Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3K23NR017663-02S1 | U.S. NIH Grant/Contract | View source | |
| 1K23NR017663-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
Alzheimer's disease and related dementias (ADRD) are serious, life limiting illnesses with no known cure. Dementia is the fifth-leading cause of death in older adults and the majority of people with advanced dementia die in nursing homes (NHs). Miller et al reported that 40% of U.S. NH residents dying with advanced dementia received Skilled Nursing Facility (SNF) care in the last 90 days of life, and receipt of this care was associated significantly with poorer end-of-life outcomes, including a higher risk of dying in a hospital, compared to decedents with no SNF care. SNF care is a Medicare post-acute rehabilitation service delivered in NHs focused on intense rehabilitation and/or aggressive, disease-modifying therapies. Regardless of life expectancy, use of SNF care precludes access to Hospice services. Palliative care (PC) offers an evidence-based alternative.
In this pragmatic clinical trial, broadcast notification will be utilized to inform all newly admitted patients at each study site of their participation in this trial. During the admission process, potential subjects will be provided with a 1-page summary sheet (Broadcast notification) detailing their participation in this study that will include contact information for the study team, should the subject or their LAR/surrogate decision maker elect to opt-out of participating.
Baseline data will be collected virtually via telephone by asking each subject or if unable to respond their surrogate decision maker to complete the Patient Outcomes Scale (POSv2), the Satisfaction With Care at the End of Life in Dementia (SWC-EOLD), and the Symptom Management at the End of Life in Dementia (SM-EOLD).
Between 14 days and 21 days after the baseline POSv2, SW-EOLD, and the SM-EOLD are administered, all subjects or if unable to respond their surrogate decision maker will be asked to complete the POSv2, SW-EOLD, and the SM-EOLD again virtually via telephone. The POSv2, SW-EOLD, and the SM-EOLD will be given a total of two times to those in the INTERVENTION and CONTROL groups; at baseline and follow up (14-21 days later).
Deidentified subject demographics will be collected on all participants in the following way: Study team members will review subject's medical records and enter de-identified data into a Research Electronic Data Capture (REDCap) database (Acts staff assists with the study team's access to subject's medical record).
Palliative Care Encounter Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | Participants will receive the standard Medicare Skilled Nursing Facility care. | |
| Palliative Care Consult | Experimental | Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care Consultation | Other | Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Completed Patient Quality of Life Survey | 12-item survey that measures quality of life in five dimensions: 1) physical; 2) emotional; 3) psychological; 4) spiritual needs, and 5) provision of information and support. Items scored on a 5 point Likert Scale (0=not at all, 4= overwhelmingly) based on symptom/need in the past week. Overall profile score is calculated by summing responses (range 0-40). Source: patient or family caregiver; Time to complete: 5-7 minutes | Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Completed Satisfaction With Care Survey (SWC-EOLD) | 10-item scale that measures caregiver satisfaction with care for persons with dementia. Each item is measured on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Specific elements include satisfaction with medical and nursing care, decision-making, and their understanding of the persons with dementia illness. All items are summed, yielding a range of scores of 10-40. Higher scores indicate greater satisfaction. |
Not provided
KEY INCLUSION CRITERIA
Patients:
Surrogate/LAR:
KEY EXCLUSION CRITERIA
Patients:
Surrogate/LAR:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acts Continuing Care Retirement Communities | Philadelphia | Pennsylvania | 19014 | United States |
Participants enrolled are patients only, not caregivers.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Participants received the standard Medicare Skilled Nursing Facility care. |
| FG001 | Palliative Care Consult | Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics were not collected for caregiver participants because they were not enrolled into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Participants (patients) received the standard Medicare Skilled Nursing Facility care. |
| BG001 | Palliative Care Consult | Participants (patients) received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Completed Patient Quality of Life Survey | 12-item survey that measures quality of life in five dimensions: 1) physical; 2) emotional; 3) psychological; 4) spiritual needs, and 5) provision of information and support. Items scored on a 5 point Likert Scale (0=not at all, 4= overwhelmingly) based on symptom/need in the past week. Overall profile score is calculated by summing responses (range 0-40). Source: patient or family caregiver; Time to complete: 5-7 minutes | Posted | Count of Participants | Participants | Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up) |
|
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Participants will receive the standard Medicare Skilled Nursing Facility care. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joan Carpenter | University of Maryland School of Nursing | 443-880-1430 | joan.carpenter@umaryland.edu |
Not provided
| 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 | Mar 30, 2023 | Jul 11, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Pre-post design where control data will be collected prior to intervention being implemented
Not provided
Not provided
Not provided
Not provided
|
| Collected upon admission to the nursing home and again 21 days post-admission to the nursing home |
| Number of Participants That Completed the Symptom Management Survey (SM-EOLD) | 9-item scale administered to a caregiver that measures persons with dementia physical and psychological symptoms. Each item is rated on a 6-point Likert scale ranging from 0 to 5 (0 = "daily", 1 = "several days a week", 2 = "once per week", 3 = "2 or 3 days a month", 4 = "once a month", 5 = "never"). Scores are summed and range from 0 to 45. Higher scores indicate better symptom management. | Collected upon admission to the nursing home and again 21 days post-admission to the nursing home |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering |
|
|
| Secondary | Number of Participants That Completed Satisfaction With Care Survey (SWC-EOLD) | 10-item scale that measures caregiver satisfaction with care for persons with dementia. Each item is measured on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Specific elements include satisfaction with medical and nursing care, decision-making, and their understanding of the persons with dementia illness. All items are summed, yielding a range of scores of 10-40. Higher scores indicate greater satisfaction. | Posted | Count of Participants | Participants | Collected upon admission to the nursing home and again 21 days post-admission to the nursing home |
|
|
|
| Secondary | Number of Participants That Completed the Symptom Management Survey (SM-EOLD) | 9-item scale administered to a caregiver that measures persons with dementia physical and psychological symptoms. Each item is rated on a 6-point Likert scale ranging from 0 to 5 (0 = "daily", 1 = "several days a week", 2 = "once per week", 3 = "2 or 3 days a month", 4 = "once a month", 5 = "never"). Scores are summed and range from 0 to 45. Higher scores indicate better symptom management. | Posted | Count of Participants | Participants | Collected upon admission to the nursing home and again 21 days post-admission to the nursing home |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Palliative Care Consult | Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided