Primary Palliative Care for Emergency Medicine (PRIM-ER)

NCT ID: NCT03424109

Last Updated: 2025-06-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98922 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Emergencies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

healthcare service utilization in the six months following the ED visit

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith S Goldfeld, DrPH, MS, MPA

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39813042 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38378532 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37262130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36865121 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33111240 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31992301 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31352424 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5UH3AT009844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-00607

Identifier Type: -

Identifier Source: org_study_id

NCT03424096

Identifier Type: -

Identifier Source: nct_alias

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