Trial Outcomes & Findings for Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting (NCT NCT03958552)

NCT ID: NCT03958552

Last Updated: 2024-07-11

Results Overview

The Patient Outcome Survey (POS) 10 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). Higher values represent a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Collected upon admission to the nursing home and enrollment and again 15-21 days after enrollment in the study (control group) or intervention received (intervention group).

Results posted on

2024-07-11

Participant Flow

Participant milestones

Participant milestones
Measure
Standard Care (Control)
Participants received the standard Medicare Skilled Nursing Facility care, Patient Outcome Survey (POS) at enrollment and follow-up 15-21 days later.
Palliative Care Consult
Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation. They also received a Patient Outcome Survey (POS) at enrollment and followup POS and Consultation Satisfaction Questionnaire (CSQ) 15-21 later.
Overall Study
STARTED
10
35
Overall Study
COMPLETED
10
35
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Care
n=10 Participants
Participants received the standard Medicare Skilled Nursing Facility care.
Palliative Care Consult
n=35 Participants
Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider discussed 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.
Total
n=45 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
>=65 years
10 Participants
n=99 Participants
35 Participants
n=107 Participants
45 Participants
n=206 Participants
Sex: Female, Male
Female
7 Participants
n=99 Participants
27 Participants
n=107 Participants
34 Participants
n=206 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
8 Participants
n=107 Participants
11 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=99 Participants
35 Participants
n=107 Participants
45 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
White
10 Participants
n=99 Participants
34 Participants
n=107 Participants
44 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
10 participants
n=99 Participants
35 participants
n=107 Participants
45 participants
n=206 Participants

PRIMARY outcome

Timeframe: Collected upon admission to the nursing home and enrollment and again 15-21 days after enrollment in the study (control group) or intervention received (intervention group).

Population: Both intervention and control groups are administered a baseline POS and follow up POS.

The Patient Outcome Survey (POS) 10 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). Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure
Standard Care (Control Group)
n=10 Participants
Participants received the standard Medicare Skilled Nursing Facility care.
Palliative Care Consult (Intervention Group)
n=35 Participants
Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider discussed 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 Who Completed Patient Quality of Life Surveys
Completed Baseline POS
10 participants
35 participants
Number of Participants Who Completed Patient Quality of Life Surveys
Completed Follow up POS
10 participants
35 participants

SECONDARY outcome

Timeframe: Collected within 15-21days of palliative care consultation for the intervention group.

Population: Participants in the Control arm were not administered the CSQ survey. Only participants in the intervention group were administered the CSQ survey

Measured using the Consultation Satisfaction Questionnaire (CSQ). The CSQ is an 18 item patient/caregiver-reported instrument that measures communication and satisfaction of a consult in four domains: 1) general satisfaction, 2) professional care, 3) depth of relationship, 4) perceived length of consultation.(scale format: 5-point Likert Scale (0= strongly disagree, 4=strongly agree).Overall score is calculated by summing responses (range 0-72). Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure
Standard Care (Control Group)
Participants received the standard Medicare Skilled Nursing Facility care.
Palliative Care Consult (Intervention Group)
n=10 Participants
Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider discussed 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 Who Completed the Consult Satisfaction Survey (CSQ)
10 participants

SECONDARY outcome

Timeframe: 30 Days post-admission

Population: Data were not collected due to study teams limited access to the medical records to review Adherence to SNF-PCC recommendations (due to Covid 19)

Adherence Protocol. Medical record review and/or phone interview with patient/caregiver We will determine a recommendation adherence score after each participants' SNF-PCC. Each recommendation will be assigned 2 points, then we will define full (2 points), partial (1 point) and no adherence (0 point) to each recommendation. We will sum the points for each SNF-PCC recommendation and use this as the denominator. We will sum each recommendation with full, partial, no adherence and use this as the numerator. The fraction will be converted to a percentage ranging from 0-100% reflecting the recommendation adherence score.

Outcome measures

Outcome data not reported

Adverse Events

Standard Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Palliative Care Consult

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 443-880-1430

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place