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

August 22, 2024 updated by: Intermountain Health Care, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • American Fork, Utah, United States, 84003
      • Layton, Utah, United States, 84041
      • Lehi, Utah, United States, 84043
      • Murray, Utah, United States, 84107
        • Not yet recruiting
        • Intermountain Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rajendu Srivastava, MD
        • Principal Investigator:
          • Nathan Dean, MD
        • Sub-Investigator:
          • Karen Conner
        • Sub-Investigator:
          • James Hart
        • Sub-Investigator:
          • Peter Haug, MD
        • Sub-Investigator:
          • Kathryn Kuttler
        • Sub-Investigator:
          • Edward Stenehjem, MD
        • Sub-Investigator:
          • Anthony Wallin
      • N. Ogden, Utah, United States, 84414
      • Orem, Utah, United States, 84057
      • Provo, Utah, United States, 84604
      • Roy, Utah, United States, 84067
      • Saratoga Springs, Utah, United States, 84045
      • South Ogden, Utah, United States, 84403
      • Spanish Fork, Utah, United States, 84660
        • Recruiting
        • Spanish Fork Instacare
        • Contact:
      • Springville, Utah, United States, 84663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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.
Other: 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).
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ePNa utilization and impact on the UCC clinical environment
Time Frame: through study completion, year 3 of the study
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unplanned subsequent ED Visits
Time Frame: within 7 days of initial encounter
within 7 days of initial encounter
Number of unplanned hospitalizations
Time Frame: within 7 days of initial encounter
within 7 days of initial encounter
Accuracy of pneumonia diagnosis given
Time Frame: through study completion, year 3 of the study
defined by compatible chief complaint (cough, dyspnea, chest pain, fever) plus . 1 pneumonia sign/symptom (temperature . 38.0C or < 36.0C, white blood cell count >10,000/ul or <4000/ul), bandemia >10%, SpO2<90% on room air, respiratory rate >20/minute)19 and radiographic confirmation
through study completion, year 3 of the study
The change in the transfer rate of UCC pneumonia patients to an ED
Time Frame: through study completion, year 3 of the study
we want a decrease of . 3% in the ePNa cluster with those transfers replaced by direct hospital admissions or discharge home.
through study completion, year 3 of the study
Use of fewer health care resources
Time Frame: through study completion, year 3 of the study
through study completion, year 3 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Collaborators

Stanford University

Investigators

  • Principal Investigator: Nathan Dean, MD, Intermountain Health Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1051464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on Physician Survey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe