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Bubble CPAP Team-Based Care Strategy Feasibility Trial

ConditionPneumonia in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-59
SponsorYale University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Known congenital heart disease

Asthma

Upper airway obstruction

Tracheostomy

Trial design

Design model

Single group

Treatments tested in this trial

  • bCPAP team-based care strategy

    Behavioral

    This intervention consists of an adaptable, team-based implementation strategy to support delivery of bubble continuous positive airway pressure (bCPAP) in routine clinical care. The strategy is implemented at the unit level and may include provider education, preparation of local champions, training of clinical staff, caregiver education and engagement, and ongoing supportive supervision. These components are designed to improve provider knowledge, skills, teamwork, communication, and caregiver understanding related to bCPAP use. The strategy may be refined over time based on local context and implementation needs. The intervention does not assign bCPAP directly but seeks to enhance the uptake, fidelity, and quality of its use within standard clinical practice. bCPAP is already available and used in participating units; this intervention does not involve introduction of a new device but rather focuses on improving the delivery and quality of existing care.

Treatment groups

95 Participants
are divided into 1 treatment group
Group A: Participants cared for under bCPAP team-based care strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of a Larger Trial

Feasibility of a larger trial of the bCPAP team-based care strategy, as assessed using predefined trial progression criteria, including recruitment and consent rates, completeness and quality of effectiveness outcomes data, and completeness and quality of implementation outcomes data, with evaluation against prespecified benchmarks defined in the study protocol. This is a composite measure defined as: if certain criteria are met, the study will proceed to a larger trial.

Time frame
From enrollment through completion of 14-day follow-up

Secondary outcomes

1

Feasibility of the bCPAP Team-Based Care Strategy Among Caregivers

Assessed using qualitative interviews with caregivers, with thematic analysis of perceived feasibility, including barriers and facilitators to participation in bCPAP care processes.

Time frame
Within 14 days after emergency department presentation during the post-implementation period
2

Implementation Fidelity to the bCPAP Team-Based Care Strategy Among Clinicians

Assessed by tracking implementation activities, including frequency of clinician champion meetings, frequency of implementation data dissemination, and clinician attendance at bCPAP training sessions.

Time frame
Throughout the post-implementation period (4 months) during delivery of the implementation strategy
3

Caregiver Engagement With bCPAP Educational Components

Assessed as the proportion of caregivers who view a bCPAP educational video during the clinical encounter.

Time frame
Within 24 hours of bCPAP therapy initiation in the post-implementation period
4

Overall Feasibility and Acceptability of the bCPAP Team-Based Care Strategy

Assessed as a composite evaluation of implementation outcomes, including caregiver-reported feasibility and acceptability (qualitative interviews), implementation fidelity among clinicians, and caregiver engagement with educational components. These domains will be considered together to characterize the overall feasibility and acceptability of the bCPAP team-based care strategy in routine clinical practice using a predefined framework to integrate findings across domains.

Time frame
Throughout the post-implementation period (4 months) during delivery of the implementation strategy

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: