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Trial registered on ANZCTR


Registration number
ACTRN12623000445673
Ethics application status
Approved
Date submitted
14/04/2023
Date registered
1/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
1/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Fever, Hyperglycaemia (Sugar), Swallow (FeSS) Protocols use in Australian hospitals. Analysis of national stroke data and clinician perspectives of critical factors that influence their use.
Scientific title
Fever, Hyperglycaemia (Sugar), Swallow (FeSS) clinical guidelines adherence. Analysis of national Stroke Foundation audit and Australian Stroke Clinical Registry (AuSCR) data and qualitative interviews with clinicians regarding their perspectives on critical factors that influence FeSS Protocol adherence.
Secondary ID [1] 309452 0
None
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Stroke 329314 0
Condition category
Condition code
Stroke 326258 326258 0 0
Ischaemic
Stroke 326259 326259 0 0
Haemorrhagic
Public Health 326684 326684 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
FeSS Protocol adherence in Australian hospitals since explicit recommendations for their use were included in the 2017 Australian Clinical Guidelines for Stroke Management.
Observational data obtained during 20–40-minute qualitative interviews with stroke clinicians will examine the influential cultural, organisational and other factors that influence uptake of clinical guidelines, specifically, those that relate to the management of Fever, Sugar, and Swallow (FeSS) complications after stroke.
Intervention code [1] 325625 0
Not applicable
Comparator / control treatment
Stroke Foundation audit years 2015 and 2017.
Process of care indicators that relate to the management of fever, hyperglycaemia and swallowing during the in-hospital admission period for stroke will be collected in addition to age, sex, pre-morbid dependency level (modified Rankin score), stroke type, receipt of endovascular therapy, receipt of care on a stroke unit, risk factors, discharge dependency level (modified Rankin Score) and discharge destination .
Control group
Historical

Outcomes
Primary outcome [1] 334135 0
FeSS Protocol adherence composite score. The composite score is a binary measure of defect-free care that has been used in an earlier study evaluating these variables using national Stroke Audit data (Purvis et al 2018) and throughout the Quality in Acute Stroke Care (QASC) Research program. This measure will enable appropriate comparison of the six treatment elements of the FeSS Protocols, specifically, the proportion of patients who received all of the following:
1. Paracetamol within one hour from first temperature equal to or greater than 37.5°C
2. Insulin within one hour from first blood glucose level (BGL) equal to or greater than 10mmol/L
3. A swallow screen or swallow assessment by speech pathologist within 24 hours.
4. A swallow screen or swallow assessment by speech pathologist before being given oral food or fluids.
5. A swallow screen or swallow assessment by speech pathologist before being given oral medications.
6. A swallow assessment by speech pathologist if failed swallow screen.
Timepoint [1] 334135 0
Analysis of FeSS composite score from the national Stroke Audit years of 2015 and 2017 when compared to national Stroke Audit years of 2019 and 2021.
Secondary outcome [1] 419459 0
'Presence of an acute stroke unit as determined from Stroke Foundation organisational survey audit data.
Timepoint [1] 419459 0
Stroke Foundation audit years 2015.2017,2019 and 2021
Secondary outcome [2] 420603 0
'Patients admitted to an acute stroke unit as determined from hospital records.
Timepoint [2] 420603 0
Stroke Foundation audit years 2015.2017,2019 and 2021
Secondary outcome [3] 420641 0
'Hospital uptake of entering into optional FeSS variable dataset in Australian Stroke Clinical Registry (AuSCR) as determined from AuSCR database.
Timepoint [3] 420641 0
AuSCR database
1 July 2019 - 31 December 2020
Secondary outcome [4] 420642 0
'Proportion of patients that have their temperature are monitored at least four times per day on day of admission as determined from hospital records.

Timepoint [4] 420642 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [5] 420643 0
The proportion of patients that received Paracetamol given within one hour from first temperature equal to or greater than 37.5°C as determined from hospital records .
Timepoint [5] 420643 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [6] 420644 0
The proportion of patients that had their blood glucose level monitored at least four times per day on day of admission as determined from hospital records.
Timepoint [6] 420644 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [7] 420765 0
The proportion of patients that received Insulin within one hour from first blood glucose level equal to or greater than 10mmol/L as determined from hospital records.
Timepoint [7] 420765 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [8] 420766 0
The proportion of patients that received a formal swallow screen or swallow assessment by a speech pathologist within four hours of admission to the Emergency Department as determined from hospital records.
Timepoint [8] 420766 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [9] 420767 0
The proportion of patients that received a swallow screen or swallowing assessment performed before being given food or fluids as determined from hospital records.
Timepoint [9] 420767 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [10] 420768 0
The proportion of patients that received a swallow screen or swallowing assessment performed before being given oral medications as determined from hospital records.
Timepoint [10] 420768 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [11] 420769 0
The proportion of patients that received a swallow assessment by speech pathologist if failed swallow screen as determined from hospital records.
Timepoint [11] 420769 0
Analysis of individual FeSS variables in AuSCR
1 July 2019 - 31 December 2020
Secondary outcome [12] 420770 0
Identification of critical individual and organisational factors, (i.e., barriers and facilitators) perceived to influence uptake and adherence of the FeSS Protocols from qualitative interviews with stroke clinicians, analysed by level of FeSS adherence (according to FeSS composite score [as defined in primary outcome] from national Stroke Foundation acute services audit years 2015, 2017, 2019 and 2021).
Timepoint [12] 420770 0
From 2011 (QASC trial publication) to time of qualitative interviews
Secondary outcome [13] 420773 0
Identification of strategies or interventions that have been used to implement the FeSS Protocols in individual stroke services from qualitative interviews with stroke clinicians. This will be explored for those services that participated in any of the FeSS Intervention studies and those that did not.
Timepoint [13] 420773 0
• For hospitals that participated in any of the FeSS Intervention studies (QASC 2005-2010, QASCIP 2013-2014 and/or T3 2013-2016) -up to time of qualitative interviews.
• For hospitals that did not participate in any of the FeSS Intervention studies from the time of 2011 QASC Trial publication and/or 2017 FeSS Protocols included in the National Clinical Guidelines for Stroke Management


Secondary outcome [14] 420774 0
Barriers and facilitators identified from qualitative interviews with stroke clinicians will be compared to barriers and facilitators previously reported in FeSS intervention studies.
Timepoint [14] 420774 0
From 2011 (QASC trial publication) to time of qualitative interviews
Secondary outcome [15] 420775 0
Barriers and facilitators identified from qualitative interviews with stroke clinicians will be mapped to the Conceptual Model for Determinants of Diffusion, Dissemination, and Implementation of Innovations in health service (Greenhalgh, et al 2004).
Timepoint [15] 420775 0
2011 (QASC trial publication) to time of qualitative interviews
Secondary outcome [16] 420776 0
Barriers and facilitators identified from qualitative interviews with stroke clinicians will be mapped to the Sustainability of Implementation Framework (Fox, Gardner, Osborne 2015).
Timepoint [16] 420776 0
2011 (QASC trial publication) to time of qualitative interviews

Eligibility
Key inclusion criteria
1. Hospitals that participated in the 2015, 2017, 2019 and 2021 National Acute Services Stroke Audits
2. Hospitals that contributed FeSS data into AuSCR from 1/7/2019-31/12/2020.
3. All patients with a primary diagnosis of stroke (ischaemic or haemorrhagic)
4. Stroke coordinators (or equivalent) and multidisciplinary stroke clinicians with knowledge of the use of FeSS Protocols in their hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Those patients that have been documented for palliative care will be excluded from analysis.
2. Stroke Coordinators (or equivalent) who have been in the position six months or less will not be eligible to participate in qualitative interviews.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Using an estimate of 130 hospitals who entered national Stroke Foundation acute services audit data for 40 stroke admissions (n=5200 episodes for each year: 2015, 2017, 2019 and 2021) will be able to detect percentage point changes in the proportion of patients that receive care according to FeSS Protocols.

A composite outcome will be derived from all FeSS Protocol treatment processes of care variables in addition to the individual FeSS Protocol variable processes of care. Risk-adjusted outcome analyses will be conducted for age/gender and pre morbid modified Rankin score. Analyses will be performed using R statistical software.

Hypothesis testing will be undertaken to compare any differences in adherence to FeSS Protocols at the aggregated cohort levels only (i.e. for all hospitals that participated in QASC, QASCIP or T3, those cared for in stroke units and not for individual hospitals). Differences in adherence to FeSS Protocols over time will be reported for aggregated data with 95% confidence intervals.

Previous findings from the QASC research program, the Conceptual Model for Diffusions of Innovations in Service Organizations (Greenhalgh, et al 2004) and the Sustainability of Innovation framework will be used to guide deductive directed content analysis for the qualitative interviews. Additional findings outside of these categories will be further analysed to determine if they belong in a sub-category or if they represent new discoveries. Exploration of coded categories and relationships and generation of themes will then be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
21/09/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
18
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313383 0
Hospital
Name [1] 313383 0
St Vincents Hospital Melbourne -Research Endowment Fund
Country [1] 313383 0
Australia
Funding source category [2] 313630 0
Government body
Name [2] 313630 0
NHMRC Investigator Grant (APP1196352)
Country [2] 313630 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
40 Edward Street,
PO Box 968,
North Sydney NSW 2059
Country
Australia
Secondary sponsor category [1] 315149 0
None
Name [1] 315149 0
Address [1] 315149 0
Country [1] 315149 0
Other collaborator category [1] 282583 0
Charities/Societies/Foundations
Name [1] 282583 0
Stroke Foundation
Address [1] 282583 0
Level 7, 461 Bourke Street Melbourne VIC 3000
Country [1] 282583 0
Australia
Other collaborator category [2] 282584 0
Government body
Name [2] 282584 0
Australian Stroke Clinical Registry (AuSCR)
Address [2] 282584 0
The Florey Institute of Neuroscience and Mental Health
245 Burgundy Street,
Heidelberg, Victoria 3084
Country [2] 282584 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312597 0
Australian Catholic University Human Research and Ethics Committee
Ethics committee address [1] 312597 0
North Sydney Campus (MacKillop)
Tenison Woods House
8-20 Napier Street-Level 16 (532.16)
North Sydney NSW 2060
Ethics committee country [1] 312597 0
Australia
Date submitted for ethics approval [1] 312597 0
11/11/2021
Approval date [1] 312597 0
01/12/2021
Ethics approval number [1] 312597 0
2021-297N

Summary
Brief summary
Clinical protocols to manage three common complications after stroke (Fever, hyperglycaemia (Sugar) and Swallowing problems [FeSS protocols]) was shown to reduce death and disability by 15.7% for patients in the Quality in Acute Stroke Care Trial. As a result of this trial, a ‘Strong Recommendation’ to support use of the FeSS Protocols was included in the 2017 Clinical Guidelines for Stroke Management.

Before the new guideline recommendation there was a significant evidence to practice gap with only 41% of patients receiving care according to the FeSS Protocols in Australian hospitals. Outside of the FeSS Intervention trials, there has been no nationwide systematic implementation efforts to introduce FeSS protocols.

The aim of this research is to determine adherence to the FeSS Protocols since their inclusion as recommended care in the 2017 National Acute Stroke Guidelines. Secondary aims of this research are to:
i) determine if participation in any of the previous FeSS Intervention studies (QASC, QASCIP or T3 Trial) improved adherence with the FeSS Protocols when compared with hospitals who did not participate;
ii) determine if admission to an acute stroke unit when compared with patients who are not admitted to an acute stroke unit improves adherence with the FeSS protocols;
iii) determine if FeSS Protocol adherence is greater for hospitals that contributed data to the FeSS optional dataset in AuSCR when compared with hospitals that did not;
iv) identify what strategies or interventions have been used to implement the FeSS protocols in individual stroke services;
v) identify critical individual and organisational factors, including barriers and facilitators, perceived to influence uptake and adherence of the FeSS Protocols by stroke clinicians;
vi) understand barriers and facilitator variability in hospitals with high, low and variable adherence rates to FeSS Protocols, and to compare these with those previously reported in FeSS Intervention studies;
vii) explore sustainability of use of FeSS Protocols for hospitals exposed to any of the FeSS Intervention studies.
Trial website
n/a
Trial related presentations / publications
nil to date
Public notes
Submission to a hospital specific Human Research and Ethics Committee is required to conduct interviews with hospital employees/clinicians (university HREC approval is not recognised). Lead HREC approval has been obtained from St Vincents Hospital Sydney (2023/ETH 00446) and subsequent site specific applications will be as required for each clinician and hospital that agree to participate in these interviews.

Contacts
Principal investigator
Name 125234 0
Prof Sandy Middleton
Address 125234 0
Nursing Research Institute
Level 5, deLacy Building
St Vincent’s Hospital Sydney
390 Victoria Street
Darlinghurst, NSW 2010
Country 125234 0
Australia
Phone 125234 0
+61 2 8382 3790
Fax 125234 0
Email 125234 0
sandy.middleton@acu.edu.au
Contact person for public queries
Name 125235 0
Ms Kelly Coughlan
Address 125235 0
Nursing Research Institute
Level 5, 215 Spring Street
Melbourne, VIC 3000
Country 125235 0
Australia
Phone 125235 0
+61 2 8382 3790
Fax 125235 0
Email 125235 0
kelly.coughlan@acu.edu.au
Contact person for scientific queries
Name 125236 0
Ms Kelly Coughlan
Address 125236 0
Nursing Research Institute
Level 5, 215 Spring Street
Melbourne, VIC 3000
Country 125236 0
Australia
Phone 125236 0
+61 2 8382 3790
Fax 125236 0
Email 125236 0
kelly.coughlan@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
Any requests for individual participant data would need to go to the data custodians at the Stroke Foundation and the Australian Stroke Clinical Registry as this would be considered use of data for a secondary purpose which was not part of our agreement with the data custodians.


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.