Clinical trial NCT04606849: Adaptation and Pilot Implementation of ePNa Clinical Decision Support for Utah Urgent Care Clinics
Official title: Adaptation and Pilot Implementation of a Validated, Electronic Real-Time Clinical Decision Support Tool for Care of Pneumonia Patients in 10 Utah Urgent Care Centers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumonia
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2020-10-28
Enrollment: 4000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We plan to adapt an innovative, validated emergency department (ED) CDS tool based on consensus guidelines for pneumonia care (ePNa) to function in urgent care clinics (Instacares at Intermountain) and combine it seamlessly with Stanford's CheXED artificial intelligence model using an interoperable platform currently under development by Care Transformation Information Services at Intermountain. We will then deploy it to one of two groups of Instacares (randomly selected) using the CFIR framework for Implementation Science best practice.

Detailed description: Clinicians' ability to accurately diagnose pneumonia and then choose the most appropriate treatment options is enhanced by well-designed clinical decision support (CDS). Pneumonia CDS has historically been focused on inpatient settings, but ambulatory care settings with high pneumonia patient volumes also might benefit. The investigators propose to adapt an innovative, validated emergency department (ED) CDS tool based on consensus guidelines for pneumonia care (ePNa) and deploy it to urgent care centers (UCC) using the CFIR framework. Electronic tools such as ePNa may become even more useful within UCCs as the COVID-19 pandemic evolves, since recommendations can be readily updated as better methods of diagnosis and effective treatment develop. ePNa within the ED has already been adapted to recommend SARS-coV-2 testing for patients with pneumonia and signs and symptoms characteristic of viral pneumonia.

The proposal supports four aims:

1. Adapt ePNa for UCC and after in silico testing, pilot it among "super user" clinicians during UCC shifts and assess its usability. ePNa needs adaptation for more limited patient data available in UCCs, calibration of severity measures for lower observed mortality, and a chest imaging prompt in patients with pneumonia signs and symptoms. ePNa for UCC will incorporate Stanford University's artificial intelligence CheXED model to provide electronic classification of chest images in \<10 seconds for elements of pneumonia diagnosis and treatment (radiographic pneumonia, single vs multiple lobes, and pleural effusion).
2. Using the CFIR framework, our prior ED implementation experience, a focus group of UCC clinicians, semi-structured interviews, and direct observations of workflow including ePNa guided transitions of care between clinicians, the investigators will identify barriers and facilitators to adaptation and implementation of ePNa to UCCs.
3. Test the implementation strategy by deploying ePNa at one of two randomly chosen Intermountain Healthcare UCC clusters each with about 800 annual pneumonia patients - the other a usual care control.
4. Co-primary outcomes are a) accuracy of pneumonia diagnosis defined by compatible chief complaint plus ≥ 1 pneumonia sign/symptom and radiographic confirmation will be ≥10% higher in the ePNa cluster, and b) the percent of UCC pneumonia patients transferred to an emergency department for further evaluation will decrease by ≥ 3% in the ePNa cluster replaced by more direct hospital admissions or discharge home. Safety measures will be unplanned subsequent 7-day ED visits/hospitalizations and 30-day mortality. Based on this rigorous pilot study, the investigators anticipate a subsequent multi-system cluster-randomized trial.

Our work incorporates the Five Rights of CDS to ensure that the strengths of this technology are optimized in the clinical environment. The investigators will leverage experience in innovative pneumonia research, pioneering CDS, and implementation science available at Intermountain to successfully complete this proposal.

Eligibility criteria: Inclusion Criteria:

* All patients ≥ 12 years of age with pneumonia: defined by the J-18.X pneumonia code or acute respiratory failure or sepsis with secondary pneumonia codes

Survey All physicians and advanced practice clinicians who are employed and actively seeing patients in the 4 Utah Valley Instacares

Exclusion Criteria:

* Patients without radiographic confirmation of pneumonia
* Subsequent episodes of pneumonia within 12 months (so as not to over-represent patients with recurrent pneumonia caused by recurrent aspiration or structural lung disease).

Survey No providers will be excluded from the survey invitation

Primary outcomes:
measure: ePNa utilization and impact on the UCC clinical environment
timeFrame: through study completion, year 3 of the study
Secondary outcomes:
measure: Number of unplanned subsequent ED Visits
timeFrame: within 7 days of initial encounter
measure: Number of unplanned hospitalizations
timeFrame: within 7 days of initial encounter
measure: Accuracy of pneumonia diagnosis given
timeFrame: through study completion, year 3 of the study
measure: The change in the transfer rate of UCC pneumonia patients to an ED
timeFrame: through study completion, year 3 of the study
measure: Use of fewer health care resources
timeFrame: through study completion, year 3 of the study
Other outcomes:
Locations:
city: American Fork
country: United States
facility: American Fork Instacare
state: Utah
city: Layton
country: United States
facility: Layton Instacare
state: Utah
city: Lehi
country: United States
facility: Lehi Instacare
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: N. Ogden
country: United States
facility: North Ogden Instacare
state: Utah
city: Orem
country: United States
facility: North Orem Instacare
state: Utah
city: Provo
country: United States
facility: Utah Valley Instacare
state: Utah
city: Roy
country: United States
facility: Herefordshire Instacare
state: Utah
city: Saratoga Springs
country: United States
facility: Saratoga Springs Instacare
state: Utah
city: South Ogden
country: United States
facility: South Ogden Instacare
state: Utah
city: Spanish Fork
country: United States
facility: Spanish Fork Instacare
state: Utah
city: Springville
country: United States
facility: Springville Instacare
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Nathan Dean, MD
role: PRINCIPAL_INVESTIGATOR
References: