NCT03358342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

November 24, 2017

Last Update Submit

October 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30 day all-cause mortality

    mortality within 30 days of initial ED visit

    30 days

Secondary Outcomes (7)

  • Matching of patient disposition from the ED with ePneumonia recommendation

    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

    30 days

  • Antibiotic utilization rates, in terms of appropriateness of spectrum

    30 days

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

    7 days

  • Direct costs

    Duration of hospital stay, censored at 90 days

  • +2 more secondary outcomes

Study Arms (2)

ED Patients treated using ePneumonia CDS

ED patients with community-acquired pneumonia treated in ED's after roll out of ePneumonia

Other: ePneumonia CDS

Usual care

ED patients with pneumonia receiving usual care without electronic CDS

Interventions

ePneumonia clinical decision support system for community-onset pneumonia

ED Patients treated using ePneumonia CDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Cassia Regional Hospital

Burley, Idaho, 83318, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Cedar City Hospital

Cedar City, Utah, 84721, United States

Location

Delta Community Hospital

Delta, Utah, 84624, United States

Location

Fillmore Hospital

Fillmore, Utah, 84631, United States

Location

Heber Valley Hospital

Heber City, Utah, 84032, United States

Location

Logan Regional Hospital

Logan, Utah, 84341, United States

Location

Sanpete Valley Hospital

Mount Pleasant, Utah, 84647, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Orem Community Hospital

Orem, Utah, 84057, United States

Location

Garfield Memorial Hospital

Panguitch, Utah, 84759, United States

Location

Park City Medical Center

Park City, Utah, 84060, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

Sevier Valley Hospital

Richfield, Utah, 84701, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84790, United States

Location

Bear River Hospital

Tremonton, Utah, 84337, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nathan Dean, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Chief of Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

November 24, 2017

First Posted

November 30, 2017

Study Start

November 22, 2017

Primary Completion

June 20, 2019

Study Completion

December 31, 2019

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations