- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06008314
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
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
- Name: Valerie Aston, MBA
- Phone Number: 801-507-4606
- Email: valerie.aston@imail.org
Study Contact Backup
- Name: David Tomer, MS
- Phone Number: 801-507-4694
- Email: David.Tomer@imail.org
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:
- 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.
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
Collaborators
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
Additional Relevant MeSH Terms
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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