Emergencies
Conditions
Keywords
Emergency Department, Palliative Care
Brief summary
This proposal builds upon the evaluation of Primary Palliative Care Education, Training, and Technical Support for Emergency Medicine (PRIM-ER) implemented in a cluster-randomized, stepped wedge design in 33 Emergency Departments (EDs).
Interventions
The analysis of the effect of PRIM-ER on ED disposition using a generalized linear binomial model with random site level effects.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients must demonstrate one-year mortality of at least 30 percent (score \> 6) according to the Gagne Index, a validated instrument used to measure all cause one-year mortality in community-dwelling older adults, calculated based on their prior 12 months before the index ED visit of Medicare claims.
Exclusion criteria
* ED patients transferred from a nursing home on the index ED visit will be excluded since prediction of mortality and disposition of such patients differs from community-dwelling adults. * Patients currently receiving hospice at the time of the index ED visit will also be excluded since they have already received services.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Care Admission | Index Visit | Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient Days | Up to Month 6 | Measured as the proportion of patients who had at least one inpatient stay in the six months following the index ED visit (Count). |
| Home Health Use | Up to Month 6 | Proportion of patients with any home health use in the six months following the index ED visit (Yes/No) |
| Proportion of Patients With Emergency Department (ED) Revisits | Up to Month 6 | Measured as the proportion of patients with at least one ED revisit in the six months following the index ED visit (Count) |
| Proportion of Patients Who Died at Month 6 Post-Index Visit | Up to Month 6 | — |
| Survival: Time-to-event | Up to Month 6 | Number of days from index ED visit to death among those who died within six months following the index ED visit (Count of days) |
| Hospice Use | Up to Month 6 | Proportion of patients with any hospice use in the six months following the index ED visit (Yes/No). |
Countries
United States
Participant flow
Pre-assignment details
This is an \*\*observational\*\* cluster-randomized \*\*quality improvement (QI) initiative\*\*. Randomization of patients occurred at the ED level; EDs (and subsequent visiting patients) were assigned to either Control (i.e., no intervention) or PRIM-ER (intervention). Medicare claims of the beneficiaries (visiting patients) from index visit and the six months following the index visit were analyzed to assess outcomes. Participant flow data is not analyzed by sequence but rather by arm/condition.
Participants by arm
| Arm | Count |
|---|---|
| Control Care as usual.
-ER). | 50,458 |
| PRIM-ER Intervention comprising primary palliative care education, training, and technical support for emergency medicine (PRIM-ER). | 48,464 |
| Total | 98,922 |
Baseline characteristics
| Characteristic | Control | Total | PRIM-ER |
|---|---|---|---|
| Age, Continuous | 78.2 years STANDARD_DEVIATION 8.5 | 78 years STANDARD_DEVIATION 8.4 | 77.7 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 735 Participants | 1462 Participants | 727 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49723 Participants | 97460 Participants | 47737 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 93 Participants | 153 Participants | 60 Participants |
| Race (NIH/OMB) Asian | 1555 Participants | 2788 Participants | 1233 Participants |
| Race (NIH/OMB) Black or African American | 6341 Participants | 13347 Participants | 7006 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 | 2827 Participants | 5684 Participants | 2857 Participants |
| Race (NIH/OMB) White | 39642 Participants | 76950 Participants | 37308 Participants |
| Region of Enrollment United States | 50458 participants | 98922 participants | 48464 participants |
| Sex: Female, Male Female | 25137 Participants | 49041 Participants | 23904 Participants |
| Sex: Female, Male Male | 25321 Participants | 49881 Participants | 24560 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14,179 / 50,458 | 13,910 / 48,464 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Acute Care Admission
Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).
Time frame: Index Visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Acute Care Admission | 0.644 Proportion of participants |
| PRIM-ER | Acute Care Admission | 0.613 Proportion of participants |
Home Health Use
Proportion of patients with any home health use in the six months following the index ED visit (Yes/No)
Time frame: Up to Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Home Health Use | 0.420 Proportion of participants |
| PRIM-ER | Home Health Use | 0.381 Proportion of participants |
Hospice Use
Proportion of patients with any hospice use in the six months following the index ED visit (Yes/No).
Time frame: Up to Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Hospice Use | 0.177 Proportion of participants |
| PRIM-ER | Hospice Use | 0.172 Proportion of participants |
Inpatient Days
Measured as the proportion of patients who had at least one inpatient stay in the six months following the index ED visit (Count).
Time frame: Up to Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Inpatient Days | 0.410 Proportion of participants |
| PRIM-ER | Inpatient Days | 0.366 Proportion of participants |
Proportion of Patients Who Died at Month 6 Post-Index Visit
Time frame: Up to Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Proportion of Patients Who Died at Month 6 Post-Index Visit | 0.281 Proportion of participants |
| PRIM-ER | Proportion of Patients Who Died at Month 6 Post-Index Visit | 0.287 Proportion of participants |
Proportion of Patients With Emergency Department (ED) Revisits
Measured as the proportion of patients with at least one ED revisit in the six months following the index ED visit (Count)
Time frame: Up to Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Proportion of Patients With Emergency Department (ED) Revisits | 0.6 Proportion of Patients |
| PRIM-ER | Proportion of Patients With Emergency Department (ED) Revisits | 0.6 Proportion of Patients |
Survival: Time-to-event
Number of days from index ED visit to death among those who died within six months following the index ED visit (Count of days)
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Survival: Time-to-event | 17.3 Days | Standard Deviation 38.8 |
| PRIM-ER | Survival: Time-to-event | 17.1 Days | Standard Deviation 37.7 |