PneumoniaNCT04606849
Adaptation and Pilot Implementation of ePNa Clinical Decision Support for Utah Urgent Care Clinics
A study testing Physician Survey and ePNa-CheXED in people with Pneumonia, run by Intermountain Health Care, Inc. at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- Physician Survey and ePNa-CheXED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 12 sitesUnited States
- Study dates
- 12 Nov 2020to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
American Fork Instacare
American Fork, Utah, 84003
Nathan Dean, nathan.dean@imail.org
- Recruiting
Layton Instacare
Layton, Utah, 84041
Nathan Dean, nathan.dean@imail.org
- Recruiting
Lehi Instacare
Lehi, Utah, 84043
Nathan Dean, nathan.dean@imail.org
- Not yet recruiting
Intermountain Medical Center
Murray, Utah, 84107
Valerie Aston, 801-507-4606, valerie.aston@imail.org
Carlos Barbagelata, 801-507-4607, carlos.barbagelata@imail.org
- Not yet recruiting
North Ogden Instacare
North Ogden, Utah, 84414
Nathan Dean, nathan.dean@imail.org
- Not yet recruiting
North Orem Instacare
Orem, Utah, 84057
Nathan Dean, nathan.dean@imail.org
- Recruiting
Utah Valley Instacare
Provo, Utah, 84604
Nathan Dean, nathan.dean@imail.org
- Not yet recruiting
Herefordshire Instacare
Roy, Utah, 84067
Nathan Dean, nathan.dean@imail.org
- Recruiting
Saratoga Springs Instacare
Saratoga Springs, Utah, 84045
Nathan Dean, nathan.dean@imail.org
- Not yet recruiting
South Ogden Instacare
South Ogden, Utah, 84403
Nathan Dean, nathan.dean@imail.org
- Recruiting
Spanish Fork Instacare
Spanish Fork, Utah, 84660
Nathan Dean, 801-891-7340, nathan.dean@imail.org
- Not yet recruiting
Springville Instacare
Springville, Utah, 84663
Nathan Dean, nathan.dean@imail.org
About this study
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
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- Physician Survey, ePNa-CheXED
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician SurveyOther
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.
ePNa-CheXEDDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Device: ePNa-CheXED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, year 3 of the study
Secondary outcomes (5)
Number of unplanned subsequent ED Visits
Measured: within 7 days of initial encounter
Number of unplanned hospitalizations
Measured: within 7 days of initial encounter
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
Measured: through study completion, year 3 of the study
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.
Measured: through study completion, year 3 of the study
Use of fewer health care resources
Measured: through study completion, year 3 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start12 Nov 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Nathan Dean, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606849
- Sponsor's protocol ID
- 1051464
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2020
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04606849
- Acronym / sponsor ID
- 1051464
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Stanford University
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician Survey | Other | Other: Physician SurveyA 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 | Other | Device: ePNa-CheXEDAdapt 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). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician SurveyOur 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 | Physician Survey |
| ePNa-CheXEDePNa-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 | Adapt ePNa-CheXED for InstaCares |
Primary outcome
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.
5 secondary outcomes
Number of unplanned subsequent ED Visits
Time frame: within 7 days of initial encounter
Number of unplanned hospitalizations
Time frame: within 7 days of initial encounter
Accuracy of pneumonia diagnosis given
Time frame: 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
Use of fewer health care resources
Time frame: through study completion, year 3 of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Dean, MD principal investigator
Intermountain Health Care, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Survey and ePNa-CheXED in people with Pneumonia, run by Intermountain Health Care, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Aston (801-507-4606, valerie.aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ePNa utilization and impact on the UCC clinical environment (time frame: through study completion, year 3 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.