Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000028707
Ethics application status
Approved
Date submitted
2/12/2021
Date registered
14/01/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
14/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Quality in Acute Stroke Care (QASC) Australasia Trial: Multi-national Translation of Fever, Sugar, Swallow (FeSS) Protocols
Scientific title
A cluster randomised controlled trial evaluating an implementation intervention to enhance multi-national translation of nurse-initiated protocols for fever, hyperglycaemia and swallowing management following stroke
Secondary ID [1] 305722 0
Nil known
Universal Trial Number (UTN)
Trial acronym
QASC Australasia Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 324211 0
Condition category
Condition code
Stroke 321698 321698 0 0
Haemorrhagic
Stroke 321699 321699 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 322123 0
Treatment: Other
Comparator / control treatment
Control group hospitals will only have access to the publicly available Fever Sugar Swallow (FeSS) Protocols. They will not receive any remote external remote facilitation but will perform usual stroke care practices and collect data on the FeSS processes of care. They will be sent project process and data collection reminders by the researchers to improve site adherence to the project timeline and deliverables. They will also receive instructions on how to undertake a medical record audit and enter data into the Australian Stroke Data Tool (Australian hospitals)/New Zealand Stroke Registry (New Zealand hospitals) for uniformity in data collection processes. If the researchers receive any proactive emails from control group hospitals regarding the study (excluding questions about data collection), these hospitals will be directed to the Quality in Acute Stroke Care webpage hosted on the Australian Catholic University website.
Control group
Active

Outcomes
Primary outcome [1] 329482 0
The primary outcome is a binary measure of defect-free care. Defect-free care is defined as adherence to a composite measure of six monitoring and treatment elements of the FeSS Protocols - Proportion of patients who: • had temperature monitored at least four times per day on day of admission (assessed via medical record audit) • had paracetamol (or other anti-pyretic) given with one hour from first temperature equal to or greater than 37.5°C (assessed via medical record audit) • had blood glucose levels (BGL) monitored at least four times per day on day of admission (assessed via medical record audit) • had insulin given within one hour from first BGL equal to or greater than 10mmol/L • had swallow screen performed within 24 hours (assessed via medical record audit) • had swallow screen or assessment performed before being given oral medications, food or fluids (assessed via medical record audit)
Timepoint [1] 329482 0
Baseline and 6 months (primary timepoint) after intervention commencement date which will be negotiated with each hospital.
Secondary outcome [1] 402983 0
Comparison between metropolitan and rural/remote hospitals for composite outcome of adherence to each of the combined monitoring and treatment elements for: i) fever, ii) hyperglycaemia (sugar) and iii) swallowing, and to the individual elements that make up each of the FeSS Protocols: Fever Protocol - Proportion of patients who had: • temperature monitored at least four times per day on day of admission (assessed via medical record audit) • temperature monitored at least four times per day on day two of admission (assessed via medical record audit) • temperature monitored at least four times per day on day three of admission (assessed via medical record audit) • paracetamol (or other anti-pyretic) given for first temperature equal to or greater than 37.5°C (assessed via medical record audit) • paracetamol (or other anti-pyretic) given with one hour from first temperature equal to or greater than 37.5°C (assessed via medical record audit) Hyperglycaemia (Sugar) Protocol - Proportion of patients who had: • venous blood glucose level sample collected and sent to laboratory (assessed via medical record audit) • blood glucose levels (BGL) monitored at least four times per day on day of admission (assessed via medical record audit) • BGL’s monitored at least four times per day on day two of admission (assessed via medical record audit) • BGL’s monitored at least four times per day on day three of admission (if BGL’s unstable) (assessed via medical record audit) • insulin given for first BGL equal to or greater than 10mmol/L (assessed via medical record audit) • insulin given within one hour from first BGL equal to or greater than 10mmol/L (assessed via medical record audit) Swallow Protocol - Proportion of patients who: • had formal swallow screen performed (assessed via medical record audit) • failed screen and subsequently had swallow assessment (assessed via medical record audit) • had swallow screen performed within 4 hours (assessed via medical record audit) • had swallow screen performed within 24 hours (assessed via medical record audit) • had swallow assessment recorded (assessed via medical record audit) • had swallow screen recorded (assessed via medical record audit) • had swallow screen or assessment performed before being given oral medications, food or fluids (assessed via medical record audit)
Timepoint [1] 402983 0
Baseline and 6 months after intervention commencement date which will be negotiated with each hospital..
Secondary outcome [2] 402984 0
A qualitative exploration of participants’ experience of contributing organisational, contextual and structural factors that impacted successful/unsuccessful uptake of the intervention through: either individual face-to-face/virtual interviews or focus group interviews with stroke unit/stroke service nurses and doctors depending on clinician availability and preference.
Timepoint [2] 402984 0
Once all sites have completed post-implementation data entry.
Secondary outcome [3] 402985 0
Additional cost per quality adjusted life year gained at 6 months post-stroke due to implementation of the FeSS Protocols.
Timepoint [3] 402985 0
180 days post-stroke.
Secondary outcome [4] 404433 0
Composite outcome of adherence to the combined monitoring and treatment elements for the Fever Protocol, and to the individual elements that make up this protocol - Proportion of patients who had:
• temperature monitored at least four times per day on day of admission (assessed via
medical record audit)
• temperature monitored at least four times per day on day two of admission (assessed
via medical record audit)
• temperature monitored at least four times per day on day three of admission (assessed
via medical record audit)
• paracetamol (or other anti-pyretic) given for first temperature equal to or greater than
37.5°C (assessed via medical record audit)
• paracetamol (or other anti-pyretic) given with one hour from first temperature equal to
or greater than 37.5°C (assessed via medical record audit)
Timepoint [4] 404433 0
Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.
Secondary outcome [5] 404434 0
Composite outcome of adherence to the combined monitoring and treatment elements for the Hyperglycaemia (Sugar) Protocol, and to the individual elements that make up this protocol - Proportion of patients who had:
• venous blood glucose level sample collected and sent to laboratory (assessed via
medical record audit)
• blood glucose levels (BGL) monitored at least four times per day on day of admission
(assessed via medical record audit)
• BGL’s monitored at least four times per day on day two of admission (assessed via
medical record audit)
• BGL’s monitored at least four times per day on day three of admission (if BGL’s
unstable) (assessed via medical record audit)
• insulin given for first BGL equal to or greater than 10mmol/L (assessed via medical
record audit)
• insulin given within one hour from first BGL equal to or greater than 10mmol/L
(assessed via medical record audit)
Timepoint [5] 404434 0
Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.
Secondary outcome [6] 404435 0
Composite outcome of adherence to the combined monitoring and treatment elements for the Hyperglycaemia (Sugar) Protocol, and to the individual elements that make up this protocol - Proportion of patients who: • had formal swallow screen performed (assessed via medical record audit) • failed screen and subsequently had swallow assessment (assessed via medical record audit) • had swallow screen performed within 4 hours (assessed via medical record audit) • had swallow screen performed within 24 hours (assessed via medical record audit) • had swallow assessment recorded (assessed via medical record audit) • had swallow screen recorded (assessed via medical record audit) • had swallow screen or assessment performed before being given oral medication, food or fluids (assessed via medical record audit)
Timepoint [6] 404435 0
Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.
Secondary outcome [7] 417495 0
Comparison between stroke units and stroke services for composite outcome of adherence to each of the combined monitoring and treatment elements for: i) fever, ii) hyperglycaemia (sugar) and iii) swallowing, and to the individual elements that make up each of the FeSS Protocols:
Fever Protocol - Proportion of patients who had:
• temperature monitored at least four times per day on day of admission (assessed via medical record audit)
• temperature monitored at least four times per day on day two of admission (assessed via medical record audit)
• temperature monitored at least four times per day on day three of admission (assessed via medical record audit)
• paracetamol (or other anti-pyretic) given for first temperature equal to or greater than 37.5°C (assessed via medical record audit)
• paracetamol (or other anti-pyretic) given with one hour from first temperature equal to or greater than 37.5°C (assessed via medical record audit)

Hyperglycaemia (Sugar) Protocol - Proportion of patients who had:
• venous blood glucose level sample collected and sent to laboratory (assessed via medical record audit)
• blood glucose levels (BGL) monitored at least four times per day on day of admission (assessed via medical record audit)
• BGL’s monitored at least four times per day on day two of admission (assessed via medical record audit)
• BGL’s monitored at least four times per day on day three of admission (if BGL’s unstable) (assessed via medical record audit)
• insulin given for first BGL equal to or greater than 10mmol/L (assessed via medical record audit)
• insulin given within one hour from first BGL equal to or greater than 10mmol/L (assessed via medical record audit)

Swallow Protocol - Proportion of patients who:
• had formal swallow screen performed (assessed via medical record audit)
• failed screen and subsequently had swallow assessment (assessed via medical record audit)
• had swallow screen performed within 4 hours (assessed via medical record audit)
• had swallow screen performed within 24 hours (assessed via medical record audit)
• had swallow assessment recorded (assessed via medical record audit)
• had swallow screen recorded (assessed via medical record audit)
• had swallow screen or assessment performed before being given oral medications, food or fluids (assessed via medical record audit)
Timepoint [7] 417495 0
Baseline and 6 months after intervention commencement date which will be negotiated with each hospital.

Eligibility
Key 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.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are admitted for palliative care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be based on clusters (hospitals) rather than individuals, and the sequence will be concealed until the intervention is assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation (using random number generating software) and stratification of the hospitals will be performed independently by a statistician blinded to group allocation and not otherwise involved in the study. Hospitals will be randomised in a 2 (high intensity):2 (low intensity):1 (no facilitation) ratio and randomisation will be stratified by country, participation in a stroke registry and remoteness area (metropolitan/major cities or regional/rural based on the Accessibility and Remoteness Index of Australia [ARIA+] and urban or non-urban based on the New Zealand REGIONS Care project classification).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We used monte carlo simulation to estimate the detectable difference-in-difference between any two treatment arms with 80% power at a 5% significance level. Previous QASC Trial and QASC Europe studies suggest we could expect an ICC of 0.075 and a cluster level correlation between baseline and post-test of 0.3. With an assumed 60 patients per site pre- and post-intervention and using an unequal randomisation ratio of 2 (high intensity):2 (low intensity):1 (no facilitation intensity), we calculated that a test between two 24 site arms would be able to detect a difference-in-difference of 1.5 (OR) and a test between one 12 site arm and one 24 site arm would be able to detect a difference-in-difference of 2 (OR).

The unit of analysis is at the patient level. Analysis will be by intention-to-treat. Demographic and clinical characteristics of patients (e.g., treatment in a stroke unit, discharge destination, ability to walk on discharge, duration of hospital stay, discharge modified Rankin Score) will be summarised using descriptive statistics and presented by group allocation. Analysis for overall adherence with all monitoring and treatment elements of the FeSS Protocols and to each of the monitoring and treatment elements for Fever, Sugar and Swallowing will be undertaken based on the following comparisons: low intensity facilitation versus control groups, high intensity facilitation versus control groups, and low intensity facilitation versus high intensity facilitation groups. Analysis will include comparison of outcomes between metropolitan and rural/remote hospitals; difference in proportions of change in monitoring and treatment for fever, hyperglycaemia and swallowing between stroke units and stroke services. Analysis of outcomes will use logistic regression with adjustment for baseline covariates and correlation of outcomes within hospitals. Effect sizes will be estimated for each intervention group relative to the control as well as for comparisons between the low intensity facilitation and high intensity facilitation intervention groups. No interim analyses are planned.

Process evaluation: Qualitative data from the process evaluation will be thematically analysed and will identify success factors and areas for strengthening the intervention for future use.

Economic evaluation: Multiple imputation will be used to handle missing data used to estimate costs and quality adjusted life years. Multivariable regression models will be used to adjust for differences in characteristics between control and intervention cohorts. Differences in costs and quality adjusted life years gained between groups will be adjusted for confounding factors. Bootstrapping will be undertaken to test the robustness of results. Sensitivity analyses will also be performed to assess the effects of various assumptions in the economic modelling.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
7/12/2022
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
7200
Accrual to date
2079
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25207 0
New Zealand
State/province [1] 25207 0

Funding & Sponsors
Funding source category [1] 310080 0
Government body
Name [1] 310080 0
National Health and Medical Research Council
Country [1] 310080 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
40 Edward Street, North Sydney, NSW 2060
Country
Australia
Secondary sponsor category [1] 311229 0
None
Name [1] 311229 0
Address [1] 311229 0
Country [1] 311229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309770 0
St Vincent's Hospital Sydney Human Research Ethics Committee
Ethics committee address [1] 309770 0
Ethics committee country [1] 309770 0
Australia
Date submitted for ethics approval [1] 309770 0
17/11/2021
Approval date [1] 309770 0
17/12/2021
Ethics approval number [1] 309770 0
2021/ETH12064

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115330 0
Prof Sandy Middleton
Address 115330 0
Nursing Research Institute, St Vincent’s Health Network Sydney, St Vincent’s Hospital Melbourne and Australian Catholic University, Level 5, deLacy Building, St Vincent’s Hospital Sydney, 390 Victoria Street, Darlinghurst, NSW 2010
Country 115330 0
Australia
Phone 115330 0
+61 2 8382 3790
Fax 115330 0
Email 115330 0
sandy.middleton@acu.edu.au
Contact person for public queries
Name 115331 0
Sandy Middleton
Address 115331 0
Nursing Research Institute, St Vincent’s Health Network Sydney, St Vincent’s Hospital Melbourne and Australian Catholic University, Level 5, deLacy Building, St Vincent’s Hospital Sydney, 390 Victoria Street, Darlinghurst, NSW 2010
Country 115331 0
Australia
Phone 115331 0
+61 2 8382 3790
Fax 115331 0
Email 115331 0
sandy.middleton@acu.edu.au
Contact person for scientific queries
Name 115332 0
Sandy Middleton
Address 115332 0
Nursing Research Institute, St Vincent’s Health Network Sydney, St Vincent’s Hospital Melbourne and Australian Catholic University, Level 5, deLacy Building, St Vincent’s Hospital Sydney, 390 Victoria Street, Darlinghurst, NSW 2010
Country 115332 0
Australia
Phone 115332 0
+61 2 8382 3790
Fax 115332 0
Email 115332 0
sandy.middleton@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In keeping with the requirements of ethics approval, only summary data not individual data will be presented or published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.