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Trial registered on ANZCTR

Registration number

ACTRN12608000563369

Ethics application status

Approved

Date submitted

3/11/2008

Date registered

10/11/2008

Date last updated

9/11/2021

Date data sharing statement initially provided

9/11/2021

Date results provided

9/11/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Managing fever, hyperglycaemia and dysphagia in acute stroke: The Quality in Acute Stroke Care Trial

Scientific title

A cluster randomised controlled trial to evaluate a multidisciplinary team building intervention to manage fever, hyperglycaemia and swallowing dysfunction in acute stroke patients when compared with distribution of national stroke guidelines applicable only to fever, hyperglycaemia and dysphagia management on reducing death and dependency 90-days post-hospital admission.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

QASC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Evidence-based clinical treatment protocols developed by a panel of clinical experts to guide multidisciplinary clinical care in the management of acute stroke patients with fever, hyperglycaemia and swallowing dysfunction; two one-hour multidisciplinary on-site workshops to be held at conclusion of baseline data collection attended by doctors, nurses and speech pathologists where the clinical protocols will be explained with the aim of determining local barriers and facilitators to clinical protocol implementation; unit-based education and support provided to the stroke co-ordinator of participating acute stroke units to champion implementation of clinical protocols; longitudinal engagement through support and feedback at local sites.
The intervention will be provided for 12 to 18 months dependent on achieving sample size required.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Abridged version of the Australian National Stroke Foundation's Clinical Guidelines for Acute Stroke Management containing only sections related to the management of fever, hyperglycaemia and swallowing dysfunction provided to doctors, nurses and speech pathologists treating patients with acute stroke.

Control group

Active

Outcomes

Primary outcome [1]

Death or disability (disability defined as Modified Rankin Score (mRS) greater than or equal to 2)

Timepoint [1]

90 days post-hospital admission

Primary outcome [2]

Level of disability (mRS)

Timepoint [2]

90-days post-hospital admission

Primary outcome [3]

Level of dependency (Barthel Index)

Timepoint [3]

90-days post-hospital admission

Secondary outcome [1]

Improved glycaemic control as measured by mean finger-prick blood glucose level readings

Timepoint [1]

First 72 hours following admission to acute stroke unit

Secondary outcome [2]

Improved temperature control as measured by mean temperature readings

Timepoint [2]

First 72 hours following admission to acute stroke unit

Secondary outcome [3]

Improved management of swallowing dysfunction as measured by swallowing screen undertaken

Timepoint [3]

within the first 24 hours of admission to acute stroke unit

Eligibility

Key inclusion criteria

English-speaking patients, aged > 18 years, presenting within 48 hours of onset of symptoms who are given a clinical diagnosis of ischaemic stroke or intracerebral haemorrhage that is subsequently confirmed by computerised tomography (CT) imaging

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients who present to the acute stroke unit 48 hours or greater following onset of symptoms, have non-cerebrovascular causes of acute focal neurological deficits (seizure, hypoglycaemia, toxic or metabolic encephalopathies), sub-arachnoid haemorrhage, or acute and chronic subdural haemorrhage, patients who require 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)

Eligible patients will be approached by clinical research assistants (CRAs) identified in each Acute Stroke Unit (ASU) using a recruitment script. CRAs recruiting patients will be blind at baseline to ASU group allocation as this will not yet have been undertaken. Once the pre-intervention patient cohort 90-day outcome data have been collected, participating ASUs will be stratified and randomised by an offshore statistician not otherwise connected with the study (central cluster randomisation). CRAs also will not be informed of group allocation during recruitment of the post-intervention patient cohort. Thus personnel who recruit patients, research interviewers who undertake the outcome measures and the offshore statistician who undertakes randomisation all will be independent and also blinded to all other components of the study design.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Acute stroke units will be stratified according to their Category classification (A or B) and then, by referring to absolute numbers of patients recruited at baseline, describe each as a ‘high recruiter’ or ‘low recruiter’. Stratification details will be provided in a de-identified form to an independent statistician located offshore and not otherwise involved in the study for randomisation within strata, this will be generated using random number generating software (SAS (ProcPlan)).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Cluster randomised controlled trial

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/06/2005

Actual

5/06/2005

Date of last participant enrolment

Anticipated

Actual

26/03/2010

Date of last data collection

Anticipated

Actual

27/11/2010

Sample size

Target

1040

Accrual to date

Final

1009

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2310

Recruitment postcode(s) [2]

2050

Recruitment postcode(s) [3]

2148

Recruitment postcode(s) [4]

2139

Recruitment postcode(s) [5]

2065

Recruitment postcode(s) [6]

2145

Recruitment postcode(s) [7]

2010

Recruitment postcode(s) [8]

2031

Recruitment postcode(s) [9]

1871

Recruitment postcode(s) [10]

2200

Recruitment postcode(s) [11]

2229

Recruitment postcode(s) [12]

2250

Recruitment postcode(s) [13]

2077

Recruitment postcode(s) [14]

2560

Recruitment postcode(s) [15]

2217

Recruitment postcode(s) [16]

2500

Recruitment postcode(s) [17]

2095

Recruitment postcode(s) [18]

2751

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Sandy Middleton

Address

Director, National Centre for Clinical Outcomes Research (NaCCOR), Nursing and Midwifery, Australia
ACU National
PO Box 968
North Sydney NSW 2059

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

A/Professor Christopher Levi

Address [1]

Director of Acute Stroke Services
Hunter Stroke Service
Neurology Unit
John Hunter Hospital & Hunter Medical Research Institute
Lookout Rd
New Lambton Heights NSW 2305

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor Jeanette Ward

Address [1]

Department of Epidemiology & Community Medicine
University of Ottawa
451 Smyth Road
Ottawa, Ontario K1H 8M5
Canada

Country [1]

Canada

Other collaborator category [2]

Individual

Name [2]

Professor Jeremy Grimshaw

Address [2]

Director, Clinical Epidemiology Program
Ottawa Health Research Institute
1053 Carling Avenue,
Administration Building, Room 2-017
Ottawa, Ontario K1Y 4E9
Canada

Country [2]

Canada

Other collaborator category [3]

Individual

Name [3]

Professor Rhonda Griffiths

Address [3]

Head, School of Nursing and Midwifery
University of Western Sydney
Locked Bag 1797
Penrith South DC NSW 1797
Australia

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University Human Research Ethics Committee

Ethics committee address [1]

PO Box 456
VIRGINIA. Qld, 4014

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/05/2005

Approval date [1]

25/07/2005

Ethics approval number [1]

N200405 31

Summary

Brief summary

The QASC study developed and trialed a multidisciplinary team building intervention to improve management of fever, raised blood glucose levels and swallowing difficulties in patients following acute stroke. We randomised 19 acute stroke units in NSW, Australia to the intervention (n=10) or control (n=9) group and patient data was obtained from 1696 participants.  Results of the trial showed that patients cared for in intervention stroke units were significantly less likely to be dead or dependent 90-days following admission to the stroke unit (p = 0.002; NNT = 6.4; adjusted absolute difference = 15.7% (95% CI 5.8 – 25.4)).  These patients also had improved mean SF-36 physical health component summary score (45.6 (SD 10.2)) compared to those in the control group (42.5 (SD 10.5), p = 002).  No improvements were noted in the mean SF-36 mental component score (49.5 (SD 10.9) vs. 49.4 (SD 10.6); p = 0.69).  There no were no statistically significance in levels of functional dependency between the two groups as measured a Barthel Index score > 60 (92% vs 90%; p = 0.44). The study protocols for management of fever, hyperglycaemia and swallowing; and the implementation strategy are available at www.acu.edu.au/QASC.

Trial website

www.acu.edu.au/QASC

Trial related presentations / publications

Peer reviewed journal articles:

Middleton S. An outcomes approach to stroke care: the importance of teamwork and evidence-based nursing care. Leading Opinion. International Journal of Stroke. 2012;7(3):224-6.

Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D'Este C, et al. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. The Lancet. 2011;378 (9804):1699-706.2

Middleton S, Levi C, D’Este C, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D. Death, dependency and health status 90-days following stroke in NSW: Preliminary results from the Quality in Acute Stroke Care (QASC) Project. Internal Medicine Journal. 2011; 41(10) 736-743

Jammali-Blasi A, McInnes E, Markus R, Faux S, O’Loughlin G, Dale S, Middleton S. 90-day outcomes for a cohort of patients admitted to a metropolitan acute stroke unit. Journal of Vascular Nursing 2011; 29(1): 3-10. 

Middleton, S., C. Levi, et al. Fever, hyperglycaemia and swallowing dysfunction management in acute stroke: A cluster randomised controlled trial of knowledge transfer.  Implementation Science 2009; 4(1) p. 16

Letters:

Middleton S, D'Este C, Grimshaw J, Ward JE, Levi C. Team-building intervention to improve acute stroke care – Authors' reply. Lancet. 2012;379(9824):1390.

Middleton S, Levi C, Ward J. QASC trial: swallow surveillance rates comparable with international data. Lancet. 2012;379(9824):1389.

Middleton S, Levi C, Dale S. Arrival time to stroke unit as crucial a measure as arrival time to emergency department. Stroke. 2008; 39:1 p 5

Published abstracts:

Dale S, Levi C, D’Este C, Griffiths R, Grimshaw J, Ward J, Middleton S.  Maximising uptake of clinical protocols to manage fever, hyperglycaemia and swallowing in acute stroke: Assessing barriers and enablers. International Journal of Stroke. 2011; 1, 6, S1:13.

Middleton S, Levi C, D’Este C, Drury P, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D, Cheung W, McElduff P  The QASC Cluster Randomised Controlled trial of a team-based intervention to improve management of fever, hyperglycaemia and swallowing dysfunction in acute stroke: Patient 90-day outcomes.  Cerebrovascular Diseases 2011 Vol 31 (suppl 2)

Drury P, Levi C, D’Este C, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D, Cheung W, McElduff P, McInnes E, Hardy J, Middleton S. The QASC Cluster Randomised Controlled trial of an intervention to improve management of fever, hyperglycaemia and swallowing dysfunction in acute stroke: Did clinician behaviour change?  Cerebrovascular Diseases 2011 Vol 31 (suppl 2)

Dale S, Middleton S, Levi C, D’Este C, Griffiths R, Grimshaw J, Ward J Challenges of a large cluster randomised controlled trial: Barriers and enablers to implementing protocols for fever, hyperglycaemia and swallowing dysfunction in the Quality in Acute Stroke (QASC) Project.  Cerebrovascular Diseases 2011 Vol 31 (suppl 2)

Middleton S, Ward J, Grimshaw J, Griffiths R, D’Este C, Dale S, Drury P, Cheung NW, Quinn C, Evans M, Cadilhac D, McElduff P, Levi C. Does a team base knowledge transfer intervention to manage fever, hyperglycaemia and swallowing dysfunction, improve 90-day outcomes following stroke? Stroke. 2011; 42, 587

Middleton S, Dale S, Levi C, D’Este C, Griffiths R, Grimshaw J, Ward J. Barriers and enablers to implementing protocols for fever, hyperglycaemia and swallowing dysfunction in acute stroke. Stroke. 2011; 42, e637

Jammali-Blasi A, McInnes E, Markus R, Faux S, O’Loughlin G, Dale S, Middleton S, Death, dependency, disability and health status of stroke patients 90-days post acute stroke unit care. International Journal of Stroke. 2010; 5; S1: 12.

Drury P, Levi C, Griffiths R, Ward J, Grimshaw J, D’Este C, Cheung W, McElduff P, Hardy J, McInnes E, Middleton S. Routine practices for fever, hyperglycaemia and dysphagia management in NSW acute stroke units. International Journal of Stroke. 2010; 5; S1: 26

Middleton S, Levi C, D’Este C, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D. 90-Day Mortality And Morbidity Post Acute Stroke:  Baseline Results From The Quality In Acute Stroke Care (QASC) Project. Internal Medicine Journal 2009 4 S1: p.9.

Middleton S, Dale S, Levi C, Ward J, Griffiths R, Grimshaw J. Challenges in Undertaking a Large Cluster Randomised Controlled Trial To Change Clinician Behaviour. International Journal of Evidence-Based Healthcare. 2009; 7; (3): 218. 

Middleton S, Levi C, D’Este C, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D.  Death Dependency and Health Status 90 Days Following Stroke in NSW:  Interim Results from the Quality in Acute Stroke Care (QASC) project.  Internal Medicine Journal 2007; 37: 4, A107

Middleton S, Levi C, Griffiths R, Grimshaw J, Ward J, ACU National.  Quality in Acute Stroke Care Project – Protocol for a Clustered Randomised Control Trial to evaluate the management of Fever, Sugar and Swallowing Dysfunction (FESS) following acute stroke.  Internal Medicine Journal 2006; 36:   A1 – A14.

Conference Presentations:

Middleton S. Can nursing care save lives and reduce dependency? Evidence from a cluster randomised controlled trial. 6th International Congress on Innovations in Nursing. Perth. 21-23 November 2012 (Invited Presentation)

Middleton S. Doing the simple things well: Nursing care making a difference.  The 21st annual Royal Brisbane and Women’s Hospital Health Care Symposium. Royal Brisbane and Women’s Hospital, Brisbane, 13 October 2012. (Invited Presentation)

Middleton S. Changing Clinician Behaviour: Nursing care makes a difference. Australian College of Nurse Practitioners Annual Conference Gold Coast 5-8 September 2012 (Invited Presentation)

Middleton S, Drury P, McElduff P, Ward J, Grimshaw J, Dale S, D’Este C, Griffiths R, Cheung NW, Hardy J, McInnes E, Levi C,. Doing the simple things well: Good nursing care reduces death and dependency. Honor Society of Nursing, Sigma Theta Tau International 23rd International Nursing Research Congress. Brisbane, 30 July – 3 Aug 2012.

Middleton S, Drury P, Levi C, D’Este C, McElduff P, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D, Cheung NW. The Quality in Acute Stroke Care (QASC) Trial: Processes of care associated with 90-day survival and independence. European Stroke Conference. Lisbon. May 2012. [Poster]

Middleton S, Fever, swallow, hyperglycaemia: implementing evidence in acute stroke care. European Stroke Conference. Lisbon. May 2012. [Invited Keynote Presentation]

Middleton S, Levi C, Ward J, Grimshaw J, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D. Improving quality of stroke care through knowledge translation: The QASC trial. International Forum on Quality and Safety in Healthcare, 17-20 April 2012, Paris. [Poster].

Middleton S, Drury P, Levi C, McElduff P, Grimshaw J, Ward J, D’Este C, Dale S, McInnes E, Hardy J, Griffiths R, Cheung NW, Quinn C, Cadilhac D, Evans M. The Quality In Acute Stroke Care (QASC) Trial: A Fever, Hyperglycaemia And Swallowing Intervention Improved Patient Outcomes But What Was Its Effect On Monitoring And Treatment Practices? International Stroke Conference. Late-Breaking Science Abstract Poster Session at the conference. 1 Feb 2012 to 3 Feb 2012. New Orleans, USA [Poster].

Middleton S, Levi C, Griffiths R, Grimshaw J, Ward J, D’Este C, Dale S, Drury P,  McInnes E, Hardy J, Cheung N, McElduff P, Cadilhac D, Evans M, Quinn C.  Changing acute stroke care practices: Final results of the Quality in Acute Stroke Care (QASC) Trial.  Smart Strokes 2011, 7th Australasian Nursing and Allied Health Stroke Conference. 4-5 August 2011. Surfers Paradise, QLD. P.35-36

Drury P, Middleton S, McElduff P, Levi C, D’Este, Grimshaw J, McInnes E, Hardy J, Dale S, Cheung W, Griffiths R, Ward J. The QASC cluster randomised controlled trial of an intervention to improve management of fever, hyperglycaemia and swallowing dysfunction in acute stroke: Did clinician behaviour change? Smart Strokes 2011, 7th Australasian Nursing and Allied Health Stroke Conference. 4-5 August 2011. Surfers Paradise, QLD. P.78-79

Dale S, Middleton S, Levi C, D'Este C, Griffiths R, Grimshaw J, Ward J.  Challenges of a large cluster randomised controlled trial: Barriers and enablers to implementing protocols for fever, hyperglycaemia and swallowing dysfunction in the QASC project.  Smart Strokes 2011, 7th Australasian Nursing and Allied Health Stroke Conference. 4-5 August 2011. Surfers Paradise, QLD. P.35-36

Jammali-Blasi A, McInnes E, Markus R, Faux S, O’Loughlin G, Dale S, Middleton S. 90-day outcomes for a cohort of patients admitted to a metropolitan acute stroke unit. Smart Strokes 2010, 6th Australasian Nursing and Allied Health Stroke Conference. 5-6 August 2010. Terrigal, NSW. P.23

Middleton S, Levi C, D’Este C, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D. Death, Dependency And Health Status 90 Days Following Stroke In NSW: Baseline Results From The Quality In Acute Stroke Care (QASC) Project. Smart Strokes 2009, 5rd Australasian Nursing and Allied Health Stroke Conference. 6-7 August 2009. Star City, Sydney.

Middleton S, Levi C, D’Este C, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D. Planning Post-discharge Needs: Death, Dependency and Health Status 90 Days following Acute Stroke in Australia. Royal College of Nursing UK (RCN) International Nursing Research Conference. Looking back, moving forward. 24 – 27 March 2009.Cardiff City Hall, Cardiff, Wales. P.92, 93

Middleton S, Levi C, D’Este C, Dale S, Griffiths R, Grimshaw J, Ward J, Evans M, Quinn C, Cadilhac D.  Death Dependency and Health Status 90 Days Following Stroke in NSW:  Preliminary Results from the Quality in Acute Stroke Care (QASC).  Smart Strokes 2007 3rd Australasian Nursing & Allied Health Stroke Conference.  Star City, Sydney 2-3 August 2007 p 12.

Middleton S, Quinn C, Levi C, Leigh T, Griffiths R, Grimshaw J, Ward J. Management of Swallowing Dysfunction in NSW Acute Stroke Units. Stroke – Its Time; 2nd Australasian Nursing and Allied Health Stroke Conference. Rydges Jamison, Sydney. 6, 7 July 2006. p. 14.

Public notes

Contacts

Principal investigator

Name

Prof Sandy Middleton

Address

Nursing Research Institute
Level 5, deLacy Building, 390 Victoria Street
Darlinghurst
NSW
2010

Country

Australia

Phone

+61283823094

Fax

sandy.middleton@acu.edu.au

Contact person for public queries

Name

Professor Sandy Middleton

Address

Director National Centre for Clinical Outcomes Research (NaCCOR), Nursing and Midwifery, Australia
ACU National
PO Box 968
NORTH SYDNEY NSW 2059

Country

Australia

Phone

+61 2 8382 3790

Fax

sandy.middleton@acu.edu.au

Contact person for scientific queries

Name

Professor Sandy Middleton

Address

Director National Centre for Clinical Outcomes Research (NaCCOR), Nursing and Midwifery, Australia
ACU National
40 Edward St
NORTH SYDNEY NSW 2059
PO Box 968
NORTH SYDNEY NSW 2059

Country

Australia

Phone

+61 2 8382 3790

Fax

sandy.middleton@acu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): A cluster randomised controlled trial.	2011	https://dx.doi.org/10.1016/S0140-6736%2811%2961485-2
Embase	Barriers and enablers to implementing clinical treatment protocols for fever, hyperglycaemia, and swallowing dysfunction in the Quality in Acute Stroke Care (QASC) Project--a mixed methods study.	2015	https://dx.doi.org/10.1111/wvn.12078
Embase	Mortality Reduction for Fever, Hyperglycemia, and Swallowing Nurse-Initiated Stroke Intervention: QASC Trial (Quality in Acute Stroke Care) Follow-Up.	2017	https://dx.doi.org/10.1161/STROKEAHA.116.016038

N.B. These documents automatically identified may not have been verified by the study sponsor.

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