Palliative Care
Conditions
Brief summary
One in three Americans dies in a nursing home (NH) or in a hospital, shortly following transfer from a long-term care facility. The proportion of deaths occurring in NHs is projected to increase to 40% by 2020. Excellence in palliative and end-of-life (EOL) care must become a priority for these long-term care institutions. However, findings from NHs point to high incidence of pain and poor management of other symptoms and excessive reliance on hospitalizations, indicating inadequate EOL care quality. Expert opinion and research have suggested that poor EOL quality in NHs may be due to lack of palliative care training among staff and absence of EOL care protocols or guidelines, but research demonstrating that attention to these factors improves outcomes is absent. While dedicated care teams have been shown to improve outcomes for NH residents in need of specialized care, the impact of palliative care teams in improving resident outcomes has remained largely unstudied and untested. This will be the first randomized controlled trial to evaluate the impact of palliative care teams (PCTeam) on resident and staff outcomes, and care processes, in NHs. Our objective is to demonstrate, using a randomized controlled trial design and a difference in difference analytic approach, that nursing home-based palliative care practice guidelines implemented through PCTeams will improve quality of care processes and outcomes for residents at the end of life. We will adapt existing palliative care guidelines for EOL care, endorsed by the National Quality Forum (NQF), to the NH environment, deploy the adapted practice guidelines through a PCTeam model, and evaluate the effectiveness of this intervention on resident EOL outcomes and staff care processes and outcomes. The specific aims (SA) will address the following questions: SA 1: Is PCTeam intervention effective in improving NH residents' EOL outcomes? SA 2: Is PCTeam intervention effective in improving NH staff EOL care processes and outcomes? In the context of these specific aims we will test the following hypotheses: H1: Residents in NHs in the intervention arm, compared to the control, will achieve better EOL risk-adjusted outcomes and care processes with regard to: * Pain * Dyspnea * Depression * In-hospital deaths * Hospitalizations * Advance directives H2: Direct care staff in NHs in the intervention arm, compared to the control, will achieve better EOL processes and outcomes measured by: * Assessment of EOL symptoms * Delivery of EOL care * Communication/coordination among providers * Communication with residents/families * Teamwork effectiveness * Staff satisfaction H3: Family caregivers of decedent residents in the intervention NHs, compared to the control, will report receiving more patient and family centered care as measured by higher levels of satisfaction with: * Shared decision making between providers, the patient and the family * Care that is respectful of the patient wishes and dignity * Attention to the emotional and spiritual needs of the family. 31 NHs in upstate New York have been recruited for the study (letters of support). Stakeholders include residents, family members, staff, policy makers, and others. The intervention will deploy theTeamSTEPPS, a team development model created by the Department of Defense and the Agency for Healthcare Research and Quality.
Interventions
BEHAVIORALPalliative Care Team (PCTeam)
Palliative care teams will be established and will round with residents in the intervention nursing homes.
Sponsors
University of California, Irvine
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* long-stay nursing home residents (\>90 days)
Exclusion criteria
* rehabilitative, post-acute residents (\<90 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Nursing Home Residents in Moderate-to-severe Pain | up to 6 months prior to death | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Palliative Care Team (PCTeam) Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes. | 2,852 |
| Standard Care Usual care will be provided to residents in the control homes. | 2,978 |
| Total | 5,830 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Facility closed | 0 | 270 |
| Overall Study | Withdrawal by facility | 407 | 1,083 |
Baseline characteristics
| Characteristic | Palliative Care Team (PCTeam) | Total | Standard Care |
|---|---|---|---|
| Age, Continuous | 86.0 years STANDARD_DEVIATION 8.9 | 86.1 years STANDARD_DEVIATION 9 | 86.2 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 19 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2851 Participants | 5811 Participants | 2960 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 22 Participants | 44 Participants | 22 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 22 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 108 Participants | 261 Participants | 153 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2711 Participants | 5503 Participants | 2792 Participants |
| Region of Enrollment United States | 2852 participants | 5830 participants | 2978 participants |
| Sex: Female, Male Female | 1813 Participants | 3743 Participants | 1930 Participants |
| Sex: Female, Male Male | 1039 Participants | 2087 Participants | 1048 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2,852 / 2,852 | 2,978 / 2,978 |
| other Total, other adverse events | 0 / 2,852 | 0 / 2,978 |
| serious Total, serious adverse events | 2,852 / 2,852 | 2,978 / 2,978 |
Outcome results
Primary
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
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.
Time frame: 1 year
Population: Nursing home residents cared for in an assigned facility, who died during the study timeframe
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palliative Care Team (PCTeam) | 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 |
| Standard Care | 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 | 441 Participants |
p-value: >0.05MOnte carlo simulation
Secondary
Hospitalizations
Number of hospitalizations in the last 90 days of life among decedents being cared for in the enrolled nursing homes
Time frame: The last 90 days of life
Population: Decedents with data on hospitalizations in the last 90 days of life
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palliative Care Team (PCTeam) | Hospitalizations | 0.34 Mean number of hospitalizations | Standard Deviation 0.69 |
| Standard Care | Hospitalizations | 0.29 Mean number of hospitalizations | Standard Deviation 0.62 |
p-value: >0.05Monte carlo simulation
Other Pre-specified
Number of Nursing Home Residents in Moderate-to-severe Pain
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.
Time frame: up to 6 months prior to death
Population: Decedents cared for in assigned nursing home facilities for whom data on pain was available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palliative Care Team (PCTeam) | Number of Nursing Home Residents in Moderate-to-severe Pain | 235 Participants |
| Standard Care | Number of Nursing Home Residents in Moderate-to-severe Pain | 218 Participants |
p-value: >0.05Monte carlo simulation