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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358342
• Other study ID #: ePneumonia - CDS
• Status: Completed
• Start date: November 22, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: December 31, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• ePneumonia CDS
ePneumonia clinical decision support system for community-onset pneumonia

Locations

Country	Name	City	State
United States	American Fork Hospital	American Fork	Utah
United States	Cassia Regional Hospital	Burley	Idaho
United States	Cedar City Hospital	Cedar City	Utah
United States	Delta Community Hospital	Delta	Utah
United States	Fillmore Hospital	Fillmore	Utah
United States	Heber Valley Hospital	Heber	Utah
United States	Logan Regional Hospital	Logan	Utah
United States	Sanpete Valley Hospital	Mount Pleasant	Utah
United States	Intermountain Medical Center	Murray	Utah
United States	McKay-Dee Hospital	Ogden	Utah
United States	Orem Community Hospital	Orem	Utah
United States	Garfield Memorial Hospital	Panguitch	Utah
United States	Park City Medical Center	Park City	Utah
United States	Utah Valley Hospital	Provo	Utah
United States	Sevier Valley Hospital	Richfield	Utah
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Bear River Hospital	Tremonton	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day all-cause mortality	mortality within 30 days of initial ED visit	30 days
Secondary	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
Secondary	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
Secondary	Antibiotic utilization rates, in terms of appropriateness of spectrum	Antibiotic utilization rates, in terms of appropriateness of spectrum versus identified pneumonia pathogen	30 days
Secondary	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
Secondary	Direct costs	ePneumonia use will produce lower direct costs (total and variable)	Duration of hospital stay, censored at 90 days
Secondary	Length of stay	ePneumonia use will shorten length of stay measured in hours	Duration of hospital stay, censored at 90 days
Secondary	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