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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06008314
Other study ID # 1052404
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2025
Est. completion date June 30, 2026

Study information

Verified date September 2023
Source Intermountain Health Care, Inc.
Contact Valerie Aston, MBA
Phone 801-507-4606
Email Valerie.Aston@imail.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 another institution's hospitals.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 6917
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Nathan Dean Agency for Healthcare Research and Quality (AHRQ), Stanford University, Vanderbilt University

Outcome

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