Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
H2: Direct care staff in NHs in the intervention arm, compared to the control, will achieve better EOL processes and outcomes measured by:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative Care Team (PCTeam) | Experimental | Palliative care teams will be established and will round with residents in the intervention homes. |
|
| Standard care | No Intervention | Usual care will be provided to residents in the control homes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care Team (PCTeam) | Behavioral | Palliative care teams will be established and will round with residents in the intervention nursing homes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations | Number of hospitalizations in the last 90 days of life among decedents being cared for in the enrolled nursing homes | The last 90 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helena Temkin-Greener, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester School of Medicine and Dentistry | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35802350 | Derived | Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2. |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Palliative Care Team (PCTeam) | Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes. |
| FG001 | Standard Care | Usual care will be provided to residents in the control homes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All decedents with data who resided in assigned facilities.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Palliative Care Team (PCTeam) | Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes. |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Nursing home residents cared for in an assigned facility, who died during the study timeframe | Posted | Count of Participants | Participants | 1 year |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palliative Care Team (PCTeam) | Palliative Care Team (PCTeam): Palliative care teams will be established and will work with residents in the intervention nursing homes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death from causes not associated with the study | General disorders | Non-systematic Assessment | We based our comparative outcomes assessment using the MDS 3.0 data available only from decedents cared for by the enrolled nursing homes. Therefore, all individual-level data was obtained from patients who suffered death, within the study timeframe. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helena Temkin-Greener | University of Rochester | 585-275-8713 | Helena_Temkin-Greener@urmc.rochester.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 6 months prior to death |
Usual care will be provided to residents in the control homes.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Individual participants were not enrolled; we report here the gender of the nursing home residents who died during the study period in our enrolled facilities, as recorded in the MDS data set used for the outcomes analyses. | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Individual participants were not enrolled; we report here the ethnicity of the nursing home residents who died during the study period in our enrolled facilities, as recorded in the MDS data set used for the outcomes analyses. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Individual participants were not enrolled; we report here the racial distribution of the nursing home residents who died during the study period in our enrolled facilities, as recorded in the MDS data set used for the outcomes analyses. | Count of Participants | Participants | No |
|
| Region of Enrollment | The nursing home in which each decedent received care serves as the geographic location for this baseline measure. | Number | participants |
|
| Standard Care |
Usual care will be provided to residents in the control homes. |
|
|
|
| Secondary | Hospitalizations | Number of hospitalizations in the last 90 days of life among decedents being cared for in the enrolled nursing homes | Decedents with data on hospitalizations in the last 90 days of life | Posted | Mean | Standard Deviation | Mean number of hospitalizations | The last 90 days of life |
|
|
|
|
| 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. | Decedents cared for in assigned nursing home facilities for whom data on pain was available | Posted | Count of Participants | Participants | up to 6 months prior to death |
|
|
|
|
| 2,852 |
| 2,852 |
| 2,852 |
| 2,852 |
| 0 |
| 2,852 |
| EG001 | Standard Care | Usual care will be provided to residents in the control homes. | 2,978 | 2,978 | 2,978 | 2,978 | 0 | 2,978 |
|
Not provided
Not provided