Primary Palliative Care for Emergency Medicine (PRIM-ER)

This proposal builds upon the evaluation of Primary Palliative Care Education, Training, and Technical Support for Emergency Medicine (PRIM-ER) implemented in 33 Emergency Departments (EDs). This is a retrospective cohort study that seeks to measure the effect of PRIM-ER on older adults with serious illness on aspects of: 1) ED disposition to an acute setting; 2) healthcare utilization in the 6 months following the index ED visit; 3) survival following the index ED visit; and 4) determine site, provider, and patient-level characteristics that are associated with variation in impact of PRIM-ER across sites.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergencies
• Intervention / Treatment: Behavioral: healthcare service utilization in the six months following the ED visit

• Study Type: Observational
• Enrollment (Estimated): 57717

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The analysis of the effect of PRIM-ER on ED disposition using a generalized linear binomial model with random site level effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute care admission	Will be measured on the index ED visit, and will be a dichotomous variable for an acute care admission (Yes/No).	Index Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED revisits	Will be measured as the number of ED revisits in the six months following the index ED visit (Count).	6 Months
Inpatient days	Will be measured as the number of inpatient stays in the six months following the index ED visit (Count)	6 Months
Home health use	Will be measured as a dichotomous variable for any home health use in the six months following the index ED visit (Yes/No)	6 Months
Hospice use	Will be measured as a dichotomous variable for any hospice use in the six months following the index ED visit (Yes/No)	6 Months
Survival	Will be measured as a dichotomous variable for death in the six months following the index ED visit (Yes/No)	6 Months
Survival: Time-to-event	Will be measured as the number of days from index ED visit to death among those who died within six months following the index ED visit (Count of days)	6 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Memorial Sloan Kettering Cancer Center; National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Keith S Goldfeld, DrPH, MS, MPA, NYU Langone Health; Principal Investigator: Corita R Grudzen, MD, MSHS, FACEP, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 1, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Department; Palliative Care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 17-01819; 5UH3AT009844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No