Alzheimer Disease, Dementia
Conditions
Keywords
Nursing Homes, Skilled Nursing Facilities, Advance Care Planning, Advance Directives, Alzheimer Disease, Dementia, Do Not Resuscitate Orders, Physician Orders for Life-Sustaining Treatment, Artificial Nutrition, Hospitalization, Intubation, Pragmatic Clinical Trials, Randomized Controlled Trials, Patient Preferences, Resuscitation Orders
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAPPROACHES 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.
OTHERStandard of care
Standard of care Advance Care Planning (ACP) procedures
Sponsors
National Institute on Aging (NIA)
Hebrew SeniorLife
Regenstrief Institute, Inc.
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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'.
Intervention model description
Behavioral: ACP Specialist Program
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Facilities are owned by NH corporate partners * Facilities are Medicare/Medicaid-certified * Facilities have an electronic medical records system * Minimum bedsize of 50 or more; * At least 50% long-stay as defined by a length of stay of 100 days or longer.
Exclusion criteria
* Problematic or unstable facilities will be removed in consultation with NH corporate leaders prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Transfers | 12 months | Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospice Enrollment | 12 months | % ADRD patients who use hospice |
| Death in Hospital | 12 months | % ADRD decedents who died in the hospital |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7,474 |
| 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 | 7,358 |
| Total | 14,832 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Resident cognitive status could not be determined from CMS data | 6,551 | 6,426 |
| Overall Study | Resident could not be linked to CMS data | 594 | 435 |
| Overall Study | Resident did not have ADRD as defined by study (exclusion criteria) | 8,386 | 8,196 |
| Overall Study | Resident did not reside in facility for at least one day of study period (exclusion criteria) | 896 | 573 |
| Overall Study | Resident was enrolled in hospice care at study start (exclusion criteria) | 247 | 260 |
Baseline characteristics
| Characteristic | Total | APPROACHES ACP Specialist Program | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13392 Participants | 6715 Participants | 6677 Participants |
| Age, Categorical Between 18 and 65 years | 1440 Participants | 759 Participants | 681 Participants |
| Age, Continuous | 79.0 years STANDARD_DEVIATION 10.9 | 78.7 years STANDARD_DEVIATION 11 | 79.3 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 485 Participants | 318 Participants | 167 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14347 Participants | 7156 Participants | 7191 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 1757 Participants | 933 Participants | 824 Participants |
| Race (NIH/OMB) More than one race | 34 Participants | 13 Participants | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1615 Participants | 868 Participants | 747 Participants |
| Race (NIH/OMB) White | 11401 Participants | 5650 Participants | 5751 Participants |
| Region of Enrollment United States | 14832 participants | 7474 participants | 7358 participants |
| Sex: Female, Male Female | 9371 Participants | 4688 Participants | 4683 Participants |
| Sex: Female, Male Male | 5461 Participants | 2786 Participants | 2675 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2,005 / 7,474 | 1,980 / 7,358 |
| other Total, other adverse events | 0 / 7,474 | 0 / 7,358 |
| serious Total, serious adverse events | 0 / 7,474 | 0 / 7,358 |
Outcome results
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
Time frame: 12 months
Population: Only the residents who were identified by our definition as being diagnosed with ADRD are included in our outcomes analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APPROACHES ACP Specialist Program | Hospital Transfers | 1.2 number of hospital transfers | Standard Deviation 2.3 |
| Control | Hospital Transfers | 1.3 number of hospital transfers | Standard Deviation 2.4 |
p-value: 0.331395% CI: [0.84, 1.06]Poisson Regression
Secondary
Death in Hospital
% ADRD decedents who died in the hospital
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APPROACHES ACP Specialist Program | Death in Hospital | 163 Participants |
| Control | Death in Hospital | 146 Participants |
p-value: 0.394695% CI: [0.85, 1.49]Regression, Logistic
Secondary
Hospice Enrollment
% ADRD patients who use hospice
Time frame: 12 months
Population: Only the residents who were identified by our definition as being diagnosed with ADRD are included in our outcomes analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APPROACHES ACP Specialist Program | Hospice Enrollment | 1095 Participants |
| Control | Hospice Enrollment | 1181 Participants |
p-value: 0.332795% CI: [0.78, 1.09]Regression, Logistic