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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia; Pediatric Disorder; Diagnostic and Monitoring Radiological Devices Associated With Adverse Incidents
• Intervention / Treatment: Device: Point of care ultrasound training

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kabale, Uganda
    • Kigezi Healthcare Foundation (KIHEFO)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trainees; Local mid-level providers who undergo five day training on point of care ultrasound for diagnosing pediatric pneumonia	Device: Point of care ultrasound training; Five-day in-person training on point of care ultrasound using portable ultrasound devices followed by remote monitoring of practice scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trainee Scan Acquisition	The frequency at which trainees are able to acquire high-quality pediatric lung scans.	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.	9 months

Collaborators and Investigators

• Sponsor: Bridge to Health Medical and Dental
• Collaborators: University of Toronto; Kigezi Healthcare Foundation
• Investigators: Principal Investigator: William Cherniak, BSc, MD, MPH, CCFP(EM), DABFM, Bridge to Health Medical and Dental

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Pneumonia; Pediatric; Uganda; Global Health; Diagnostic Imaging; Point of Care Ultrasound; Rural Healthcare
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Individual Participant Data (IDP) sharing plan.

Drug and device information, study documents

• 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