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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
3/05/2012
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] 262882 0
Nil
Universal Trial Number (UTN)
Trial acronym
QASC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 3915 0
Condition category
Condition code
Stroke 4038 4038 0 0
Haemorrhagic
Stroke 4107 4107 0 0
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] 3573 0
Behaviour
Intervention code [2] 3634 0
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] 4940 0
Death or disability (disability defined as Modified Rankin Score (mRS) greater than or equal to 2)
Timepoint [1] 4940 0
90 days post-hospital admission
Primary outcome [2] 4941 0
Level of disability (mRS)
Timepoint [2] 4941 0
90-days post-hospital admission
Primary outcome [3] 4942 0
Level of dependency (Barthel Index)
Timepoint [3] 4942 0
90-days post-hospital admission
Secondary outcome [1] 8326 0
Improved glycaemic control as measured by mean finger-prick blood glucose level readings
Timepoint [1] 8326 0
First 72 hours following admission to acute stroke unit
Secondary outcome [2] 8327 0
Improved temperature control as measured by mean temperature readings
Timepoint [2] 8327 0
First 72 hours following admission to acute stroke unit
Secondary outcome [3] 8328 0
Improved management of swallowing dysfunction as measured by swallowing screen undertaken
Timepoint [3] 8328 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1242 0
2310
Recruitment postcode(s) [2] 1243 0
2050
Recruitment postcode(s) [3] 1244 0
2148
Recruitment postcode(s) [4] 1245 0
2139
Recruitment postcode(s) [5] 1246 0
2065
Recruitment postcode(s) [6] 1247 0
2145
Recruitment postcode(s) [7] 1248 0
2010
Recruitment postcode(s) [8] 1249 0
2031
Recruitment postcode(s) [9] 1250 0
1871
Recruitment postcode(s) [10] 1251 0
2200
Recruitment postcode(s) [11] 1252 0
2229
Recruitment postcode(s) [12] 1253 0
2250
Recruitment postcode(s) [13] 1254 0
2077
Recruitment postcode(s) [14] 1255 0
2560
Recruitment postcode(s) [15] 1256 0
2217
Recruitment postcode(s) [16] 1257 0
2500
Recruitment postcode(s) [17] 1258 0
2095
Recruitment postcode(s) [18] 1259 0
2751

Funding & Sponsors
Funding source category [1] 4100 0
Government body
Name [1] 4100 0
National Health and Medical Research Council (NHMRC)
Address [1] 4100 0
GPO Box 1421
Canberra ACT 2601
Country [1] 4100 0
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] 3691 0
Individual
Name [1] 3691 0
A/Professor Christopher Levi
Address [1] 3691 0
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] 3691 0
Australia
Other collaborator category [1] 458 0
Individual
Name [1] 458 0
Professor Jeanette Ward
Address [1] 458 0
Department of Epidemiology & Community Medicine
University of Ottawa
451 Smyth Road
Ottawa, Ontario K1H 8M5
Canada
Country [1] 458 0
Canada
Other collaborator category [2] 459 0
Individual
Name [2] 459 0
Professor Jeremy Grimshaw
Address [2] 459 0
Director, Clinical Epidemiology Program
Ottawa Health Research Institute
1053 Carling Avenue,
Administration Building, Room 2-017
Ottawa, Ontario K1Y 4E9
Canada
Country [2] 459 0
Canada
Other collaborator category [3] 460 0
Individual
Name [3] 460 0
Professor Rhonda Griffiths
Address [3] 460 0
Head, School of Nursing and Midwifery
University of Western Sydney
Locked Bag 1797
Penrith South DC NSW 1797
Australia
Country [3] 460 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6171 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 6171 0
PO Box 456
VIRGINIA. Qld, 4014
Ethics committee country [1] 6171 0
Australia
Date submitted for ethics approval [1] 6171 0
24/05/2005
Approval date [1] 6171 0
25/07/2005
Ethics approval number [1] 6171 0
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 29051 0
Address 29051 0
Country 29051 0
Phone 29051 0
Fax 29051 0
Email 29051 0
Contact person for public queries
Name 12208 0
Professor Sandy Middleton
Address 12208 0
Director National Centre for Clinical Outcomes Research (NaCCOR), Nursing and Midwifery, Australia
ACU National
PO Box 968
NORTH SYDNEY NSW 2059
Country 12208 0
Australia
Phone 12208 0
+61 2 8382 3790
Fax 12208 0
Email 12208 0
sandy.middleton@acu.edu.au
Contact person for scientific queries
Name 3136 0
Professor Sandy Middleton
Address 3136 0
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 3136 0
Australia
Phone 3136 0
+61 2 8382 3790
Fax 3136 0
Email 3136 0
sandy.middleton@acu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary