Clinical trial NCT06008314: Pilot Deployment of ePNa Into Epic EHR
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pneumonia
Keywords: Decision Support
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Vanderbilt University
name: Stanford University
First posted: 2023-08-23
Enrollment: 6917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 14-day hospital-free days
timeFrame: 14 days after initial presentation to the emergency department
Secondary outcomes:
measure: 30-day all-cause mortality
timeFrame: At 30 days after initial ED presentation
measure: ED length of stay (hours)
timeFrame: At ED discharge
measure: ICU length of stay (days)
timeFrame: At ICU discharge
measure: Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours
timeFrame: At 72 hours after inpatient admission
measure: Time from ED presentation to first antibiotic dose (minutes)
timeFrame: At time of first antibiotic dose
Other outcomes:
Locations:
Study officials:
affiliation: Intermountain Health
name: Nathan Dean, MD
role: PRINCIPAL_INVESTIGATOR
References: