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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Observational implementation: multimodal (MM) operational feasibility
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Observational implementation: multimodal (MM) operational feasibility
时间窗: 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
时间窗: 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.
次要结局
- 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)