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

October 5, 2020 updated by: Nathan Dean, Intermountain Health Care, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
30 day all-cause mortality
Time Frame: 30 days
mortality within 30 days of initial ED visit
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 30 days
Sensitivity, specificity, positive and negative predictive values for DRIP score versus identified pathogens
30 days
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
30 days
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
7 days
Direct costs
Time Frame: Duration of hospital stay, censored at 90 days
ePneumonia use will produce lower direct costs (total and variable)
Duration of hospital stay, censored at 90 days
Length of stay
Time Frame: Duration of hospital stay, censored at 90 days
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
Time Frame: 3 year study duration
Qualitative outcome based on provider surveys
3 year study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intermountain Health Care, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathan Dean, MD, Intermountain Health Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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