PneumoniaNCT03358342
ePneumonia: Development of an Electronic Clinical Decision Support System for Community-Onset Pneumonia
An observational study of Pneumonia, run by Intermountain Health Care, Inc. at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- ePneumonia CDS
- How many people
- 10,000 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Nov 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
American Fork Hospital
American Fork, Utah, 84003
Cassia Regional Hospital
Burley, Idaho, 83318
Cedar City Hospital
Cedar City, Utah, 84721
Delta Community Hospital
Delta, Utah, 84624
Fillmore Hospital
Fillmore, Utah, 84631
Heber Valley Hospital
Heber City, Utah, 84032
Logan Regional Hospital
Logan, Utah, 84341
Sanpete Valley Hospital
Mount Pleasant, Utah, 84647
Intermountain Medical Center
Murray, Utah, 84157
McKay-Dee Hospital
Ogden, Utah, 84403
Orem Community Hospital
Orem, Utah, 84057
Garfield Memorial Hospital
Panguitch, Utah, 84759
Park City Medical Center
Park City, Utah, 84060
Utah Valley Hospital
Provo, Utah, 84604
Sevier Valley Hospital
Richfield, Utah, 84701
Dixie Regional Medical Center
St. George, Utah, 84790
Bear River Hospital
Tremonton, Utah, 84337
About this study
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- ePneumonia CDS
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePneumonia CDSOther
ePneumonia clinical decision support system for community-onset pneumonia
| Study group | Role | What they receive |
|---|---|---|
| ED Patients treated using ePneumonia CDS | ED patients with community-acquired pneumonia treated in ED's after roll out of ePneumonia Receives: Other: ePneumonia CDS | |
| Usual care | ED patients with pneumonia receiving usual care without electronic CDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day all-cause mortality
mortality within 30 days of initial ED visit
Measured: 30 days
Secondary outcomes (7)
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
Measured: 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
Measured: 30 days
Antibiotic utilization rates, in terms of appropriateness of spectrum
Antibiotic utilization rates, in terms of appropriateness of spectrum versus identified pneumonia pathogen
Measured: 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
Measured: 7 days
Direct costs
ePneumonia use will produce lower direct costs (total and variable)
Measured: Duration of hospital stay, censored at 90 days
Length of stay
ePneumonia use will shorten length of stay measured in hours
Measured: 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
Measured: 3 year study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start22 Nov 2017
- Primary completion20 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Dean, Intermountain Health Care, Inc.
- Investigators
- Nathan Dean, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358342
- Sponsor's protocol ID
- ePneumonia - CDS
- Status last verified
- Oct 2020
- First submitted
- 24 Nov 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35258444
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ePneumonia: Development of an Electronic Clinical Decision Support System for Community-Onset Pneumonia
- ClinicalTrials.gov ID
- NCT03358342
- Acronym / sponsor ID
- ePneumonia - CDS
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED Patients treated using ePneumonia CDS | – | Other: ePneumonia CDSED patients with community-acquired pneumonia treated in ED's after roll out of ePneumonia |
| Usual care | – | –ED patients with pneumonia receiving usual care without electronic CDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePneumonia CDSePneumonia clinical decision support system for community-onset pneumonia | Other | ED Patients treated using ePneumonia CDS |
Primary outcome
30 day all-cause mortality
Time frame: 30 days
mortality within 30 days of initial ED visit
7 secondary outcomes
Matching of patient disposition from the ED with ePneumonia recommendation
Time frame: 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
Antibiotic utilization rates, in terms of appropriateness of spectrum
Time frame: 30 days
Rate of secondary hospital admission within 7 days for ED patients whose initial disposition was outpatient care
Time frame: 7 days
Direct costs
Time frame: Duration of hospital stay, censored at 90 days
Length of stay
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 35258444Dean 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Dean, MD principal investigator
Intermountain Health Care, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Intermountain Health Care, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day all-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.