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

Primary Purpose

Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician Survey
ePNa-CheXED
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • American Fork Instacare
  • Layton Instacare
  • Lehi Instacare
  • Intermountain Medical Center
  • North Ogden Instacare
  • North Orem Instacare
  • Utah Valley Instacare
  • Herefordshire Instacare
  • Saratoga Springs Instacare
  • South Ogden Instacare
  • Springville Instacare

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Physician Survey

Adapt ePNa-CheXED for InstaCares

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of unplanned subsequent ED Visits
Number of unplanned hospitalizations
Accuracy of pneumonia diagnosis given
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
The change in the transfer rate of UCC pneumonia patients to an ED
we want a decrease of . 3% in the ePNa cluster with those transfers replaced by direct hospital admissions or discharge home.
Use of fewer health care resources

Full Information

First Posted
October 19, 2020
Last Updated
February 4, 2021
Sponsor
Intermountain Health Care, Inc.
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04606849
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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). 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physician Survey
Arm Type
Other
Arm Description
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
Arm Title
Adapt ePNa-CheXED for InstaCares
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Physician Survey
Intervention Description
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
Device
Intervention Name(s)
ePNa-CheXED
Intervention Description
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).
Primary Outcome Measure Information:
Title
ePNa utilization and impact on the UCC clinical environment
Description
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.
Time Frame
through study completion, year 3 of the study
Secondary Outcome Measure Information:
Title
Number of unplanned subsequent ED Visits
Time Frame
within 7 days of initial encounter
Title
Number of unplanned hospitalizations
Time Frame
within 7 days of initial encounter
Title
Accuracy of pneumonia diagnosis given
Description
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
Time Frame
through study completion, year 3 of the study
Title
The change in the transfer rate of UCC pneumonia patients to an ED
Description
we want a decrease of . 3% in the ePNa cluster with those transfers replaced by direct hospital admissions or discharge home.
Time Frame
through study completion, year 3 of the study
Title
Use of fewer health care resources
Time Frame
through study completion, year 3 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Dean, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Fork Instacare
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Layton Instacare
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Lehi Instacare
City
Lehi
State/Province
Utah
ZIP/Postal Code
84043
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
North Ogden Instacare
City
N. Ogden
State/Province
Utah
ZIP/Postal Code
84414
Country
United States
Facility Name
North Orem Instacare
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
Facility Name
Utah Valley Instacare
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Herefordshire Instacare
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
Saratoga Springs Instacare
City
Saratoga Springs
State/Province
Utah
ZIP/Postal Code
84045
Country
United States
Facility Name
South Ogden Instacare
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Springville Instacare
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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