- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05308004
Palliative Care for Persons With ADRD and CI in SNF
Palliative Care Consultations for Persons With Alzheimer's Disease and Related Dementia and Cognitive Impairment in the Medicare Skilled Nursing Facility (SNF) Setting
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19014
- Acts Continuing Care Retirement Communities
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
KEY INCLUSION CRITERIA
Patients:
- Admitted for SNF post-acute care at a participating NHs following a recent hospitalization
- Age ≥ 60 years old
- Speaks English (if verbal)
- 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
- Documented ADRD diagnosis in the medical record or history of cognitive impairment (defined as BIMS score ≤ 12)
- 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:
- ≥18 years old
- Family member or friend of an eligible patient as determined by ACTs staff
- Speaks English
KEY EXCLUSION CRITERIA
Patients:
- Who have previously received or are referred for PC by their primary care team
- With a discharge plan within 48 hours of screening
- Currently receiving hospice care
- Who do not have one global indicator of need
- No documented ADRD diagnosis or history of cognitive impairment in the medical record
- That are non-English speaking, (if verbal)
- If unable to make decisions, do not have an LAR/surrogate decision maker.
Surrogate/LAR:
- < 18 years of age
- Not a family Member or friend of an eligible patient
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Care
Participants will receive the standard Medicare Skilled Nursing Facility care.
|
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Experimental: Palliative Care Consult
Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient/Caregiver Quality of Life
Time Frame: 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
|
Collected upon admission to the nursing home and again 14-21 days post-admission to the nursing home
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with Care
Time Frame: 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.
|
Collected upon admission to the nursing home and again 14-21 days post-admission to the nursing home
|
Symptom Management
Time Frame: 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.
|
Collected upon admission to the nursing home and again 14-21 days post-admission to the nursing home
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00100348
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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