Children's Emergency Department, Starship Children's Hospital, Private Bag, Auckland, 92019, New Zealand.
Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.
BMC Health Serv Res. 2021 Nov 29;21(1):1282. doi: 10.1186/s12913-021-07279-2.
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.
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.
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.
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.
Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415 .
毛细支气管炎是婴儿住院的最常见原因。所有国际毛细支气管炎指南都建议提供支持性护理，但实践中仍存在相当大的差异，婴儿接受了没有证据支持的治疗。我们开发了六项针对性的、基于理论的干预措施；临床负责人、利益相关者会议、培训师培训、教育提供、其他教育材料以及审核和反馈。一项集群随机对照试验（cRCT）发现这些干预措施可有效减少毛细支气管炎婴儿使用五种非循证治疗方法。本过程评估旨在确定干预措施是否按计划实施（忠实度），探讨最终用户对干预措施的看法，并将 cRCT 结果数据与干预忠实度数据进行评估。
在 cRCT 期间，根据 cRCT 过程评估和复杂干预措施的框架，进行了一项预先指定的混合方法过程评估。在研究期间，从 13 家干预医院收集了干预措施忠实度、剂量和覆盖范围的定量数据，并使用描述性统计进行分析。在研究结束时，从 42 家干预医院的临床负责人收集了定性数据，以确定干预措施的看法和可接受性，并使用主题分析进行分析。
cRCT 发现，有针对性的、基于理论的干预措施可将毛细支气管炎的管理改善 14.1%。过程评估数据发现，干预措施在集群和个体层面的实施情况存在差异。各干预医院的总忠实度评分范围为 55%至 98%（平均 78%；SD=13%）。临床负责人的使用忠实度最高（平均 98%；SD=7%），其他教育材料的使用忠实度最低（平均 65%；SD=19%）和审核和反馈的使用忠实度最低（平均 65%；SD=20%）。临床负责人对干预措施评价积极，但使用面临的最大障碍是时间限制。
我们的有针对性的、基于理论的干预措施具有中等程度的忠实度，并得到了临床负责人的好评。尽管临床负责人面临时间限制的挑战，但忠实度水平对成功取消毛细支气管炎婴儿的非循证护理产生了积极影响。这些发现将为我们的毛细支气管炎干预措施的广泛推广提供信息，并为急性护理环境中的未来实践变革提供指导。
澳大利亚和新西兰临床试验注册中心：ACTRN12616001567415。
