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Trial registered on ANZCTR


Registration number
ACTRN12616000646448
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
18/05/2016
Date last updated
18/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementing best clinical practice for stroke patients across a private health service
Scientific title
Implementation of Stroke Clinical Practice Guidelines across a private health service; adherence to the guidelines and the impact from a patient, staff and economic perspective
Secondary ID [1] 288811 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298080 0
Condition category
Condition code
Stroke 298245 298245 0 0
Haemorrhagic
Stroke 298867 298867 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the implementation of the Stroke CG's as per the Cabrini policies, procedures and guidelines in line with the Stroke CG's from the National Stroke Foundation (NSF). Implementation commenced in September 2014 and was completed in June 2015.

Hospital staff did not receive a specific education package relating to the implementation of the guidelines, although they were notified via multiple modes of communication that the guidelines (in the form of updated hospital policies) should be followed as of September 2014. The modes of communication include the hospital bulletin (email and hard copy), announcement in management communication forum as well as announcement and discussion in hospital department meetings.

Key measurable elements of the Stroke CG's include: Admitted to a stroke unit, Brain imaging within 24 hours, Received intravenous thrombolysis if ischaemic stroke, Aspirin within 48 hours if ischaemic stroke, Assessed by physiotherapy within 48 hours, Assessed by Speech pathologist within 48 hours, Swallow screened before given food, drink or oral medication, Assessment results and treatment plans discussed with patient, Discharged on antihypertensives and Documented discharge plan.

Each health professional shall use physical and informational materials that are usually available to them. For example, the stroke care coordinator shall provide the "My Journey" information and personal reflection diary to the patient post stroke. This is available from the National Stroke Foundation. This is not new information, but provision of this information is consistent for all patients post stroke.

The intervention is broadly generic to all patients post stroke, that is the Stroke CG's, but there will be individual variation pending on the health professionals assessment.

As intervention adherence is a primary aim of this study, this shall be measured via patient medical record audit against a number of criteria that reflect the Stroke CG's. Adherence shall be compared between the pre and post implementation time periods, as well as againt the National benchmarks (data provided by the National Stroke Foundation).
Intervention code [1] 294265 0
Other interventions
Comparator / control treatment
The patient pre intervention group data shall be collected via a retrospective audit of 100 consecutive patients admitted to Cabrini with a diagnosis of a stroke prior to the implementation of Stroke CG. The post intervention group data shall be collected via a prospective audit of 100 consecutive patients admitted to Cabrini after the implementation of Stroke CG. Pre intervention refers to the period prior to September 2014. Intervention implementation refers to the period from September 2014 until June 2015 when the Stroke CG's were being implemented. Post intervention refers to the period after June 2015 and follows the implementation of the Stroke CG's.
Control group
Historical

Outcomes
Primary outcome [1] 297919 0
Compliance with the Stroke Clinical Guidelines (National Stroke Foundation "Clinical Guidelines for Stroke Management' 2010) will be measured via patient medical record audit against the set criteria set out in the Stroke Clinical Guidelines.
Timepoint [1] 297919 0
There are three periods for the research project and two groups.
Pre-intervention Group: Period prior to September 2014 and prior to the implementation of the Stroke Clinical Guidelines.
Intervention Implementation: Period from September 2014 till June 2015 and refers to the period of time when the Clinical Guidelines were being implemented.
Post Intervention Group: Period after June 2015 and is following the implention of the stroke clinical guidelines.

Compliance is assessed for the pre and post intervention groups only (not the middle intervention implementation time period).
Secondary outcome [1] 322628 0
There are six multiple seperate secondary outcomes. This is the first of these:

* Patient functional status on admission and discharge to Cabrini. The use of the Modified Rankin Score in acute care and the use of the Functional Independnece Measure in rehabilitation.
Timepoint [1] 322628 0
For both the pre and post intervention groups, functional status shall be measured on admission and on discharge from hospital. This will be done seperatley for acute and rehabilitaiton inpatient admissions.
Secondary outcome [2] 323641 0
There are six multiple seperate secondary outcomes. This is the second of these:

* Cost per admission to acute hospital services

The cost per admission data shall be sourced from the administrative hospital system.
Timepoint [2] 323641 0
The cost per episode and resource utilisation shall be collected for the pre-intervention group (February to September 2014) and for the post intervention group (July 2015 until April 2016). All cost data shall be collected in May 2016 and in $AUD.

During the analysis phase, the patient functional status outcomes (secondary outcome number 1) shall be combined with the cost data (secondary outcome number 2) to establish the incremental cost effectiveness ratio to represent cost-effectiveness.
Secondary outcome [3] 323642 0
There are six multiple seperate secondary outcomes. This is the third of these:

* A gap analysis to determine the barriers and facilitators of Stroke Clinical Guidelines Implementation across Cabrini, as perceived by hospital staff. An online staff survey was specifically designed to assess this outcome.
Timepoint [3] 323642 0
The staff gap analysis (via survey), shall be collected for the pre-intervention group (survey completed in April 2015 - asking for retrospective replies that relate to the period of February to September 2014) and for the post intervention group (survey completed in December 2015 and relating to the period of July 2015 until December 2015).
Secondary outcome [4] 323643 0
There are six multiple seperate secondary outcomes. This is the fourth of these:

* An economic evaluation to determine the cost of implementation of the Stroke Clinical Guidelines to Cabrini. An online survey was specifically designed to assess this outcome.
Timepoint [4] 323643 0
Cost of implementation refers to the time period February 2014 to September 2014 and this data was collected by both the staff survey (the survey included questions on the financial and staff resource cost of implementation) as well as from supplementary data such as committee meeting minutes.
Secondary outcome [5] 323644 0
There are six multiple seperate secondary outcomes. This is the fifth of these:

* Patient feedback via survey to report the effect on patient satisfaction with their episode of care at Cabrini following a stroke.
Timepoint [5] 323644 0
Cabrini routinely collects patient satisfaction data through the Press Ganey patient survey using a standardised set of questions. The Press Ganey survey has been validated and is used internationally across multiple health services (highest uptake is in the USA). This survey was not designed or modified for this trial.

Patient feedback via survey is collected post discharge from the hospital, for the pre-intervention group (February to September 2014) and for the post intervention group (July 2015 until April 2016). The hard copy of the survey is sent to the patient via mail. This is within a month of discharge from the hospital.
Secondary outcome [6] 323784 0
There are six multiple seperate secondary outcomes. This is the sixth of these:

* To determine if the introduction of health service policies that align stroke care to stroke clinical practice guidelines is cost effective. An incremental cost effectivness ratio shall be completed to report cost effectiveness, comparing pre-implementation and post-implementation data (which combines the cost data and patient functional status data).
Timepoint [6] 323784 0
The cost per episode as well as the patient functional status on discharge shall be collected for the pre-intervention group (February to September 2014) and for the post intervention group (July 2015 until April 2016). This data shall then be analysed to report the incremental cost effectiveness ratio and determine if the introduction of stroke clinical practice guidelines is cost effective.

Eligibility
Key inclusion criteria
Patients admitted to Cabrini with a diagnosis of a stroke prior to the implementation of Stroke Clinical Guidelines (pre intervention group), and patients admitted to Cabrini after the implementation of Stroke Clinical Guidelines (post intervention group). Patients are adults admitted to Cabrini with either a primary or secondary diagnosis of stroke. A primary diagnosis of stroke indicates that a diagnosis of a new stroke was the primary reason for admission to Cabrini. A secondary diagnosis of stroke typically indicates that the patient was admitted to Cabrini with another unrelated diagnosis and has had a diagnosis of a new stroke during the hospital admission.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are excluded if they are admitted to a hospital that is not Cabrini.
Any patient who has not had an ischaemic or haemorrhagic stroke within the dedicated retrospective and prospective time frames is excluded from the trial.
Note that a past medical history of stroke is not a secondary diagnosis of stroke.
Only the first 100 retrospective patients (working in reverse chronological order) and 100 prospective patients (working in chronological order) are evaluated. Patients who fall outside of said time frames and patient number will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The project has a quasi experimental pre-post test design. The patient pre intervention group shall be selected via a retrospective audit of 100 consecutive patients admitted to Cabrini with a stroke diagnosis prior to the implementation of the Stroke Clinical Guidelines, September 2014. The patient post intervention group shall be selected via a prospective audit of 100 consecutive patients admitted to Cabrini after the implementation of the Stroke Clinical Guidelines, June 2015.

Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Using the National Stroke Foundation Clinical Guideline Audit Tool, Cabrini patient histories shall be audited for compliance against the Stroke Clinical Guidelines. Results of the audit shall compare the proportions of compliance between the pre and post intervention groups, as well as compared to the National Stroke Foundation benchmarks. A sub group analysis shall be completed for patients admitted with a primary versus secondary diagnosis of stroke.

These patient numbers were deemed suitable as approximately 100 patients are admitted to Cabrini Malvern with a diagnosis of stroke annually. Sample size estimation is based on the outcome of admitted to a stroke unit during the acute admission. The 2013 audit of Cabrini patients reported 49% of patients were colocated on ward 3 South (Stroke Unit) and it is expected that post intervention this proportion shall increase to 71% to be aligned with the national benchmark. To show this improvement the pre and post intervention groups would each need approximately 51 patients. This is with a power of 0.8 and a significance level of 0.05.

This number of 51 was doubled as there are patients admitted to Cabrini with a primary diagnosis of stroke, and those admitted to Cabrini with another diagnosis and they have a stroke during their hospital admission. There is approximatley a 1:1 ratio. In order to have enough power to detect a difference for those with a primary diagnosis (pre versus post intervention), compared to a secondary diagnosis (pre versus post intervention), a total of 100 in the pre and post intervention groups is needed,

In summary, there are effectively two groups of stroke pateints in the pre and post intervention groups, so to have the 50 for each sub-group, we needed to double this number to 100 in each group. This is a total of 200 patients included in the two groups.

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)
VIC
Recruitment hospital [1] 5600 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 13037 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 293304 0
Charities/Societies/Foundations
Name [1] 293304 0
Cabrini Foundation
Address [1] 293304 0
Cabrini Hospital
154 Wattletree Rd
Malvern,
VICTORIA 3144
Country [1] 293304 0
Australia
Primary sponsor type
Individual
Name
Dr Natasha Brusco
Address
Cabrini Physiotherapy Services
c/o Education Department
Level 2, Cabrini Institute
154 Wattletree Rd
Malvern,
VICTORIA, 3144.
Country
Australia
Secondary sponsor category [1] 292111 0
None
Name [1] 292111 0
Address [1] 292111 0
Country [1] 292111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294816 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 294816 0
Cabrini Research Institute
154 Wattletree Road
Malvern,
VICTORIA, 3144
Ethics committee country [1] 294816 0
Australia
Date submitted for ethics approval [1] 294816 0
23/07/2015
Approval date [1] 294816 0
12/11/2015
Ethics approval number [1] 294816 0
CHREC- 05-05-10-15

Summary
Brief summary
Stroke is the most common cause of complex disability for adults (Adamson, et al. 2004) and there is strong evidence that implementation of stroke clinical practice guidelines will improve the quality and effectiveness of the health care received by patients following a stroke (Donnellan, et al, 2013). Despite this, there is wide variation in the quality of stroke care provided by different health organisations (Lindsay, et al. 2011).

Clinical practice guidelines are documents that integrate current evidence on how to most effectively structure and provide health services for a given condition (Weisz, et al. 2007). They can inform health care decision making for the patient, clinician and the health service. They can also inform an evaluation of the health care sevice (Gagliardi, et al. 2015).

In March 2014, Cabrini appointed a stroke service steering committee with the aim of enhancing care to Cabrini stroke patients to a level that is consistent with the (Australian) National Stroke Foundation's (NSF) 'Clinical Guidelines for Stroke Management' (Bodice, et al. 2010.)

The NSF's Acute Stroke Services Framework (2011) recommends all hospitals admitting 100 or more patients with stroke per year should be a primary stroke centre (PSC). Cabrini has patient numbers admitted that are consistent with this criterion and therefore has aimed to provide a PSC service for our patients. The NSF defines a PSC as having a dedicated sroke unit with clinicians who have stroke expertise; written stroke protocols for emergency services, acute care and rehabilitation; ability to offer thrombolytic therapy or protocols to transfer appropriate patients to a comprehensive stroke centre; timely neurovascular imaging and coordinated processes for patient transition to ongoing rehabilitation and secondary prevention services.

It is the transition from the previous non-specific model of care for patients admitted to Cabrini following a stroke, to the current evidence-based practice, which is central to the current evaluation. This follows the implementation at Cabrini of the Clinical Guidelines for Stroke Management between September 2014 and July 2015. The broader project shall complete a comprehensive medical history audit to investigate how well Cabrini performs against the Clinical Guidelines for stroke Management, including patient clinical outcomes, before and after the implementation of the Clinical Guidelines for Stroke Management.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 64542 0
Dr Natasha Brusco
Address 64542 0
Cabrini Physiotherapy Services
c/o Education Department
Level 2, Cabrini Institute
154 Wattletree Rd
Malvern, VICTORIA, 3144
Country 64542 0
Australia
Phone 64542 0
+61 408 251 124
Fax 64542 0
Email 64542 0
nbrusco@cabrini.com.au
Contact person for public queries
Name 64543 0
Dr Natasha Brusco
Address 64543 0
Cabrini Physiotherapy Services
c/o Education Department
Level 2, Cabrini Institute
154 Wattletree Rd
Malvern, VICTORIA, 3144
Country 64543 0
Australia
Phone 64543 0
+61 408 251 124
Fax 64543 0
Email 64543 0
nbrusco@cabrini.com.au
Contact person for scientific queries
Name 64544 0
Dr Natasha Brusco
Address 64544 0
Cabrini Physiotherapy Services
c/o Education Department
Level 2, Cabrini Institute
154 Wattletree Rd
Malvern, VICTORIA, 3144
Country 64544 0
Australia
Phone 64544 0
+61 408 251 124
Fax 64544 0
Email 64544 0
nbrusco@cabrini.com.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