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Standardization of Mid-Level Providers Using Point of Care Ultrasound to Diagnose Pediatric Pneumonia (POCUS)

Primary Purpose

Pneumonia, Pediatric Disorder, Diagnostic and Monitoring Radiological Devices Associated With Adverse Incidents

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Point of care ultrasound training
Sponsored by
Bridge to Health Medical and Dental
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonia focused on measuring Pediatric, Pneumonia, Ultrasound, Point of Care Ultrasound, Diagnostic Imaging, Global Health, Uganda, Rural Healthcare

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to continue practicing POCUS in Kabale through the duration of the study

Sites / Locations

  • Kigezi Healthcare Foundation (KIHEFO)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trainees

Arm Description

Local mid-level providers who undergo five day training on point of care ultrasound for diagnosing pediatric pneumonia

Outcomes

Primary Outcome Measures

Trainee Scan Acquisition
The frequency at which trainees are able to acquire high-quality pediatric lung scans.
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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2019
Last Updated
May 29, 2019
Sponsor
Bridge to Health Medical and Dental
Collaborators
University of Toronto, Kigezi Healthcare Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03969342
Brief Title
Standardization of Mid-Level Providers Using Point of Care Ultrasound to Diagnose Pediatric Pneumonia
Acronym
POCUS
Official Title
Standardization of Mid-Level Providers Using Point of Care Ultrasound to Diagnose Pediatric Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bridge to Health Medical and Dental
Collaborators
University of Toronto, Kigezi Healthcare Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trainees
Arm Type
Experimental
Arm Description
Local mid-level providers who undergo five day training on point of care ultrasound for diagnosing pediatric pneumonia
Intervention Type
Device
Intervention Name(s)
Point of care ultrasound training
Intervention Description
Five-day in-person training on point of care ultrasound using portable ultrasound devices followed by remote monitoring of practice scanning
Primary Outcome Measure Information:
Title
Trainee Scan Acquisition
Description
The frequency at which trainees are able to acquire high-quality pediatric lung scans.
Time Frame
7 months
Title
Trainee / Reviewer Diagnostic Agreement
Description
The extent to which agreement between the diagnoses provided by our trainees, and that provided by our expert reviewers, is statistically significant.
Time Frame
9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Inability to continue practicing POCUS in Kabale through the duration of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Cherniak, BSc, MD, MPH, CCFP(EM), DABFM
Organizational Affiliation
Bridge to Health Medical and Dental
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kigezi Healthcare Foundation (KIHEFO)
City
Kabale
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No Individual Participant Data (IDP) sharing plan.

Learn more about this trial

Standardization of Mid-Level Providers Using Point of Care Ultrasound to Diagnose Pediatric Pneumonia

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