ePNa-Epic: Pilot Deployment of ePNa Into Epic EHR

• Sponsor: Nathan Dean (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06008314
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed), Vanderbilt University (Other), Stanford University (Other)
• Enrollment: 6,917
• Arm: 1
• Anticipated Duration (Months): 33.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Other: ePNa	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 6917 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2026
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 14-day hospital-free days [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)

Secondary Outcome Measures

1. 30-day all-cause mortality [At 30 days after initial ED presentation]

2. ED length of stay (hours) [At ED discharge]

3. ICU length of stay (days) [At ICU discharge]

4. Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours [At 72 hours after inpatient admission]

5. Time from ED presentation to first antibiotic dose (minutes) [At time of first antibiotic dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nathan Dean
• Agency for Healthcare Research and Quality (AHRQ)
• Vanderbilt University
• Stanford University

Investigators

• Principal Investigator: Nathan Dean, MD, Intermountain Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nathan Dean, Professor, Pulmonary and Critical Care Medicine, Intermountain Health Care, Inc.
• ClinicalTrials.gov Identifier: NCT06008314
• Other Study ID Numbers: 1052404
• First Posted: Aug 23, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nathan Dean, Professor, Pulmonary and Critical Care Medicine, Intermountain Health Care, Inc.: Decision Support
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Aug 23, 2023