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Pilot Deployment of ePNa Into Epic EHR (ePNa-Epic)

Primary Purpose

Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ePNa
Sponsored by
Nathan Dean
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Decision Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For the baseline database and assessment of clinical outcomes, all data will be pulled from the Epic Clarity data warehouse. 2500 patients that presented to the Vanderbilt and Wilson county EDs who are >= 18 years old will be identified by ICD-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes for the baseline database. An additional 2500 patients that presented to the Vanderbilt and Wilson county EDs who are >= 18 years old will be identified by having had conventional PA (posteroanterior) and lateral or portable CXRs (chest X-rays), independent of ICD-10 codes. During the one year pilot trial, patients seen in the 2 EDs, who are >= 18 years old will be identified by ICD(International Classification of Diseases)-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes (estimated to comprise 1800 patients). Exclusion Criteria: For all above patients: Patients seen with a history of recent trauma. Subsequent episodes of pneumonia from the same patient within the study period. Patients directly admitted to hospice/comfort care. Patients admitted to a non-study hospital for further care. Patients transferred from outside hospitals. For the groups selected by ICD-10 pneumonia codes, an additional exclusion is: • Patients without radiographic evidence of pneumonia or with clear radiographic evidence for an alternative diagnosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital

    Arm Description

    ePNa (the decision support tool) will be implemented at 2 EDs that are part of the Vanderbilt Health system.

    Outcomes

    Primary Outcome Measures

    14-day hospital-free days
    14-day hospital-free days (a metric which captures outpatient disposition from the emergency department, secondary hospital admission, and length of stay)

    Secondary Outcome Measures

    30-day all-cause mortality
    ED length of stay (hours)
    ICU length of stay (days)
    Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours
    Time from ED presentation to first antibiotic dose (minutes)

    Full Information

    First Posted
    August 4, 2023
    Last Updated
    September 25, 2023
    Sponsor
    Nathan Dean
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University, Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06008314
    Brief Title
    Pilot Deployment of ePNa Into Epic EHR
    Acronym
    ePNa-Epic
    Official Title
    Development of "SMART on FHIR (Fast Healthcare Interoperability Resources)" Interoperable Clinical Decision Support (CDS) for Emergency Department (ED) Patients With Pneumonia & Pilot Deployment Into Novel Epic Electronic Health Record (EHR) Environments
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2025 (Anticipated)
    Primary Completion Date
    June 30, 2026 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nathan Dean
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University, Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Intermountain Health has developed a electronic decision support tool to help doctors provide the best care for pneumonia. The purpose of this study is to enhance the existing tool (called ePneumonia (electronic Pneumonia) or ePNa) so that it can be used at other institutions, and to test deployment of the tool at another institution's hospitals.
    Detailed Description
    This study as funded by the AHRQ (Agency for Healthcare Research and Quality) involves making the current ePNa system a "SMART on FHIR" compatible application that will enable the same core software and processes to work across the Cerner and Epic electronic health record platforms. The investigators will then engage with emergency department providers and patients to improve user centered design, considering clinician preferences and feedback for use as well as patient needs for information. Finally, the investigators will evaluate the feasibility and acceptability via a pilot implementation trial of the interoperable ePNa platform at two Vanderbilt affiliated hospitals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia
    Keywords
    Decision Support

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6917 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital
    Arm Type
    Experimental
    Arm Description
    ePNa (the decision support tool) will be implemented at 2 EDs that are part of the Vanderbilt Health system.
    Intervention Type
    Other
    Intervention Name(s)
    ePNa
    Intervention Description
    Real-time, automated clinical decision support tool for pneumonia (called "ePNa")
    Primary Outcome Measure Information:
    Title
    14-day hospital-free days
    Description
    14-day hospital-free days (a metric which captures outpatient disposition from the emergency department, secondary hospital admission, and length of stay)
    Time Frame
    14 days after initial presentation to the emergency department
    Secondary Outcome Measure Information:
    Title
    30-day all-cause mortality
    Time Frame
    At 30 days after initial ED presentation
    Title
    ED length of stay (hours)
    Time Frame
    At ED discharge
    Title
    ICU length of stay (days)
    Time Frame
    At ICU discharge
    Title
    Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours
    Time Frame
    At 72 hours after inpatient admission
    Title
    Time from ED presentation to first antibiotic dose (minutes)
    Time Frame
    At time of first antibiotic dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: For the baseline database and assessment of clinical outcomes, all data will be pulled from the Epic Clarity data warehouse. 2500 patients that presented to the Vanderbilt and Wilson county EDs who are >= 18 years old will be identified by ICD-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes for the baseline database. An additional 2500 patients that presented to the Vanderbilt and Wilson county EDs who are >= 18 years old will be identified by having had conventional PA (posteroanterior) and lateral or portable CXRs (chest X-rays), independent of ICD-10 codes. During the one year pilot trial, patients seen in the 2 EDs, who are >= 18 years old will be identified by ICD(International Classification of Diseases)-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes (estimated to comprise 1800 patients). Exclusion Criteria: For all above patients: Patients seen with a history of recent trauma. Subsequent episodes of pneumonia from the same patient within the study period. Patients directly admitted to hospice/comfort care. Patients admitted to a non-study hospital for further care. Patients transferred from outside hospitals. For the groups selected by ICD-10 pneumonia codes, an additional exclusion is: • Patients without radiographic evidence of pneumonia or with clear radiographic evidence for an alternative diagnosis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valerie Aston, MBA
    Phone
    801-507-4606
    Email
    Valerie.Aston@imail.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Tomer, MS
    Phone
    801-507-4694
    Email
    David.Tomer@imail.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nathan Dean, MD
    Organizational Affiliation
    Intermountain Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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