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Process evaluation of a cluster randomised controlled trial to improve bronchiolitis management - a PREDICT
Libby Haskell1,2, Emma J Tavender3,4, Sharon O'Brien5,6
1Children's Emergency Department, Starship Children's Hospital, Private Bag, Auckland, 92019, New Zealand.
Insights
Targeted interventions effectively reduced non-evidence-based therapies for infant bronchiolitis. Despite moderate fidelity and time constraints, these interventions improved care and support future practice changes.
Area of Science:
- Pediatrics
- Health Services Research
- Implementation Science
Background:
- Bronchiolitis is a leading cause of infant hospitalization, often managed with supportive care.
- Significant variation exists in clinical practice, with some infants receiving non-evidence-based therapies.
- Developed and tested targeted, theory-informed interventions to improve bronchiolitis management.
Purpose of the Study:
- To evaluate the implementation fidelity and end-user perceptions of interventions aimed at reducing non-evidence-based care for bronchiolitis.
- To correlate intervention fidelity with outcomes from a cluster randomized controlled trial (cRCT).
Main Methods:
- A mixed-methods process evaluation was conducted alongside a cRCT.
- Quantitative data on intervention fidelity, dose, and reach were collected from 13 hospitals.
- Qualitative data on perceptions and acceptability were gathered from 42 clinical leads via thematic analysis.
Main Results:
- The cRCT demonstrated a 14.1% improvement in bronchiolitis management with the interventions.
- Intervention fidelity varied across hospitals, with scores ranging from 55% to 98% (mean 78%).
- Clinical leads perceived interventions positively, but time constraints were a significant barrier.
Conclusions:
- Targeted interventions for bronchiolitis were implemented with moderate fidelity and were well-received.
- Intervention fidelity positively impacted the de-implementation of non-evidence-based care.
- Findings will guide the broader rollout of bronchiolitis interventions and future practice change initiatives.
Background:
Bronchiolitis is the most common reason for hospitalisation in infants. All international bronchiolitis guidelines recommend supportive care, yet considerable variation in practice continues with infants receiving non-evidence based therapies. We developed six targeted, theory-informed interventions; clinical leads, stakeholder meeting, train-the-trainer, education delivery, other educational materials, and audit and feedback. A cluster randomised controlled trial (cRCT) found the interventions to be effective in reducing use of five non-evidence based therapies in infants with bronchiolitis. This process evaluation paper aims to determine whether the interventions were implemented as planned (fidelity), explore end-users' perceptions of the interventions and evaluate cRCT outcome data with intervention fidelity data.
Methods:
A pre-specified mixed-methods process evaluation was conducted alongside the cRCT, guided by frameworks for process evaluation of cRCTs and complex interventions. Quantitative data on the fidelity, dose and reach of interventions were collected from the 13 intervention hospitals during the study and analysed using descriptive statistics. Qualitative data identifying perception and acceptability of interventions were collected from 42 intervention hospital clinical leads on study completion and analysed using thematic analysis.
Results:
The cRCT found targeted, theory-informed interventions improved bronchiolitis management by 14.1%. The process evaluation data found variability in how the intervention was delivered at the cluster and individual level. Total fidelity scores ranged from 55 to 98% across intervention hospitals (mean = 78%; SD = 13%). Fidelity scores were highest for use of clinical leads (mean = 98%; SD = 7%), and lowest for use of other educational materials (mean = 65%; SD = 19%) and audit and feedback (mean = 65%; SD = 20%). Clinical leads reflected positively about the interventions, with time constraints being the greatest barrier to their use.
Conclusion:
Our targeted, theory-informed interventions were delivered with moderate fidelity, and were well received by clinical leads. Despite clinical leads experiencing challenges of time constraints, the level of fidelity had a positive effect on successfully de-implementing non-evidence-based care in infants with bronchiolitis. These findings will inform widespread rollout of our bronchiolitis interventions, and guide future practice change in acute care settings.
Trial Registration:
Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415 .
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