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Changing the health system to increase the adoption of "clot busters" in stroke treatment

Evaluating the effectiveness of a strategy to increase the adoption of best evidence practice. A cluster randomised controlled trial in acute stroke care.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000939796
Acronym
TIPS
Enrollment
20
Registered
2013-08-26
Start date
2010-08-31
Completion date
2013-01-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will examine whether a hospital-focussed multicomponent multidisciplinary collaborative approach can increase stroke thrombolysis rates, while maintaining accepted benchmarks for low rates of intracranial haemorrhage and high rates of functional outcome at three months. The approach will be tested using a cluster randomised controlled trial involving 20 hospitals in the early stages of thrombolysis implementation. Outcomes will include thrombolysis rates in intervention and control hospitals at follow up as well as intracranial haemorrhage rates and functional outcomes at 3 months.

Interventions

Cluster randomised controlled trial of hospitals across New South Wales, Victoria and Queensland. PRE-INTERVENTION PERIOD & POST-INTERVENTION PERIOD Stroke care data including thrombolysis rates and stroke imaging will be obtained for a 24 month pre-intervention (baseline) period, followed by a 12 month intervention implementation period and then 12 months post-intervention data collection, with an additional 3 months for measurements of functional outcomes. Stroke care data and imaging for th

Cluster randomised controlled trial of hospitals across New South Wales, Victoria and Queensland. PRE-INTERVENTION PERIOD & POST-INTERVENTION PERIOD Stroke care data including thrombolysis rates and stroke imaging will be obtained for a 24 month pre-intervention (baseline) period, followed by a 12 month intervention implementation period and then 12 months post-intervention data collection, with an additional 3 months for measurements of functional outcomes. Stroke care data and imaging for thrombolysed patients will be entered into the TIPS National Stroke Foundation database by staff from participating hospitals. Nurses and physicians from participating departments including Stroke Care Units (SCUs) and Emergency Departments will be invited to complete a pre-intervention survey regarding perceived barriers to thrombolysis implementation. This survey will be repeated during the follow-up phase. Rates of symptomatic intracranial haemorrhage and functional outcome will be assessed three months after thrombolytic treatment to ensure that rates are maintained at or below accepted benchmarks. Monitoring of adverse events will not interfere with established governance processes for reporting and monitoring of adverse events in the health system. INTERVENTION Intervention hospitals will receive a multi-component multidisciplinary collaborative intervention while control hospitals will follow usual care practices and are free to make practice changes of their own accord. The multicomponent intervention is based on thorough analysis of the steps, roles and barriers relating to rapid assessment for thrombolysis eligibility and collaborative implementation of a comprehensive range of strategies addressing change at the level of both the individual health professional and the health system. The intervention activities include pre-workshop meetings, collaborative communal workshops, site workshops and bi-weekly site meetings, web-based training modules, weekly case monitoring by telephone, bi-monthly performance feedback, and bi-monthly problem solving teleconferences. Pre-workshop meetings: A meeting will be held at each hospital between the primary change agent and site champions at that hospital. The meeting will involve preliminary target setting for thrombolysis at the site, analysis of situational barriers to change and a readiness for change assessment. Meetings will be held prior to the first communal workshop. Communal workshops: These two workshops will be held at the beginning and at the end of the intervention phase and will include the evidence base for thrombolysis, principles and components of the TIPS intervention, introduction to the TIPS educational website, setting overall and interim targets for thrombolysis, discussion of situational barriers and solutions to thrombolysis, action planning and change management strategies. The workshops will enable clinicians from different hospitals to work together and share their experiences in a team environment. Site workshops: A site-workshop will be held shortly after each communal workshop. The aims of these two site-workshops are to ensure any team members not able to attend the communal workshops are brought up to date, and to provide an opportunity to gather further support for the project at each hospital by involving appropriate senior executives and staff members whose support may be important to achieve project goals. Bi-weekly site meetings: The site working group, led by the site champions at each hospital, will include clinicians and executives with the ability to drive the project and communicate the changes to others. The aim of the meetings is to set targets, identify actions and review performance designed to achieve change in thrombolysis rates. Web-based training modules: The TIPS website will include didactic training modules for clinicians with a test at the end of each module and a series of case studies where clinicians test their clinical judgement against a consensus-based logic frame for a randomly-chosen set of stroke cases. In each case the clinician is provided with feedback regarding the appropriateness of the decision and links to further reading if required. Clinicians are asked to continue with the case studies until they have achieved an agreed level of competence in decision making. Additional training modules will be provided for nurses (NET SMART) and paramedics (PAST). Some components of the training will remain available beyond the intervention phase to support sustainability. Weekly case monitoring by telephone: During the intervention phase, the primary change agent will make weekly contact (by email or telephone) with site champions to discuss any questions or concerns relating to recent cases of thrombolysis. Bi-monthly performance feedback: Hospitals will be provided with their 3-monthly estimated proportion of ischaemic stroke cases who receive thrombolysis, graphed against site targets. Comparative data will be provided, showing each hospital how it compares to other intervention hospitals in a de-identified format (e.g. other hospital names not disclosed), to create a positive level of competition among peers. Bi-monthly problem solving teleconferences: Teleconference with primary change agent and site representatives for inter-site collaborative problem solving. Throughout the intervention period there will be a focus on identifying and enacting strategies to embed relevant elements of the above into ongoing practice. The intervention period for this project is 12 months, which is anticipated to commence late 2013.

Sponsors

The University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

Eligible hospitals are those with a Stroke Care Unit (or staffing equivalent of a stroke physician and stroke nurse) and an Emergency Department and where the hospital is at early stages of thrombolysis implementation. All participating hospitals are required to record all cases of thrombolysis for stroke, including adverse events and patient functional outcomes at three months. Both public and private hospitals are eligible to be included in the sample as are teaching and non-teaching hospitals.

Exclusion criteria

Hospitals without a stroke care unit or equivalent (stroke physician and stroke nurse)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 21, 2026