- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03296280
Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
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San Antonio, Texas, United States, 78229
- South Texas Health Care System, San Antonio, TX
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- Chief of staff desires POCUS training for his/her facility
- >=2 Service Chiefs from emergency medicine, critical care medicine, or hospital medicine desire training for his/her physicians, AND
- >=1 portable ultrasound machine(s) available to physicians within these services
Exclusion Criteria:
- Chief of staff does not desire POCUS training for his/her facility
- <2 Service Chiefs from emergency medicine, critical care medicine, or hospital medicine desire training for his/her physicians, OR
- No portable ultrasound machine(s) available to physicians within these services
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Early Intervention
This cohort of 10 facilities will undergo early training by participating in the first 6 POCUS course sessions during FY17
|
Late Intervention
This cohort of 10 facilities will undergo late training by participating in the last 6 POCUS courses during FY17.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Frequency of Point-of-care Ultrasound Use for Diagnostic and Procedural Applications at Baseline and 6-9 Months
Time Frame: Baseline compared to 6-9 months later.
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Provider self-reported data pre- and post-intervention on frequency of point-of-care ultrasound use, based on number of exams per week.
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Baseline compared to 6-9 months later.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Point-of-care Ultrasound Knowledge From Baseline to 6-9 Months
Time Frame: Baseline compared to 6-9 months later.
|
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.
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Change in Point-of-care Ultrasound Cardiac Skills From Baseline to 6-9 Months
Time Frame: Baseline compared to 6-9 months later.
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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.
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Baseline compared to 6-9 months later.
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Change in Point-of-care Ultrasound Lung Skills From Baseline to 6-9 Months
Time Frame: Baseline compared to 6-9 months later.
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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.
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Baseline compared to 6-9 months later.
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Change in Point-of-care Ultrasound Peripheral IV Skills From Baseline to 6-9 Months
Time Frame: Baseline compared to 6-9 months later.
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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.
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Baseline compared to 6-9 months later.
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Change in Point-of-care Ultrasound Abdominal Skills From Baseline to 6-9 Months
Time Frame: Baseline compared to 6-9 months later.
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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.
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Baseline compared to 6-9 months later.
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Change in Barrier to Point-of-care Ultrasound Use (Ability to Operate) From Baseline to 6-9 Months Post-Course
Time Frame: Baseline compared to 6-9 months later.
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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.
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Baseline compared to 6-9 months later.
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Change in Barriers to Point-of-care Ultrasound Use (Skill Maintenance) From Baseline to 6-9 Months Post-Course
Time Frame: Baseline compared to 6-9 months later.
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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.
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Baseline compared to 6-9 months later.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nilam Jayant Soni, MD MSc, South Texas Health Care System, San Antonio, TX
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Infections
- Respiratory Tract Diseases
- Kidney Diseases
- Urologic Diseases
- Inflammation
- Pleural Diseases
- Connective Tissue Diseases
- Urination Disorders
- Embolism and Thrombosis
- Skin Diseases, Infectious
- Suppuration
- Gallbladder Diseases
- Biliary Tract Diseases
- Aneurysm
- Aortic Diseases
- Cellulitis
- Cholecystitis
- Cholecystitis, Acute
- Thrombosis
- Venous Thrombosis
- Urinary Retention
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
- Pleural Effusion
- Hydronephrosis
Other Study ID Numbers
- PEX 16-003
- I50HX002263-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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