79.3 years
STANDARD_DEVIATION 10.8 • n=6 Participants
|
79.0 years
STANDARD_DEVIATION 10.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
4688 Participants
n=9 Participants
|
4683 Participants
n=6 Participants
|
9371 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2786 Participants
n=9 Participants
|
2675 Participants
n=6 Participants
|
5461 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
318 Participants
n=9 Participants
|
167 Participants
n=6 Participants
|
485 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7156 Participants
n=9 Participants
|
7191 Participants
n=6 Participants
|
14347 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
933 Participants
n=9 Participants
|
824 Participants
n=6 Participants
|
1757 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5650 Participants
n=9 Participants
|
5751 Participants
n=6 Participants
|
11401 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
34 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
868 Participants
n=9 Participants
|
747 Participants
n=6 Participants
|
1615 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
7474 participants
n=9 Participants
|
7358 participants
n=6 Participants
|
14832 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Only the residents who were identified by our definition as being diagnosed with ADRD are included in our outcomes analyses.
Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs
Outcome measures
| Measure |
APPROACHES ACP Specialist Program
n=7474 Participants
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
APPROACHES ACP Specialist Program: The APPROACHES Advance Care Planning (ACP) Specialist will work with nursing home leaders (in intervention arm facilities) to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP Specialist Program with patients who have Alzheimer's disease/related dementias and their family caregivers.
|
Control
n=7358 Participants
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Standard of care: Standard of care Advance Care Planning (ACP) procedures
|
|---|---|---|
|
Hospital Transfers
|
1.2 number of hospital transfers
Standard Deviation 2.3
|
1.3 number of hospital transfers
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only the residents who were identified by our definition as being diagnosed with ADRD are included in our outcomes analyses.
% ADRD patients who use hospice
Outcome measures
| Measure |
APPROACHES ACP Specialist Program
n=7474 Participants
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
APPROACHES ACP Specialist Program: The APPROACHES Advance Care Planning (ACP) Specialist will work with nursing home leaders (in intervention arm facilities) to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP Specialist Program with patients who have Alzheimer's disease/related dementias and their family caregivers.
|
Control
n=7358 Participants
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Standard of care: Standard of care Advance Care Planning (ACP) procedures
|
|---|---|---|
|
Hospice Enrollment
|
1095 Participants
|
1181 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only the residents who were identified by our definition as being diagnosed with ADRD are included in our outcomes analyses. Numbers are reported only for participants whose location of death could be confirmed. Participants analyzed is ADRD deaths.
% ADRD decedents who died in the hospital
Outcome measures
| Measure |
APPROACHES ACP Specialist Program
n=2 Participants
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
APPROACHES ACP Specialist Program: The APPROACHES Advance Care Planning (ACP) Specialist will work with nursing home leaders (in intervention arm facilities) to: i. Consolidate nursing home ACP procedures; ii. Train and educate staff; and iii. Facilitate ACP Specialist Program with patients who have Alzheimer's disease/related dementias and their family caregivers.
|
Control
n=1 Participants
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Standard of care: Standard of care Advance Care Planning (ACP) procedures
|
|---|---|---|
|
Death in Hospital
|
163 Participants
|
146 Participants
|
Adverse Events
APPROACHES ACP Specialist Program
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place