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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 . [ABSTRACT FROM AUTHOR]

Background: Despite international guidelines providing evidence-based recommendations on appropriate management of infants with bronchiolitis, wide variation in practice occurs. This results in infants receiving care of no benefit, with associated cost and is potentially harmful. Theoretical frameworks are increasingly used to develop interventions, utilising behaviour change techniques specifically chosen to target factors contributing to practice variation, with de-implementation often viewed as harder than implementing. This paper describes the stepped process using the Theoretical Domains Framework (TDF) to develop targeted, theory-informed interventions which subsequently successfully improved management of infants with bronchiolitis by de-implementing ineffective therapies. Explicit description of the process and rationale used in developing de-implementation interventions is critical to dissemination of these practices into real world clinical practice.Methods: A stepped approach was used: (1) Identify evidence-based recommendations and practice variation as targets for change, (2) Identify factors influencing practice change (barriers and enablers) to be addressed, and (3) Identification and development of interventions (behaviour change techniques and methods of delivery) addressing influencing factors, considering evidence of effectiveness, feasibility, local relevance and acceptability. The mode of delivery for the intervention components was informed by evidence from implementation science systematic reviews, and setting specific feasibility and practicality.Results: Five robust evidence-based management recommendations, targeting the main variation in bronchiolitis management were identified: namely, no use of chest x-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline. Interventions developed to target recommendations addressed seven TDF domains (identified following qualitative clinician interviews (n = 20)) with 23 behaviour change techniques chosen to address these domains. Final interventions included: (1) Local stakeholder meetings, (2) Identification of medical and nursing clinical leads, (3) Train-the-trainer workshop for all clinical leads, (4) Local educational materials for delivery by clinical leads, (5) Provision of tools and materials targeting influencing factors, and prompting recommended behaviours, and (6) Audit and feedback.Conclusion: A stepped approach based on theory, evidence and issues of feasibility, local relevance and acceptability, was successfully used to develop interventions to improve management of infants with bronchiolitis. The rationale and content of interventions has been explicitly described allowing others to de-implement unnecessary bronchiolitis management, thereby improving care. [ABSTRACT FROM AUTHOR]