ChildL-POCUSNCT03594383
Lung Ultrasound for Acute Respiratory Infections by Community Health Workers
An observational study of Child and Pneumonia, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The specific objectives focus on using a train-the-trainer model to educate CHWs in Pakistan on performing and interpreting pediatric lung POCUS. In the first phase, the POCUS experts from Toronto will rigorously train the first generation of local lung POCUS users who are Pakistani health care providers to become… Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- What is being tested?
- ULTRASOUND
- Type of treatment
- Medical device
- How many people
- 246 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Apr 2018to 30 Apr 2021
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between age of 2 months to 5 years and presenting with signs and symptoms of pneumonia, will be identified and approached by clinical team members in the AKUH emergency department, outpatient clinic and pediatric ward. The research member will review the study with the family and obtain informed consent from parents.
Who may be able to join
None listed.
Who cannot join
- patients that previously underwent lung POCUS by the same lung POCUS operator during the same visit to AKUH
- chest tube insertion or video-assisted thoracoscopic surgery (VATS) during the current visit to AKUH (since the equipment in situ and/or dressing might bias POCUS interpretation)
- inability to understand informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Point-of-care Ultrasound for Acute Respiratory Infections in Resource-constrained Settings - a Pilot Study for Training Community Health Workers
The specific objectives focus on using a train-the-trainer model to educate CHWs in Pakistan on performing and interpreting pediatric lung POCUS. In the first phase, the POCUS experts from Toronto will rigorously train the first generation of local lung POCUS users who are Pakistani health care providers to become local lung POCUS trainers. These first generation trainers will subsequently collaborate with the POCUS experts from Toronto to develop a two-day training program for lung POCUS image interpretation and acquisition that is tailored to novice users (CHWs) in low-resource settings. In the second phase, the first generation local lung POCUS trainers will deliver and evaluate the new training program to the second generation of users - a group of CHWs in Karachi. In the third phase, we will establish the reliability of CHWs to perform lung POCUS on pediatric patients with respiratory symptoms, upon completion of the training program developed by local trainers.
Read the detailed description
POCUS is an example of technologies that are moving out of hospitals and to the point-of-care. The true potential of these novel diagnostics to improve global pediatric pneumonia outcomes will only be realized if they can be employed by CHWs in community settings in LMICs. No work has yet focused on the performance of POCUS by non-medically-trained CHWs in LMICs. Demonstrating that accurate POCUS performance and interpretation can be achieved by non-medically-trained CHWs after focused and succinct training is the first step towards developing a novel pediatric pneumonia diagnosis and management algorithm for LMICs. Feedback from these ultrasound-naïve users about their lung POCUS learning experience is also needed to clarify which POCUS findings would be best suited to this algorithm.
The research team in AKUH will recruit and consent interested CHWs from AKU field sites in Karachi. The target is to recruit a convenience sample of 3 CHWs, who will be as representative as possible of the experience and skill sets as the average CHW in a government program. Study participants will be identified and approached by clinical team members in the AKUH emergency department, outpatient clinic and pediatric ward.
Triaging children with ARI into accurate treatment categories will lead to increased paediatric pneumonia survival, improved antibiotic stewardship, and more appropriate resource use, all of which are clinically and programmatically significant in highest disease burden settings. This project also lays the foundation for future projects that harness the trans-formative potential of POCUS for global child health.
- Being tested
- ULTRASOUND
- Keywords
- Lung, POCUS, Pneumonia, ARI, CHWs
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASOUNDDevice
Lung ultrasound done through POCUS to diagnose pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome of interest will be the inter-rater reliability of lung POCUS findings (on a cohort of patients at AKUH with ARI) between the newly trained CHWs and a local lung POCUS trainer.
Proportion of CHWs undergoing training in lung POCUS with a passing score 80% in a computer-based test (consisting of 60 lung POCUS video clips) with questions to determine their image interpretation skills as a reflection of technical performance. On completion of training program, they will perform lung POCUS on pediatric patients presenting to Aga Khan University Hospital (AKUH) with respiratory symptoms.
For primary outcome of inter-rater reliability, the Cohen's kappa statistic will be calculated using standardized formulas. in the end will be describing the kappa statistic between final interpretations (overall and for each lung zone) of each scan by the CHWs as compared to the POCUS expert.
Measured: 12 months
Secondary outcomes (3)
Train the trainer
the assessment of the first generation local lung trainers will include:
- a computer-based test with 60 questions as an indication of general knowledge pertaining to lung POCUS
- OSATS as indication of their technical performance
- 5 mentored scans observed by POCUS experts
- 20 lung scans with quality assurance performed by POCUS experts
Upon completion of the Train the trainer phase, the first generation users will be deemed qualified local lung POCUS trainers. Subsequently, these new trainers will collaborate with the POCUS experts from Toronto to develop training program B, which will be modified to target novice non-physician users.
Measured: 20 days
Train novice users
- Performance assessment of the CHWs upon completion of training program B delivered by local lung POCUS trainers:
- CHWs' scores on a newly developed computer-based test (consisting of 60 lung POCUS video clips) as an indication of their image interpretation skills
- CHWs' scores on a checklist titled Observed Structured Assessment of Technical Skills (OSATS) as a reflection of technical performance in POCUS
- Program evaluation (descriptive feedback) of training program B provided by CHWs
Proportion of CHWs undergoing training in lung POCUS with a passing score 80% in a computer-based test (consisting of 60 lung POCUS video clips) with questions to determine their image interpretation skills as a reflection of technical performance. On completion of training program, they will perform lung POCUS on pediatric patients presenting to Aga Khan University Hospital (AKUH) with respiratory symptoms.
Measured: 2 days
Reliability of CHW lung POCUS use on children with acute respiratory illnesses
- Raw agreement between:
- POCUS findings of CHWs and chest x-ray findings (if performed)
- POCUS findings of CHWs and final diagnosis in chart
- Chest x-ray findings (if performed) and final diagnosis in chart
- Descriptive feedback of the CHWs' user experience of lung POCUS
POCUS recordings (with no patient identifiers) will be made for each patient scan performed by the CHWs. These clips will be captured via the Lumify device and uploaded to a computer and then to an online server, from which a blinded pediatric lung POCUS expert in Toronto can download and perform the quality assurance check. This second expert will not have participated in the study intervention phase at AKUH.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start12 Apr 2018
- Primary completion30 Dec 2019
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Grand Challenges Canada
- Responsible party
- Principal investigator, Dr Fatime Mir, Aga Khan University
- Investigators
- Fatima Mir, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594383
- Sponsor's protocol ID
- 5106-Ped-ERC-17
- Acronym
- L-POCUS
- Status last verified
- Mar 2022
- First submitted
- 3 May 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Point-of-care Ultrasound for Acute Respiratory Infections in Resource-constrained Settings - a Pilot Study for Training Community Health Workers
- ClinicalTrials.gov ID
- NCT03594383
- Acronym / sponsor ID
- L-POCUS / 5106-Ped-ERC-17
- Keywords
- Lung, POCUS, Pneumonia, ARI, CHWs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Grand Challenges Canada
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 20 Jul 2018 (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 specific objectives focus on using a train-the-trainer model to educate CHWs in Pakistan on performing and interpreting pediatric lung POCUS. In the first phase, the POCUS experts from Toronto will rigorously train the first generation of local lung POCUS users who are Pakistani health care providers to become local lung POCUS trainers. These first generation trainers will subsequently collaborate with the POCUS experts from Toronto to develop a two-day training program for lung POCUS image interpretation and acquisition that is tailored to novice users (CHWs) in low-resource settings. In the second phase, the first generation local lung POCUS trainers will deliver and evaluate the new training program to the second generation of users - a group of CHWs in Karachi. In the third phase, we will establish the reliability of CHWs to perform lung POCUS on pediatric patients with respiratory symptoms, upon completion of the training program developed by local trainers.
Detailed description
POCUS is an example of technologies that are moving out of hospitals and to the point-of-care. The true potential of these novel diagnostics to improve global pediatric pneumonia outcomes will only be realized if they can be employed by CHWs in community settings in LMICs. No work has yet focused on the performance of POCUS by non-medically-trained CHWs in LMICs. Demonstrating that accurate POCUS performance and interpretation can be achieved by non-medically-trained CHWs after focused and succinct training is the first step towards developing a novel pediatric pneumonia diagnosis and management algorithm for LMICs. Feedback from these ultrasound-naïve users about their lung POCUS learning experience is also needed to clarify which POCUS findings would be best suited to this algorithm.
The research team in AKUH will recruit and consent interested CHWs from AKU field sites in Karachi. The target is to recruit a convenience sample of 3 CHWs, who will be as representative as possible of the experience and skill sets as the average CHW in a government program. Study participants will be identified and approached by clinical team members in the AKUH emergency department, outpatient clinic and pediatric ward.
Triaging children with ARI into accurate treatment categories will lead to increased paediatric pneumonia survival, improved antibiotic stewardship, and more appropriate resource use, all of which are clinically and programmatically significant in highest disease burden settings. This project also lays the foundation for future projects that harness the trans-formative potential of POCUS for global child health.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between age of 2 months to 5 years and presenting with signs and symptoms of pneumonia, will be identified and approached by clinical team members in the AKUH emergency department, outpatient clinic and pediatric ward. The research member will review the study with the family and obtain informed consent from parents.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- patients that previously underwent lung POCUS by the same lung POCUS operator during the same visit to AKUH
- chest tube insertion or video-assisted thoracoscopic surgery (VATS) during the current visit to AKUH (since the equipment in situ and/or dressing might bias POCUS interpretation)
- inability to understand informed consent
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 |
|---|---|---|
| ULTRASOUNDLung ultrasound done through POCUS to diagnose pneumonia | Device | – |
Primary outcome
primary outcome of interest will be the inter-rater reliability of lung POCUS findings (on a cohort of patients at AKUH with ARI) between the newly trained CHWs and a local lung POCUS trainer.
Time frame: 12 months
Proportion of CHWs undergoing training in lung POCUS with a passing score 80% in a computer-based test (consisting of 60 lung POCUS video clips) with questions to determine their image interpretation skills as a reflection of technical performance. On completion of training program, they will perform lung POCUS on pediatric patients presenting to Aga Khan University Hospital (AKUH) with respiratory symptoms. For primary outcome of inter-rater reliability, the Cohen's kappa statistic will be calculated using standardized formulas. in the end will be describing the kappa statistic between final interpretations (overall and for each lung zone) of each scan by the CHWs as compared to the POCUS expert.
3 secondary outcomes
Train the trainer
Time frame: 20 days
Train novice users
Time frame: 2 days
Reliability of CHW lung POCUS use on children with acute respiratory illnesses
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Fatima Mir, FCPS principal investigator
Aga Khan University
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 Child and Pneumonia, run by Aga Khan University at 1 site in Pakistan.
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 0 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 31 Mar 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
primary outcome of interest will be the inter-rater reliability of lung POCUS findings (on a cohort of patients at AKUH with ARI) between the newly trained CHWs and a local lung POCUS trainer. (time frame: 12 months). 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 Mar 2022.