Primary Palliative Care for Emergency Medicine (PRIM-ER)

NCT03424109 | Completed Results

• 2 other identifiers: 18-006075UH3AT009844
• Study Type: observational
• Target: 98,922
• Locations: 1 country
• Sites: 1

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).

Conditions

Emergencies

Keywords

Emergency Department; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Acute Care Admission

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

  Index Visit

Secondary Outcomes (6)

• Proportion of Patients With Emergency Department (ED) Revisits

  Up to Month 6

• Inpatient Days

  Up to Month 6

• Home Health Use

  Up to Month 6

• Hospice Use

  Up to Month 6

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

  Up to Month 6

Study Arms (1)

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.

Behavioral: healthcare service utilization in the six months following the ED visit

Interventions

healthcare service utilization in the six months following the ED visit BEHAVIORAL

The analysis of the effect of PRIM-ER on ED disposition using a generalized linear binomial model with random site level effects.

Beneficiaries with a one-year mortality of at least 30%

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institutes of Health (NIH): collaborator
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (7)

• 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.

  PMID: 39813042 DERIVED

• 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.

  PMID: 38378532 DERIVED

• 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.

  PMID: 37262130 DERIVED

• 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.

  PMID: 36865121 DERIVED

• 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.

  PMID: 33111240 DERIVED

• 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.

  PMID: 31992301 DERIVED

• 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.

  PMID: 31352424 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Allison Cuthel
• Organization: NYU Langone Health

Allison.Cuthel@nyulangone.org

212-263-8631

Study Officials

• Keith S Goldfeld, DrPH, MS, MPA

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: July 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 22, 2025
• Results First Posted: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)