Clinical trial NCT03358342: ePneumonia: Development of an Electronic Clinical Decision Support System for Community-Onset Pneumonia
Official title: ePneumonia: Development of an Electronic Clinical Decision Support System for Community-Onset Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 30 day all-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: Matching of patient disposition from the ED with ePneumonia recommendation
timeFrame: End of initial ED visit, <24 hours after ED arrival
measure: Accuracy of Drug Resistance in Pneumonia (DRIP) score within the ePneumonia logic to predict Multi-Drug Resistant (MDR) pathogens
timeFrame: 30 days
measure: Antibiotic utilization rates, in terms of appropriateness of spectrum
timeFrame: 30 days
measure: Rate of secondary hospital admission within 7 days for ED patients whose initial disposition was outpatient care
timeFrame: 7 days
measure: Direct costs
timeFrame: Duration of hospital stay, censored at 90 days
measure: Length of stay
timeFrame: Duration of hospital stay, censored at 90 days
measure: Healthcare providers will affirm ePneumonia usability, lack of interference with clinical workflow and only minor unintended consequences of use
timeFrame: 3 year study duration
Other outcomes:
Locations:
city: Burley
country: United States
facility: Cassia Regional Hospital
state: Idaho
city: American Fork
country: United States
facility: American Fork Hospital
state: Utah
city: Cedar City
country: United States
facility: Cedar City Hospital
state: Utah
city: Delta
country: United States
facility: Delta Community Hospital
state: Utah
city: Fillmore
country: United States
facility: Fillmore Hospital
state: Utah
city: Heber
country: United States
facility: Heber Valley Hospital
state: Utah
city: Logan
country: United States
facility: Logan Regional Hospital
state: Utah
city: Mount Pleasant
country: United States
facility: Sanpete Valley Hospital
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Orem
country: United States
facility: Orem Community Hospital
state: Utah
city: Panguitch
country: United States
facility: Garfield Memorial Hospital
state: Utah
city: Park City
country: United States
facility: Park City Medical Center
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Richfield
country: United States
facility: Sevier Valley Hospital
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
city: Tremonton
country: United States
facility: Bear River Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Nathan Dean, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.