Feasibility Trial of a Bubble Continuous Positive Airway Pressure Team-Based Care Strategy in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 95
- 试验地点
- 2
研究概览
简要总结
The goal of this pre/post, effectiveness-implementation feasibility trial is to learn if a larger, multisite trial of a bubble continuous positive airway pressure (bCPAP) team-based care strategy is feasible in children with severe pneumonia. The main questions it aims to answer are:
Is a future, larger, multisite trial of a bCPAP team-based care strategy feasible? Is the bCPAP team-based care strategy feasible and acceptable to clinicians and caregivers?
详细描述
This study is a single-group, pre-post implementation study designed to evaluate the feasibility and preliminary effectiveness of a team-based care strategy to improve delivery of bubble continuous positive airway pressure (bCPAP) among children presenting with severe pneumonia to participating hospitals.
The study uses a repeated cross-sectional design in which distinct cohorts of participants are enrolled during a 4-month pre-implementation period and a 4-month post-implementation period based on timing of emergency department presentation. A unit-level implementation strategy is introduced between these periods, and outcomes are compared across time rather than between concurrently assigned groups.
The intervention consists of an adaptable, team-based care implementation strategy to support delivery of bCPAP in routine clinical care. Components may include provider education, preparation of local champions, training of clinical staff, caregiver education and engagement, and ongoing supportive supervision. The strategy may be refined over time based on local context and implementation needs. bCPAP is already available and used in participating units; this study does not involve introduction of a new device but instead focuses on improving the uptake, fidelity, and quality of its use within standard care.
The study population includes pediatric participants meeting criteria for severe pneumonia, as well as caregivers and clinicians who contribute survey and qualitative interview data related to implementation outcomes. Quantitative and qualitative data are collected to evaluate feasibility, acceptability, implementation fidelity, and clinical outcomes, including follow-up after presentation.
The primary objective is to assess feasibility of progression to a larger trial using predefined criteria. Secondary objectives include evaluating feasibility and acceptability of the implementation strategy and characterizing implementation processes in the post-implementation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric participants:
- •Provision of signed and dated informed consent form by legal guardian (as determined by local policies and laws)
- •Stated willingness (by guardian) to comply with all study procedures and availability for the duration of the study
- •Presentation to the Emergency Department with cough or difficulty breathing (as documented in triage notes)
- •Meeting the World Health Organization definition for severe pneumonia: Exhibiting severe respiratory distress (clinical respiratory score of at least 8) OR Exhibiting hypoxemia (SpO2<90%) OR Exhibiting a general danger sign (Vomiting everything (as reported by child's caregiver), Inability to feed (as reported by child's caregiver), Seizure/convulsion (as documented in medical chart or reported by child's caregiver), Reduced level of consciousness (as assessed at screening)
- •In addition, exhibiting either:
- •Severe respiratory distress (clinical respiratory score of at least 8)
- •Hypoxemia (SpO2<90%)
- •Physicians and nurses:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, over 18 years of age
- •Directly cared for any child receiving bCPAP therapy during the post-implementation period of the study
- •Caregivers:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, any age
- •Primary caregiver at bedside of a child enrolled in the post-implementation period of our study.
排除标准
- •Pediatric participants:
- •Known congenital heart disease
- •Upper airway obstruction
- •Tracheostomy
- •Physicians and nurses:
- •Temporarily rotating through the department, ward, or unit
- •Caregivers:
- •Does not speak Urdu or English fluently