Trial Outcomes & Findings for Improving Palliative Care Through Teamwork (NCT NCT01990742)
NCT ID: NCT01990742
Last Updated: 2018-09-17
Results Overview
This outcome measure, Hospital Site of Death, assesses whether death occured in a nursing home or in a hospital following transfer from the nursing home, among nursing home residents who were cared for in an enrolled facility.
COMPLETED
NA
31 participants
1 year
2018-09-17
Participant Flow
Nursing Homes, not individual participants, were enrolled in this RCT study, and were the unit of intervention. However, the outcomes analysis was performed on decedents who were cared for in the enrolled Nursing Homes.
Unit of analysis: Nursing Homes
Participant milestones
| Measure |
Palliative Care Team (PCTeam)
Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
|
Standard Care
Usual care will be provided to residents in the control homes.
|
|---|---|---|
|
Overall Study
STARTED
|
3259 16
|
4331 15
|
|
Overall Study
COMPLETED
|
2852 14
|
2978 11
|
|
Overall Study
NOT COMPLETED
|
407 2
|
1353 4
|
Reasons for withdrawal
| Measure |
Palliative Care Team (PCTeam)
Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
|
Standard Care
Usual care will be provided to residents in the control homes.
|
|---|---|---|
|
Overall Study
Withdrawal by facility
|
407
|
1083
|
|
Overall Study
Facility closed
|
0
|
270
|
Baseline Characteristics
Improving Palliative Care Through Teamwork
Baseline characteristics by cohort
| Measure |
Palliative Care Team (PCTeam)
n=2852 Participants
Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
|
Standard Care
n=2978 Participants
Usual care will be provided to residents in the control homes.
|
Total
n=5830 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
86.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
86.2 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
86.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1813 Participants
n=5 Participants
|
1930 Participants
n=7 Participants
|
3743 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1039 Participants
n=5 Participants
|
1048 Participants
n=7 Participants
|
2087 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2851 Participants
n=5 Participants
|
2960 Participants
n=7 Participants
|
5811 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 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
|
108 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2711 Participants
n=5 Participants
|
2792 Participants
n=7 Participants
|
5503 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
|
2852 participants
n=5 Participants
|
2978 participants
n=7 Participants
|
5830 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Nursing home residents cared for in an assigned facility, who died during the study timeframe
This outcome measure, Hospital Site of Death, assesses whether death occured in a nursing home or in a hospital following transfer from the nursing home, among nursing home residents who were cared for in an enrolled facility.
Outcome measures
| Measure |
Palliative Care Team (PCTeam)
n=2852 Participants
Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
|
Standard Care
n=2978 Participants
Usual care will be provided to residents in the control homes.
|
|---|---|---|
|
Hospital Site of Death: Number of Decedents Cared for in an Enrolled and Assigned NH Facility, Who Were Transferred to a Hospital and Died in the Hospital During the Study Period
|
579 Participants
|
441 Participants
|
SECONDARY outcome
Timeframe: The last 90 days of lifePopulation: Decedents with data on hospitalizations in the last 90 days of life
Number of hospitalizations in the last 90 days of life among decedents being cared for in the enrolled nursing homes
Outcome measures
| Measure |
Palliative Care Team (PCTeam)
n=1907 Participants
Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
|
Standard Care
n=1930 Participants
Usual care will be provided to residents in the control homes.
|
|---|---|---|
|
Hospitalizations
|
0.34 Mean number of hospitalizations
Standard Deviation 0.69
|
0.29 Mean number of hospitalizations
Standard Deviation 0.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 months prior to deathPopulation: Decedents cared for in assigned nursing home facilities for whom data on pain was available
Presence of moderate-to-severe pain within 6 months of the date of death, among decedents cared for in the enrolled nursing homes. The verbal descriptor pain scale, where the resident is asked to rate the intensity of their worst pain in the last five day was most often used, where 0 = no pain, 1 = mild pain , 2 = moderate pain, 3 = severe pain, 4 = very severe pain, and 9 = unable to answer. Lower numbers (0 or 1 ) on the scale are preferred, and a lower percentage of residents reporting pain intensity in the moderate or higher ranges is a better outcome. The verbal descriptor scale can be shared with elders verbally, as the name implies, or by asking the resident to point to a setting on a visual thermometer with these word choices.
Outcome measures
| Measure |
Palliative Care Team (PCTeam)
n=1844 Participants
Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
|
Standard Care
n=1851 Participants
Usual care will be provided to residents in the control homes.
|
|---|---|---|
|
Number of Nursing Home Residents in Moderate-to-severe Pain
|
235 Participants
|
218 Participants
|
Adverse Events
Palliative Care Team (PCTeam)
Standard Care
Serious adverse events
| Measure |
Palliative Care Team (PCTeam)
n=2852 participants at risk
Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes.
|
Standard Care
n=2978 participants at risk
Usual care will be provided to residents in the control homes.
|
|---|---|---|
|
General disorders
Death from causes not associated with the study
|
100.0%
2852/2852 • Number of events 2852 • 1 year
We only collected and used data on decedents in our enrolled nursing homes, therefore ALL individual level outcomes measures are based on residents who died during the study period. However, the intervention was not at the individual level, but rather a facility-level. The study was not directly associated with, or a cause of, any of these deaths. Rather, we aimed to teach nursing home staff in the intervention facilities how to improve the quality of care for residents who were dying.
|
100.0%
2978/2978 • Number of events 2978 • 1 year
We only collected and used data on decedents in our enrolled nursing homes, therefore ALL individual level outcomes measures are based on residents who died during the study period. However, the intervention was not at the individual level, but rather a facility-level. The study was not directly associated with, or a cause of, any of these deaths. Rather, we aimed to teach nursing home staff in the intervention facilities how to improve the quality of care for residents who were dying.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place