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

NCT04606849 | Recruiting

• 1 other identifier: 1051464
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 12

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• ePNa utilization and impact on the UCC clinical environment

  Frequency of clinicians' disagreement with different ePNa recommendations will be monitored along with a tally of the structured reasons for disagreement entered by clinicians into ePNa.

  through study completion, year 3 of the study

Secondary Outcomes (5)

• Number of unplanned subsequent ED Visits

  within 7 days of initial encounter

• Number of unplanned hospitalizations

  within 7 days of initial encounter

• Accuracy of pneumonia diagnosis given

  through study completion, year 3 of the study

• The change in the transfer rate of UCC pneumonia patients to an ED

  through study completion, year 3 of the study

• Use of fewer health care resources

  through study completion, year 3 of the study

Study Arms (2)

Physician Survey

OTHER

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

Other: Physician Survey

Adapt ePNa-CheXED for InstaCares

OTHER

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).

Device: ePNa-CheXED

Interventions

Physician Survey 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.

Physician Survey

ePNa-CheXED 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).

Adapt ePNa-CheXED for InstaCares

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Stanford University: collaborator

Study Sites (12)

American Fork Instacare

American Fork, Utah, 84003, United States

RECRUITING

Layton Instacare

Layton, Utah, 84041, United States

RECRUITING

Lehi Instacare

Lehi, Utah, 84043, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

NOT YET RECRUITING

North Ogden Instacare

North Ogden, Utah, 84414, United States

NOT YET RECRUITING

North Orem Instacare

Orem, Utah, 84057, United States

NOT YET RECRUITING

Utah Valley Instacare

Provo, Utah, 84604, United States

RECRUITING

Herefordshire Instacare

Roy, Utah, 84067, United States

NOT YET RECRUITING

Saratoga Springs Instacare

Saratoga Springs, Utah, 84045, United States

RECRUITING

South Ogden Instacare

South Ogden, Utah, 84403, United States

NOT YET RECRUITING

Spanish Fork Instacare

Spanish Fork, Utah, 84660, United States

RECRUITING

Springville Instacare

Springville, Utah, 84663, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nathan Dean, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Aston

CONTACT

801-507-4606; valerie.aston@imail.org

Carlos Barbagelata, MS

CONTACT

801-507-4607; carlos.barbagelata@imail.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 28, 2020
• Study Start: November 12, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (12)