Trial Outcomes & Findings for Primary Palliative Care for Emergency Medicine (PRIM-ER) (NCT NCT03424109)

NCT ID: NCT03424109

Last Updated: 2025-06-22

Results Overview

Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).

Recruitment status

COMPLETED

Target enrollment

98922 participants

Primary outcome timeframe

Index Visit

Results posted on

2025-06-22

Participant Flow

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.

Unit of analysis: Emergency Departments

Participant milestones

Participant milestones
Measure	Control for Six Months, Then PRIM-ER Care as usual for six months - participants did not cross over. At six months, intervention comprising primary palliative care education, training, and technical support for emergency medicine (PRIM-ER) implemented at participating emergency departments.
Control Period STARTED	50458 33
Control Period COMPLETED	50458 33
Control Period NOT COMPLETED	0 0
PRIM-ER Intervention Period STARTED	48464 33
PRIM-ER Intervention Period COMPLETED	48464 33
PRIM-ER Intervention Period NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Primary Palliative Care for Emergency Medicine (PRIM-ER)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=50458 Participants Care as usual. -ER).	PRIM-ER n=48464 Participants Intervention comprising primary palliative care education, training, and technical support for emergency medicine (PRIM-ER).	Total n=98922 Participants Total of all reporting groups
Age, Continuous	78.2 years STANDARD_DEVIATION 8.5 • n=93 Participants	77.7 years STANDARD_DEVIATION 8.3 • n=4 Participants	78 years STANDARD_DEVIATION 8.4 • n=27 Participants
Sex: Female, Male Female	25137 Participants n=93 Participants	23904 Participants n=4 Participants	49041 Participants n=27 Participants
Sex: Female, Male Male	25321 Participants n=93 Participants	24560 Participants n=4 Participants	49881 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	735 Participants n=93 Participants	727 Participants n=4 Participants	1462 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49723 Participants n=93 Participants	47737 Participants n=4 Participants	97460 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	93 Participants n=93 Participants	60 Participants n=4 Participants	153 Participants n=27 Participants
Race (NIH/OMB) Asian	1555 Participants n=93 Participants	1233 Participants n=4 Participants	2788 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	6341 Participants n=93 Participants	7006 Participants n=4 Participants	13347 Participants n=27 Participants
Race (NIH/OMB) White	39642 Participants n=93 Participants	37308 Participants n=4 Participants	76950 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2827 Participants n=93 Participants	2857 Participants n=4 Participants	5684 Participants n=27 Participants
Region of Enrollment United States	50458 participants n=93 Participants	48464 participants n=4 Participants	98922 participants n=27 Participants

PRIMARY outcome

Timeframe: Index Visit

Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).

Outcome measures

Outcome measures
Measure	Control n=33 Emergency Departments (EDs) Patients who received care as usual.	PRIM-ER n=33 Emergency Departments (EDs) Patients who received PRIM-ER.
Acute Care Admission	0.644 Proportion of participants	0.613 Proportion of participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Control n=33 Emergency Departments (EDs) Patients who received care as usual.	PRIM-ER n=33 Emergency Departments (EDs) Patients who received PRIM-ER.
Proportion of Patients With Emergency Department (ED) Revisits	0.6 Proportion of Patients	0.6 Proportion of Patients

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Control n=33 Emergency Departments (EDs) Patients who received care as usual.	PRIM-ER n=33 Emergency Departments (EDs) Patients who received PRIM-ER.
Inpatient Days	0.410 Proportion of participants	0.366 Proportion of participants

SECONDARY outcome

Timeframe: Up to Month 6

Proportion of patients with any home health use in the six months following the index ED visit (Yes/No)

Outcome measures

Outcome measures
Measure	Control n=33 Emergency Departments (EDs) Patients who received care as usual.	PRIM-ER n=33 Emergency Departments (EDs) Patients who received PRIM-ER.
Home Health Use	0.420 Proportion of participants	0.381 Proportion of participants

SECONDARY outcome

Timeframe: Up to Month 6

Proportion of patients with any hospice use in the six months following the index ED visit (Yes/No).

Outcome measures

Outcome measures
Measure	Control n=33 Emergency Departments (EDs) Patients who received care as usual.	PRIM-ER n=33 Emergency Departments (EDs) Patients who received PRIM-ER.
Hospice Use	0.177 Proportion of participants	0.172 Proportion of participants

SECONDARY outcome

Timeframe: Up to Month 6

Outcome measures

Outcome measures
Measure	Control n=33 Emergency Departments (EDs) Patients who received care as usual.	PRIM-ER n=3 Emergency Departments (EDs) Patients who received PRIM-ER.
Proportion of Patients Who Died at Month 6 Post-Index Visit	0.281 Proportion of participants	0.287 Proportion of participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Control n=33 Emergency Departments (EDs) Patients who received care as usual.	PRIM-ER n=48464 Participants Patients who received PRIM-ER.
Survival: Time-to-event	17.3 Days Standard Deviation 38.8	17.1 Days Standard Deviation 37.7

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14179 deaths

PRIM-ER

Serious events: 0 serious events

Other events: 0 other events

Deaths: 13910 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison Cuthel

NYU Langone Health

Phone: 212-263-8631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place