Bubble CPAP Team-Based Care Strategy Feasibility Trial
Feasibility Trial of a Bubble Continuous Positive Airway Pressure Team-Based Care Strategy in Pakistan
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?
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Nadir Ijaz, MD, MHS
- Número de telefone: (203) 785-4148
- E-mail: nadir.ijaz@yale.edu
Locais de estudo
-
-
-
Karachi, Paquistão
- Aga Khan University Hospital
-
Contato:
- Qalab Abbas, MBBS
- Número de telefone: +922134864796
- E-mail: qalab.abbas@aku.edu
-
Karachi, Paquistão
- Abbasi Shaheed Hospital
-
Contato:
- Ibrahim Shakoor, MBBS
- E-mail: ishakoor@yahoo.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Participants cared for under bCPAP team-based care strategy
This single arm includes pediatric participants and their caregivers, nurses, and physicians enrolled during pre-implementation and post-implementation periods based on timing of hospital presentation.
A team-based, unit-level bCPAP care implementation strategy is introduced between periods and may include provider education, local champion engagement, training activities, and supportive supervision, with potential refinement over time.
Outcomes are compared across pre- and post-implementation cohorts, which consist of different participants.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of a Larger Trial
Prazo: From enrollment through completion of 14-day follow-up
|
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.
|
From enrollment through completion of 14-day follow-up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of the bCPAP Team-Based Care Strategy Among Caregivers
Prazo: Within 14 days after emergency department presentation during the post-implementation period
|
Assessed using qualitative interviews with caregivers, with thematic analysis of perceived feasibility, including barriers and facilitators to participation in bCPAP care processes.
|
Within 14 days after emergency department presentation during the post-implementation period
|
|
Implementation Fidelity to the bCPAP Team-Based Care Strategy Among Clinicians
Prazo: Throughout the post-implementation period (4 months) during delivery of the implementation strategy
|
Assessed by tracking implementation activities, including frequency of clinician champion meetings, frequency of implementation data dissemination, and clinician attendance at bCPAP training sessions.
|
Throughout the post-implementation period (4 months) during delivery of the implementation strategy
|
|
Caregiver Engagement With bCPAP Educational Components
Prazo: Within 24 hours of bCPAP therapy initiation in the post-implementation period
|
Assessed as the proportion of caregivers who view a bCPAP educational video during the clinical encounter.
|
Within 24 hours of bCPAP therapy initiation in the post-implementation period
|
|
Overall Feasibility and Acceptability of the bCPAP Team-Based Care Strategy
Prazo: Throughout the post-implementation period (4 months) during delivery of the implementation 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.
|
Throughout the post-implementation period (4 months) during delivery of the implementation strategy
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nadir Ijaz, MD, MHS, Yale University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2000042882
- 1K23HL181402-01A1 (Outro identificador: Pending NIH grant application supporting this study)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .