Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19
Phase: NA
Conditions: Covid19
Sponsor: University of Colorado, Denver

Lung Ultrasound Implementation in the Management of Patients Hospitalized With COVID-19 
 
NCT04542421 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background/Significance 
The pandemic of coronavirus 2 (SARS-CoV-2) began in December of last year Hubei Province of 
China has now spread to 124 countries. The number of confirmed cases and deaths grow daily 
by the thousands. The Institute for Health metrics and Evaluation (IHME) at University of 
Washington most conservative estimates indicate that even if all preventative measures taken 
to slow the spread of this disease, 100,000-200,000 people will predicted die from COVID 
globally7. Given what is currently known about the pace of its spread and the prevalence of 
severe disease requiring hospitalization, it is projected that even the most advanced healthcare 
systems will be overwhelmed, and resources will be severely constrained8 which is the current 
reality at the proposed study site, University of Colorado Hospital. 
 
Interstitial pneumonia and Acute Respiratory Distress Syndrome (ARDS) are the most common 
serious manifestation of COVID-19 which has an estimated case-fatality rate of 0.25-3%, with a 
definitive increased risk for patients older than 609 who have an estimated mortality rate of 
10%. Patients evaluated using chest CT have shown to present with bilateral ground-glass 
opacities (GGO) that are peripheral in distribution that progress to and consolidative pulmonary 
opacities as the disease progresses. Changes in CT due to COVID have been shown to manifest 
in many patients prior to symptoms and before the PCR for the virus becomes positive. 
Although CT has been shown to be more sensitive than PCR in the detection of this 
disease10the American College of Radiology has recommended against using this modality as a 
screening tool in patients with suspected COVID-19 and recommends only sparing use in 
patients with known COVID in largely because of the infectious risk to hospital staff and the 
stress it will put on the imaging services of a health care system given the number of patients 
with COVID-19 that will be affected with respiratory failure. 
 
LUS is known to have comparable sensitivity to CT in the diagnosis of interstitial processes like 
pulmonary edema11, the earliest manifestation of COVID lung involvement. Other LUS findings 
described thus far in COVID patients include irregular or thickened pleura, and subpleural 
consolidations. In Italy, where LUS is more commonly used than other parts of the world, 
clinicians report using LUS as their primary imaging modality in COVID patients due to its 
accuracy and practical advantages over CT and chest x-ray and have already published a 
proposed standardized protocol for LUS in patients with suspected or confirmed COVID- 1912. 
Even prior to the COVID pandemic multiple society guidelines4,13 have endorsed the use of LUS 
by generalists for the diagnosis of pulmonary edema and pneumonia because of the robust 
data demonstrating it high accuracy, feasibility (easy to learn and perform), patient 
centeredness (avoids radiation and improves patient satisfaction), and the reduction in time to 
diagnosis associated with its use14. In addition, there is growing evidence that it improves 
patient outcomes15. This endorsement by multiple national societies are in part driven by 
recent improvement in affordability and portability of handheld ultrasound machines. Devices 
with good image resolution that can be plugged into small tablet devices and cost $2000-5000 
dollars are now available. 
 
LUS has the potential to greatly improve resource utilization and management of COVID 
patients in both high and low resources settings. In high resource settings, like the proposed 

pilot site, University Colorado Hospital, implementation of LUS will conserve PPE, technician 
exposure and help prevent monopoly of the CT scanner and radiology services by COVID 
patients which would otherwise overwhelm hospital resources given the number of COVID 
patients and additional time needed to perform appropriate disinfection which would delay 
care to all hospitalized patients. In resource limited settings, given that nearly half of the world 
have no access to imaging including x-ray16, LUS will provide chest imaging where no imaging is 
otherwise available and provide more certainty in diagnosis of COVID where the PCR, currently 
the gold standard test, is not available. The data collected from the proposed study will serve as 
pilot data for a larger multicenter study to evaluate implementation in settings of diverse 
typologies allowing for the expedited dissemination of LUS to all clinical settings. 
 
Brief Approach 
 
Objective:  Evaluate this pilot implementation of LUS by adult hospitalists using the Reach, 
Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. 
 
Conceptual Framework 
We will use the Practical, Robust, Implementation, and Sustainability Model (PRISM) as the 
conceptual framework for our study. PRISM is the conceptually expanded version of RE-AIM 
developed from different models arising from other spheres important to implementing 
evidenced-based practice including chronic illness care, diffusion of innovation, and quality 
improvement concepts17. The contextual domains of PRISM allow for evaluation of how an 
intervention is received by recipients of the health care setting, helping to identify 
implementation strategies that will result in a better fit between intervention and setting and 
ultimately resulting in improved implementation and effectiveness as measured by the RE-AIM 
domains of PRISM which are Reach, Effectiveness, Adoption, Implementation, and 
Maintenance. Contextual domains in PRISM include: External context (i.e. national policies, 
guidelines, incentives) and Internal context (i.e. multilevel organizational characteristics, 
perspectives, implementation and sustainability infrastructure). Use of 
  
PRISM allows for consideration of a multilevel, dynamic context and will guide us in adapting 
and tailoring our implementation strategies to our dynamic inpatient context enhancing 
implementation and effectiveness. 
 
Study overview:. 
We will begin LUS implementation using strategies that target barriers already identified by 
hospitalists in our prior qualitative work. We 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- AIM18 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, Adoption, Implementation. 
Effectiveness and Maintenance will not be evaluated given this is a pilot study. Data collection 
will occur over 12 months.  
 
Study Setting: University of Colorado Hospital is a 620 beds academic level 1 trauma 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) and who care for 190 hospitalized patients daily. All 
hospitalized patients with COVID that are not triaged to the ICU are admitted to the hospitalist 
service. 
 
Study Procedures: 
All hospitalist physicians and APPs will be offered training in LUS. Once a provider has 
completed training, they 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 bi 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, we 
will use qualitative methods19 to obtain stakeholder perspectives of barriers and suggestions 
for adaptations to existing strategies or new strategies. 
 
Measures/Data Collection Study Outcomes: 
Reach: We will measure the percentage of patients hospitalized with a positive COVID test 
result who received a LUS during the hospitalization. We 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. We will explore the underlying reasons for disparities in Reach using qualitative 
interviews of providers and other stakeholders as appropriate. 
 
 
Adoption: 
Adoption by clinicians will be measured by calculating the percentage of clinicians who 
completed the LUS training module within the UCH hospitalist group. We will also measure the 
percentage of clinicians who performed at least 1 LUS exam. We will evaluate for differences 
between providers who did and did not complete training. We will interview hospitalists who 
did not complete training or did not perform LUS to understand why LUS was not adopted. 
 
Implementation: 

We 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, we will assess whether image acquisition was adequate using a checklist of 
image requirements. 2. Image interpretation: we 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. 
 
Analysis: 
 
Descriptive statistics will be performed for the outcome