None listed
Conditions
Brief summary
In this research we are doing a cluster randomised controlled trial in which 26 - 32 individual hospitals (clusters) are randomly allocated to either the intervention or control arms of the study. At sites which are in the intervention arm, clinicians are given access to a website (RART-Bronch platform) that contains resources and they will receive EXTRA implementation support to plan improved clinical care in bronchiolitis. The control sites can also access the website and resources to improve clinical care in bronchiolitis without the additional implementation support and training. The primary outcome is the proportion of infants who receive care adherent to 5 key of the Australasian Bronchiolitis Guideline recommendations, in the acute care period (first 24 hours), throughout the study period, with data collected retrospectively. A process evaluation will be undertaken which involves interviews with a sample of 1 - 2 staff at each site post implementation to examine: fidelity and adaption, reach, acceptability, appropriateness, feasibility and organisational culture/leadership. Data will also be collected on use of the materials supplied and how the website has been used. Health economics analysis will also be undertaken.
Interventions
The Regional and Rural Translation-Bronchiolitis (RART-Bronch) cluster randomised controlled trial (cRCT) is a multicentre two-arm cluster randomised controlled trial evaluating the impact of higher versus lower-intensity facilitation (exposure) on implementation of evidence-based bronchiolitis care in infants under 12 months across 26 -32 regional and rural Australian hospitals. Our study builds on the previous PREDICT Bronchiolitis Knowledge Translation (KT) Study (ACTRN12616001567415) which successfully implemented a targeted, theory-informed bronchiolitis intervention which reduced the use of five inappropriate therapies (chest X-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline). The KT study intervention included the following components: engagement of local nursing and medical clinical opinion leaders; a one-day train the trainer workshop; educational materials; and audit and feedback. Our current study proposes that the optimal level of implementation facilitation of the targeted theory-informed interventions may vary for regional and rural hospitals where resources and experience with bronchiolitis management may be limited. The development of the RART platform, a digital platform that houses clinical educational materials, implementation education/guides and audit and feedback dashboards (via Power BI) will be made available to both arms of the cRCT study, however the level of exposure (implementation facilitation intensity) will differ, as outlined below. The RART-Bronch study is anticipated to be conducted over approximately 4.25 years, with key phases outlined below: • Nov 25 – Oct 26: Preparation and administration phase Following ethics approval, finalisation of participating sites will occur over a 12-month period. This will involve completion of site governance and finalising participation agreements. • Jun 26 – Dec 26: Baseline data collection phase Once governance is complete, a 6-month period will be dedicated to activation of sites and collecting retrospective baseline data prior to the study (sites may start earlier/later depending on governance approval). This will include collecting retrospective clinical data relevant to bronchiolitis care prior to the study commencing. Data cleaning will take place simultaneously to finalise the data. • Dec 26 – Feb 27: Randomisation phase Sites will be randomised into intervention or control arms of the study. This step will be conducted immediately following completion of baseline data collection to facilitate a seamless transition to the embedding phase of the study in March 2027. • Mar 27 – Sept 27: Embedding phase All sites will commence using the RART-platform materials and tools to support bronchiolitis care. At intervention sites, this phase will include four online facilitation meetings with the implementation team to support strategies to address local barriers. Process evaluation data collection will commence and be ongoing. • Oct 27 – Sept 28: Intervention phase During this phase, teams should be using the bronchiolitis education and implementation materials and undertaking short audits to support bronchiolitis care. • Oct 28 – Dec 28: Post-study data collection phase Data collection phase will occur over a 3-month period at the end of the study. This will involve extracting retrospective clinical data on bronchiolitis care that occurred during the intervention phase for both intervention and control sites. Clinician interviews for process evaluation will commence during this time. • Oct 28 - Mar 29: Data cleaning phase Data cleaning of the process evaluation data and the post study infant record data will be undertaken as in an ongoing process as the data accrues. • Apr 29 – Jun 29: Data analysis phase Quantitative data will be analysed to assess the effectiveness of the intervention, using pre-specified outcome measures. This will include comparative analyses between intervention and control arms. • Jan 29 – Jun 29: Economic and process evaluation data analysis Concurrent with quantitative data analysis, analysis of economic and process evaluations data will be conducted. These evaluations will assess the cost-effectiveness and implementation processes underpinning the intervention, guided by relevant economic and implementation science frameworks. • Jul 29 – Dec 30: Final reporting and dissemination The final phase of the project will involve preparation of study reports, policy briefs, academic publications, and dissemination to participating sites, stakeholders, and broader audiences. Exposure: Level of implementation facilitation During the embedding phase (Mar 27 – Sept 27) Lower-intensity sites (control group) will be exposed to Components 1-2 and will be provided with their pre-study audit results and provided with their baseline adherence rate. They will be exposed to the RART-bronch platform and all associated materials housed within. Activity: Site PIs will be provided with log-in details of how to access the RART platform content. The content on this platform will consist of specifically designed materials for this study, including: -bronchiolitis education materials (materials from the KT Bronch study with new High Flow Nasal Cannula (HFNC) training materials, discharge information for families), -implementation support and training materials, -links to the updated PREDICT bronchiolitis guideline, and - audit and feedback capability. A staff contact number will be provided to answer any questions they might have about the platform. Higher-intensity sites (intervention group) will be exposed to components 1-5 during the embedding phase: Component 1 - Clinical Leads Activity; Identification of medical and nursing clinical leads Component 2 - RART Platform Access Activity: Clinical leads will be provided with log-in details of how to access the RART platform content along with their pre-study audit results and provided with their baseline adherence rate. This content on this platform will consist of specifically designed for this study, including: -bronchiolitis education materials (materials from the KT Bronch study with new High Flow Nasal Cannula (HFNC) training materials, discharge information for families), -implementation support and training materials, -links to the updated PREDICT bronchiolitis guideline, and - audit and feedback capability. A staff contact number will be provided to site PIs and clinical leads answer any questions they might have about the platform. Component 3 - RART Platform Training Activity: In addition to RART Platform access and manual, clinical leads will attend an online Teams meeting (as part of meeting 1) with research staff to train them in the effective use of the platform content. The topics of this training will include: - understanding of how the materials can be used to drive improvements in their hospital -how to incorporate benchmarking tools, and -how to effectively use and incorporate feedback reports. Materials used during these training sessions will be developed specific for this study. Contact details for research staff will be provided to answer any questions they might have about the platform. Component 4 - External implementation strategy facilitation sessions Activity: Four (1-hour) structured facilitation meetings will be held via Teams with clinical leads and an implementation scientist over 4 months. These meetings will be scheduled at key project milestones, specifically: Meeting 1 (Introduction to the RART-Bronch platform and Audit review) to high facilitation sites - Initial study timeline, review audit and feedback results from baseline data collection at each site (60 retrospective medical records of infants under 12 months of age who presented to the ED or were admitted to the inpatient ward with a clinical diagnosis of bronchiolitis during the pre-study period of 1 January 2025 to 31 December 2025) to identify areas to target for improvement, preparing for a multidisciplinary team (MDT) meeting, Meeting 2 (Post MDT meeting) to high facilitation sites - Debrief of MDT meeting, Problem solving session, strategy identification, and action plan development, peer matching Meeting 3 (Strategy review) to high facilitation sites -Review of outcomes, address strengths and weaknesses of strategies in local context, identify sustainable strategies Meeting 4 (Prior to bedding down /intervention phase) to high facilitation sites: Preparation of bedding down, review of barriers and strategies, address any unexpected outcomes, peer matching check-in. The Teams videoconference sessions will be targeted at the clinical leads. Sessions will be repeated as many times as necessary to ensure all clinical leads receive the same high-intensity dose of external remote facilitation. Any additional sessions beyond the four planned sessions and their timing will be determined by the research group. The researchers will also provide the clinical leads from the high intensity external remote facilitation intervention group with ongoing proactive and reactive email and telephone remote support as follows: • Proactive check-in emails from research team to clinical leads during key milestones (post-audit review; post-MDT meeting; post-strategy review, post-bedding down review) • Proactive telephone contact from research team to clinical leads following completion of pre-intervention audit data collection • Reactive emails from clinical leads to research team when required • Reactive telephone contact from clinical leads to research team when required During the intervention phase (Oct 27-Sept 28), Low intensity sites (control group) teams should be using the RART-Bronch platform, bronchiolitis education and implementation materials and undertaking short audits to support bronchiolitis care. High Intensity sites (Intervention group) will be exposed to: Component 5 - Peer matching (up to 12 month duration) with peer-matched meetings, email/telephone communication from research team, peer-matched support. Activity: Peer matching will connect higher intensity support sites to each other and peer sites that have successfully adopted change to share ideas and strategies during the embedding phase. An initial 1-hour Teams meeting, facilitated by the research team, will be held with clinical leads from the higher intensity sites to meet with each other and learn from hospitals who have previously successfully improved bronchiolitis care in their hospital. Regular (every 1-2 months) Teams meetings, prompted by the research team, will be held throughout the intervention period to share improvement stories. The researchers will also provide the clinical leads from the high intensity external remote facilitation intervention group with ongoing proactive and reactive email and telephone remote support with relation to peer matched support including - Proactive check-in emails from research team to clinical leads re: peer support, facilitation of peer support meetings as required. Reactive emails from clinical leads to research team when required Reactive telephone contact from clinical leads to research team when required Peer support
Sponsors
Study design
Eligibility
Inclusion criteria
Eligible sites criteria: • Be located in regional or rural Australia (Modified Monash Model MM2 -MM7) • Provide acute paediatric care, including either emergency department and/or inpatient services for children under 2 years of age • Provide care in the ED and or inpatient area for 60 or more infants with bronchiolitis per year. • Have not participated in previous PREDICT bronchiolitis improvement research (cRCT (HREC/16/RCHM/84), WA KT (Child and Adolescent Health Service Human Research Ethics Committee (RGS 4273 13 January 2021) or development of the RART-Bronchiolitis platform (HREC 115675) • Be willing to participate and abide by the randomisation schedule (either "lower or "higher” intensity facilitation). • Have at least one staff member to fulfil the role of hospital clinical champion for the during the duration of the trial • Can collect the required retrospective patient data from medical records. Infant record data eligibility criteria Inclusion criteria: • Aged <12 months at date of presentation to hospital, AND • Presented to the ED or inpatient ward during the defined audit period, AND • Medical record must have a date/time of presentation to and discharge from the hospital recorded, AND • A recorded diagnosis of bronchiolitis (in the medical record) on discharge from ED to home, OR • If admitted, a recorded diagnosis of bronchiolitis (in the medical record) in ED and on discharge from the inpatient area Clinician eligibility criteria Inclusion criteria: • Clinical champions or key clinicians working in the ED or inpatient paediatric area at the site, who have been involved in bronchiolitis care AND • Those who have used the RART-Bronch platform and materials, during the 2027/2028 bronchiolitis season.
Exclusion criteria
Infant record data exclusion criteria: •Infants transferred to another hospital upon arrival (prior to being assessed), OR •Infants received by the hospital already started on high flow nasal cannula support prior to arrival. Clinician exclusion criteria: Clinicians who have taken part in the co-design development or usability testing of the RART-Bronch platform (project 115675)