Adaptation and Pilot Implementation of ePNa Clinical Decision Support for Utah Urgent Care Clinics

NCT ID: NCT04606849

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physician Survey

A modified version of a previously validated REDCap questionnaire will be administered to Instacare clinicians in the cluster where ePNa-CheXED was deployed via email at 6 months after ePNa-CheXED implementation. Our questionnaire includes questions on respondent demographics and Likert-style questions about respondents' experiences with ePNa. We will validate our modified questionnaire by calculating component loadings and Cronbach Alphas (i.e., internal consistency) of Likert questions loading onto the same components

Group Type OTHER

Physician Survey

Intervention Type OTHER

Our questionnaire includes questions on respondent demographics and Likert-style questions about respondent experiences with ePNa. We will validate our modified questionnaire by calculating component loadings and Cronbach Alphas (i.e., internal consistency) of Likert questions loading onto the same components.

Adapt ePNa-CheXED for InstaCares

Adapt ePNa-CheXED for Instacares and after in silico testing, pilot it among "super user" clinicians during Instacare shifts and assess its usability. ePNa needs adaptation for more limited patient data available in Instacare clinics, calibration of severity measures for lower observed mortality, and a chest imaging prompt in patients with pneumonia signs and symptoms. ePNa-CheXED will incorporate Stanford University's artificial intelligence CheXED model to provide electronic classification of chest images in \<1 second for elements of pneumonia diagnosis and treatment (radiographic pneumonia, single vs multiple lobes, and pleural effusion).

Group Type OTHER

ePNa-CheXED

Intervention Type DEVICE

ePNa-CheXED will incorporate Stanford University's artificial intelligence CheXED model to provide electronic classification of chest images in \<1 second for elements of pneumonia diagnosis and treatment (radiographic pneumonia, single vs multiple lobes, and pleural effusion).

Interventions

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Physician Survey

Our questionnaire includes questions on respondent demographics and Likert-style questions about respondent experiences with ePNa. We will validate our modified questionnaire by calculating component loadings and Cronbach Alphas (i.e., internal consistency) of Likert questions loading onto the same components.

Intervention Type OTHER

ePNa-CheXED

ePNa-CheXED will incorporate Stanford University's artificial intelligence CheXED model to provide electronic classification of chest images in \<1 second for elements of pneumonia diagnosis and treatment (radiographic pneumonia, single vs multiple lobes, and pleural effusion).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Dean, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

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American Fork Instacare

American Fork, Utah, United States

Site Status RECRUITING

Layton Instacare

Layton, Utah, United States

Site Status RECRUITING

Lehi Instacare

Lehi, Utah, United States

Site Status RECRUITING

Intermountain Medical Center

Murray, Utah, United States

Site Status NOT_YET_RECRUITING

North Ogden Instacare

North Ogden, Utah, United States

Site Status NOT_YET_RECRUITING

North Orem Instacare

Orem, Utah, United States

Site Status NOT_YET_RECRUITING

Utah Valley Instacare

Provo, Utah, United States

Site Status RECRUITING

Herefordshire Instacare

Roy, Utah, United States

Site Status NOT_YET_RECRUITING

Saratoga Springs Instacare

Saratoga Springs, Utah, United States

Site Status RECRUITING

South Ogden Instacare

South Ogden, Utah, United States

Site Status NOT_YET_RECRUITING

Spanish Fork Instacare

Spanish Fork, Utah, United States

Site Status RECRUITING

Springville Instacare

Springville, Utah, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Valerie Aston

Role: CONTACT

801-507-4606

Carlos Barbagelata, MS

Role: CONTACT

801-507-4607

Facility Contacts

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Nathan Dean

Role: primary

Nathan Dean

Role: primary

Nathan Dean

Role: primary

Valerie Aston

Role: primary

801-507-4606

Carlos Barbagelata

Role: backup

801-507-4607

Nathan Dean

Role: primary

Nathan Dean

Role: primary

Nathan Dean

Role: primary

Nathan Dean

Role: primary

Nathan Dean

Role: primary

Nathan Dean

Role: primary

Nathan Dean

Role: primary

801-891-7340

Nathan Dean

Role: primary

Other Identifiers

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1051464

Identifier Type: -

Identifier Source: org_study_id

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