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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Focus of Study: Accurate Clinical Measurement and Diagnosis
- Sponsor
- PATH
- Enrollment
- 650
- Locations
- 2
- Primary Endpoint
- Observational implementation: multimodal (MM) operational feasibility
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Observational implementation: multimodal (MM) operational feasibility
Time Frame: 16 weeks
To evaluate the operational feasibility of implementing an approved next generation pulse oximeter at the primary care level.
Diagnostic accuracy: Performance of clinical measurement tools
Time Frame: 19 weeks
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.
Secondary Outcomes
- DA: Data repository(19 weeks)
- DA: MM Usability(2 weeks)
- OI: MM/clinical measurement system requirements(16 weeks)
- OI: MM co-design(1 week)
- DA: MM Acceptability(21 weeks)