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| ID | Type | Description | Link |
|---|---|---|---|
| 5UH3AT009844 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institutes of Health (NIH) | NIH |
| Memorial Sloan Kettering Cancer Center | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Care Admission | Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service). | Index Visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to Month 6 |
| Inpatient Days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Keith S Goldfeld, DrPH, MS, MPA | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39813042 | Derived | 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. | |
| 38378532 |
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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.
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control Period |
| |||||||||||||
| PRIM-ER Intervention Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Care as usual. -ER). |
| BG001 | PRIM-ER | Intervention comprising primary palliative care education, training, and technical support for emergency medicine (PRIM-ER). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Care Admission | Proportion of eligible patients whose disposition is to an acute care setting (inpatient, non-palliative service). | Posted | Number | Proportion of participants | Index Visit | Emergency Departments (EDs) | Emergency Departments (EDs) |
|
|
12 months
Adverse event (serious and non-serious) information data were not collected among participants in this retrospective study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients who received care as usual. | 14,179 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Cuthel | NYU Langone Health | 212-263-8631 | Allison.Cuthel@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2022 | Feb 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Measured as the proportion of patients who had at least one inpatient stay in the six months following the index ED visit (Count).
| 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) | Up to Month 6 |
| Hospice Use | Proportion of patients with any hospice use in the six months following the index ED visit (Yes/No). | Up to Month 6 |
| Proportion of Patients Who Died at Month 6 Post-Index Visit | 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) | Up to Month 6 |
| 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. |
| 37262130 | 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. |
| 36865121 | 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. |
| 33111240 | 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. |
| 31992301 | 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. |
| 31352424 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| Emergency Departments (EDs) |
|
|
| 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) | Posted | Number | Proportion of Patients | Up to Month 6 | Emergency Departments (EDs) | Emergency Departments (EDs) |
|
|
|
| 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). | Posted | Number | Proportion of participants | Up to Month 6 | Emergency Departments (EDs) | Emergency Departments (EDs) |
|
|
|
| Secondary | Home Health Use | Proportion of patients with any home health use in the six months following the index ED visit (Yes/No) | Posted | Number | Proportion of participants | Up to Month 6 | Emergency Departments (EDs) | Emergency Departments (EDs) |
|
|
|
| Secondary | Hospice Use | Proportion of patients with any hospice use in the six months following the index ED visit (Yes/No). | Posted | Number | Proportion of participants | Up to Month 6 | Emergency Departments (EDs) | Emergency Departments (EDs) |
|
|
|
| Secondary | Proportion of Patients Who Died at Month 6 Post-Index Visit | Posted | Number | Proportion of participants | Up to Month 6 | Emergency Departments (EDs) | Emergency Departments (EDs) |
|
|
|
| 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) | Posted | Mean | Standard Deviation | Days | Up to Month 6 | Emergency Departments (EDs) | Emergency Departments (EDs) |
|
|
|
| 50,458 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | PRIM-ER | Patients who received PRIM-ER. | 13,910 | 48,464 | 0 | 0 | 0 | 0 |
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