NCT06008314

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,917

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Feb 2025Jun 2026

First Submitted

Initial submission to the registry

August 4, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

August 4, 2023

Last Update Submit

September 25, 2023

Conditions

Keywords

Decision Support

Outcome Measures

Primary Outcomes (1)

  • 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)

    14 days after initial presentation to the emergency department

Secondary Outcomes (5)

  • 30-day all-cause mortality

    At 30 days after initial ED presentation

  • ED length of stay (hours)

    At ED discharge

  • ICU length of stay (days)

    At ICU discharge

  • Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours

    At 72 hours after inpatient admission

  • Time from ED presentation to first antibiotic dose (minutes)

    At time of first antibiotic dose

Study Arms (1)

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.

Other: ePNa

Interventions

ePNaOTHER

Real-time, automated clinical decision support tool for pneumonia (called "ePNa")

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For the baseline database and assessment of clinical outcomes, all data will be pulled from the Epic Clarity data warehouse.
  • 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).

You may not qualify if:

  • 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.
  • Patients without radiographic evidence of pneumonia or with clear radiographic evidence for an alternative diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nathan Dean, MD

    Intermountain Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Aston, MBA

CONTACT

David Tomer, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 23, 2023

Study Start

February 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share