Clinical trial NCT03424109: Primary Palliative Care for Emergency Medicine (PRIM-ER)
Official title: Primary Palliative Care for Emergency Medicine (PRIM-ER)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Emergencies
Keywords: Emergency Department
Palliative Care
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institutes of Health (NIH)
name: Memorial Sloan Kettering Cancer Center
First posted: 2018-02-06
Enrollment: 57717
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute care admission
timeFrame: Index Visit
Secondary outcomes:
measure: ED revisits
timeFrame: 6 Months
measure: Inpatient days
timeFrame: 6 Months
measure: Home health use
timeFrame: 6 Months
measure: Hospice use
timeFrame: 6 Months
measure: Survival
timeFrame: 6 Months
measure: Survival: Time-to-event
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Keith S Goldfeld, DrPH, MS, MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.