None listed
Conditions
Brief summary
Our landmark trial published in The Lancet in 2011 demonstrated that facilitated implementation of nurse-initiated protocols to manage fever, hyperglycaemia (sugar) and swallowing difficulties (FeSS Protocols) resulted in significantly reduced 90-day death and dependency for stroke patients. However, ten years on, a significant gap remains in translation of the FeSS Protocols into standard stroke care across Australia, particularly notable in rural and remote settings. A program of systematic Australia-wide implementation is urgently needed. To date, systematic implementation of the FeSS Protocols has not occurred in New Zealand. Therefore, the specific aims of this study are: 1) To determine the effectiveness of a large scale intervention with varying intensities of external remote facilitation in enhancing simultaneous multi-site delivery to promote multi-national uptake of the FeSS Protocols to improve management of fever, hyperglycaemia and swallowing difficulties in the first 72 hours of stroke unit/stroke service admission. Specifically, we will compare the effectiveness of: a) low intensity versus high intensity external remote facilitation. b) low intensity versus no external remote facilitation. c) high intensity versus no external remote facilitation. 2) To determine whether post-intervention implementation changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between metropolitan and rural/remote hospitals. 3) To determine whether post-intervention changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between stroke units and stroke services. 4) To describe the potential cost-effectiveness of the different facilitation methods (economic evaluation). 5) To identify clinicians’ views regarding factors that influence uptake of the FeSS Protocols in metropolitan and rural/remote hospitals (process evaluation). A three-arm cluster randomised controlled trial, process evaluation and economic evaluation (sub-study) will be undertaken. Hospitals will be randomised to one of two intervention (low and high intensity external remote facilitation) or control (no facilitation) groups. Australian and new Zealand hospitals with a pre-existing stroke unit/service will be eligible. Multi-national implementation of the proven FeSS Protocols into innovative policy and practice will result in better outcomes for survivors of stroke, particularly in rural and remote Australian and New Zealand settings.
Interventions
The intervention is testing the amount of external remote facilitation (high, low or none) needed to improve implementation of the Fever Sugar Swallow (FeSS) Protocols for stroke patients admitted to stroke units/stroke services in Australia and New Zealand. Hospitals will be randomised to one of the three study groups – high intensity external remote facilitation intervention group, low intensity external remote facilitation intervention group, or a no facilitation control group - in a 2 (high intensity):2 (low intensity):1 (no facilitation) ratio. All participating hospitals will nominate at least one nurse where possible (if not, then a speech pathologist) currently working in the stroke unit/stroke service to act as a site clinical champion and will receive the intervention components depending on study group allocation as outlined below. High intensity external remote facilitation intervention group: Hospitals randomised to this group will receive: i) the FeSS Protocols (refined from the Quality in Acute Stroke Care (QASC) trial, ACTRN12608000563369) ii) the online FeSS education package consisting of three components which will be designed specifically for this study: a) an Online Education Resource Package: An online education resource package comprising a suite of short (5-7 minute) videos and downloadable hard-copy resources will be developed by the research team and provided to site champions. It is anticipated that the package will be hosted on the Australian Catholic University Open Learning webpage. Video topics will be based on case studies using role-playing actors and animations. The video topics include: 1. FeSS is one of the most cost-effective interventions in acute stroke care 2. A fever is not the smoke, it's the fire. Put it out ASAP 3. Blood sugar is the fuel on the fire: keep it regulated 4. A sip of water can be deadly after strokes: Check their swallowing first 5. Leading change can be hard. Here’s how to make it easier 6. Why do an audit? 7. How to do an audit b) a Train-the-Trainer Education Package: Site champions will be encouraged to form their own local team consisting of themselves, at least a medical doctor and speech pathologist, from the Stroke Unit/Stroke Service with expertise in acute stroke patient management. Site champions will receive all components of the online FeSS education package and will be required to watch all the video topics. Site champions in the high intensity external remote facilitation intervention group will be guided remotely by the researchers, who will act as external facilitators, in undertaking self-directed training to develop their capability and capacity in leading and negotiating evidence-based change. However, site champions in the low intensity external remote facilitation intervention group will not receive guidance from the researchers but will be provided with the flowchart of project milestones to encourage them to undertake the training within the specified timeframe of two-four weeks. Following completion of the online training, all site champions will receive a certificate which will count towards their continuing professional development. Site champions will have continued access to the online FeSS education package during the duration of the project to support them in implementing the FeSS Protocols. c) a Clinician Education Package: Site champions will be responsible for educating all clinicians in their stroke units/stoke services. They will use the online education resources to conduct one on-site multidisciplinary education session (one-hour duration) for stroke unit clinicians to explain the monitoring and treatment elements of the FeSS Protocols, how to implement the protocols including audit and data entry procedures. The multidisciplinary education session will be run multiple times to reach all clinicians. A detailed explanation of the research evidence underpinning the protocols including the rationale for its inclusion in the stroke guidelines will also be provided at the session. The site champions will be encouraged to share modules from the online education package with clinicians who are unable to attend the session and arrange make-up training. iii) the FeSS audit and feedback report. Site champions will also be provided with high-intensity external remote facilitation by the researchers. This includes a minimum of four one-hour videoconference sessions held at key project milestones, specifically: post-randomisation; post-receipt of online FeSS education package; post-multidisciplinary meeting; commencement of three-month bedding down period. The videoconference sessions will be targeted at site champions and delivered in groups. The number of site champions in a group will depend on their availability to attend a scheduled session. Sessions will be repeated as many times as necessary to ensure all site champions 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 demand from the site champions group. The researchers will also provide site champions from the high intensity external remote facilitation intervention group with ongoing proactive and reactive email and telephone remote support as follows: • Proactive emails from research team to site champions during key milestones (post-randomisation; post-receipt of online FeSS education package; post-multidisciplinary meeting; commencement of three-month bedding down period) • Proactive telephone contact from research team to site champions following completion of pre-intervention audit data collection • Reactive emails from site champions to research team when required • Reactive telephone contact from site champions to research team when required Low intensity external remote facilitation intervention group: Hospitals randomised to this group will receive: (i) the FeSS Protocols; (ii) the online FeSS education package; and (iii) the FeSS audit and feedback report. In addition, they will be provided with low-intensity external remote facilitation by the researchers. This includes reactive email and telephone remote support for the site champions as follows: • Reactive emails from clinical champions to research team when required • Reactive telephone contact from clinical champions to research team when required Both intervention groups will receive email reminders to prompt them to progress with intervention implementation and data collection according to the anticipated project timeline as follows: - Identification of site clinical champions (at the time of signing Agreement Form) - Randomisation of hospitals (following completion of pre-intervention audit) - Hospitals randomised to the intervention groups receive FeSS Protocols and online FeSS education package (education package to be completed four to six weeks after randomisation) - Pre-intervention audit completion (within within four weeks of obtaining site specific governance approval) - Reliability cases sent to sites for data checks (one week after completion of pre-intervention audit) - Completion of data reliability checks (one week after completion of pre-intervention audit) - Pre-intervention audit feedback report (two weeks after completion of pre-intervention audit) - FeSS implementation multidisciplinary meeting (two weeks after completion of pre-intervention audit) - Action plan (two weeks post-multidisciplinary meeting) - Clinician education session (two weeks post-multidisciplinary meeting) - FeSS implementation ‘go-live’ date (three months post-multidisciplinary meeting) - FeSS Protocol implementation (total duration of six months - three months implementation and three months ‘bedding down’ of the intervention for it to become routine practice) - Post-intervention audit (end of three months bedding down period) - Reliability cases sent to sites for data checks (one week post-intervention audit completion) - Completion of data reliability checks (one week post-intervention audit completion) - Post-intervention audit feedback report (two weeks post-intervention audit completion) - Organisational survey of site-specific characteristics (survey link to be sent after receiving Agreement Form)
Sponsors
Study design
Eligibility
Inclusion criteria
Hospitals To be eligible to participate in the study, hospitals must: - have a pre-existing acute stroke unit (organised care within a specific ward in a hospital by a multidisciplinary team who specialise in stroke management) or a stroke service (no dedicated stroke unit but with integrated hospital stroke services based on agreed hospital service delineations) - have at least one staff member to fulfill the role of site clinical champion - Advise on obtaining human research ethics and site-specific governance approvals - nominate staff to undertake patient medical record audits pre- and post-intervention implementation and enter data into the Australian Stroke Data Tool - grant permission to the researchers to obtain patient medical record audit data from the Australian Stroke Data Tool data custodian Patients The medical records of eligible patients will be audited by participating hospital staff. Patients will be eligible if they: - are aged 18 years or older and - have a diagnosis of ischaemic stroke or intracerebral haemorrhage.
Exclusion criteria
Patients will be excluded if they are admitted for palliative care.