Trial Outcomes & Findings for Palliative Care for Persons With ADRD and CI in SNF (NCT NCT05308004)
NCT ID: NCT05308004
Last Updated: 2024-12-27
Results Overview
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
COMPLETED
NA
7 participants
Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up)
2024-12-27
Participant Flow
Participants enrolled are patients only, not caregivers.
Participant milestones
| Measure |
Standard Care
Participants received the standard Medicare Skilled Nursing Facility care.
|
Palliative Care Consult
Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Standard Care
Participants received the standard Medicare Skilled Nursing Facility care.
|
Palliative Care Consult
Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.
|
|---|---|---|
|
Overall Study
Not seen by Palliative Care NP
|
0
|
1
|
Baseline Characteristics
Palliative Care for Persons With ADRD and CI in SNF
Baseline characteristics by cohort
| Measure |
Standard Care
n=4 Participants
Participants (patients) received the standard Medicare Skilled Nursing Facility care.
|
Palliative Care Consult
n=3 Participants
Participants (patients) received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up)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
Outcome measures
| Measure |
Standard Care
n=4 Participants
Participants will receive the standard Medicare Skilled Nursing Facility care.
|
Palliative Care Consult
n=3 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
|
|---|---|---|
|
Number of Participants That Completed Patient Quality of Life Survey
Baseline
|
4 Participants
|
3 Participants
|
|
Number of Participants That Completed Patient Quality of Life Survey
Follow up
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Collected upon admission to the nursing home and again 21 days post-admission to the nursing home10-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.
Outcome measures
| Measure |
Standard Care
n=4 Participants
Participants will receive the standard Medicare Skilled Nursing Facility care.
|
Palliative Care Consult
n=3 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
|
|---|---|---|
|
Number of Participants That Completed Satisfaction With Care Survey (SWC-EOLD)
Baseline SWC-EOLD
|
4 Participants
|
3 Participants
|
|
Number of Participants That Completed Satisfaction With Care Survey (SWC-EOLD)
Follow-up SWC-EOLD
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Collected upon admission to the nursing home and again 21 days post-admission to the nursing home9-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.
Outcome measures
| Measure |
Standard Care
n=4 Participants
Participants will receive the standard Medicare Skilled Nursing Facility care.
|
Palliative Care Consult
n=3 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
|
|---|---|---|
|
Number of Participants That Completed the Symptom Management Survey (SM-EOLD)
Baseline SM-EOLD
|
4 Participants
|
3 Participants
|
|
Number of Participants That Completed the Symptom Management Survey (SM-EOLD)
Follow-up SM-EOLD
|
3 Participants
|
3 Participants
|
Adverse Events
Standard Care
Palliative Care Consult
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Joan Carpenter
University of Maryland School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place