Palliative Care for Persons With ADRD in SNF
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 newly admitted patient or their surrogate 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 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).
The goal of the intervention is to prevent, identify and treat symptoms early during SNF care, establish goal directed treatment decisions, and support the patient and family in decision making. The study team anticipates that many Palliative Care encounters involve a single encounter with the patient and/or LAR/surrogate decision maker, but the study team has made allowances for follow up visits depending on individual patient and family needs (e.g., symptom management, continuing goals of care discussions). Study team members will use usual care as the control condition. Usual care consists of traditional resources focused on skilled nursing care without services to support specialty palliative care. A usual care comparison will test whether the Palliative Care Encounter improves patient/family reported outcomes compared to traditional services. Study team members chosen to not use an attention control condition because the goal of this pilot clinical trial is to assess feasibility and determine the effect size of the intervention on the primary outcome.
Study team members will collect measures via phone or through a secured online template to minimize missing data at two time points (baseline & 14-21 days later) during the study. All data will be entered and managed in REDCap by the RA, project manager, or the PI.
Patient/Caregiver Quality of Life: Baseline, follow-up (14-21 days later) measured by the Palliative Outcomes Scale version 2 (POSv2), a 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. (RESEARCH PROCEDURE)
Satisfaction With Care at the End of Life in Dementia (SWC-EOLD). The SWC-EOLD is a validated, 10-item scale that measures SDMs' satisfaction with care for persons with Alzheimer's Disease (PWAD). Each item is measured on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree") and uses a "prior 90 days" timeframe. Specific elements include satisfaction with medical and nursing care, decision-making, and their understanding of the PWAD's illness. All items are summed, yielding a range of scores of 10-40. Higher scores indicate greater satisfaction. (RESEARCH PROCEDURE)
Symptom Management at the End of Life in Dementia (SM-EOLD). The SM-EOLD is a valid and reliable 9 item scale completed by a nurse that measures PWAD physical and psychological symptoms over the previous 90 days. 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). (RESEARCH PROCEDURE)
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. (STANDARD OF CARE)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard Care Participants will receive the standard Medicare Skilled Nursing Facility care. |
|
| Experimental: Palliative Care Consult Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- Patient/Caregiver Quality of Life [Collected upon admission to the nursing home and again 14-21 days post-admission to the nursing home]
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
Secondary Outcome Measures
- Satisfaction with Care [Collected upon admission to the nursing home and again 14-21 days post-admission to the nursing home]
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.
- Symptom Management [Collected upon admission to the nursing home and again 14-21 days post-admission to the nursing home]
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.
Eligibility Criteria
Criteria
KEY INCLUSION CRITERIA
Patients:
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Admitted for SNF post-acute care at a participating NHs following a recent hospitalization
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Age ≥ 60 years old
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Speaks English (if verbal)
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If non-verbal/unable to participate in a conversation and/or unable to make decisions, a legally authorized representative (LAR)/surrogate decision maker who can make decisions for the patient as determined by ACTs staff
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Documented ADRD diagnosis in the medical record
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At least one global indicator for PC at SNF admission (provider would not be surprised if patient died within 1 year, believes the patient would benefit from advance care planning or symptom management; frequent hospital or NH SNF admissions; complex care requirements; decline in function; feeding intolerance; unintended decline in weight; or previous hospice assessment or enrollment and subsequent discharge)
Surrogate/LAR:
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18 years old
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Family member or friend of an eligible patient as determined by ACTs staff
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Speaks English
KEY EXCLUSION CRITERIA
Patients:
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Who have previously received or are referred for PC by their primary care team
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With a discharge plan within 48 hours of screening
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Currently receiving hospice care
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Who do not have one global indicator of need
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Not recently hospitalized, 6) not diagnosed with ADRD, <60 years of age
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That are non-English speaking, (if verbal) and 8) if unable to make decisions, do not have an LAR/surrogate decision maker.
Surrogate/LAR:
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< 18 years of age
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Not a family Member or friend of an eligible patient
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Non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Acts Continuing Care Retirement Communities | Philadelphia | Pennsylvania | United States | 19014 |
Sponsors and Collaborators
- University of Maryland, Baltimore
- National Institute on Aging (NIA)
- National Institute of Nursing Research (NINR)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HP-00100348