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

September 25, 2023 updated by: Nathan Dean

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

6917

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  1. Patients seen with a history of recent trauma.
  2. Subsequent episodes of pneumonia from the same patient within the study period.
  3. Patients directly admitted to hospice/comfort care.
  4. Patients admitted to a non-study hospital for further care.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital
ePNa (the decision support tool) will be implemented at 2 EDs that are part of the Vanderbilt Health system.
Real-time, automated clinical decision support tool for pneumonia (called "ePNa")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
14-day hospital-free days
Time Frame: 14 days after initial presentation to the emergency department
14-day hospital-free days (a metric which captures outpatient disposition from the emergency department, secondary hospital admission, and length of stay)
14 days after initial presentation to the emergency department

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day all-cause mortality
Time Frame: At 30 days after initial ED presentation
At 30 days after initial ED presentation
ED length of stay (hours)
Time Frame: At ED discharge
At ED discharge
ICU length of stay (days)
Time Frame: At ICU discharge
At ICU discharge
Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours
Time Frame: At 72 hours after inpatient admission
At 72 hours after inpatient admission
Time from ED presentation to first antibiotic dose (minutes)
Time Frame: At time of first antibiotic dose
At time of first antibiotic dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Nathan Dean, MD, Intermountain Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1052404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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