Contributions to the literature
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This study will test whether high- or low-intensity external remote facilitation versus no external facilitation is more effective at improving implementation of the Fever Sugar Swallow (FeSS) Protocols for stroke patients in Australia and New Zealand.
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This study leverages a cluster randomized trial design, implementation science frameworks, a process evaluation and economic evaluation to enhance understanding of facilitation, and its contribution to implementation of evidence-based stroke interventions.
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This study aims to provide evidence on the most effective facilitation intensity for large-scale implementation of the FeSS Protocols in stroke patients.
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Findings will be relevant to FeSS Protocol adoption worldwide.
Background
Study aims
Methods
Study design
Study setting
Eligibility and recruitment of participants
Hospitals
Patients
Randomisation and blinding
Intervention
Components | Intervention groups | Control group | |
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High-intensity facilitation | Low-intensity facilitation | No facilitation | |
FeSS Protocols | ✓ | ✓ | ✓ |
Online FeSS education package | ✓ | ✓ | X |
Evidence-based audit and feedback report | ✓ | ✓ | X |
External remote facilitation: | |||
Videoconference sessions for timeline, action plan development and implementation | ✓ | X | X |
Reminders | Project process, intervention and data collection reminders | Project process, intervention and data collection reminders | Project process and data collection reminders only |
Email and telephone support | Proactive and reactive | Reactive | X |
FeSS protocols
Fever (n=2) • Temperature readings monitored and recorded at least four times per day for the first 72 h • If temperature => 37.5°C treat with paracetamol or other anti-pyretic Sugar (Hyperglycaemia) (n=3) • Formal venous glucose on admission to Emergency Department or stroke service • Blood glucose level readings monitored and recorded at least four times per day for the first 48 h, to continue for 72 h if BGL unstable • If blood glucose level >10 mmol/L (180mg/dl) treat with insulin Swallowing (n=2) • Swallow screen or swallow assessment within 4 h of admission and prior to being given oral food, drink, or medications • Referral to speech pathologist for full assessment for those who fail the swallow screen |
Implementation strategy
Online FeSS education package
Online Education Resource Package • Videos with the following topics: o FeSS is one of the most cost-effective interventions in acute stroke care o A fever is not the smoke, it’s the fire. Put it out ASAP o Blood sugar is the fuel on the fire: keep it regulated o A sip of water can be deadly after strokes: Check their swallowing first o Leading change can be hard. Here’s how to make it easier o Why do an audit? o How to do an audit • Downloadable hard-copy resources o FeSS Protocols o PowerPoint slides for multidisciplinary meeting o PowerPoint slides for education session o Action plan template o PowerPoint slides for ASSIST education o PowerPoint slides for ASSIST competency assessment o QASC Australia data dictionary o QASC Australia data collection user manual o Flowchart of project milestones o Frequently asked questions (FAQ) document | |
Train-the-Trainer Education Package (relevant to study group allocation) • High- and low-intensity external remote facilitation groups o All components of the online education resource package • Control group will receive only downloadable hard-copy resources o FeSS Protocols o PowerPoint slides for ASSIST education o PowerPoint slides for ASSIST competency assessment o QASC Australia data dictionary o QASC Australia data collection user manual o Frequently asked questions (FAQ) document | |
Clinician Education Package (high- and low-intensity external remote facilitation groups only) • Short (5-7 minute) videos with the following topics: o FeSS is one of the most cost-effective interventions in acute stroke care o A fever is not the smoke, it's the fire. Put it out ASAP o Blood sugar is the fuel on the fire: keep it regulated o A sip of water can be deadly after strokes: Check their swallowing first o Why do an audit? o How to do an audit • Downloadable hard-copy resources o FeSS Protocols |
FeSS audit and feedback report
External remote facilitation
• Post-randomisation - To discuss pre-implementation audit results and the online FeSS education package • After clinical champions receive the online FeSS education package - To discuss progress with completing the package • After clinical champions conduct the multidisciplinary meeting - To assist with action plan development • At commencement of 3-month bedding down period - To discuss any issues with FeSS Protocol implementation |
Videoconference sessions
Local team meeting to assess barriers and develop action plan
Reminders
Milestone | First email | Second email | Third emaila |
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Project process reminders (high- and low-intensity intervention group and control group hospitals) | |||
EOI received to participate in study | Email to sign Agreement Form, nominate clinical champion(s), complete organisational survey online and assist with obtaining site-specific governance approval | Two weeks later same email if no response | Two weeks later same email if no response |
Site-specific governance approval received | Confirmation email sent | ||
Data collection reminders (high- and low-intensity intervention group and control group hospitals)* | |||
Pre-implementation audit | Email sent 1 week before pre-implementation audit date (3 months post-study commencement) with data entry instructions | Email sent 2 weeks after pre-implementation audit date if no data entry | Email sent 4 weeks after pre-implementation audit date if no data entry |
Completion of pre-implementation audit and data queries from statistician | Confirmation email sent with any requests for data checks (if required) based on preliminary data cleaning 1 week after completion of audit | ||
Reliability cases sent to hospitals for data checks | Email sent requesting data reliability checks 1 week after completion of audit | Email sent 2 weeks later if no response | Email sent 2 weeks later if no response |
Pre-implementation audit and feedback report | Email sent with report 2 weeks after completion of audit | ||
Post-implementation audit | Email sent on post-implementation audit date (6 months post-implementation) | Email sent 4 weeks after post-implementation audit date if no data entry | Email sent 6 weeks after post-implementation audit date if no data entry |
Completion of post-implementation audit and data queries from statistician | Confirmation email sent with any requests for data checks (if required) based on preliminary data cleaning 1 week after completion of audit | ||
Reliability cases sent to hospitals for data checks | Email sent requesting data reliability checks 1 week after completion of audit | Email sent 2 weeks later if no response | Email sent 2 weeks later if no response |
Post-implementation audit and feedback report | Email sent with report 2 weeks after completion of audit | ||
Intervention reminders (high-intensity and low-intensity intervention group hospitals only) | |||
FeSS Protocol implementation | Email sent requesting multidisciplinary meeting date/s | Email sent 2 weeks later if no response | Email sent 2 weeks later if no response |
Action plan | Email sent requesting action plan | Email sent 2 weeks later if no response | Email sent 2 weeks later if no response |
FeSS Protocol implementation ‘go-live’ date | Email sent 1 month after meeting requesting ‘go-live’ date | Email sent 1 month later if no response | Email sent 2 weeks later if no response |
Email and telephone support
Email ▪ Proactive emails from research team to clinical champions during key milestones (post-randomisation; post-receipt of online FeSS education package; post-multidisciplinary meeting; commencement of 3-month bedding down period) ▪ Reactive emails from clinical champions to research team when required Telephone ▪ Proactive telephone contact from research team to clinical champions following completion of pre-implementation audit data collection ▪ Reactive telephone contact from clinical champions to research team when required |
Control group
Data collection
Study procedure
TIMEPOINT | Study period | |||||||
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Pre-intervention activities | Randomisation | Intervention | Post-intervention activities | Close-out/completion of trial | ||||
Q4 2022 | Q1 2023 | Q2–Q4 2023 | Q4 2023–Q3 2024 | Q4 2024 | ||||
ENROLMENT: | x | x | ||||||
Eligibility screen | x | x | ||||||
Informed Agreement | x | x | ||||||
HREC and Governance applications | x | x | ||||||
Baseline data collection | x | x | ||||||
Randomisation of hospitals | x | |||||||
INTERVENTION | High facilitation | Low facilitation | Control | |||||
Baseline audit and feedback report | x | x | ||||||
Email FeSS Protocols | x | |||||||
Videoconference 1 | x | |||||||
Email link to online FeSS education package | x | x | ||||||
Videoconference 2 | x | |||||||
Multidisciplinary Team barrier assessment workshop (Action plan development) | x | x | ||||||
Videoconference 3 | x | |||||||
Education sessions for stroke unit/stroke service clinicians | x | x | ||||||
Recruitment of clinicians for process evaluation interviews and focus groups | x | x | x | |||||
Videoconference 4 | x | |||||||
3 months bedding down of FeSS Protocols | x | x | x | |||||
Post-intervention audit data collection | x | x | x | x | ||||
Post-intervention audit and feedback report | x | x | ||||||
ASSESSMENTS | ||||||||
Overall FeSS adherence composite measure | x | x | ||||||
Individual monitoring and treatment elements of the FeSS Protocols | x | x | ||||||
Death and dependency (mRS) sub-study only | x | x | ||||||
EQ-5D-3L questionnaire sub-study only | x | x | ||||||
Costs of implementing the FeSS Protocols | x | x | x | x | x | x | x | x |
Process evaluation interviews and focus groups | x | x | ||||||
Economic evaluation | x | x | x |
Economic evaluation
Process evaluation
Outcome measures
• bFever Protocol o Temperature monitored at least four times per day on day of admissiona o Temperature monitored at least four times per day on day 2 of admission o Temperature monitored at least four times per day on day 3 of admission o Paracetamol (or other antipyretic) given for first temperature ≥37.5°C o Paracetamol (or other antipyretic) given with 1 h from first temperature ≥37.5°Ca • bHyperglycaemia (Sugar) Protocol o Venous blood glucose level sample collected and sent to laboratory on admission to hospital o Blood glucose levels (BGL) monitored at least four times per day on day of admissiona o BGLs monitored at least four times per day on day 2 of admission o BGLs monitored at least four times per day on day 3 of admission (if BGLs unstable) o Insulin given for first BGL >10mmol/L o Insulin given within 1 h from first BGL >10mmol/La • bSwallow Protocol o Formal swallow screen performed o Failed screen and subsequently had swallow assessment o Swallow screen performed within 4 h o Swallow screen performed within 24 ha o Swallow assessment recorded o Swallow screen recorded o Swallow screen or assessment performed before being given oral medications, food, or fluidsa |