Health TrialsbyHealthPanel

Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized SMART Design

ConditionAsthma in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-14
SponsorBasque Health Service

About this trial

The main goal of this study is to evaluate the effectiveness of adaptive sequential implementation strategies based on facilitation in promoting the sustainable and widespread adoption and scaling up of the Integrated Care Pathway for Acute Asthma - ASMAbat across all Primary Care and Hospital Pediatric Services of Osakidetza - Basque Health Service.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary Care pediatricians and nurses

Pediatricians and nurses in the Pediatric Emergency Department

Pediatricians and nurses on the inpatient ward

Pediatric Intensive Care pediatricians and nurses

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Internal + External Facilitation for Implementation

    Behavioral

    Non-responding sites randomized to receive both internal and external facilitation focused on addressing determinants (barriers) of low adoption

  • Internal + External Facilitation for Sustainability

    Behavioral

    Responding sites randomized to receive both internal and external facilitation focused on consolidate factors required for sustained adoption

  • Internal Facilitation

    Behavioral

    Both responding and non-responding randomized to receive the standard scaling

Treatment groups

4,680 Participants
are divided into 3 treatment groups
Group A: Implementation facilitation (IF) strategyExperimental treatment 1 intervention
Group B: Sustainability facilitation (SF) strategyExperimental treatment 1 intervention
Group C: Standard scaling (SS) strategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the registration rate of bronchodilator treatment

Between-period change by strategy (e.g., the change from month 8 to month 16 under one strategy compared with the corresponding change under another strategy) in the rates of mild-to-moderate acute asthma episodes with documented administration of bronchodilator therapy delivered via MDI with spacer device.

Time frame
Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)

Secondary outcomes

1

Change in the registration rate of Pulmonary Score

Between-period change by strategy in the rates of registration of Pulmonary Score in children diagnosed with mild-moderate asthma attacks. The Pulmonary Score has a scale range of 0-9 with lower values representing better outcomes.

Time frame
Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)
2

Change in the registration rate of persistent asthma symptoms

Between-period change by strategy in the rate of registration of persistent asthma symptoms in children diagnosed with mild-moderate asthma attacks using the M-PACT form (Mini-Pediatric Asthma Control Tool).

Time frame
Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)
3

Change in the registration rate of the initiation of background treatment in children with persistent asthma symptoms

Between-period change by strategy in the rate of registration of initiation of background treatment in children with persistent asthma symptoms.

Time frame
Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Basque Health Service

Lead sponsor

Basque Government Department of Public Health

Collaborator

Source ClinicalTrials.gov

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