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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03424096
Other study ID # 17-01790
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 30, 2018
Last updated February 5, 2018
Start date September 2018
Est. completion date February 2023

Study information

Verified date February 2018
Source New York University School of Medicine
Contact Nicole Tang
Phone 646 201 4033
Email nicole.tang@nyumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this cluster-randomized stepped wedge design is to test the effectiveness of primary palliative care education, training, and technical support for emergency medicine (PRIM-ER) in 35 Emergency Departments (EDs). PRIM-ER includes four core components: 1) evidence-based multidisciplinary primary palliative care education, 2) simulation-based workshops on communication in serious illness, 3) clinical decision support, and 4) provider audit and feedback.


Description:

The specific aims of this study are divided into a UG3 phase and a UH3 phase.

In the UG3 phase, investigator will: 1) tailor PRIM-ER to the emergency provider workforce and a more diverse ED context using an agile implementation framework approach; and 2) pilot test PRIM-ER at two sites for feasibility, fidelity, and usability.

In the UH3 phase, investigators will: 3) implement PRIM-ER in a cluster-randomized, stepped wedge design in the remaining 33 EDs.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Eligible key informants will be a member of the local palliative care team and a local representative from emergency medicine, nursing, and social work/case management, and informatics from each of the 18 health systems.

- Eligible physicians, physician assistants, and nurse practitioners will include emergency physicians, physician assistants, and nurse practitioners employed as full-time emergency providers in any of the participating EDs.

- Eligible nurses will include full-time emergency nurses employed as full-time emergency nurses at any of the participating EDs.

- Eligible social workers and case managers will include full-time emergency social workers or case managers employed by any of the health systems.

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Primary Palliative Care Education
Palliative care is medical care that specializes in pain and symptom management. Palliative care is also referred to as supportive care.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York University School of Medicine National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of Usability using MORAE Software to analyze questions from CDS system MORAE software will be utilized to perform screen captures and audio record participants verbalizing their actions, thoughts, and feelings as they progress through a simulated Clinical Decision Support (CDS) system 8 Hours
Primary Measure of Feasibility using MORAE Software to analyze questions from CDS system Data analysis to identify local barriers and facilitators of ED-based palliative care in serious illness 8 Hours
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