Bubble CPAP Team-Based Care Strategy Feasibility Trial

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.

Participants will:

• Be enrolled during either the pre-implementation or post-implementation period based on timing of hospital admission
• Have relevant clinical information obtained through medical record review
• Undergo a study-specific physical examination, as applicable
• Have their caregivers complete surveys assessing experiences, perceptions of care, and/or clinical outcomes
• Have treating clinicians complete surveys assessing implementation outcomes such as feasibility, acceptability, and usability
• Receive clinical care that may include bubble continuous positive airway pressure (bCPAP) delivered as part of routine practice
• Be cared for in units implementing an adaptable, team-based bCPAP care strategy, which may include provider education, local champion engagement, training activities, and supportive supervision, and may be refined over time based on implementation needs
• Be invited (subset of caregivers and clinicians) to participate in qualitative interviews to assess feasibility, acceptability, and experiences with the care strategy
• Be followed for 14 days after initial emergency department presentation to assess clinical outcomes, including mortality (via medical record review and/or caregiver contact, as applicable)
• Contribute data that will be compared across pre-implementation and post-implementation periods involving different participant cohorts

Inclusion criteria

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.

Exclusion criteria

Pediatric participants:

• Known congenital heart disease
• Asthma
• Upper airway obstruction
• Tracheostomy

Physicians and nurses:

• Temporarily rotating through the department, ward, or unit

Caregivers:

• Does not speak Urdu or English fluently