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Completed

NCT Number: NCT03358342

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cassia Regional Hospital, Burley, Idaho, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ePneumonia CDS

Other

ePneumonia clinical decision support system for community-onset pneumonia

Primary outcomes

  1. 30 day all-cause mortality

    Time frame: 30 days

    mortality within 30 days of initial ED visit

Secondary outcomes

  1. Matching of patient disposition from the ED with ePneumonia recommendation

    Time frame: End of initial ED visit, <24 hours after ED arrival

    ePneumonia use will increase simple agreement between patient disposition from the ED with ePneumonia recommendation based on illness severity

  2. Accuracy of Drug Resistance in Pneumonia (DRIP) score within the ePneumonia logic to predict Multi-Drug Resistant (MDR) pathogens

    Time frame: 30 days

    Sensitivity, specificity, positive and negative predictive values for DRIP score versus identified pathogens

  3. Antibiotic utilization rates, in terms of appropriateness of spectrum

    Time frame: 30 days

    Antibiotic utilization rates, in terms of appropriateness of spectrum versus identified pneumonia pathogen

  4. Rate of secondary hospital admission within 7 days for ED patients whose initial disposition was outpatient care

    Time frame: 7 days

    Rate of secondary hospital admission within 7 days for ED patients whose initial disposition was outpatient care

  5. Direct costs

    Time frame: Duration of hospital stay, censored at 90 days

    ePneumonia use will produce lower direct costs (total and variable)

  6. Length of stay

    Time frame: Duration of hospital stay, censored at 90 days

    ePneumonia use will shorten length of stay measured in hours

  7. Healthcare providers will affirm ePneumonia usability, lack of interference with clinical workflow and only minor unintended consequences of use

    Time frame: 3 year study duration

    Qualitative outcome based on provider surveys

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2017
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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