PneumoniaePNa-EpicNCT06008314
Pilot Deployment of ePNa Into Epic EHR
A study testing ePNa in people with Pneumonia, run by Nathan Dean.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- ePNa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,917 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- ePNa
- Keywords
- Decision Support
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePNaOther
Real-time, automated clinical decision support tool for pneumonia (called "ePNa")
| Study group | Role | What they receive |
|---|---|---|
| Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital | Experimental | ePNa (the decision support tool) will be implemented at 2 EDs that are part of the Vanderbilt Health system. Receives: Other: ePNa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days after initial presentation to the emergency department
Secondary outcomes (5)
30-day all-cause mortality
Measured: At 30 days after initial ED presentation
ED length of stay (hours)
Measured: At ED discharge
ICU length of stay (days)
Measured: At ICU discharge
Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours
Measured: At 72 hours after inpatient admission
Time from ED presentation to first antibiotic dose (minutes)
Measured: At time of first antibiotic dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Feb 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6,917 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Dean
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University, Stanford University
- Responsible party
- Sponsor-investigator, Nathan Dean, Intermountain Health Care, Inc.
- Investigators
- Nathan Dean, MD, Principal investigator, Intermountain Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008314
- Sponsor's protocol ID
- 1052404
- Acronym
- ePNa-Epic
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06008314
- Acronym / sponsor ID
- ePNa-Epic / 1052404
- Conditions
- Pneumonia
- Keywords
- Decision Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,917 participants (estimated)
- Lead sponsor
- Nathan DeanUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University, Stanford University
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital | Experimental | Other: ePNaePNa (the decision support tool) will be implemented at 2 EDs that are part of the Vanderbilt Health system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePNaReal-time, automated clinical decision support tool for pneumonia (called "ePNa") | Other | Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital |
Primary outcome
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)
5 secondary outcomes
30-day all-cause mortality
Time frame: At 30 days after initial ED presentation
ED length of stay (hours)
Time frame: At ED discharge
ICU length of stay (days)
Time frame: 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
Time from ED presentation to first antibiotic dose (minutes)
Time frame: At time of first antibiotic dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Dean, MD principal investigator
Intermountain Health
Questions about this trial
What is this clinical trial studying?
A study testing ePNa in people with Pneumonia, run by Nathan Dean.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Aston, MBA (801-507-4606, Valerie.Aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-day hospital-free days (time frame: 14 days after initial presentation to the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.