Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05308004 |
| Other study ID # |
HP-00100348 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2022 |
| Est. completion date |
December 14, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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)
