Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lung ultrasound use in patients hospitalized with COVID
Sponsored by

About this trial
This is an interventional health services research trial for Covid19 focused on measuring COVID-19, lung ultrasound
Eligibility Criteria
Inclusion Criteria:
- Physicians and advanced care provider faculty in the Division of hospital medicine at University of Colorado Hospital, Aurora Colorado
Exclusion Criteria:
- 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
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lung ultrasound Implementation arm
Arm Description
Hospitalists undergo training to use lung ultrasound in their patients hospitalized with COVID
Outcomes
Primary Outcome Measures
Hospitalists Who Adopt Lung Ultrasound
Number of hospitalists who adopt lung ultrasound in the care of patients hospitalized with COVID
Secondary Outcome Measures
Patients With COVID Who Receive Lung Ultrasound
patients with COVID who receive a lung ultrasound
Full Information
NCT ID
NCT04542421
First Posted
September 4, 2020
Last Updated
February 14, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT04542421
Brief Title
Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19
Official Title
Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, lung ultrasound
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung ultrasound Implementation arm
Arm Type
Experimental
Arm Description
Hospitalists undergo training to use lung ultrasound in their patients hospitalized with COVID
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasound use in patients hospitalized with COVID
Intervention Description
Hospitalists will be taught to use lung ultrasound in the management of their patients with COVID
Primary Outcome Measure Information:
Title
Hospitalists Who Adopt Lung Ultrasound
Description
Number of hospitalists who adopt lung ultrasound in the care of patients hospitalized with COVID
Time Frame
number of hospitalists who adopt lung ultrasound over a twelve month period
Secondary Outcome Measure Information:
Title
Patients With COVID Who Receive Lung Ultrasound
Description
patients with COVID who receive a lung ultrasound
Time Frame
patients with COVID who received a lung ultrasound by a hospitalist over a 12 month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Physicians and advanced care provider faculty in the Division of hospital medicine at University of Colorado Hospital, Aurora Colorado
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Maw, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80238
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19
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