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Primary Palliative Care for Emergency Medicine (PRIM-ER)

Primary Palliative Care for Emergency Medicine (PRIM-ER)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03424109
Enrollment
98922
Registered
2018-02-06
Start date
2019-07-01
Completion date
2022-12-31
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies

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

BEHAVIORALhealthcare 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.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Acute Care AdmissionIndex VisitProportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).

Secondary

MeasureTime frameDescription
Inpatient DaysUp to Month 6Measured as the proportion of patients who had at least one inpatient stay in the six months following the index ED visit (Count).
Home Health UseUp to Month 6Proportion 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) RevisitsUp to Month 6Measured 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 VisitUp to Month 6
Survival: Time-to-eventUp to Month 6Number of days from index ED visit to death among those who died within six months following the index ED visit (Count of days)
Hospice UseUp to Month 6Proportion 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

ArmCount
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
Total98,922

Baseline characteristics

CharacteristicControlTotalPRIM-ER
Age, Continuous78.2 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 Participants1462 Participants727 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49723 Participants97460 Participants47737 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
93 Participants153 Participants60 Participants
Race (NIH/OMB)
Asian
1555 Participants2788 Participants1233 Participants
Race (NIH/OMB)
Black or African American
6341 Participants13347 Participants7006 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2827 Participants5684 Participants2857 Participants
Race (NIH/OMB)
White
39642 Participants76950 Participants37308 Participants
Region of Enrollment
United States
50458 participants98922 participants48464 participants
Sex: Female, Male
Female
25137 Participants49041 Participants23904 Participants
Sex: Female, Male
Male
25321 Participants49881 Participants24560 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
14,179 / 50,45813,910 / 48,464
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Acute Care Admission

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

Time frame: Index Visit

ArmMeasureValue (NUMBER)
ControlAcute Care Admission0.644 Proportion of participants
PRIM-ERAcute Care Admission0.613 Proportion of participants
Secondary

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

ArmMeasureValue (NUMBER)
ControlHome Health Use0.420 Proportion of participants
PRIM-ERHome Health Use0.381 Proportion of participants
Secondary

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

ArmMeasureValue (NUMBER)
ControlHospice Use0.177 Proportion of participants
PRIM-ERHospice Use0.172 Proportion of participants
Secondary

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

ArmMeasureValue (NUMBER)
ControlInpatient Days0.410 Proportion of participants
PRIM-ERInpatient Days0.366 Proportion of participants
Secondary

Proportion of Patients Who Died at Month 6 Post-Index Visit

Time frame: Up to Month 6

ArmMeasureValue (NUMBER)
ControlProportion of Patients Who Died at Month 6 Post-Index Visit0.281 Proportion of participants
PRIM-ERProportion of Patients Who Died at Month 6 Post-Index Visit0.287 Proportion of participants
Secondary

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

ArmMeasureValue (NUMBER)
ControlProportion of Patients With Emergency Department (ED) Revisits0.6 Proportion of Patients
PRIM-ERProportion of Patients With Emergency Department (ED) Revisits0.6 Proportion of Patients
Secondary

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

ArmMeasureValue (MEAN)Dispersion
ControlSurvival: Time-to-event17.3 DaysStandard Deviation 38.8
PRIM-ERSurvival: Time-to-event17.1 DaysStandard Deviation 37.7

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026