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Trial registered on ANZCTR


Registration number
ACTRN12619001072101
Ethics application status
Approved
Date submitted
5/07/2019
Date registered
31/07/2019
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Date results information initially provided
31/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Shared Team Efforts Leading to Adherence Results (STELAR)– trial of a quality improvement program in acute stroke care
Scientific title
Shared Team Efforts Leading to Adherence Results – the STELAR stepped-wedge cluster randomised controlled study in acute stroke care
Secondary ID [1] 298117 0
Nil known
Universal Trial Number (UTN)
Trial acronym
STELAR-Acute Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 312647 0
Condition category
Condition code
Stroke 311142 311142 0 0
Ischaemic
Stroke 311143 311143 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The STELAR program is a complex intervention (i.e. has multiple and interacting parts).

The STELAR program is designed to be delivered in four discrete stages: pre-workshop survey, two facilitated workshops and then ongoing support by the program team. The program is based on a multi-component quality improvement (knowledge translation) intervention that includes external facilitation using audit and feedback; educational meetings with action planning; and use of local opinion leaders. Each site had a ‘change champion’ appointed to ensure local responsibility and commitment to the action plan and agreed strategies. Local opinion leaders deliver the educational component of the face-to-face workshop as there is strong evidence that local opinion leaders can influence rapid uptake of evidence. The hospital participants include some or all of the following staff: medical, nursing, allied health, pharmacy, executives and quality managers.

Stage 1: Pre-workshop survey: To gain a better understanding of current practice regarding processes of care, staff involved in providing acute stroke care from participating hospitals are asked to complete a pre-workshop survey. The questionnaire is designed to identify potential barriers, and enablers to providing “best practice” stroke care. It covers a broad range of hospital practices including: current systems, practice protocols, team structures, culture and roles. Information is then collated to identify potential clinical aspects of care for discussion during the first workshop. The survey is distributed electronically by the external facilitator approximately two weeks prior to Workshop 1 and remains open for one week.

Stage 2: Workshop 1 (data feed back) is an hour-long workshop presented as a videoconference to minimize travel costs and promote reach, especially to regional sites. The workshop is presented by the external facilitator approximately one week after the pre-workshop survey has been conducted. The aim of this workshop is to review the survey results and local clinical performance data obtained from the Australian Stroke Clinical Registry (AuSCR) against national benchmarks. Participants are asked to consider local barriers and enablers to providing ‘best-practice' care and the most important policies, team roles, and resources that could be modified. Potential opportunities for interventions, that are deemed feasible by the participants, are discussed for consideration and categorised into low, medium and high priority. The information from this workshop is then used to tailor the content of Workshop 2 which includes tailored education and evidence-informed action planning (see below). Potential leaders within the participant group are also identified to assist with Workshop 2.

Stage 3: Workshop 2 (~ 2 weeks after Workshop 1), includes tailored education and evidence-informed action planning that is conducted as a two-hour face-to-face meeting at the local site with an external facilitator trained in knowledge translation methods. The education component is presented by a ‘local opinion leader’ or other content expert. Then the external facilitator provides a summary of the local gaps between current practices and 'best practice' that were identified from the initial review of the AuSCR data during Workshop 1. A summary of the Workshop 1 discussion of perceived barriers and enablers is also presented. The external facilitator then works with the participants to draft a local action plan to be implemented by the clinicians responsible for these activities, which targets the identified ‘mission critical’ modifiable barriers related to the processes of care to be improved. A ‘change champion’ is appointed. The actions plans are to be implemented with a view to maximizing existing processes and activities to improve efficiencies within sites, rather than increasing staff workloads. At the end of the workshop, a survey is completed by all participants to gauge their satisfaction with the workshop.

Stage 4: The 'change champion' or other designated hospital contact is provided with ongoing support by the external facilitator for a minimum two month period following Workshop 2 in order to implement the action plans and were encouraged to meet the agreed timelines and goals. Support includes regular email contact and phone calls with the staff responsible for leading work on the action plan. The support provided to all hospitals is recorded by the Facilitator on the STELAR program 'support activity log'. Regular local hospital performance monitoring regarding adherence to the selected care processes, using AuSCR ‘live reports’, is also encouraged by the external facilitator as part of encouraging regular audit and feedback cycle reviews.
Intervention code [1] 314341 0
Treatment: Other
Comparator / control treatment
All hospitals will be recruited and enrolled at baseline and followed for the entire duration of the study. Hospitals will be randomised to an order using a two stage process and will be assigned to a particular step based on that order. There are six ‘steps’ in this trial design with each step representing a two-month period. All hospitals will act as controls in the first step and by the end of the trial all hospitals will have received the intervention, but for varying amounts of time.

Patients treated in a hospital during the sites control phase (i.e. hospitals that have not yet received the intervention) will contribute control data and patients treated in a hospital during or after the intervention has been implemented will contribute intervention data. During the control period, usual care will be provided to patients admitted with stroke. Usual care is defined as the usual, local quality improvement activities undertaken within each site, such as submission of data into the Australian Stroke Clinical Registry and adhoc review of summary reports of data that can be downloaded at anytime.
Control group
Active

Outcomes
Primary outcome [1] 319994 0
The primary outcome is the net change in a composite score (raw composite score) for adherence to nominated clinical care processes to be addressed in STELAR action plans derived from data collected in the Australian Stroke Clinical Registry by participating hospitals in Victoria.

The raw composite score will be calculated by dividing the total number of episodes of care that received each of the clinical care processes by the total number of episodes of care that were eligible for each care process.
Timepoint [1] 319994 0
First control period 2 months from 05/05/2017 before the first workshop at the first hospital.
Intervention delivery (workshop and implementation phase) two months for each hospital.
Last post intervention data collection period was 09/09/2018 for all hospitals.
Secondary outcome [1] 370135 0
Individual clinical care processes: Differences in adherence (i.e. the number of patients that received a clinical care process divided by the number eligible) between the control periods and intervention periods will be calculated and reported for each individual clinical care processes included in actions plans.
Timepoint [1] 370135 0
First control period 2 months from 05/05/2017 before the first workshop at the first hospital.
Intervention delivery (workshop and implementation phase) two months for each hospital.
Last post intervention data collection period was 09/09/2018 for all hospitals.
Secondary outcome [2] 370136 0
Composite performance gap scores: Benchmarks were calculated for each clinical care process based on the Achievable Benchmarks of Care method (Kiefe CI et al, Int J Qual Health Care. 1998 Oct;10(5):443-7). The benchmarks were also used to calculate a composite gap score for each hospital based on: (a) the clinical care process recorded in the AuSCR; and (b) only the clinical care process that they chose to address as part of their action plans. To calculate this, the adherence for each clinical care process was divided by the benchmark for that process to provide a performance gap score (e.g. if a site had an adherence of 40% and the benchmark was 80% the gap score would be 50% [40/80] since they would be halfway towards meeting the benchmark).
Timepoint [2] 370136 0
First control period 2 months from 05/05/2017 before the first workshop at the first hospital.
Intervention delivery (workshop and implementation phase) two months for each hospital.
Last post intervention data collection period was 09/09/2018 for all hospitals.
Secondary outcome [3] 370137 0
Process evaluation: Mixed methods via observation and recording of workshop activities and focus groups/interviews performed by an independent researcher not involved in the delivery of the program to fully describe the real-world implementation of the intervention.
Timepoint [3] 370137 0
One month after the last implementation support period ended from 09/07/2018
Secondary outcome [4] 370138 0
Effect modifiers on the Primary Outcome: The association between the amount of facilitator support and intervention delivery timeframe on the primary outcome will be assessed by an independant researcher through a series of structured interviews and review of the facilitator log detailing support that was provided to clinicians at each hospital.
Timepoint [4] 370138 0
2 months after Workshop 2 with the last implementation support period for the final site ending 09/07/2018
Secondary outcome [5] 370139 0
Program Satisfaction: Hospital staff were also asked about barriers and facilitators that they encountered during implementation of the intervention and about how the program could be improved. This information was collected using specifically designed and adapted surveys currently being used in the Queensland StrokeLink program.
Timepoint [5] 370139 0
One month after the last implementation support period ended from 09/07/2018.
Secondary outcome [6] 370140 0
Patient health outcomes-Health-related Quality of Life (EQ5D) 90-180 day after admission for acute stroke.

De-identified data from AuSCR on health-related quality of life will be evaluated.

This is an exploratory analysis as the study was not powered to detect difference in patient outcomes.
Timepoint [6] 370140 0
90-180 days after the last episode of patient care was eligible to be included; 2 months after the final support period 09/07/2018.

Data will be available in August 2019 once the 90-180 day patient follow-up surveys of eligible AuSCR registrants is completed and the dataset can be closed.
Secondary outcome [7] 372738 0
Composite health outcome: death and disability (modified Rankin scores 3-6 versus 0-2)

This is an exploratory analysis as the study was not powered to detect differences in patient outcomes.
Timepoint [7] 372738 0
90-180 days after the last episode of patient care was eligible to be included; 2 months after the final support period 09/07/2018.

Data will be available in August 2019 once the 90-180 day patient follow-up surveys of eligible AuSCR registrants is completed and the dataset can be closed.
Secondary outcome [8] 372767 0
Intervention fidelity: The extent to which all components of the intervention were implemented at a site level including timeframe to complete the intervention. Intervention fidelity will be assessed by an independant researcher through a series of structured interviews with clinicians at each hospital.



Timepoint [8] 372767 0
2 months after Workshop 2 with the last implementation support period for the final site ending 09/07/2018
Secondary outcome [9] 372768 0
Disability: Assessed with the modified Rankin Scale (scores 1-5)

De-identified data from AuSCR will be evaluated.

This is an exploratory analysis as the study was not powered to detect difference in patient outcomes.
Timepoint [9] 372768 0
90-180 days after the last episode of patient care was eligible to be included; 2 months after the final support period 09/07/2018.

Data will be available in August 2019 once the 90-180 day patient follow-up surveys of eligible AuSCR registrants is completed and the dataset can be closed.
Secondary outcome [10] 372769 0
Survival following stroke: measured at two separate timepoints (30-day survival and 90-day survival)

De-identified data from AuSCR on survival status will be evaluated.

This is an exploratory analysis as the study was not powered to detect difference in patient outcomes.
Timepoint [10] 372769 0
30-days and 90-days following stroke

Data will be available in August 2019 once the 90-180 day patient follow-up surveys of eligible AuSCR registrants is completed and the dataset can be closed.

Eligibility
Key inclusion criteria
Hospitals: Victorian hospitals registered in the Australian Stroke Clinical Registry (AuSCR) and that have been contributing data to the registry for six or more months prior to enrolment will be eligible to participate.
Patient-level data: Admissions for acute stroke that are eligible to be included in the AuSCR www.auscr.com.au
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hospitals exclusions:
-not actively contributing data into the Australian Stroke Clinical Registry (AuSCR)
-less than six months AuSCR data prior to commencement of project

Patient exclusions:
-age <18 years
-no evidence of stroke or TIA

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)
Stepped-wedge design with all hospitals having received the intervention. Allocation was not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Hospitals will be randomised (two-phase process) into groups of three, to receive the intervention in phases (four steps). The randomisation process will be performed by an independent statistician in Stata to generate a 50% random sample.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Step wedge design in which participating hospitals will implement the intervention at staggered time points
Clinical Quality Registry trial (real-world, pragmatic design for capture of outcome data)
Process evaluation
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An independent statistician not involved in providing the program has set up of the randomization schedule and will analyse the data.
Use of de-identified patient level and hospital level data from the Australian Stroke Clinical Trial (pragmatic, real-world, design).
Descriptive statistics and multi-level, multivariable analyses.

Recruitment
Recruitment status
Active, not recruiting
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)
NSW,VIC
Recruitment hospital [1] 13702 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 13703 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 13704 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [4] 13705 0
Echuca Regional Health - Echuca
Recruitment hospital [5] 13706 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [6] 13707 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [7] 13708 0
Mildura Base Hospital - Mildura
Recruitment hospital [8] 13709 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [9] 13710 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment postcode(s) [1] 26397 0
2640 - Albury
Recruitment postcode(s) [2] 26398 0
3084 - Heidelberg
Recruitment postcode(s) [3] 26399 0
3550 - Bendigo
Recruitment postcode(s) [4] 26400 0
3564 - Echuca
Recruitment postcode(s) [5] 26401 0
3630 - Shepparton
Recruitment postcode(s) [6] 26402 0
3844 - Traralgon
Recruitment postcode(s) [7] 26403 0
3500 - Mildura
Recruitment postcode(s) [8] 26404 0
3050 - Parkville
Recruitment postcode(s) [9] 26405 0
3280 - Warrnambool

Funding & Sponsors
Funding source category [1] 302650 0
Charities/Societies/Foundations
Name [1] 302650 0
Ian Potter Foundation
Address [1] 302650 0
Level 3, 111 Collins Street
Melbourne VIC 3000
Country [1] 302650 0
Australia
Funding source category [2] 302713 0
Commercial sector/Industry
Name [2] 302713 0
Boehringer Ingelheim PTY Ltd
Address [2] 302713 0
Level 1/78 Waterloo Rd
Macquarie Park NSW 2113
Country [2] 302713 0
Australia
Funding source category [3] 302714 0
Charities/Societies/Foundations
Name [3] 302714 0
Stroke Foundation
Address [3] 302714 0
Level 7/461 Bourke St
Melbourne VIC 3000
Country [3] 302714 0
Australia
Funding source category [4] 302715 0
University
Name [4] 302715 0
Monash University
Address [4] 302715 0
Wellington Rd
Clayton VIC 3800
Country [4] 302715 0
Australia
Primary sponsor type
University
Name
Florey Institute of Neuroscience and Mental Health
Address
245 Burgundy St
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 302658 0
None
Name [1] 302658 0
Address [1] 302658 0
Country [1] 302658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303274 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 303274 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 303274 0
Australia
Date submitted for ethics approval [1] 303274 0
31/08/2016
Approval date [1] 303274 0
25/10/2016
Ethics approval number [1] 303274 0
HREC/16/MH/273

Summary
Brief summary
The objective of the Shared Team Efforts Leading to Adherence Results (STELAR) study is to demonstrate whether an active, multi-component quality improvement program that is aligned with a prospective clinical quality disease registry is effective for improving care in hospitals. In this study we sought to increase the proportion of patients with stroke or transient ischaemic attack (TIA) receiving nationally endorsed clinical care processes. Each participating hospital will contribe control data (usual care provided to patients with stroke) which will be compared to care provided following the intervention. The intervention in this step-wedged cluster randomized trial included four phases: pre-workshop survey, two externally facilitated workshops and a two-month support period.
Trial website
Trial related presentations / publications
Public notes
Composite performance gaps scores (Secondary Outcome 2) are calculated using achievable benchmarks for each clinical care process. This enabled us to account for the fact that some clinical care processes, such as tPA are much more difficult to achieve and have lower benchmarks than other clinical care processes. This will reduce the influence of ceiling or floor effects for certain clinical care processes since the magnitude of relative change will differ and, therefore provides equivalent weighting for when they are combined into a composite score.

Process Evaluation (Secondary Outcome 3): These data are used in reporting of the study in accordance with the Template for Intervention Description and Replication (TIDieR) checklist (https://www.bmj.com/content/348/bmj.g1687) to enable replication in the field; and the CONSORT extension for stepped-wedge cluster randomised trials. (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3116-3).

Contacts
Principal investigator
Name 93094 0
Prof Dominique Cadilhac
Address 93094 0
Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg VIC 3084
Country 93094 0
Australia
Phone 93094 0
+61 3 9035 7032
Fax 93094 0
Email 93094 0
dominique.cadilhac@florey.edu.au
Contact person for public queries
Name 93095 0
Prof Dominique Cadilhac
Address 93095 0
Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg VIC 3084
Country 93095 0
Australia
Phone 93095 0
+61 3 9035 7032
Fax 93095 0
Email 93095 0
dominique.cadilhac@florey.edu.au
Contact person for scientific queries
Name 93096 0
Prof Dominique Cadilhac
Address 93096 0
The Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg VIC 3084
Country 93096 0
Australia
Phone 93096 0
+61 3 9035 7032
Fax 93096 0
Email 93096 0
dominique.cadilhac@florey.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
The data are provide by the Australian Stroke Clinical Registry for this specific purpose. Permission would need to be sought to share this data with other researchers for a secondary purpose.
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3179 0
Study protocol
Citation [1] 3179 0
Link [1] 3179 0
Email [1] 3179 0
dominique.cadilhac@florey.edu.au
Other [1] 3179 0
Attachment [1] 3179 0
Type [2] 3180 0
Ethical approval
Citation [2] 3180 0
Link [2] 3180 0
Email [2] 3180 0
dominique.cadilhac@florey.edu.au
Other [2] 3180 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary