An interventional study of APPROACHES ACP Specialist Program and Standard of care in Alzheimer Disease and Dementia, sponsored by Indiana University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Indiana University · Not applicable, Interventional, and Supportive care
Nursing home (NH) patients with Alzheimer's disease and related dementias often receive unwanted, burdensome treatments such as hospitalization. Advance care planning (ACP) is a key strategy to support patients and family-caregivers in making informed decisions and ensuring treatment preferences are proactively known and honored. The ACP Specialist Program will improve care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation delivered by existing NH staff.
A significant number of patients with Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Unfortunately, many of these patients experience unwanted and burdensome medical treatments, such as potentially avoidable hospitalizations, that negatively impact quality of life. Advance care planning (ACP) discussions with patients and family caregivers are important to explore goals in advance of a crisis and support informed, values-based decision-making. The ACP process helps ensure that preferences about treatments such as hospitalization are known, documented, and honored. Research indicates that ACP can reduce burdensome treatments and increase the likelihood that care will match documented preferences. Nursing homes are currently required by regulations to offer ACP to patients and families. However, there are no training requirements for nursing home staff and approaches to fulfilling this regulatory and ethical responsibility vary widely, resulting in inconsistent ACP. The "Aligning Patient Preferences - a Role Offering Alzheimer's patients, Caregivers, and Healthcare providers Education and Support (APPROACHES)" trial will test the APPROACHES ACP Specialist Program. Existing nursing home staff members will be trained to enhance care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation. The primary trial outcome is annual hospital transfers (admissions and emergency department visits). Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical or billing purposes. In the 18 month R21 pilot phase, the aims are to: 1) Establish the trial's organizational structure and processes; and 2) Pilot test the intervention in 4 nursing homes. In the R33 phase, a pragmatic cluster randomized clinical trial will be conducted in partnership with 2 nursing home corporations who operate a combined total of 142 diverse urban and rural facilities in 8 states. The aims of the 42 month R33 phase are to: 3) Evaluate the primary outcome of hospital transfers over 12 months among patients with dementia in intervention versus control nursing homes; and 4) Compare measures of quality of care at the end of life between the intervention versus control nursing homes. If successful, the APPROACHES ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve quality of care for patients with dementia. Actual enrollment and outcomes will not be available until Centers for Medicare \& Medicaid Services (CMS) claims and Minimum Data Set (MDS) data become available. Actual trial enrollment numbers will be updated at that time.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 47,396 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program.
Behavioral: APPROACHES ACP Specialist Program
Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures.
Other: Standard of care
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.
Standard of care Advance Care Planning (ACP) procedures
Hospital Transfers
Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs
Time frame: 12 months
Hospice Enrollment
% ADRD patients who use hospice
Time frame: 12 months
Death in Hospital
% ADRD decedents who died in the hospital
Time frame: 12 months
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.
| Milestone | APPROACHES ACP Specialist Program | Control |
|---|---|---|
| Started | 24148 | 23248 |
| Completed | 7474 | 7358 |
| Not completed | 16674 | 15890 |
| Withdrew: Resident could not be linked to cms data | 594 | 435 |
| Withdrew: Resident cognitive status could not be determined from cms data | 6551 | 6426 |
| Withdrew: Resident was enrolled in hospice care at study start (exclusion criteria) | 247 | 260 |
| Withdrew: Resident did not reside in facility for at least one day of study period (exclusion criteria) | 896 | 573 |
| Withdrew: Resident did not have adrd as defined by study (exclusion criteria) | 8386 | 8196 |
Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs
| number of hospital transfers | APPROACHES ACP Specialist Program | Control |
|---|---|---|
| Hospital Transfers | 1.2 ± 2.3 | 1.3 ± 2.4 |
% ADRD patients who use hospice
| Participants | APPROACHES ACP Specialist Program | Control |
|---|---|---|
| Hospice Enrollment | 1095 | 1181 |
% ADRD decedents who died in the hospital
| Participants | APPROACHES ACP Specialist Program | Control |
|---|---|---|
| Death in Hospital | 163 | 146 |
Collected over One year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| APPROACHES ACP Specialist Program | 2,005/7,474 (26.8%) | 0/7,474 (0%) | 0/7,474 (0%) |
| Control | 1,980/7,358 (26.9%) | 0/7,358 (0%) | 0/7,358 (0%) |
There were 31414 residents residing in participating nursing homes (NH), 15860 in APPROACHES ACP Specialist Program and 15554 in Control. The subpopulation of interest for analysis is residents identified to have Alzheimer's disease, dementia or a Cognitive Function Scale (CFS) score of \>=2, therefore the population reported is 7474 residents in APPROACHES ACP Specialist Program and 7358 in Control for a total of 14832.
| Age, Categorical(Participants) | APPROACHES ACP Specialist Program | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 759 | 681 | 1440 |
| >=65 years | 6715 | 6677 | 13392 |
| Age, Continuous(years) | APPROACHES ACP Specialist Program | Control | Total |
|---|---|---|---|
| Mean | 78.7 ± 11 | 79.3 ± 10.8 | 79.0 ± 10.9 |
| Sex: Female, Male(Participants) | APPROACHES ACP Specialist Program | Control | Total |
|---|---|---|---|
| Female | 4688 | 4683 | 9371 |
| Male | 2786 | 2675 | 5461 |
| Ethnicity (NIH/OMB)(Participants) | APPROACHES ACP Specialist Program | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 318 | 167 | 485 |
| Not Hispanic or Latino | 7156 | 7191 | 14347 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | APPROACHES ACP Specialist Program | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 3 | 5 |
| Asian | 6 | 12 | 18 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 933 | 824 | 1757 |
| White | 5650 | 5751 | 11401 |
| More than one race | 13 | 21 | 34 |
| Unknown or Not Reported | 868 | 747 | 1615 |
| Region of Enrollment(participants) | APPROACHES ACP Specialist Program | Control | Total |
|---|---|---|---|
| United States | 7474 | 7358 | 14832 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2020 to primary completion in Aug 2022, 30 months.
Results were first posted in Aug 2025, 2 years 11 months after primary completion. A results delay was requested in Dec 2022.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 30 months is close to that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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