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

NCT ID: NCT04542421

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-02-01

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

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Lung ultrasound Implementation arm

Hospitalists undergo training to use lung ultrasound in their patients hospitalized with COVID

Group Type: EXPERIMENTAL

Lung ultrasound use in patients hospitalized with COVID

Intervention Type: DIAGNOSTIC_TEST

Hospitalists will be taught to use lung ultrasound in the management of their patients with COVID

Interventions

Lung ultrasound use in patients hospitalized with COVID

Hospitalists will be taught to use lung ultrasound in the management of their patients with COVID

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Maw, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Denver, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-0781

Identifier Type: -

Identifier Source: org_study_id