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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG057463-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Hebrew SeniorLife | OTHER |
| Regenstrief Institute, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APPROACHES ACP Specialist Program | Experimental | Enrolled facilities that will be trained in the APPROACHES Advance Care Planning (ACP) Specialist Program. |
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| Control | Active Comparator | Enrolled facilities that will perform standard of care Advance Care Planning (ACP) procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APPROACHES ACP Specialist Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospice Enrollment | % ADRD patients who use hospice | 12 months |
| Death in Hospital | % ADRD decedents who died in the hospital | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Hickman, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miller's Merry Manor | Warsaw | Indiana | 46580 | United States | ||
| Signature HealthCARE LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35815777 | Derived | Hickman SE, Mitchell SL, Hanson LC, Tu W, Stump TE, Unroe KT. The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia. Clin Trials. 2022 Dec;19(6):623-635. doi: 10.1177/17407745221108992. Epub 2022 Jul 10. |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2025 |
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Behavioral: ACP Specialist Program
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Cluster Randomized Pragmatic Trial: Randomization will occur at the facility level. In order to implement the intervention in the treatment arms facilities, study staff will be required to know the identity of participating facilities. Since this trial involves training staff at intervention facilities, the masking will be 'open label'.
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| Standard of care | Other | Standard of care Advance Care Planning (ACP) procedures |
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| Louisville |
| Kentucky |
| 40299 |
| United States |
| FG001 | 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 |
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| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 | Only the residents who were identified by our definition as being diagnosed with ADRD are included in our outcomes analyses. | Posted | Mean | Standard Deviation | number of hospital transfers | 12 months |
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| Secondary | Hospice Enrollment | % ADRD patients who use hospice | Only the residents who were identified by our definition as being diagnosed with ADRD are included in our outcomes analyses. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Death in Hospital | % ADRD decedents who died in the hospital | 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. | Posted | Count of Participants | Participants | 12 months |
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One year
We do not believe that death should be considered an SAE for this trial as: 1) death is often not unexpected in this nursing home population with ADRD; 2) death is not an adverse outcome for patients and families with goals of comfort or palliation if those goals are met; and 3) it is not known whether or not aggressive care provided at the hospital results in lower mortality compared with conservative care in the nursing home
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2,005 | 7,474 | 0 | 7,474 | 0 | 7,474 |
| EG001 | 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 | 1,980 | 7,358 | 0 | 7,358 | 0 | 7,358 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Hickman | Indiana University School of Nursing | 317-274-0032 | hickman@iu.edu |
| Jul 28, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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