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Trial registered on ANZCTR


Registration number
ACTRN12623000633684
Ethics application status
Approved
Date submitted
13/05/2023
Date registered
13/06/2023
Date last updated
29/10/2024
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
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
Secondary ID [1] 309438 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 329692 0
Condition category
Condition code
Stroke 326590 326590 0 0
Haemorrhagic
Stroke 326591 326591 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RES-Q will send a feedback email prompt from the administration email (with the signature block of the Chair of the RES-Q International Scientific Committee) to all eligible RES-Q local coordinators randomised to the intervention group. The content of the email message is aimed at encouraging the RES-Q local coordinators to view and use their hospital data to improve practice and promote stroke care quality improvement. It will be designed to meet nine of the 15 recommendations believed to be associated with effective audit and feedback interventions. The email will include instructions on how to access the report and dashboard via the link to the secure RES-Q Data Management Portal as well as information on how to generate the RES-Q report (PowerPoint and excel/csv file format). The RES-Q local coordinators will also be encouraged to share the report with other members of their hospital stroke team and use the data for quality improvement. A copy of the report will not be included in the email, only instructions on how to access and generate the report.

The feedback prompt intervention email will be sent monthly by RES-Q. Hence, a total of 12 identical emails will be sent to the RES-Q local coordinators over the 12-month intervention period (one per calendar month).

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.
Intervention code [1] 325867 0
Treatment: Other
Comparator / control treatment
RES-Q local coordinators in hospitals randomised to the control group will not receive the monthly feedback prompt intervention email. As per the usual RES-Q process, they will only continue to receive communication/alert emails about regular processes such as ESO/WSO Angels Awards data entry deadline and award announcement, EMS RES-Q portal launch and updates on any new feature, enhancements or legal framework which will also be sent to the hospitals randomized to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 334447 0
Number of hospitals that generated at least one report file format (that is, PowerPoint and/or raw data in Excel/csv files). This outcome will be assessed through RES-Q server tools reading apache2 logs: Elasticsearch and Kibana.
Timepoint [1] 334447 0
Baseline and 12 months (primary timepoint) after intervention commencement date.
Secondary outcome [1] 420695 0
Number of times reports were generated. This outcome will be assessed through RES-Q server tools reading apache2 logs: Elasticsearch and Kibana.
Timepoint [1] 420695 0
Baseline and 12 months after intervention commencement date.
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.
Timepoint [2] 420697 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [3] 420698 0
National Institutes of Health Stroke Scale (NIHSS) score (assessed via medical record audit)
Timepoint [3] 420698 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [4] 422625 0
Treatment with thrombolysis (assessed via medical record audit)
Timepoint [4] 422625 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [5] 422626 0
Treatment with thrombectomy (assessed via medical record audit)
Timepoint [5] 422626 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [6] 422627 0
Door-to-Needle time (DTN) (assessed via medical record audit)
Timepoint [6] 422627 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [7] 422628 0
Recanalization proportion (assessed via medical record audit)
Timepoint [7] 422628 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [8] 422629 0
Administration of paracetamol (or other antipyretic) for the first elevated temperature (assessed via medical record audit)
Timepoint [8] 422629 0
Baseline and 12 months after intervention commencement date.
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)
Timepoint [9] 422630 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [10] 422631 0
Swallow screen performed (assessed via medical record audit)
Timepoint [10] 422631 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [11] 422632 0
Physiotherapy received (assessed via medical record audit)
Timepoint [11] 422632 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [12] 422633 0
Discharged on anticoagulants (atrial fibrillation patients) (assessed via medical record audit)
Timepoint [12] 422633 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [13] 422634 0
Hospitalisation in a stroke unit/intensive care unit (assessed via medical record audit)
Timepoint [13] 422634 0
Baseline and 12 months after intervention commencement date.
Secondary outcome [14] 441108 0
Number of RES-Q users who generated reports. This outcome will be assessed through RES-Q server tools reading apache2 logs: Elasticsearch and Kibana.
Timepoint [14] 441108 0
Secondary outcome [15] 441109 0
Number of RES-Q users who generated reports. This outcome will be assessed through RES-Q server tools reading apache2 logs: Elasticsearch and Kibana.
Timepoint [15] 441109 0
Baseline and 12 months after intervention commencement date.

Eligibility
Key inclusion criteria
All hospitals registered with RES-Q and entering data to the RES-Q database up to 31st July 2024 will be eligible for inclusion in the study. Hospitals that captured data on more than 10 patients in 2024 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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 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.
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.
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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 25436 0
Albania
State/province [1] 25436 0
Country [2] 25437 0
Algeria
State/province [2] 25437 0
Country [3] 25438 0
Argentina
State/province [3] 25438 0
Country [4] 25439 0
Azerbaijan
State/province [4] 25439 0
Country [5] 25440 0
Bahrain
State/province [5] 25440 0
Country [6] 25441 0
Belarus
State/province [6] 25441 0
Country [7] 25442 0
Bolivia
State/province [7] 25442 0
Country [8] 25443 0
Brazil
State/province [8] 25443 0
Country [9] 25444 0
Bulgaria
State/province [9] 25444 0
Country [10] 25445 0
Chile
State/province [10] 25445 0
Country [11] 25446 0
Colombia
State/province [11] 25446 0
Country [12] 25447 0
Croatia
State/province [12] 25447 0
Country [13] 25448 0
Czech Republic
State/province [13] 25448 0
Country [14] 25449 0
Ecuador
State/province [14] 25449 0
Country [15] 25450 0
Egypt
State/province [15] 25450 0
Country [16] 25451 0
Estonia
State/province [16] 25451 0
Country [17] 25452 0
Georgia
State/province [17] 25452 0
Country [18] 25453 0
Ghana
State/province [18] 25453 0
Country [19] 25454 0
Greece
State/province [19] 25454 0
Country [20] 25455 0
Guatemala
State/province [20] 25455 0
Country [21] 25456 0
Hungary
State/province [21] 25456 0
Country [22] 25457 0
India
State/province [22] 25457 0
Country [23] 25458 0
Indonesia
State/province [23] 25458 0
Country [24] 25459 0
Iran, Islamic Republic Of
State/province [24] 25459 0
Country [25] 25460 0
Iraq
State/province [25] 25460 0
Country [26] 25461 0
Italy
State/province [26] 25461 0
Country [27] 25462 0
Jordan
State/province [27] 25462 0
Country [28] 25463 0
Kazakhstan
State/province [28] 25463 0
Country [29] 25464 0
Kyrgyzstan
State/province [29] 25464 0
Country [30] 25465 0
Latvia
State/province [30] 25465 0
Country [31] 25466 0
Lithuania
State/province [31] 25466 0
Country [32] 25467 0
Malaysia
State/province [32] 25467 0
Country [33] 25468 0
Mexico
State/province [33] 25468 0
Country [34] 25469 0
Moldova, Republic Of
State/province [34] 25469 0
Country [35] 25470 0
Namibia
State/province [35] 25470 0
Country [36] 25471 0
Nepal
State/province [36] 25471 0
Country [37] 25472 0
Macedonia, The Former Yugoslav Republic Of
State/province [37] 25472 0
Country [38] 25473 0
Palestinian Territory, Occupied
State/province [38] 25473 0
Country [39] 25474 0
Peru
State/province [39] 25474 0
Country [40] 25475 0
Philippines
State/province [40] 25475 0
Country [41] 25476 0
Poland
State/province [41] 25476 0
Country [42] 25477 0
Portugal
State/province [42] 25477 0
Country [43] 25478 0
Romania
State/province [43] 25478 0
Country [44] 25479 0
Russian Federation
State/province [44] 25479 0
Country [45] 25480 0
Saudi Arabia
State/province [45] 25480 0
Country [46] 25481 0
Serbia and Montenegro
State/province [46] 25481 0
Country [47] 25482 0
South Africa
State/province [47] 25482 0
Country [48] 25483 0
Korea, Republic Of
State/province [48] 25483 0
Country [49] 25484 0
Spain
State/province [49] 25484 0
Country [50] 25485 0
Thailand
State/province [50] 25485 0
Country [51] 25486 0
Turkey
State/province [51] 25486 0
Country [52] 25487 0
Ukraine
State/province [52] 25487 0
Country [53] 25488 0
United Arab Emirates
State/province [53] 25488 0
Country [54] 25489 0
Viet Nam
State/province [54] 25489 0
Country [55] 25503 0
Afghanistan
State/province [55] 25503 0
Country [56] 25506 0
Armenia
State/province [56] 25506 0
Country [57] 25507 0
Belgium
State/province [57] 25507 0
Country [58] 25508 0
Bhutan
State/province [58] 25508 0
Country [59] 25509 0
Bosnia and Herzegovina
State/province [59] 25509 0
Country [60] 25510 0
Cameroon
State/province [60] 25510 0
Country [61] 25511 0
Cayman Islands
State/province [61] 25511 0
Country [62] 25512 0
Costa Rica
State/province [62] 25512 0
Country [63] 25513 0
Dominican Republic
State/province [63] 25513 0
Country [64] 25514 0
Ethiopia
State/province [64] 25514 0
Country [65] 25515 0
France
State/province [65] 25515 0
Country [66] 25516 0
Germany
State/province [66] 25516 0
Country [67] 25517 0
Jamaica
State/province [67] 25517 0
Country [68] 25518 0
Japan
State/province [68] 25518 0
Country [69] 25519 0
Kenya
State/province [69] 25519 0
Country [70] 25520 0
Kuwait
State/province [70] 25520 0
Country [71] 25521 0
Maldives
State/province [71] 25521 0
Country [72] 25522 0
Malta
State/province [72] 25522 0
Country [73] 25523 0
Myanmar
State/province [73] 25523 0
Country [74] 25524 0
Netherlands
State/province [74] 25524 0
Country [75] 25525 0
Nigeria
State/province [75] 25525 0
Country [76] 25526 0
Panama
State/province [76] 25526 0
Country [77] 25527 0
Paraguay
State/province [77] 25527 0
Country [78] 25528 0
Sao Tome and Principe
State/province [78] 25528 0
Country [79] 25529 0
Sierra Leone
State/province [79] 25529 0
Country [80] 25530 0
Slovakia
State/province [80] 25530 0
Country [81] 25531 0
Tanzania, United Republic Of
State/province [81] 25531 0
Country [82] 25532 0
Tunisia
State/province [82] 25532 0
Country [83] 25533 0
United States of America
State/province [83] 25533 0
Country [84] 25534 0
Uruguay
State/province [84] 25534 0
Country [85] 25535 0
Uzbekistan
State/province [85] 25535 0

Funding & Sponsors
Funding source category [1] 313634 0
Government body
Name [1] 313634 0
National Health and Medical Research Council
Country [1] 313634 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
40 Edward Street, North Sydney, NSW 2060
Country
Australia
Secondary sponsor category [1] 315495 0
None
Name [1] 315495 0
Address [1] 315495 0
Country [1] 315495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312804 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 312804 0
Ethics committee country [1] 312804 0
Australia
Date submitted for ethics approval [1] 312804 0
19/04/2023
Approval date [1] 312804 0
22/05/2023
Ethics approval number [1] 312804 0
2023-3137E

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

Contacts
Principal investigator
Name 125982 0
Prof Sandy Middleton
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
Country 125982 0
Australia
Phone 125982 0
+61 2 8382 3790
Fax 125982 0
Email 125982 0
[email protected]
Contact person for public queries
Name 125983 0
Sandy Middleton
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
Country 125983 0
Australia
Phone 125983 0
+61 2 8382 3790
Fax 125983 0
Email 125983 0
[email protected]
Contact person for scientific queries
Name 125984 0
Sandy Middleton
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
Country 125984 0
Australia
Phone 125984 0
+61 2 8382 3790
Fax 125984 0
Email 125984 0
[email protected]

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.