EmergenciesNCT03424109

Primary Palliative Care for Emergency Medicine (PRIM-ER)

An observational study of Emergencies, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 66 years and older
Conditions the study is for: Emergencies
What is being tested?: healthcare service utilization in the six months following the ED visit
Type of treatment: Lifestyle or therapy programme
How many people: 98,922 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2019to 31 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 66 years and older
All sexes
No healthy volunteers
Older adult

Study population: 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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Conditions: Emergencies
Being tested: healthcare service utilization in the six months following the ED visit
Keywords: Emergency Department, Palliative Care
Medical subject headings: Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

healthcare service utilization in the six months following the ED visitBehavioural
The analysis of the effect of PRIM-ER on ED disposition using a generalized linear binomial model with random site level effects.

Study groups in NCT03424109
Study group	Role	What they receive
Beneficiaries with a one-year mortality of at least 30%		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. Receives: Behavioral: healthcare service utilization in the six months following the ED visit

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute Care Admission
Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).
Measured: Index Visit

Secondary outcomes (6)

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)
Measured: 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).
Measured: 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)
Measured: Up to Month 6
Hospice Use
Proportion of patients with any hospice use in the six months following the index ED visit (Yes/No).
Measured: Up to Month 6
Proportion of Patients Who Died at Month 6 Post-Index Visit
Measured: 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)
Measured: Up to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201931 Dec 2022

First posted6 Feb 2018
Study start1 Jul 2019
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for EmergenciesStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 98,922 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03424109
Sponsor's protocol ID: 18-00607
Other IDs: 5UH3AT009844
Status last verified: Jun 2025
First submitted: 30 Jan 2018
Last updated: 22 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Adeyemi OJ, Siman N, Cuthel AM, Goldfeld KS, Grudzen CR. Healthy days at home and prognosis of older adults with cancer and non-cancer serious life-limiting illnesses. BMC Geriatr. 2025 Jul 3;25(1):487. doi: 10.1186/s12877-025-06160-9.
PubMed 40610903
Adeyemi O, Hill J, Siman N, Goldfeld KS, Cuthel AM, Grudzen CR. Acute Care Use and Prognosis in Older Adults Presenting to the Emergency Department. J Pain Symptom Manage. 2025 Jun;69(6):559-568. doi: 10.1016/j.jpainsymman.2025.01.006. Epub 2025 Jan 31.
PubMed 39892477
Grudzen CR, Siman N, Cuthel AM, Adeyemi O, Yamarik RL, Goldfeld KS; PRIM-ER Investigators; Abella BS, Bellolio F, Bourenane S, Brody AA, Cameron-Comasco L, Chodosh J, Cooper JJ, Deutsch AL, Elie MC, Elsayem A, Fernandez R, Fleischer-Black J, Gang M, Genes N, Goett R, Heaton H, Hill J, Horwitz L, Isaacs E, Jubanyik K, Lamba S, Lawrence K, Lin M, Loprinzi-Brauer C, Madsen T, Miller J, Modrek A, Otero R, Ouchi K, Richardson C, Richardson LD, Ryan M, Schoenfeld E, Shaw M, Shreves A, Southerland LT, Tan A, Uspal J, Venkat A, Walker L, Wittman I, Zimny E. Palliative Care Initiated in the Emergency Department: A Cluster Randomized Clinical Trial. JAMA. 2025 Feb 18;333(7):599-608. doi: 10.1001/jama.2024.23696.
PubMed 39813042
Adeyemi O, Ginsburg AD, Kaur R, Cuthel AM, Zhao N, Siman N, Goldfeld KS, Emlet LL, DiMaggio C, Yamarik RL, Bouillon-Minois JB, Chodosh J, Grudzen CR; PRIM-E. R. Investigators. Serious illness communication skills training for emergency physicians and advanced practice providers: a multi-method assessment of the reach and effectiveness of the intervention. BMC Palliat Care. 2024 Feb 21;23(1):48. doi: 10.1186/s12904-024-01349-y.
PubMed 38378532
Adeyemi OJ, Siman N, Goldfeld KS, Cuthel AM, Bouillon-Minois JB, Grudzen CR. Emergency Providers' Knowledge and Attitudes Toward Hospice and Palliative Care: A Cross-Sectional Analysis Across 35 Emergency Departments in the United States. J Palliat Med. 2023 Sep;26(9):1252-1260. doi: 10.1089/jpm.2022.0545. Epub 2023 Jun 1.
PubMed 37262130
Adeyemi O, Ginsburg AD, Kaur R, Cuthel A, Zhao N, Siman N, Goldfeld K, Emlet LL, DiMaggio C, Yamarik R, Bouillon-Minois JB, Chodosh J, Grudzen CR; PRIM-ER Investigators. Serious Illness Communication Skills Training for Emergency Physicians and Advanced Practice Providers: A Multi-Method Assessment of the Reach and Effectiveness of the Intervention. Res Sq [Preprint]. 2023 Feb 21:rs.3.rs-2561749. doi: 10.21203/rs.3.rs-2561749/v1.
PubMed 36865121
Chung FR, Turecamo S, Cuthel AM, Grudzen CR; PRIM-ER Investigators. Effectiveness and Reach of the Primary Palliative Care for Emergency Medicine (PRIM-ER) Pilot Study: a Qualitative Analysis. J Gen Intern Med. 2021 Feb;36(2):296-304. doi: 10.1007/s11606-020-06302-2. Epub 2020 Oct 27.
PubMed 33111240
Tan A, Durbin M, Chung FR, Rubin AL, Cuthel AM, McQuilkin JA, Modrek AS, Jamin C, Gavin N, Mann D, Swartz JL, Austrian JS, Testa PA, Hill JD, Grudzen CR; Group Authorship: Corita R. Grudzen on behalf of the PRIM-ER Clinical Informatics Advisory Board. Design and implementation of a clinical decision support tool for primary palliative Care for Emergency Medicine (PRIM-ER). BMC Med Inform Decis Mak. 2020 Jan 28;20(1):13. doi: 10.1186/s12911-020-1021-7.
PubMed 31992301
Grudzen CR, Brody AA, Chung FR, Cuthel AM, Mann D, McQuilkin JA, Rubin AL, Swartz J, Tan A, Goldfeld KS; PRIM-ER Investigators. Primary Palliative Care for Emergency Medicine (PRIM-ER): Protocol for a Pragmatic, Cluster-Randomised, Stepped Wedge Design to Test the Effectiveness of Primary Palliative Care Education, Training and Technical Support for Emergency Medicine. BMJ Open. 2019 Jul 27;9(7):e030099. doi: 10.1136/bmjopen-2019-030099.
PubMed 31352424

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Emergencies trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Primary Palliative Care for Emergency Medicine (PRIM-ER)
ClinicalTrials.gov ID: NCT03424109
Acronym / sponsor ID: 18-00607
Conditions: Emergencies
Keywords: Emergency Department, Palliative Care
Study type: Observational
Recruitment status: Completed
Enrolment: 98,922 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH), Memorial Sloan Kettering Cancer Center
Study start: 1 Jul 2019 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 6 Feb 2018 (actual)
Results: Posted 22 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Beneficiaries with a one-year mortality of at least 30%	–	Behavioral: healthcare service utilization in the six months following the ED visitThe 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.

Who may qualify

Ages: 66 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: 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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
healthcare service utilization in the six months following the ED visitThe analysis of the effect of PRIM-ER on ED disposition using a generalized linear binomial model with random site level effects.	Behavioural	Beneficiaries with a one-year mortality of at least 30%

Primary outcome

Acute Care Admission
Time frame: Index Visit
Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service).

6 secondary outcomes

Proportion of Patients With Emergency Department (ED) Revisits
Time frame: Up to Month 6
Inpatient Days
Time frame: Up to Month 6
Home Health Use
Time frame: Up to Month 6
Hospice Use
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
Time frame: Up to Month 6

Results and safety

Results posted to the registry on 22 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control for Six Months, Then PRIM-ER	50,458	50,458

Primary outcome: Acute Care Admission

Time frame: Index Visit. Number. Unit: Proportion of participants

Measure	Control n = 50458	PRIM-ER n = 48464
Value	0.644	0.613

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 0	0 of 0	14,179 of 50,458
PRIM-ER	0 of 0	0 of 0	13,910 of 48,464

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40610903Adeyemi OJ, Siman N, Cuthel AM, Goldfeld KS, Grudzen CR. Healthy days at home and prognosis of older adults with cancer and non-cancer serious life-limiting illnesses. BMC Geriatr. 2025 Jul 3;25(1):487. doi: 10.1186/s12877-025-06160-9.
Derived from this study: PubMed 39892477Adeyemi O, Hill J, Siman N, Goldfeld KS, Cuthel AM, Grudzen CR. Acute Care Use and Prognosis in Older Adults Presenting to the Emergency Department. J Pain Symptom Manage. 2025 Jun;69(6):559-568. doi: 10.1016/j.jpainsymman.2025.01.006. Epub 2025 Jan 31.
Derived from this study: PubMed 39813042Grudzen CR, Siman N, Cuthel AM, Adeyemi O, Yamarik RL, Goldfeld KS; PRIM-ER Investigators; Abella BS, Bellolio F, Bourenane S, Brody AA, Cameron-Comasco L, Chodosh J, Cooper JJ, Deutsch AL, Elie MC, Elsayem A, Fernandez R, Fleischer-Black J, Gang M, Genes N, Goett R, Heaton H, Hill J, Horwitz L, Isaacs E, Jubanyik K, Lamba S, Lawrence K, Lin M, Loprinzi-Brauer C, Madsen T, Miller J, Modrek A, Otero R, Ouchi K, Richardson C, Richardson LD, Ryan M, Schoenfeld E, Shaw M, Shreves A, Southerland LT, Tan A, Uspal J, Venkat A, Walker L, Wittman I, Zimny E. Palliative Care Initiated in the Emergency Department: A Cluster Randomized Clinical Trial. JAMA. 2025 Feb 18;333(7):599-608. doi: 10.1001/jama.2024.23696.
Derived from this study: PubMed 38378532Adeyemi O, Ginsburg AD, Kaur R, Cuthel AM, Zhao N, Siman N, Goldfeld KS, Emlet LL, DiMaggio C, Yamarik RL, Bouillon-Minois JB, Chodosh J, Grudzen CR; PRIM-E. R. Investigators. Serious illness communication skills training for emergency physicians and advanced practice providers: a multi-method assessment of the reach and effectiveness of the intervention. BMC Palliat Care. 2024 Feb 21;23(1):48. doi: 10.1186/s12904-024-01349-y.
Derived from this study: PubMed 37262130Adeyemi OJ, Siman N, Goldfeld KS, Cuthel AM, Bouillon-Minois JB, Grudzen CR. Emergency Providers' Knowledge and Attitudes Toward Hospice and Palliative Care: A Cross-Sectional Analysis Across 35 Emergency Departments in the United States. J Palliat Med. 2023 Sep;26(9):1252-1260. doi: 10.1089/jpm.2022.0545. Epub 2023 Jun 1.
Derived from this study: PubMed 36865121Adeyemi O, Ginsburg AD, Kaur R, Cuthel A, Zhao N, Siman N, Goldfeld K, Emlet LL, DiMaggio C, Yamarik R, Bouillon-Minois JB, Chodosh J, Grudzen CR; PRIM-ER Investigators. Serious Illness Communication Skills Training for Emergency Physicians and Advanced Practice Providers: A Multi-Method Assessment of the Reach and Effectiveness of the Intervention. Res Sq [Preprint]. 2023 Feb 21:rs.3.rs-2561749. doi: 10.21203/rs.3.rs-2561749/v1.
Derived from this study: PubMed 33111240Chung FR, Turecamo S, Cuthel AM, Grudzen CR; PRIM-ER Investigators. Effectiveness and Reach of the Primary Palliative Care for Emergency Medicine (PRIM-ER) Pilot Study: a Qualitative Analysis. J Gen Intern Med. 2021 Feb;36(2):296-304. doi: 10.1007/s11606-020-06302-2. Epub 2020 Oct 27.
Derived from this study: PubMed 31992301Tan A, Durbin M, Chung FR, Rubin AL, Cuthel AM, McQuilkin JA, Modrek AS, Jamin C, Gavin N, Mann D, Swartz JL, Austrian JS, Testa PA, Hill JD, Grudzen CR; Group Authorship: Corita R. Grudzen on behalf of the PRIM-ER Clinical Informatics Advisory Board. Design and implementation of a clinical decision support tool for primary palliative Care for Emergency Medicine (PRIM-ER). BMC Med Inform Decis Mak. 2020 Jan 28;20(1):13. doi: 10.1186/s12911-020-1021-7.
Derived from this study: PubMed 31352424Grudzen CR, Brody AA, Chung FR, Cuthel AM, Mann D, McQuilkin JA, Rubin AL, Swartz J, Tan A, Goldfeld KS; PRIM-ER Investigators. Primary Palliative Care for Emergency Medicine (PRIM-ER): Protocol for a Pragmatic, Cluster-Randomised, Stepped Wedge Design to Test the Effectiveness of Primary Palliative Care Education, Training and Technical Support for Emergency Medicine. BMJ Open. 2019 Jul 27;9(7):e030099. doi: 10.1136/bmjopen-2019-030099.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Keith S Goldfeld, DrPH, MS, MPA principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Emergencies, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Care Admission (time frame: Index Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03424109, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.