An observational study in Emergencies, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by NYU Langone Health · Observational
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).
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligible patients will include ED patients 66 years or older with serious, life-limiting illness who visited any of our EDs during the implementation of PRIM-ER.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The patient cohort will be extracted via the Centers for Medicare and Medicaid Services (CMS) Research Data Assistance Center (ResDAC) using a two-step process to maximize diversity, and minimize intentional or unintentional exclusions based on risk, age, health literacy, demographics, or expected adherence.
Behavioral: healthcare service utilization in the six months following the ED visit
The analysis of the effect of PRIM-ER on ED disposition using a generalized linear binomial model with random site level effects.
Acute Care Admission
Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).
Time frame: Index Visit
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
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
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
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
Proportion of Patients Who Died at Month 6 Post-Index Visit
Time frame: Up to Month 6
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
| Milestone | Control for Six Months, Then PRIM-ER |
|---|---|
| Started | 50458 |
| Completed | 50458 |
| Not completed | 0 |
| Milestone | Control for Six Months, Then PRIM-ER |
|---|---|
| Started | 48464 |
| Completed | 48464 |
| Not completed | 0 |
Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).
| Proportion of participants | Control | PRIM-ER |
|---|---|---|
| Acute Care Admission | 0.644 | 0.613 |
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 | Control | PRIM-ER |
|---|---|---|
| Proportion of Patients With Emergency Department (ED) Revisits | 0.6 | 0.6 |
Measured as the proportion of patients who had at least one inpatient stay in the six months following the index ED visit (Count).
| Proportion of participants | Control | PRIM-ER |
|---|---|---|
| Inpatient Days | 0.410 | 0.366 |
Proportion of patients with any home health use in the six months following the index ED visit (Yes/No)
| Proportion of participants | Control | PRIM-ER |
|---|---|---|
| Home Health Use | 0.420 | 0.381 |
Proportion of patients with any hospice use in the six months following the index ED visit (Yes/No).
| Proportion of participants | Control | PRIM-ER |
|---|---|---|
| Hospice Use | 0.177 | 0.172 |
| Proportion of participants | Control | PRIM-ER |
|---|---|---|
| Proportion of Patients Who Died at Month 6 Post-Index Visit | 0.281 | 0.287 |
Number of days from index ED visit to death among those who died within six months following the index ED visit (Count of days)
| Days | Control | PRIM-ER |
|---|---|---|
| Survival: Time-to-event | 17.3 ± 38.8 | 17.1 ± 37.7 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 14,179/50,458 (28.1%) | — | — |
| PRIM-ER | 13,910/48,464 (28.7%) | — | — |
| Age, Continuous(years) | Control | PRIM-ER | Total |
|---|---|---|---|
| Mean | 78.2 ± 8.5 | 77.7 ± 8.3 | 78 ± 8.4 |
| Sex: Female, Male(Participants) | Control | PRIM-ER | Total |
|---|---|---|---|
| Female | 25137 | 23904 | 49041 |
| Male | 25321 | 24560 | 49881 |
| Ethnicity (NIH/OMB)(Participants) | Control | PRIM-ER | Total |
|---|---|---|---|
| Hispanic or Latino | 735 | 727 | 1462 |
| Not Hispanic or Latino | 49723 | 47737 | 97460 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | PRIM-ER | Total |
|---|---|---|---|
| American Indian or Alaska Native | 93 | 60 | 153 |
| Asian | 1555 | 1233 | 2788 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6341 | 7006 | 13347 |
| White | 39642 | 37308 | 76950 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2827 | 2857 | 5684 |
| Region of Enrollment(participants) | Control | PRIM-ER | Total |
|---|---|---|---|
| United States | 50458 | 48464 | 98922 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Will share all policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, including clinical workflows, design specifications for our clinical decision support and learning management system, code sets for extraction, and definition of data from Medicare administrative claims. PI will comply with the ResDAC VRDC rules regarding the sharing and reporting of data in aggregate form only. A final dataset will not be available for collaboration, reuse, and replication of the findings because of our decision to use the ResDAC VRDC.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Immediately following publication. No end date.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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