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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03296280
Other study ID # PEX 16-003
Secondary ID I50HX002263-01A1
Status Completed
Phase
First received
Last updated
Start date October 3, 2016
Est. completion date September 30, 2020

Study information

Verified date November 2020
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This VA QUERI Partnered Evaluation Initiative will evaluate the impact of an immersive Point-of-care Ultrasound (POCUS) Training Course on provider skill acquisition and retention; the frequency of POCUS use by trained providers; and the barriers/facilitators to POCUS in the VHA. Data sources include pre- and post-course assessment tools, medical coding data, and course evaluations. Providers that participate in the POCUS Training Course will be compared to control providers from wait-listed facilities. Additionally, participating facilities vs. wait-listed facilities for the POCUS Training Course will be compared. Findings from this project will guide ongoing efforts of the investigators' operating partners, VA Specialty Care Centers of Innovation (SCCI) and the VA Simulation Learning and Research Network (SimLEARN), to develop a national POCUS training program and facilitate implementation of POCUS use system-wide in the VA healthcare system.


Description:

Background: Point-of-care ultrasonography (POCUS) has been shown to reduce procedure-related complications from invasive bedside procedures, reduce time to diagnosis, and reduce ancillary testing, which ultimately reduces patient radiation exposure and healthcare costs. Despite its potential advantages, POCUS has not been universally adopted in healthcare due to limited numbers of providers trained in use of POCUS. The VA's Simulation Learning, Education and Research Network (SimLEARN) and Specialty Care Centers of Innovation (SCCI) have launched a collaborative initiative to develop a national POCUS training program. The goal of this collaborative training program is to teach VA providers basic diagnostic and procedural applications of POCUS. The proposed project will evaluate the effectiveness of an immersive POCUS training course developed by SimLEARN on provider skill acquisition and retention, frequency of use, and identify barriers/facilitators to POCUS use at participating VHA facilities. Methods: Approximately 120 participants from a convenience sample of 20 diverse VA facilities will participate in a 2.5-day immersive POCUS training course at the SimLEARN National Simulation Center in Orlando during fiscal year 2017. The investigators' evaluation plan will collect data from facility Chiefs of Staff, providers from facilities participating in POCUS training, and providers from wait-listed facilities at different time points using different assessment tools: VA Facility POCUS Survey, Provider POCUS Survey, Brief Provider POCUS Survey, Pre-/Post-course Knowledge and Skills Test, and Coding Data. Objective 1: Evaluate provider skill acquisition and retention, and frequency of POCUS use after participation in the POCUS Training Course. Pre- and post-course testing will be used to assess acquisition of knowledge and technical skills to perform POCUS exams. Post-course testing for knowledge and skill retention, and frequency of use, will be performed 6-9 months after the training course. Objective 2: Determine the effect of the POCUS Training Course and implementation facilitation on facility-level frequency of POCUS use. Facilities with providers that infrequently use POCUS will be eligible to participate in the POCUS Training Course. However, not all facilities will be able to be accommodated in the 1st year of the training program, requiring a facility waiting list. Facilities with providers participating in the POCUS Training Course will be compared to wait-listed facilities with regard to frequency of POCUS use. Using the Brief Provider POCUS Survey, frequency of POCUS use by providers in both participating and waitlisted facilities will be compared. Additionally, coding data will be reviewed to assess frequency of procedures performed with and without imaging guidance and procedural complication rates comparing the two groups of facilities. Objective 3: Determine provider and facility-level barriers and facilitators to POCUS use. Provider and facility-level barriers will be assessed using 3 tools: Provider POCUS Survey (trained providers), Brief Provider POCUS Survey (wait-listed and participating facilities), and Facility POCUS Survey (all facilities). Differences in barriers reported and their relationship to frequency of POCUS use will be compared. Objective 4: Development of POCUS Champions course to facilitate local implementation by addressing facility-level barriers. The POCUS Champions course will address several facility-level barriers to implementation that have been identified by the PEI: lack of image archiving, limited access to ultrasound machines, undefined credentialing/privileging processes, need for a quality assurance process, and lack of trained providers. The POCUS Champions course will include an annual 3-day boot camp, bi-monthly conference calls, and ongoing mentorship. The goal of the 3-day boot camp will be for Champions to prepare a local implementation plan that can be presented to their facility's leadership. During the bimonthly conference calls, a brief didactic on a focused topic will be presented followed by an update on local progress from each site. The initial goal of the POCUS Champions course is to facilitate implementation of POCUS use in VA facilities, starting with 4-6 facilities that can serve as models for other facilities. The research to date has identified these elements as core components of a successful POCUS program. The POCUS Champions course will support progress on intermediate milestones towards ensuring these core components are in place, to facilitate adoption, reach, and sustainment. This provides a roadmap to sustainable POCUS use. Deliverables: The primary deliverable will be report that will summarize the effect of training on provider skill acquisition and retention, frequency of use of POCUS, and barriers and facilitators to POCUS implementation. This project will guide SimLEARN's and SCCI's efforts to develop a National POCUS Training Program and implement POCUS use nationally in the VA healthcare system. Additionally, this report may serve as a roadmap for the VHA for implementation of similar simulation-based educational innovations.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date September 30, 2020
Est. primary completion date June 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Selection of VA facilities invited to participate in the national POCUS training course was based on data from a national needs assessment conducted by the VA's Health Analysis and Information Group. VA facilities that meet all of the following inclusion criteria are eligible to send physicians to participate in the POCUS training course: 1. Chief of staff desires POCUS training for his/her facility 2. >=2 Service Chiefs from emergency medicine, critical care medicine, or hospital medicine desire training for his/her physicians, AND 3. >=1 portable ultrasound machine(s) available to physicians within these services Exclusion Criteria: 1. Chief of staff does not desire POCUS training for his/her facility 2. <2 Service Chiefs from emergency medicine, critical care medicine, or hospital medicine desire training for his/her physicians, OR 3. No portable ultrasound machine(s) available to physicians within these services

Study Design


Locations

Country Name City State
United States South Texas Health Care System, San Antonio, TX San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Frequency of Point-of-care Ultrasound Use for Diagnostic and Procedural Applications at Baseline and 6-9 Months Provider self-reported data pre- and post-intervention on frequency of point-of-care ultrasound use, based on number of exams per week. Baseline compared to 6-9 months later.
Secondary Change in Point-of-care Ultrasound Knowledge From Baseline to 6-9 Months Provider knowledge will be tested pre- and post-intervention (at baseline [pre-course] and 6-9 months post-course). Knowledge Exam has a minimum of 0 points and a maximum of 30 points (1 pt per question). A higher score indicates more knowledge about POCUS. A positive change in score means a better outcome post-course (net increase in knowledge) compared to baseline. Baseline compared to 6-9 months later.
Secondary Change in Point-of-care Ultrasound Cardiac Skills From Baseline to 6-9 Months Provider hands-on cardiac skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Cardiac Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline. Baseline compared to 6-9 months later.
Secondary Change in Point-of-care Ultrasound Lung Skills From Baseline to 6-9 Months Provider hands-on lung skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Lung Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline. Baseline compared to 6-9 months later.
Secondary Change in Point-of-care Ultrasound Peripheral IV Skills From Baseline to 6-9 Months Provider hands-on peripheral IV skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Peripheral IV Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline. Baseline compared to 6-9 months later.
Secondary Change in Point-of-care Ultrasound Abdominal Skills From Baseline to 6-9 Months Provider hands-on abdominal skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Abdominal Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline. Baseline compared to 6-9 months later.
Secondary Change in Barrier to Point-of-care Ultrasound Use (Ability to Operate) From Baseline to 6-9 Months Post-Course Change in percentage of providers who reported not knowing how to operate POCUS 6-9 months post-course compared to pre-course. A positive percentage indicates a better outcome post-course. Baseline compared to 6-9 months later.
Secondary Change in Barriers to Point-of-care Ultrasound Use (Skill Maintenance) From Baseline to 6-9 Months Post-Course Change in percentage of providers who reported experiencing difficulty with maintaining POCUS skills pre-course compared to 6-9 months post-course. A positive percentage indicates more providers are experiencing this barrier post-course, which is not unexpected as more providers acquire POCUS skills. Baseline compared to 6-9 months later.
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