Covid19NCT04542421
Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19
A study testing Lung ultrasound use in patients hospitalized with COVID in people with Covid19, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Lung ultrasound (LUS) has also been shown to be more accurate than chest x-ray in identifying pulmonary consolidation and pulmonary edema, both of which are found in patients with COVID. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Lung ultrasound use in patients hospitalized with COVID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians and advanced care provider faculty in the Division of hospital medicine at University of Colorado Hospital, Aurora Colorado
Who cannot join
- Physicians and advanced care provider Faulty within the Division of Hospital medicine at University of Colorado Hospital who care for hospitalized patients less than 2 weeks per year
Trial locations and contacts
1 site in 1 country.
About this study
Lung ultrasound (LUS) has also been shown to be more accurate than chest x-ray in identifying pulmonary consolidation and pulmonary edema, both of which are found in patients with COVID.
The investigators hypothesize implementation of LUS by hospitalists in the management of suspected or diagnosed patients with COVID-19 will reduce the need for Chest CT and chest x-ray, thereby conserving PPE, reducing risk of transmission to technicians and conserving the resources of radiology services that would otherwise be overwhelmed by patients with COVID-19 in need of chest imaging. Using the methods of implementation science, the investigators propose to respond to the urgent need for rapid implementation of LUS by hospitalists in management of adult patients hospitalized for COVID.
Read more
Aim 1a: Using a rapid-cycle weekly Plan-Do-Study-Act cycle and Rapid Iterative RE-AIM, to optimize the implementation of LUS by adult hospitalists in the management of COVID-19 patients in a pilot study
Aim 1b: Evaluate this pilot implementation of LUS by adult hospitalists using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Read the detailed description
Study overview:. The investigators will begin LUS implementation using strategies that target barriers already identified by hospitalists in prior qualitative work. The investigators will then proceed to conduct weekly rapid Plan-Do-Study-Act cycles informed by Rapid Iterative RE-AIM, in order to ensure timely identification of implementation barriers. Rapid Iterative RE- AIM is an innovative application of the RE-AIM framework in which screening assessments of RE-AIM outcomes (e.g. level of reach, adoption, implementation) which is performed at regular intervals during implementation and has been shown to be a feasible means of assessing interval implementation. For outcomes not meeting target implementation at our interval assessments, we will perform rapid qualitative interviews of key stakeholders to identify current barriers. Using the contextual domains of PRISM and rapid qualitative data from stakeholders we will select new or adapt existing implementation strategies, facilitating robust implementation. Study outcomes will be measured using the RE-AIM outcomes from PRISM including Reach, Effectiveness, Adoption, Implementation, and Maintenance.
Study Setting: University of Colorado Hospital is a 620 beds academic tertiary care center in Denver, Colorado.
Participant Recruitment: Hospitalist participants will be recruited from among the faculty of University of Colorado Hospital Division of hospital medicine which has over 100 physician and advanced practice clinicians (APPs).
Study Procedures:
All hospitalist physicians and APPs will be offered training in LUS. The training module to be used has been shown to be effective at training providers to competency. The investigators will evaluate acceptability and feasibility of the training module using rapid qualitative techniques and questionnaires of both completers and non-completers. Once a provider has completed training, she may begin performing LUS on COVID patients. The images will be wirelessly uploaded into PACS. The provider's LUS interpretation will be documented in the EMR. Rapid Iterative RE-AIM will be performed on a weekly basis as a means of iteratively screening for implementation barriers. The implementation outcomes of both fidelity and adaptation will be prioritized although all aspects of implementation will be evaluated. Interval Reach will be screened for using EMR data. For RE-AIM domains with poor implementation, the investigators will use rapid qualitative methods to obtain stakeholder perspectives of barriers and suggestions for adaptations to existing strategies or new strategies.
Measures/Data Collection Study Outcomes:
Reach: The investigators will measure the percentage of patients hospitalized with a positive COVID test result who received a LUS during the hospitalization. The investigators will compare the demographics and characteristics of the eligible patients who received a LUS versus those that did not in order to identify disparities in implementation that can be addressed by adapting our implementation strategies. The investigators will explore the underlying reasons for disparities in Reach using rapid qualitative interviews of providers and other stakeholders as appropriate.
Effectiveness: Using a quasi-experimental interrupted time series design, the investigators will compare the number of chest x-rays and CTs performed, PPE use and inpatient mortality in patient hospitalized with COVID before implementation of LUS versus after.
Adoption:
Adoption by clinicians will be measured by calculating the percentage of clinicians who completed the LUS training module within the UCH hospitalist group. The investigators will also measure the percentage of clinicians who performed at least 1 LUS exam. The investigators will evaluate for differences between providers who did and did not complete training. The investigators will interview hospitalists who did not complete training or did not perform LUS to understand why LUS was not adopted.
Implementation:
The investigators will focus on collecting implementation outcomes that are particularly relevant to the evaluation of diagnostic tests. Fidelity will be measured using data available through the EMR and through qualitative interviews of providers regarding their clinical decision-making. EMR data will be gathered by random selection of at least 10% of LUS exams within the EMR over the prior 30 days using the following 3 components to evaluate fidelity. 1. Image quality: Through the EMR, the investigators will assess whether image acquisition was adequate using a checklist of image requirements. 2. Image interpretation: the investigators will review interpretation of POCUS by assessing ultrasound reports in the EMR using a checklist 3. Clinical Decision-making using the LUS result: Assess appropriate integration of POCUS findings into the clinical decision-making by review of the LUS report in the EMR and daily clinician progress notes well as through qualitative interviews of providers.
Feasibility/Acceptability:
The investigators will measure feasibility and acceptability of the 1) LUS training module 2) use of LUS for evaluation of patients with COVID using a questionnaire as well as rapid qualitative interviews of hospitalists and other stakeholders
- Conditions
- Covid19
- Being tested
- Lung ultrasound use in patients hospitalized with COVID
- Keywords
- COVID-19, lung ultrasound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound use in patients hospitalized with COVIDDiagnostic test
Hospitalists will be taught to use lung ultrasound in the management of their patients with COVID
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasound Implementation arm | Experimental | Hospitalists undergo training to use lung ultrasound in their patients hospitalized with COVID Receives: Diagnostic Test: Lung ultrasound use in patients hospitalized with COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalists Who Adopt Lung Ultrasound
Number of hospitalists who adopt lung ultrasound in the care of patients hospitalized with COVID
Measured: number of hospitalists who adopt lung ultrasound over a twelve month period
Secondary outcomes (1)
Patients With COVID Who Receive Lung Ultrasound
patients with COVID who receive a lung ultrasound
Measured: patients with COVID who received a lung ultrasound by a hospitalist over a 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Maw, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542421
- Sponsor's protocol ID
- 20-0781
- Status last verified
- Feb 2023
- First submitted
- 4 Sep 2020
- Last updated
- 13 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19
- ClinicalTrials.gov ID
- NCT04542421
- Acronym / sponsor ID
- 20-0781
- Conditions
- Covid19
- Keywords
- COVID-19, lung ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 13 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung ultrasound (LUS) has also been shown to be more accurate than chest x-ray in identifying pulmonary consolidation and pulmonary edema, both of which are found in patients with COVID.
The investigators hypothesize implementation of LUS by hospitalists in the management of suspected or diagnosed patients with COVID-19 will reduce the need for Chest CT and chest x-ray, thereby conserving PPE, reducing risk of transmission to technicians and conserving the resources of radiology services that would otherwise be overwhelmed by patients with COVID-19 in need of chest imaging. Using the methods of implementation science, the investigators propose to respond to the urgent need for rapid implementation of LUS by hospitalists in management of adult patients hospitalized for COVID.
Aim 1a: Using a rapid-cycle weekly Plan-Do-Study-Act cycle and Rapid Iterative RE-AIM, to optimize the implementation of LUS by adult hospitalists in the management of COVID-19 patients in a pilot study
Aim 1b: Evaluate this pilot implementation of LUS by adult hospitalists using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Detailed description
Study overview:. The investigators will begin LUS implementation using strategies that target barriers already identified by hospitalists in prior qualitative work. The investigators will then proceed to conduct weekly rapid Plan-Do-Study-Act cycles informed by Rapid Iterative RE-AIM, in order to ensure timely identification of implementation barriers. Rapid Iterative RE- AIM is an innovative application of the RE-AIM framework in which screening assessments of RE-AIM outcomes (e.g. level of reach, adoption, implementation) which is performed at regular intervals during implementation and has been shown to be a feasible means of assessing interval implementation. For outcomes not meeting target implementation at our interval assessments, we will perform rapid qualitative interviews of key stakeholders to identify current barriers. Using the contextual domains of PRISM and rapid qualitative data from stakeholders we will select new or adapt existing implementation strategies, facilitating robust implementation. Study outcomes will be measured using the RE-AIM outcomes from PRISM including Reach, Effectiveness, Adoption, Implementation, and Maintenance.
Study Setting: University of Colorado Hospital is a 620 beds academic tertiary care center in Denver, Colorado.
Participant Recruitment: Hospitalist participants will be recruited from among the faculty of University of Colorado Hospital Division of hospital medicine which has over 100 physician and advanced practice clinicians (APPs).
Study Procedures:
All hospitalist physicians and APPs will be offered training in LUS. The training module to be used has been shown to be effective at training providers to competency. The investigators will evaluate acceptability and feasibility of the training module using rapid qualitative techniques and questionnaires of both completers and non-completers. Once a provider has completed training, she may begin performing LUS on COVID patients. The images will be wirelessly uploaded into PACS. The provider's LUS interpretation will be documented in the EMR. Rapid Iterative RE-AIM will be performed on a weekly basis as a means of iteratively screening for implementation barriers. The implementation outcomes of both fidelity and adaptation will be prioritized although all aspects of implementation will be evaluated. Interval Reach will be screened for using EMR data. For RE-AIM domains with poor implementation, the investigators will use rapid qualitative methods to obtain stakeholder perspectives of barriers and suggestions for adaptations to existing strategies or new strategies.
Measures/Data Collection Study Outcomes:
Reach: The investigators will measure the percentage of patients hospitalized with a positive COVID test result who received a LUS during the hospitalization. The investigators will compare the demographics and characteristics of the eligible patients who received a LUS versus those that did not in order to identify disparities in implementation that can be addressed by adapting our implementation strategies. The investigators will explore the underlying reasons for disparities in Reach using rapid qualitative interviews of providers and other stakeholders as appropriate.
Effectiveness: Using a quasi-experimental interrupted time series design, the investigators will compare the number of chest x-rays and CTs performed, PPE use and inpatient mortality in patient hospitalized with COVID before implementation of LUS versus after.
Adoption:
Adoption by clinicians will be measured by calculating the percentage of clinicians who completed the LUS training module within the UCH hospitalist group. The investigators will also measure the percentage of clinicians who performed at least 1 LUS exam. The investigators will evaluate for differences between providers who did and did not complete training. The investigators will interview hospitalists who did not complete training or did not perform LUS to understand why LUS was not adopted.
Implementation:
The investigators will focus on collecting implementation outcomes that are particularly relevant to the evaluation of diagnostic tests. Fidelity will be measured using data available through the EMR and through qualitative interviews of providers regarding their clinical decision-making. EMR data will be gathered by random selection of at least 10% of LUS exams within the EMR over the prior 30 days using the following 3 components to evaluate fidelity. 1. Image quality: Through the EMR, the investigators will assess whether image acquisition was adequate using a checklist of image requirements. 2. Image interpretation: the investigators will review interpretation of POCUS by assessing ultrasound reports in the EMR using a checklist 3. Clinical Decision-making using the LUS result: Assess appropriate integration of POCUS findings into the clinical decision-making by review of the LUS report in the EMR and daily clinician progress notes well as through qualitative interviews of providers.
Feasibility/Acceptability:
The investigators will measure feasibility and acceptability of the 1) LUS training module 2) use of LUS for evaluation of patients with COVID using a questionnaire as well as rapid qualitative interviews of hospitalists and other stakeholders
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasound Implementation arm | Experimental | Diagnostic Test: Lung ultrasound use in patients hospitalized with COVIDHospitalists undergo training to use lung ultrasound in their patients hospitalized with COVID |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians and advanced care provider faculty in the Division of hospital medicine at University of Colorado Hospital, Aurora Colorado
Key exclusion criteria (1 listed)
- Physicians and advanced care provider Faulty within the Division of Hospital medicine at University of Colorado Hospital who care for hospitalized patients less than 2 weeks per year
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 |
|---|---|---|
| Lung ultrasound use in patients hospitalized with COVIDHospitalists will be taught to use lung ultrasound in the management of their patients with COVID | Diagnostic test | Lung ultrasound Implementation arm |
Primary outcome
Hospitalists Who Adopt Lung Ultrasound
Time frame: number of hospitalists who adopt lung ultrasound over a twelve month period
Number of hospitalists who adopt lung ultrasound in the care of patients hospitalized with COVID
1 secondary outcome
Patients With COVID Who Receive Lung Ultrasound
Time frame: patients with COVID who received a lung ultrasound by a hospitalist over a 12 month period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anna Maw, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound use in patients hospitalized with COVID in people with Covid19, run by University of Colorado, Denver at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalists Who Adopt Lung Ultrasound (time frame: number of hospitalists who adopt lung ultrasound over a twelve month period). 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 13 Mar 2023.