PneumoniaPOCUSNCT03969342
Standardization of Mid-Level Providers Using Point of Care Ultrasound to Diagnose Pediatric Pneumonia
A study testing Point of care ultrasound training in people with Pneumonia and Pediatric Disorder, run by Bridge to Health Medical and Dental at 1 site in Uganda.
Trial summary
The POCUS training program aims to bring sustainable, affordable access to POCUS to patients in need of diagnostic services in Uganda. This research study seeks to demonstrate that Clinical Officers (COs) in rural Uganda can be trained on POCUS for pediatric pneumonia, and that this training can be completed through… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pediatric Disorder, Diagnostic and Monitoring Radiological Devices Associated With Adverse Incidents
- What is being tested?
- Point of care ultrasound training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUganda
- Study dates
- 15 Jan 2018to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Mid-level provider working in Kabale, Uganda
- Participated in pre-program needs assessment
- Able to continue practicing POCUS in Kabale through the duration of the study
Who cannot join
- Inability to continue practicing POCUS in Kabale through the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
The POCUS training program aims to bring sustainable, affordable access to POCUS to patients in need of diagnostic services in Uganda. This research study seeks to demonstrate that Clinical Officers (COs) in rural Uganda can be trained on POCUS for pediatric pneumonia, and that this training can be completed through remote monitoring and observation.
Read the detailed description
Objectives To prove that mid-level providers in low-resource settings can be trained to use POCUS to diagnose pediatric pneumonia through a five-day training program followed by six months of remote analysis.
Study Design and Methods The investigators propose a remote evaluation study assessing the ability of POCUS program trainees in Kabale to obtain and evaluate pediatric lung scans. The indicator of interest will be diagnosis of pneumonia or lack thereof.
Trainee Selection:
Trainees were selected from the pool of mid-level providers who work with Kigezi Healthcare Foundation (KIHEFO) and who participated in needs assessment questionnaires in February 2018. From those respondents who indicated that they would like to participate in the training program, seven were selected based on their work ethic and their likelihood of working in the Kabale region for the foreseeable future.
Data Collection, Management, and Sharing:
Scanning will take place during the KIHEFO clinics in town and outreach. As well, some scanning may take place during the Bridge to Health Medical and Dental (BTH) and KIHEFO partnered brigade. Additionally, some scans will be collected at the Kabale Regional Referral Hospital.
KIHEFO is a Ugandan registered non-profit organization and a rural teaching site of Mbarara University of Science and Technology. KIHEFO has organized all brigades for the past six years and regularly conducts outreach clinics through a grant provided by the Ugandan Government and USAID.
Trainees will ask to conduct an ultrasound scan for practice on pediatric (under 18 years) patients with a cough, fever, and/or increased work of breathing. To avoid the possibility of trainees diagnosing patients based on scans, trainees will not scan their own patients, but rather, the patients of their peers. Ultimately, all trainees are Ugandan clinicians and licensed and regulated by appropriate Ugandan agencies. While the investigators cannot confirm that clinicians will act with integrity at all times, the investigators rely on the good training and integrity of the trainees as well as the relevant Ugandan health agencies to monitor care of patients.
Should the patient provide informed consent, while scanning, the trainee will fill out a case report form (CRF). The patient will be assigned an anonymous patient identification (ID) number, and trainees have each received a unique trainee ID number in order to conceal their identity from reviewers and maintain a blind study.
Scans and CRFs will be uploaded to an online "cloud." Each time a reviewer accesses a scan from the cloud, the reviewer will fill out a CRF. The CRFs of the trainee and the reviewer will later be compared to determine agreement or disagreement. As well, the trainee will record their clinical management and whether or not antibiotics were prescribed. This clinical information will be managed by the study coordinator.
Once trainees reach a predetermined level of agreement with expert reviewers, trainees will be considered standardized and permitted to use POCUS to diagnose pneumonia.
Ethical Consideration:
Expert reviewers will be blinded as to the identity of the trainees while reviewing scans; this will ensure that reviewers remain impartial while reading images.
Patient identifying information will not be disclosed to reviewers, or to any other non-essential parties. Each patient will be assigned an ID number upon receiving a scan, which is used when uploading the scan and on the CRF. Should a reviewer have a concern about a patient, the reviewer can give the patient's ID number to the local coordinator in Uganda, who has a coded list of patient information. The local coordinator can use this information to get in touch with the patient.
Until they are standardized, trainees are not experts in POCUS, and are not allowed to use POCUS to diagnose patients. All patients will receive a standard examination, and will be diagnosed and treated as usual before being asked to participate in the study.
- Conditions
- Pneumonia, Pediatric Disorder, Diagnostic and Monitoring Radiological Devices Associated With Adverse Incidents
- Being tested
- Point of care ultrasound training
- Keywords
- Pediatric, Pneumonia, Ultrasound, Point of Care Ultrasound, Diagnostic Imaging, Global Health, Uganda, Rural Healthcare
- Medical subject headings
- Pneumonia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasound trainingDevice
Five-day in-person training on point of care ultrasound using portable ultrasound devices followed by remote monitoring of practice scanning
| Study group | Role | What they receive |
|---|---|---|
| Trainees | Experimental | Local mid-level providers who undergo five day training on point of care ultrasound for diagnosing pediatric pneumonia Receives: Device: Point of care ultrasound training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trainee Scan Acquisition
The frequency at which trainees are able to acquire high-quality pediatric lung scans.
Measured: 7 months
Trainee / Reviewer Diagnostic Agreement
The extent to which agreement between the diagnoses provided by our trainees, and that provided by our expert reviewers, is statistically significant.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start15 Jan 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridge to Health Medical and Dental
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Kigezi Healthcare Foundation
- Responsible party
- Sponsor
- Investigators
- William Cherniak, BSc, MD, MPH, CCFP(EM), DABFM, Principal investigator, Bridge to Health Medical and Dental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969342
- Sponsor's protocol ID
- 2
- Acronym
- POCUS
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No Individual Participant Data (IDP) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Mid-Level Providers Using Point of Care Ultrasound to Diagnose Pediatric Pneumonia
- ClinicalTrials.gov ID
- NCT03969342
- Acronym / sponsor ID
- POCUS / 2
- Conditions
- Pneumonia, Pediatric Disorder, Diagnostic and Monitoring Radiological Devices Associated With Adverse Incidents
- Keywords
- Pediatric, Pneumonia, Ultrasound, Point of Care Ultrasound, Diagnostic Imaging, Global Health, Uganda, Rural Healthcare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bridge to Health Medical and DentalUniversity, hospital or other
- Collaborators
- University of Toronto, Kigezi Healthcare Foundation
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The POCUS training program aims to bring sustainable, affordable access to POCUS to patients in need of diagnostic services in Uganda. This research study seeks to demonstrate that Clinical Officers (COs) in rural Uganda can be trained on POCUS for pediatric pneumonia, and that this training can be completed through remote monitoring and observation.
Detailed description
Objectives To prove that mid-level providers in low-resource settings can be trained to use POCUS to diagnose pediatric pneumonia through a five-day training program followed by six months of remote analysis.
Study Design and Methods The investigators propose a remote evaluation study assessing the ability of POCUS program trainees in Kabale to obtain and evaluate pediatric lung scans. The indicator of interest will be diagnosis of pneumonia or lack thereof.
Trainee Selection:
Trainees were selected from the pool of mid-level providers who work with Kigezi Healthcare Foundation (KIHEFO) and who participated in needs assessment questionnaires in February 2018. From those respondents who indicated that they would like to participate in the training program, seven were selected based on their work ethic and their likelihood of working in the Kabale region for the foreseeable future.
Data Collection, Management, and Sharing:
Scanning will take place during the KIHEFO clinics in town and outreach. As well, some scanning may take place during the Bridge to Health Medical and Dental (BTH) and KIHEFO partnered brigade. Additionally, some scans will be collected at the Kabale Regional Referral Hospital.
KIHEFO is a Ugandan registered non-profit organization and a rural teaching site of Mbarara University of Science and Technology. KIHEFO has organized all brigades for the past six years and regularly conducts outreach clinics through a grant provided by the Ugandan Government and USAID.
Trainees will ask to conduct an ultrasound scan for practice on pediatric (under 18 years) patients with a cough, fever, and/or increased work of breathing. To avoid the possibility of trainees diagnosing patients based on scans, trainees will not scan their own patients, but rather, the patients of their peers. Ultimately, all trainees are Ugandan clinicians and licensed and regulated by appropriate Ugandan agencies. While the investigators cannot confirm that clinicians will act with integrity at all times, the investigators rely on the good training and integrity of the trainees as well as the relevant Ugandan health agencies to monitor care of patients.
Should the patient provide informed consent, while scanning, the trainee will fill out a case report form (CRF). The patient will be assigned an anonymous patient identification (ID) number, and trainees have each received a unique trainee ID number in order to conceal their identity from reviewers and maintain a blind study.
Scans and CRFs will be uploaded to an online "cloud." Each time a reviewer accesses a scan from the cloud, the reviewer will fill out a CRF. The CRFs of the trainee and the reviewer will later be compared to determine agreement or disagreement. As well, the trainee will record their clinical management and whether or not antibiotics were prescribed. This clinical information will be managed by the study coordinator.
Once trainees reach a predetermined level of agreement with expert reviewers, trainees will be considered standardized and permitted to use POCUS to diagnose pneumonia.
Ethical Consideration:
Expert reviewers will be blinded as to the identity of the trainees while reviewing scans; this will ensure that reviewers remain impartial while reading images.
Patient identifying information will not be disclosed to reviewers, or to any other non-essential parties. Each patient will be assigned an ID number upon receiving a scan, which is used when uploading the scan and on the CRF. Should a reviewer have a concern about a patient, the reviewer can give the patient's ID number to the local coordinator in Uganda, who has a coded list of patient information. The local coordinator can use this information to get in touch with the patient.
Until they are standardized, trainees are not experts in POCUS, and are not allowed to use POCUS to diagnose patients. All patients will receive a standard examination, and will be diagnosed and treated as usual before being asked to participate in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trainees | Experimental | Device: Point of care ultrasound trainingLocal mid-level providers who undergo five day training on point of care ultrasound for diagnosing pediatric pneumonia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mid-level provider working in Kabale, Uganda
- Participated in pre-program needs assessment
- Able to continue practicing POCUS in Kabale through the duration of the study
Key exclusion criteria (1 listed)
- Inability to continue practicing POCUS in Kabale through the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care ultrasound trainingFive-day in-person training on point of care ultrasound using portable ultrasound devices followed by remote monitoring of practice scanning | Device | Trainees |
Primary outcome
Trainee Scan Acquisition
Time frame: 7 months
The frequency at which trainees are able to acquire high-quality pediatric lung scans.
Trainee / Reviewer Diagnostic Agreement
Time frame: 9 months
The extent to which agreement between the diagnoses provided by our trainees, and that provided by our expert reviewers, is statistically significant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No. No Individual Participant Data (IDP) sharing plan.
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
William Cherniak, BSc, MD, MPH, CCFP(EM), DABFM principal investigator
Bridge to Health Medical and Dental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care ultrasound training in people with Pneumonia and Pediatric Disorder, run by Bridge to Health Medical and Dental at 1 site in Uganda.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 May 2019. 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 Uganda. 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?
Results are not available in the source record.
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?
Trainee Scan Acquisition (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2019.