ePneumonia: Development of an Electronic Clinical Decision Support System for Community-Onset Pneumonia

The investigators plan to further develop a prototype, evidence-based, electronic clinical decision support system (CDSS) for pneumonia care (ePneumonia) with interoperability across Electronic Health Records in order to improve clinical outcomes and reduce healthcare resource utilization. The specific aims of this study are to evaluate the usability of ePneumonia adapted for Cerner and its impact on clinical, patient-centered and healthcare resource utilization outcomes in a stepped-wedge implementation study in 16 hospital emergency departments (EDs) across the Intermountain Healthcare integrated health system.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Other: ePneumonia CDS

Detailed Description

Since the launch of a paper-based pneumonia care process model in 1994, decision support for pneumonia care has been under continuous development at Intermountain. Studies published in 2001 and 2006 demonstrated decreased mortality using paper-based methods. An electronic pneumonia Clinical Decision Support System was later developed in the original Intermountain computing environment and implemented in 4 regional emergency departments (ED) in 2011. This tool featured a novel mortality predictor and real-time synthesis of clinical data to guide diagnosis, risk stratification, admission triage and guideline-concordant treatment. An outcome study published in 2015 demonstrated reduction in mortality with tool use compared to usual care. Most recently, Intermountain researchers led by study co-Investigator, Dr. Brandon Webb, developed an innovative tool to predict risk of drug-resistant bacteria and demonstrated its potential to improve antibiotic use and outcomes.

The investigators have entered a robust phase of additional development and adaptation of ePneumonia into the Cerner Electronic Health Record (EHR) system. The objective of this study is to advance development of an evidence-based, electronic CDSS for pneumonia care with interoperability across EHRs in order to improve clinical outcomes and reduce healthcare resource utilization. The specific aim of this study is to evaluate the usability of ePneumonia and its associated impact on clinical, patient-centered and healthcare resource utilization outcomes in a stepped-wedge implementation study in 16 hospital EDs in the Intermountain Healthcare integrated health system.

• Hypothesis #1: Healthcare providers will affirm ePneumonia usability, lack of interference with clinical workflow and only minor unintended consequences of use.
• Hypothesis #2: In patients with community-onset pneumonia, ePneumonia use will improve clinical and patient-centered outcomes and decrease healthcare resource utilization.

One year of baseline clinical outcome data will be gathered for all 16 emergency departments. The first of 6 clusters of ED's will begin prospective data collection in January 2018, with the remaining coming on at 2 month intervals until ePneumonia has been deployed at all sites. An additional 1 year of data collection will be continued through 2019.

• Study Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Burley, Idaho, United States, 83318
      • Cassia Regional Hospital
  • Utah
    • American Fork, Utah, United States, 84003
      • American Fork Hospital
    • Cedar City, Utah, United States, 84721
      • Cedar City Hospital
    • Delta, Utah, United States, 84624
      • Delta Community Hospital
    • Fillmore, Utah, United States, 84631
      • Fillmore Hospital
    • Heber, Utah, United States, 84032
      • Heber Valley Hospital
    • Logan, Utah, United States, 84341
      • Logan Regional Hospital
    • Mount Pleasant, Utah, United States, 84647
      • Sanpete Valley Hospital
    • Murray, Utah, United States, 84157
      • Intermountain Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital
    • Orem, Utah, United States, 84057
      • Orem Community Hospital
    • Panguitch, Utah, United States, 84759
      • Garfield Memorial Hospital
    • Park City, Utah, United States, 84060
      • Park City Medical Center
    • Provo, Utah, United States, 84604
      • Utah Valley Hospital
    • Richfield, Utah, United States, 84701
      • Sevier Valley Hospital
    • Saint George, Utah, United States, 84790
      • Dixie Regional Medical Center
    • Tremonton, Utah, United States, 84337
      • Bear River Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

(1) All patients ≥ 18 years who are identified by either (2a) ICD-10 codes for pneumonia; or acute respiratory failure or sepsis with secondary pneumonia codes or (2b) clinician completion of ePneumonia for Cerner.

Intermountain Healthcare physicians

Description

Inclusion Criteria:

• All patients ≥ 18 years who are identified by either (2a) ICD-10 codes for pneumonia; or acute respiratory failure or sepsis with secondary pneumonia codes or (2b) clinician completion of ePneumonia for Cerner.
• Intermountain Healthcare physicians working in the 16 ED's

Exclusion Criteria:

• Patients without radiographic confirmation of pneumonia
• subsequent episodes of pneumonia within the study period, so as not to over-represent patients with recurrent pneumonia caused by recurrent aspiration or structural lung disease, and
• immunosuppressed patients, such as those with AIDS.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ED Patients treated using ePneumonia CDS; ED patients with community-acquired pneumonia treated in ED's after roll out of ePneumonia	Other: ePneumonia CDS; ePneumonia clinical decision support system for community-onset pneumonia
Usual care; ED patients with pneumonia receiving usual care without electronic CDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day all-cause mortality	mortality within 30 days of initial ED visit	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Matching of patient disposition from the ED with ePneumonia recommendation	ePneumonia use will increase simple agreement between patient disposition from the ED with ePneumonia recommendation based on illness severity	End of initial ED visit, <24 hours after ED arrival
Accuracy of Drug Resistance in Pneumonia (DRIP) score within the ePneumonia logic to predict Multi-Drug Resistant (MDR) pathogens	Sensitivity, specificity, positive and negative predictive values for DRIP score versus identified pathogens	30 days
Antibiotic utilization rates, in terms of appropriateness of spectrum	Antibiotic utilization rates, in terms of appropriateness of spectrum versus identified pneumonia pathogen	30 days
Rate of secondary hospital admission within 7 days for ED patients whose initial disposition was outpatient care	Rate of secondary hospital admission within 7 days for ED patients whose initial disposition was outpatient care	7 days
Direct costs	ePneumonia use will produce lower direct costs (total and variable)	Duration of hospital stay, censored at 90 days
Length of stay	ePneumonia use will shorten length of stay measured in hours	Duration of hospital stay, censored at 90 days
Healthcare providers will affirm ePneumonia usability, lack of interference with clinical workflow and only minor unintended consequences of use	Qualitative outcome based on provider surveys	3 year study duration

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Nathan Dean, MD, Intermountain Health Care, Inc.

Publications and helpful links

General Publications

• Dean NC, Vines CG, Carr JR, Rubin JG, Webb BJ, Jacobs JR, Butler AM, Lee J, Jephson AR, Jenson N, Walker M, Brown SM, Irvin JA, Lungren MP, Allen TL. A Pragmatic, Stepped-Wedge, Cluster-controlled Clinical Trial of Real-Time Pneumonia Clinical Decision Support. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1330-1336. doi: 10.1164/rccm.202109-2092OC.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: ePneumonia - CDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No