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Trial registered on ANZCTR


Registration number
ACTRN12615001161516
Ethics application status
Approved
Date submitted
28/10/2015
Date registered
30/10/2015
Date last updated
30/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Expert consensus communication for acute stroke treatment
Scientific title
Effect of an expert consensus communication strategy on knowledge and treatment decisions for stroke among hospital outpatients: A randomised controlled crossover trial.
Secondary ID [1] 287497 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 296245 0
Condition category
Condition code
Stroke 296515 296515 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants watched a video simulation in which a neurologist informed an individual (actor) that their family member had experienced a stroke, and described tissue Plasminogen Activator (tPA) therapy as an option for treatment. The simulation lasted around 5 minutes, the approximate amount of time clinicians have available to convey stroke treatment information. The neurologist was provided with a hypothetical scenario which involved a stroke patient eligible for tPA. During the simulated consultation, the neurologist described the treatment options available to the patient using the essential communication strategies developed by an expert advisory group, which related to: 1) the environment in which the discussion takes place; 2) introduction and purpose of the discussion; 3) information provision; 4) risk communication; 5) addressing emotions and assessing understanding; 6) summarising the discussion. There was no wash-out period between the viewing expert consensus and usual care communication.
Intervention code [1] 292881 0
Behaviour
Comparator / control treatment
Participants watched a video simulation in which a neurologist informed an individual (actor) that their family member had experienced a stroke and described tPA therapy as a treatment option. The video lasted approximately 3 minutes. The neurologist, actor, and scenario provided were the same as the expert communication scenario. The neurologist was instructed to use their usual routine of providing information about stroke and tPA treatment, and was not given any specific directions or advice regarding communication strategies. While usual care may vary, this simulation involved the neurologist providing a recommendation for tPA treatment, and information about the risks of treatment. Visual information was not given, and little information about the likelihood of positive and negative outcomes associated with no treatment was provided. To avoid contamination, the usual care video was recorded prior to the neurologist being instructed on the communication strategies to employ for the expert communication video.
Control group
Active

Outcomes
Primary outcome [1] 296139 0
Mean knowledge of stroke treatment score as assessed via the following 5 multiple choice items. Participants were asked to select the true statement.
1) Stroke is caused by:
- A blockage in the lung
- A blockage in blood flow to the heart
- A blockage in blood flow in the brain

2) tissue Plasminogen Activator (tPA) treatment works by:
- Thinning the blood to dissolve the clot
- Reducing inflammation around the clot
- Causing tissue damaged by the stroke to re-grow

3) tPA treatment:
- Only has risks
- Has both risks and benefits
- Only has benefits

4) tPA treatment:
- Cannot not save lives
- Can reduce the amount of brain damage caused by stroke
- Cannot cause bleeding

5) Out of 50 people treated with the clot busting medicine, approximately how many would experience bleeding in the brain as a side effect of the treatment?
- 1
- 15
- 20
Timepoint [1] 296139 0
Immediately following viewing of the first video.
Primary outcome [2] 296140 0
Hypothetical treatment choice assessed via “Imagine that you were in the position of the patient discussed in the video, would you choose to have the clot busting treatment?” Response options ranged “Yes, definitely”, “Yes, probably” to “No, probably not”, “No, definitely not” (1 - 4).
Timepoint [2] 296140 0
Following viewing of video 1 and again after video 2.
Primary outcome [3] 296467 0
Hypothetical treatment choice for a family member assessed via “Imagine that you were in the position of the person in the video and had to make a decision about treatment for a family member. Would you choose for your family member to have the clot busting treatment?” Response options ranged “Yes, definitely”, “Yes, probably” to “No, probably not”, “No, definitely not” (1 - 4).
Timepoint [3] 296467 0
Following viewing of video 1 and again after video 2.
Secondary outcome [1] 317594 0
Acceptability of the communication strategy and information provided in the video as assessed via 16 items using a 4-point likert scale (1 = strongly agree; 4 = strongly disagree). Given the ratings were from the perspective of the family member, not the hypothetical stroke patient, items were derived from the Decisional Conflict Scale (DCS). The DSC measures personal perceptions of choice uncertainty, factors contributing to uncertainty, and effective decision making.
Timepoint [1] 317594 0
Following viewing of video 1 and again after video 2.
Secondary outcome [2] 317595 0
Preferred communication method was identified by asking participants "If you had to make a decision about whether you wanted clot busting treatment to be given to a family member, which style of information giving would you prefer?". An additional 6 items regarding the reasons for their preference were assessed on a 4-point likert scale (1= strongly agree; 4 = strongly disagree).
Timepoint [2] 317595 0
Following viewing of video 2.

Eligibility
Key inclusion criteria
Patients attending the out-patient clinic for any type of condition, aged 18 years or older during the study period were eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with insufficient English as determined by a research assistant, or without an email address or internet access were excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were randomised to receive either the usual care or expert consensus communication video first via a computer generated sequence (central randomisation by computer).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomised to receive either the usual care or expert consensus communication video first, using block sizes of 4 via a computer generated sequence (simple randomisation using a randomisation table created by computer software).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample of 150 patients has allowed detection of a true difference in the mean stroke knowledge scores between groups of +/- 0.26 with 80% power at the 5% significant level.

Descriptive statistics including means, standard deviations, frequencies and percentages were calculated to describe both the demographic characteristics of consenters, and survey responses. Gender of consenting and non-consenting patients was compared using chi-squared tests. The analysis sample is defined here as all the participants that were randomised to a particular condition order, viewed the first video and responded to at least one survey item. Knowledge scores were calculated by summing the number of correct responses to give a score out of five for each participant. Mean knowledge scores after viewing the first video were compared between groups using the independent sample t-test, and individual knowledge items were compared using binomial tests. Responses to the treatment decision items were collapsed into a dichotomous variable (yes, definitely/yes, probably vs. no, definitely not/no probably not). Treatment decisions for the patient and the family member after viewing each communication video were compared using McNemar’s test (assuming no period effect), separate tests were also performed based on order of randomisation. Acceptability of the communication methods after viewing each video were compared using McNemar’s test. Responses to the acceptability items were collapsed into a dichotomous variable (strongly agree/agree vs. strongly disagree/disagree). Differences in the proportions of communication method preferences after viewing both videos and reasons for communication preference were assessed using binomial tests. To check for order effects, differences in the proportions of communication method preference according to order of video presentation was assessed using binomial tests.

Missing knowledge and preferred communication responses were imputed by assigning the most frequent value of all available responses within each randomised condition. Missing reasons for preferred communication ratings were imputed by assigning the most frequent value of all available responses within their identified communication preference. Missing treatment decision and acceptability ratings were imputed by assigning the most frequent value of all available responses within each randomised condition and assuming the response had not changed. A threshold of 5% was set for the significance level of all hypothesis tests.

Recruitment
Recruitment status
Completed
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
Recruitment hospital [1] 4359 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 10581 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 292071 0
Other
Name [1] 292071 0
Hunter Medical Research Institute
Address [1] 292071 0
1 Kookaburra Circuit
New Lambton Heights
NSW 2305
Country [1] 292071 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 290746 0
None
Name [1] 290746 0
Address [1] 290746 0
Country [1] 290746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293554 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 293554 0
Hunter New England Local Health District
Lookout Road
New Lambton NSW 2305
Ethics committee country [1] 293554 0
Australia
Date submitted for ethics approval [1] 293554 0
Approval date [1] 293554 0
12/05/2011
Ethics approval number [1] 293554 0
11/05/18/5.04
Ethics committee name [2] 293555 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 293555 0
University Drive
Callaghan
NSW 2308
Ethics committee country [2] 293555 0
Australia
Date submitted for ethics approval [2] 293555 0
Approval date [2] 293555 0
26/08/2011
Ethics approval number [2] 293555 0
H-2011-0158

Summary
Brief summary
Background: Despite thrombolytic therapy using intravenous tissue Plasminogen Activator (tPA) being a recommended treatment for appropriately selected ischaemic stroke patients, use of this treatment remains low. tPA is only provided to 7% of ischemic stroke patients within Australia. A number of factors including, risk of haemorrhage, limited time-frame of 4.5 hours from stroke onset in which the treatment can be given, and difficulties obtaining informed consent, may be factors limiting the administration of this therapy.

Patients with acute stroke are often mentally and physically unable to discuss treatment options, and the challenge of obtaining informed consent is only exacerbated in situations that require immediate action. In such situations alternative forms of consent must be sought and the treatment decision may become the responsibility of the patient’s next of kin. Little attention has been paid to the decision making process for patients and their families in such situations.

Given the need for an immediate treatment decision to be made, clinicians need to convey the potential benefits and risks of tPA treatment in order for family members to provide informed consent. Employment of best practice communication guidelines may aid the decision making process for family members and help clinicians to clearly convey the recommended treatment for ischaemic
stroke patients.

Aims: The purpose of the study was to compare, using a randomised controlled crossover trial among hospital out-patients, the effect of an expert consensus communication strategy compared to a usual care communication strategy (shown via video) on 1) participant knowledge of stroke treatment; 2) treatment decisions for tPA treatment for a) patients and b) a family member; 3) the acceptability of the communication strategies; and 4) the preferred communication strategy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60390 0
Prof Rob Sanson-Fisher
Address 60390 0
Health Behaviour Research Group
W4, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 60390 0
Australia
Phone 60390 0
+61 2 4042 0713
Fax 60390 0
+61 2 4042 0044
Email 60390 0
Rob.Sanson-Fisher@newcastle.edu.au
Contact person for public queries
Name 60391 0
Miss Alice Grady
Address 60391 0
Health Behaviour Research Group
W4, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 60391 0
Australia
Phone 60391 0
+61 2 4042 0644
Fax 60391 0
+61 2 4042 0044
Email 60391 0
Alice.Grady@newcastle.edu.au
Contact person for scientific queries
Name 60392 0
Miss Alice Grady
Address 60392 0
Health Behaviour Research Group
W4, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 60392 0
Australia
Phone 60392 0
+61 2 4042 0644
Fax 60392 0
+61 2 4042 0044
Email 60392 0
Alice.Grady@newcastle.edu.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