TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters

A Study of Next-generation Pulse Oximeters to Support the Integrated Management of Childhood Illnesses in Primary Care Settings. A Mixed Methods Type 2 Effectiveness-implementation Study Measuring the Performance and Feasibility, of Multimodal Pulse Oximeter Devices by Primary Care Providers

This study aims to provide evidence on next-generation clinical measurement tools through a mixed methods diagnostic accuracy and implementation study in Kenya, Senegal, Tanzania, and Uttar Pradesh, India.

Study Overview

• Status: Recruiting
• Conditions: Focus of Study: Accurate Clinical Measurement and Diagnosis
• Intervention / Treatment: Device: Multimodal PO

Detailed Description

Performance and feasibility of photoplethysmograph (PPG)-derived clinical measurement tools (medical device and smartphone-based screening technologies) by primary care providers will be assessed using a type 2 hybrid design to conduct a mixed methods diagnostic accuracy and implementation study.

The diagnostic accuracy study will consist of 3 components to achieve the primary and secondary objectives: 1) a usability assessment of observed user-product interactions and a system usability score, 2) measurement of multimodal PO device performance through comparison against a reference standard, and 3) caregiver/provider acceptability through semi-structured interviews.

The observational implementation (OI) study consists of 3 components to achieve the primary and secondary objectives: 1) a human-centered design workshop, 2) an observational study to evaluate the feasibility of implementing an approved multimodal PO device in clinical care, and 3) semi-structured in-depth interviews to assess provider and caregiver acceptability and adaptation.

The interventions for this study are PPG-derived clinical measurement tools that measure oxygen saturation (SpO2), pulse rate, respiratory rate, and/or temperature. The interventions will also be compared to a reference standard for the different clinical measurements

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Helen Storey, PhD.; Phone Number: 510-541-4160; Email: hstorey@path.org
• Study Contact Backup: Name: Megan Horlacher; Phone Number: 7345365674; Email: mhorlacher@path.org

Study Locations

• Kenya
  • Nairobi, Kenya
    • Recruiting
    • Mathare North Health Center
    • Contact: Ambrose Agweyu
  • Nairobi, Kenya
    • Recruiting
    • Ngiri Health Center
    • Contact: Ambrose Agweyu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children 0 - 59 months consulting for or reported to have a respiratory illness.

Description

Inclusion Criteria:

• Children 0 - 59 months for whom caregivers provide consent to participate in the research study, following completion of clinical consultation
• Consulting for a respiratory illness, or reported to have a respiratory illness when attending for a routine visit as an outpatient (e.g., vaccination, growth, or chronic disease monitoring)

Exclusion Criteria:

• Children in the immediate post-natal period or first day of life
• Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds)
• Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother)
• Children who are critically ill, requiring emergency treatment, or received a recommendation of immediate referral during clinical consultation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy: Performance of clinical measurement tools	To determine the performance of PPG-derived clinical measurement tools (medical device and smartphone-based screening technologies) compared to an accepted reference standard, among children 0-59 months seeking care at the primary care level.	19 weeks
Observational implementation: multimodal (MM) operational feasibility	To evaluate the operational feasibility of implementing an approved next generation pulse oximeter at the primary care level.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DA: MM Usability	To measure the usability of multimodal PO devices, measuring pulse oximetry and respiratory rate in addition to other relevant clinical measurements, by healthcare providers at the primary care level.	2 weeks
DA: MM Acceptability	To assess the acceptability of multimodal PO devices among healthcare providers and caregivers at the primary care level.	21 weeks
DA: Data repository	To create an open-source data repository for future research on PPG-derived clinical measurement tools for children.	19 weeks
OI: MM/clinical measurement system requirements	To explore future multimodal PO device and smartphone based clinical measurement product concepts and prototypes to further define the user and health system requirements for potential device integration within integrated management of childhood illness (IMCI) care practices, among country stakeholders and healthcare providers.	16 weeks
OI: MM co-design	To co-design integration of an approved multimodal PO device within existing IMCI practices, mapping current and future state workflows, prioritizing outcomes, and determining training needs.	1 week

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: Bill and Melinda Gates Foundation; UNITAID

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: RES-00317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No