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

February 14, 2023 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80238
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung ultrasound Implementation arm
Hospitalists undergo training to use lung ultrasound in their patients hospitalized with COVID
Hospitalists will be taught to use lung ultrasound in the management of their patients with COVID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
number of hospitalists who adopt lung ultrasound over a twelve month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
patients with COVID who receive a lung ultrasound
patients with COVID who received a lung ultrasound by a hospitalist over a 12 month period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound Feasibility score
Time Frame: 1 year
Feasibility of using lung ultrasound as measured by a validated survey completed by hospitalists
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anna Maw, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

September 6, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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