Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623000633684
Ethics application status
Approved
Date submitted
13/05/2023
Date registered
13/06/2023
Date last updated
12/06/2024
Date data sharing statement initially provided
13/06/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Registry of Stroke Care Quality (RES-Q) Feedback Prompt Intervention Trial
Query!
Scientific title
Effect of a feedback prompt intervention on the frequency of use of Registry of Stroke Care Quality (RES-Q) data: protocol for a randomised controlled trial
Query!
Secondary ID [1]
309438
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Stroke
329692
0
Query!
Condition category
Condition code
Stroke
326590
326590
0
0
Query!
Haemorrhagic
Query!
Stroke
326591
326591
0
0
Query!
Ischaemic
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The feedback prompt intervention comprises emails with a message and link to the secure Registry of Stroke Care Quality (RES-Q) Data Management Portal. A total of four emails, coinciding with the release of the RES-Q quarterly reports, will be sent to the RES-Q local coordinators over the 12 month intervention period. The content of the email messages are aimed at engaging the RES-Q local coordinators with using the data in the report and dashboard to improve practice. The content will include instructions on how to access the report and dashboard via the link as well as information on how to download the RES-Q report and share with other members of their hospital stroke team. A copy of the report will not be included in the email, only instructions on how to access and download the report. The emails will be sent from the RES-Q Global Manager.
The RES-Q local coordinators in the intervention group will also receive monthly email reminders from the RES-Q team to download their report and view their dashboard. Similar to the prompt emails sent quarterly, the monthly email reminders will also include a link to the secure Registry of Stroke Care Quality(RES-Q) Data Management Portal. The RES-Q local coordinators will also be encouraged to share the report with other members of the stroke team and use the data to improve practice.
To monitor adherence to the intervention, emails will be sent to RES-Q local coordinators via the Mailchimp Platform to determine email delivery and/or email opened rates.
Query!
Intervention code [1]
325867
0
Treatment: Other
Query!
Comparator / control treatment
RES-Q local coordinators in hospitals randomised to the control group will not receive the feedback prompt intervention and email reminders. As per the usual RES-Q process, they will only be notified that their quarterly RES-Q hospital report is available for viewing and/or downloading via a message displayed on the RES-Q Global website.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
334447
0
Number of hospitals that downloaded at least one report file format (that is, PowerPoint presentation, Excel spreadsheet and/or raw data). This outcome will be assessed through RES-Q server tools reading apache2 logs: Elasticsearch and Kibana.
Query!
Assessment method [1]
334447
0
Query!
Timepoint [1]
334447
0
Baseline and 12 months (primary timepoint) after intervention commencement date.
Query!
Secondary outcome [1]
420695
0
Number of times reports were downloaded. This outcome will be assessed through RES-Q server tools reading apache2 logs: Elasticsearch and Kibana.
Query!
Assessment method [1]
420695
0
Query!
Timepoint [1]
420695
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [2]
420697
0
Number of dashboard views. This outcome will be assessed through RES-Q server tools reading apache2 logs: Elasticsearch and Kibana.
Query!
Assessment method [2]
420697
0
Query!
Timepoint [2]
420697
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [3]
420698
0
National Institutes of Health Stroke Scale (NIHSS) score (assessed via medical record audit)
Query!
Assessment method [3]
420698
0
Query!
Timepoint [3]
420698
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [4]
422625
0
Treatment with thrombolysis (assessed via medical record audit)
Query!
Assessment method [4]
422625
0
Query!
Timepoint [4]
422625
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [5]
422626
0
Treatment with thrombectomy (assessed via medical record audit)
Query!
Assessment method [5]
422626
0
Query!
Timepoint [5]
422626
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [6]
422627
0
Door-to-Needle time (DTN) (assessed via medical record audit)
Query!
Assessment method [6]
422627
0
Query!
Timepoint [6]
422627
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [7]
422628
0
Recanalization proportion (assessed via medical record audit)
Query!
Assessment method [7]
422628
0
Query!
Timepoint [7]
422628
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [8]
422629
0
Administration of paracetamol (or other antipyretic) for the first elevated temperature (assessed via medical record audit)
Query!
Assessment method [8]
422629
0
Query!
Timepoint [8]
422629
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [9]
422630
0
Administration of insulin for the first elevated glucose equal to or greater than 10 mmol/L (180 mg/dl) (assessed via medical record audit)
Query!
Assessment method [9]
422630
0
Query!
Timepoint [9]
422630
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [10]
422631
0
Swallow screen performed (assessed via medical record audit)
Query!
Assessment method [10]
422631
0
Query!
Timepoint [10]
422631
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [11]
422632
0
Physiotherapy received (assessed via medical record audit)
Query!
Assessment method [11]
422632
0
Query!
Timepoint [11]
422632
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [12]
422633
0
Discharged on anticoagulants (atrial fibrillation patients) (assessed via medical record audit)
Query!
Assessment method [12]
422633
0
Query!
Timepoint [12]
422633
0
Baseline and 12 months after intervention commencement date.
Query!
Secondary outcome [13]
422634
0
Hospitalisation in a stroke unit/intensive care unit (assessed via medical record audit)
Query!
Assessment method [13]
422634
0
Query!
Timepoint [13]
422634
0
Baseline and 12 months after intervention commencement date.
Query!
Eligibility
Key inclusion criteria
All hospitals registered with RES-Q and entering data to the RES-Q database up to 31st December 2022 will be eligible for inclusion in the study. Hospitals that captured data on more than 10 patients in 2022 will be categorised as active and those capturing data on 10 patients or less will be classified as inactive. All active and inactive hospitals registered with RES-Q will be included in the study.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Hospitals in the Czech Republic will be excluded because these hospitals currently have a different feedback mechanism to the other RES-Q hospitals.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation sequence will be concealed until the intervention is assigned. Randomisation will be done by an independent statistician blinded to group allocation and not involved in the study thereby ensuring allocation concealment.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation will be used to assign hospitals in the trial to the intervention or control group in a 1:1 ratio. Randomisation will be stratified by country and active and inactive volume in RES-Q.
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Not Applicable
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Analysis will be by intention-to-treat. Descriptive statistics will be used to compare baseline data between the intervention and control groups. Numerical data will be reported as mean and standard deviation or median and interquartile range. Categorical data will be reported as proportions. Analysis will include multivariable statistical models (as appropriate for the outcome measure). A trend analysis will be performed to identify patterns in quarterly report downloads and dashboard views over the 12 month intervention period. An assessment for correlation between changes in stroke processes of care and report downloads and dashboard views will also be undertaken using the Spearman’s rank correlation coefficient.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
4/11/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/12/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2026
Query!
Actual
Query!
Sample size
Target
1500
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment outside Australia
Country [1]
25436
0
Albania
Query!
State/province [1]
25436
0
Query!
Country [2]
25437
0
Algeria
Query!
State/province [2]
25437
0
Query!
Country [3]
25438
0
Argentina
Query!
State/province [3]
25438
0
Query!
Country [4]
25439
0
Azerbaijan
Query!
State/province [4]
25439
0
Query!
Country [5]
25440
0
Bahrain
Query!
State/province [5]
25440
0
Query!
Country [6]
25441
0
Belarus
Query!
State/province [6]
25441
0
Query!
Country [7]
25442
0
Bolivia
Query!
State/province [7]
25442
0
Query!
Country [8]
25443
0
Brazil
Query!
State/province [8]
25443
0
Query!
Country [9]
25444
0
Bulgaria
Query!
State/province [9]
25444
0
Query!
Country [10]
25445
0
Chile
Query!
State/province [10]
25445
0
Query!
Country [11]
25446
0
Colombia
Query!
State/province [11]
25446
0
Query!
Country [12]
25447
0
Croatia
Query!
State/province [12]
25447
0
Query!
Country [13]
25448
0
Czech Republic
Query!
State/province [13]
25448
0
Query!
Country [14]
25449
0
Ecuador
Query!
State/province [14]
25449
0
Query!
Country [15]
25450
0
Egypt
Query!
State/province [15]
25450
0
Query!
Country [16]
25451
0
Estonia
Query!
State/province [16]
25451
0
Query!
Country [17]
25452
0
Georgia
Query!
State/province [17]
25452
0
Query!
Country [18]
25453
0
Ghana
Query!
State/province [18]
25453
0
Query!
Country [19]
25454
0
Greece
Query!
State/province [19]
25454
0
Query!
Country [20]
25455
0
Guatemala
Query!
State/province [20]
25455
0
Query!
Country [21]
25456
0
Hungary
Query!
State/province [21]
25456
0
Query!
Country [22]
25457
0
India
Query!
State/province [22]
25457
0
Query!
Country [23]
25458
0
Indonesia
Query!
State/province [23]
25458
0
Query!
Country [24]
25459
0
Iran, Islamic Republic Of
Query!
State/province [24]
25459
0
Query!
Country [25]
25460
0
Iraq
Query!
State/province [25]
25460
0
Query!
Country [26]
25461
0
Italy
Query!
State/province [26]
25461
0
Query!
Country [27]
25462
0
Jordan
Query!
State/province [27]
25462
0
Query!
Country [28]
25463
0
Kazakhstan
Query!
State/province [28]
25463
0
Query!
Country [29]
25464
0
Kyrgyzstan
Query!
State/province [29]
25464
0
Query!
Country [30]
25465
0
Latvia
Query!
State/province [30]
25465
0
Query!
Country [31]
25466
0
Lithuania
Query!
State/province [31]
25466
0
Query!
Country [32]
25467
0
Malaysia
Query!
State/province [32]
25467
0
Query!
Country [33]
25468
0
Mexico
Query!
State/province [33]
25468
0
Query!
Country [34]
25469
0
Moldova, Republic Of
Query!
State/province [34]
25469
0
Query!
Country [35]
25470
0
Namibia
Query!
State/province [35]
25470
0
Query!
Country [36]
25471
0
Nepal
Query!
State/province [36]
25471
0
Query!
Country [37]
25472
0
Macedonia, The Former Yugoslav Republic Of
Query!
State/province [37]
25472
0
Query!
Country [38]
25473
0
Palestinian Territory, Occupied
Query!
State/province [38]
25473
0
Query!
Country [39]
25474
0
Peru
Query!
State/province [39]
25474
0
Query!
Country [40]
25475
0
Philippines
Query!
State/province [40]
25475
0
Query!
Country [41]
25476
0
Poland
Query!
State/province [41]
25476
0
Query!
Country [42]
25477
0
Portugal
Query!
State/province [42]
25477
0
Query!
Country [43]
25478
0
Romania
Query!
State/province [43]
25478
0
Query!
Country [44]
25479
0
Russian Federation
Query!
State/province [44]
25479
0
Query!
Country [45]
25480
0
Saudi Arabia
Query!
State/province [45]
25480
0
Query!
Country [46]
25481
0
Serbia and Montenegro
Query!
State/province [46]
25481
0
Query!
Country [47]
25482
0
South Africa
Query!
State/province [47]
25482
0
Query!
Country [48]
25483
0
Korea, Republic Of
Query!
State/province [48]
25483
0
Query!
Country [49]
25484
0
Spain
Query!
State/province [49]
25484
0
Query!
Country [50]
25485
0
Thailand
Query!
State/province [50]
25485
0
Query!
Country [51]
25486
0
Turkey
Query!
State/province [51]
25486
0
Query!
Country [52]
25487
0
Ukraine
Query!
State/province [52]
25487
0
Query!
Country [53]
25488
0
United Arab Emirates
Query!
State/province [53]
25488
0
Query!
Country [54]
25489
0
Viet Nam
Query!
State/province [54]
25489
0
Query!
Country [55]
25503
0
Afghanistan
Query!
State/province [55]
25503
0
Query!
Country [56]
25506
0
Armenia
Query!
State/province [56]
25506
0
Query!
Country [57]
25507
0
Belgium
Query!
State/province [57]
25507
0
Query!
Country [58]
25508
0
Bhutan
Query!
State/province [58]
25508
0
Query!
Country [59]
25509
0
Bosnia and Herzegovina
Query!
State/province [59]
25509
0
Query!
Country [60]
25510
0
Cameroon
Query!
State/province [60]
25510
0
Query!
Country [61]
25511
0
Cayman Islands
Query!
State/province [61]
25511
0
Query!
Country [62]
25512
0
Costa Rica
Query!
State/province [62]
25512
0
Query!
Country [63]
25513
0
Dominican Republic
Query!
State/province [63]
25513
0
Query!
Country [64]
25514
0
Ethiopia
Query!
State/province [64]
25514
0
Query!
Country [65]
25515
0
France
Query!
State/province [65]
25515
0
Query!
Country [66]
25516
0
Germany
Query!
State/province [66]
25516
0
Query!
Country [67]
25517
0
Jamaica
Query!
State/province [67]
25517
0
Query!
Country [68]
25518
0
Japan
Query!
State/province [68]
25518
0
Query!
Country [69]
25519
0
Kenya
Query!
State/province [69]
25519
0
Query!
Country [70]
25520
0
Kuwait
Query!
State/province [70]
25520
0
Query!
Country [71]
25521
0
Maldives
Query!
State/province [71]
25521
0
Query!
Country [72]
25522
0
Malta
Query!
State/province [72]
25522
0
Query!
Country [73]
25523
0
Myanmar
Query!
State/province [73]
25523
0
Query!
Country [74]
25524
0
Netherlands
Query!
State/province [74]
25524
0
Query!
Country [75]
25525
0
Nigeria
Query!
State/province [75]
25525
0
Query!
Country [76]
25526
0
Panama
Query!
State/province [76]
25526
0
Query!
Country [77]
25527
0
Paraguay
Query!
State/province [77]
25527
0
Query!
Country [78]
25528
0
Sao Tome and Principe
Query!
State/province [78]
25528
0
Query!
Country [79]
25529
0
Sierra Leone
Query!
State/province [79]
25529
0
Query!
Country [80]
25530
0
Slovakia
Query!
State/province [80]
25530
0
Query!
Country [81]
25531
0
Tanzania, United Republic Of
Query!
State/province [81]
25531
0
Query!
Country [82]
25532
0
Tunisia
Query!
State/province [82]
25532
0
Query!
Country [83]
25533
0
United States of America
Query!
State/province [83]
25533
0
Query!
Country [84]
25534
0
Uruguay
Query!
State/province [84]
25534
0
Query!
Country [85]
25535
0
Uzbekistan
Query!
State/province [85]
25535
0
Query!
Funding & Sponsors
Funding source category [1]
313634
0
Government body
Query!
Name [1]
313634
0
National Health and Medical Research Council
Query!
Address [1]
313634
0
16 Marcus Clarke Street, Canberra, ACT 2601
Query!
Country [1]
313634
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Australian Catholic University
Query!
Address
40 Edward Street, North Sydney, NSW 2060
Query!
Country
Australia
Query!
Secondary sponsor category [1]
315495
0
None
Query!
Name [1]
315495
0
Query!
Address [1]
315495
0
Query!
Country [1]
315495
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
312804
0
Australian Catholic University Human Research Ethics Committee
Query!
Ethics committee address [1]
312804
0
North Sydney Campus (MacKillop)
Tenison Woods House
8-20 Napier Street-Level 16 (532.16)
North Sydney NSW 2060
Query!
Ethics committee country [1]
312804
0
Australia
Query!
Date submitted for ethics approval [1]
312804
0
19/04/2023
Query!
Approval date [1]
312804
0
22/05/2023
Query!
Ethics approval number [1]
312804
0
2023-3137E
Query!
Summary
Brief summary
The Registry of Stroke Care Quality (RES-Q) is a global stroke registry used to collect stroke quality of care metrics with benchmarking at both hospital and national levels. RES-Q provides feedback to participating hospitals via downloadable reports and dashboards. Providing feedback on the registry data to hospitals and clinicians helps them identify and prioritize areas for stroke care quality improvement. Findings from our recent survey of hospitals participating in RES-Q showed that feedback of RES-Q data to hospital staff and department heads about progress in stroke management was suboptimal. Although there was a high awareness of RES-Q hospital reports and dashboards, staff downloads and views respectively, were low. Current RES-Q feedback mechanisms are passive and rely on the active role of users, which is only partly successful. For RES-Q data to be more effective in driving clinical practice change, evidence-based performance feedback mechanisms are needed. Hence the aim of this study is to evaluate the effectiveness of a feedback prompt intervention involving a ‘push’ email with a message and link to the RES-Q hospital report and dashboard sent to the RES-Q hospital coordinators by the RES-Q Global Manager in improving report downloading, dashboard viewing and stroke care processes. A randomised controlled trial will be undertaken. Hospitals participating in RES-Q will be randomised to the feedback prompt intervention or a control group. All hospitals registered with RES-Q and entering data to the RES-Q database up to 31st December 2022 will be eligible for inclusion in the study. The study findings have the potential to increase hospitals’ use of RES-Q data to drive practice change within their stroke unit/service.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
125982
0
Prof Sandy Middleton
Query!
Address
125982
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
Query!
Country
125982
0
Australia
Query!
Phone
125982
0
+61 2 8382 3790
Query!
Fax
125982
0
Query!
Email
125982
0
[email protected]
Query!
Contact person for public queries
Name
125983
0
Prof Sandy Middleton
Query!
Address
125983
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
Query!
Country
125983
0
Australia
Query!
Phone
125983
0
+61 2 8382 3790
Query!
Fax
125983
0
Query!
Email
125983
0
[email protected]
Query!
Contact person for scientific queries
Name
125984
0
Prof Sandy Middleton
Query!
Address
125984
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
Query!
Country
125984
0
Australia
Query!
Phone
125984
0
+61 2 8382 3790
Query!
Fax
125984
0
Query!
Email
125984
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
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.
Query!
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.
Download to PDF