Other Acute Illnesses Presenting to the HospitalNCT03296280
Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
An observational study of Other Acute Illnesses Presenting to the Hospital and Heart Failure, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Other Acute Illnesses Presenting to the Hospital, Heart Failure, Pneumonia
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2016to 30 Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: VA physicians
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Other Acute Illnesses Presenting to the Hospital, Heart Failure, Pneumonia, Deep Venous Thrombosis, Cellulitis, Abdominal Aortic Aneurysm
- Keywords
- ultrasound, ultrasonography, point of care, Doppler ultrasound, ultrasound imaging, diagnostic ultrasound
- Medical subject headings
- Heart Failure, Pneumonia, Venous Thrombosis, Cellulitis, Aortic Aneurysm, Abdominal, Cholecystitis, Acute, Hydronephrosis, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline compared to 6-9 months later.
Secondary outcomes (7)
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.
Measured: Baseline compared to 6-9 months later.
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.
Measured: Baseline compared to 6-9 months later.
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.
Measured: Baseline compared to 6-9 months later.
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.
Measured: Baseline compared to 6-9 months later.
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.
Measured: Baseline compared to 6-9 months later.
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.
Measured: Baseline compared to 6-9 months later.
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.
Measured: Baseline compared to 6-9 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start3 Oct 2016
- Primary completion29 Jun 2018
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Other Acute Illnesses Presenting to the HospitalStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Nilam Jayant Soni, MD MSc, Principal investigator, South Texas Health Care System, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296280
- Sponsor's protocol ID
- PEX 16-003
- Other IDs
- I50HX002263-01A1
- Status last verified
- Nov 2020
- First submitted
- 19 Sep 2017
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iqbal A, Ahmad M, Murray KJ, Sim J, Lund TJS, Andrade AJ, Perez-Sanchez A, Mader MJ, Haro EK, Williams JP, Nathanson R, Soni NJ. Current Use and Barriers to Point-of-Care Ultrasound in Rheumatology: A National Survey of VA Medical Centers. Rheumatol Ther. 2024 Jun;11(3):855-867. doi: 10.1007/s40744-024-00665-2. Epub 2024 Apr 6.
PubMed 38581600Boyd JS, LoPresti CM, Core M, Schott C, Mader MJ, Lucas BP, Haro EK, Finley EP, Restrepo MI, Kessler C, Colon-Molero A, Pugh J, Soni NJ. Current use and training needs of point-of-care ultrasound in emergency departments: A national survey of VA hospitals. Am J Emerg Med. 2019 Sep;37(9):1794-1797. doi: 10.1016/j.ajem.2019.02.043. Epub 2019 Feb 28. No abstract available.
PubMed 30878406
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
- ClinicalTrials.gov ID
- NCT03296280
- Acronym / sponsor ID
- PEX 16-003
- Conditions
- Other Acute Illnesses Presenting to the Hospital, Heart Failure, Pneumonia, Deep Venous Thrombosis, Cellulitis, Abdominal Aortic Aneurysm
- Keywords
- ultrasound, ultrasonography, point of care, Doppler ultrasound, ultrasound imaging, diagnostic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VA physicians
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Provider self-reported data pre- and post-intervention on frequency of point-of-care ultrasound use, based on number of exams per week.
7 secondary outcomes
Change in Point-of-care Ultrasound Knowledge From Baseline to 6-9 Months
Time frame: Baseline compared to 6-9 months later.
Change in Point-of-care Ultrasound Cardiac Skills From Baseline to 6-9 Months
Time frame: Baseline compared to 6-9 months later.
Change in Point-of-care Ultrasound Lung Skills From Baseline to 6-9 Months
Time frame: Baseline compared to 6-9 months later.
Change in Point-of-care Ultrasound Peripheral IV Skills From Baseline to 6-9 Months
Time frame: Baseline compared to 6-9 months later.
Change in Point-of-care Ultrasound Abdominal Skills From Baseline to 6-9 Months
Time frame: Baseline compared to 6-9 months later.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38581600Iqbal A, Ahmad M, Murray KJ, Sim J, Lund TJS, Andrade AJ, Perez-Sanchez A, Mader MJ, Haro EK, Williams JP, Nathanson R, Soni NJ. Current Use and Barriers to Point-of-Care Ultrasound in Rheumatology: A National Survey of VA Medical Centers. Rheumatol Ther. 2024 Jun;11(3):855-867. doi: 10.1007/s40744-024-00665-2. Epub 2024 Apr 6.
- Derived from this study: PubMed 30878406Boyd JS, LoPresti CM, Core M, Schott C, Mader MJ, Lucas BP, Haro EK, Finley EP, Restrepo MI, Kessler C, Colon-Molero A, Pugh J, Soni NJ. Current use and training needs of point-of-care ultrasound in emergency departments: A national survey of VA hospitals. Am J Emerg Med. 2019 Sep;37(9):1794-1797. doi: 10.1016/j.ajem.2019.02.043. Epub 2019 Feb 28. No abstract available.
- VA Quality Enhancemen Research Initiative (QUERI)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilam Jayant Soni, MD MSc principal investigator
South Texas Health Care System, San Antonio, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Acute Illnesses Presenting to the Hospital and Heart Failure, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03296280, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.