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Trial registered on ANZCTR
Registration number
ACTRN12617000192381
Ethics application status
Not required
Date submitted
2/02/2017
Date registered
6/02/2017
Date last updated
18/01/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The association between looking or smiling at a patient and requests for assistance: A single-centre, blinded, randomised, controlled clinical trial
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Scientific title
A randomised controlled trial to determine if either looking or smiling at an Emergency Department patient increases patient requests for assistance
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Secondary ID [1]
291059
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nil
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Universal Trial Number (UTN)
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Trial acronym
The SMIRK Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
patient requests for assistance
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Condition category
Condition code
Public Health
301534
301534
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The interventions will be administered as the researcher (medical student) walks past the patient's cubicle on a single occasion. Walking past will take approximately 4-5 seconds. - Arm 1: neither looking nor smiling at the patient. Arm 2: looking at the patient only, for the duration of the time walking past. Arm 3: looking and smiling at the patient for the duration of the time walking past..
The researchers administering the intervention will have classes from a departmental physiotherapist and speech pathologist to standardise the walking past and smile prior to commencement of the study. Both actions will be checked for intervention adherence by these health professionals after the first 50 patients have been enrolled and on subsequent occasions if adherence is thought to be inconsistent.
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Intervention code [1]
297046
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Behaviour
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Comparator / control treatment
The control intervention (study arm) is Arm 1 - simply walking past the cubicle and neither looking nor smiling at the patient
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Control group
Active
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Outcomes
Primary outcome [1]
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Patient request for assistance. This is defined as either a call out by the patient to the intervention administrator or a wave/gesture as an attempt to attract attention. Requests for attention are very clear.
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Assessment method [1]
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Timepoint [1]
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While administering the intervention. That is, while walking past the patient's cubicle
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Secondary outcome [1]
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The nature of the patient's request for assistance. For example, assistance to go to the toilet
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Assessment method [1]
331244
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Timepoint [1]
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Within a few seconds of administering the intervention and responding to the patient's request.
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Secondary outcome [2]
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Confounding variables associated with requests for assistance e.g. age/gender of patient, age/gender/ethnicity of the researcher administering the intervention
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Assessment method [2]
331245
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Timepoint [2]
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Immediately following the intervention
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Eligibility
Key inclusion criteria
Emergency department patients, aged 18 years of more, who are alert and looking out of their cubicle
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Family or friends in attendance with the patient
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be identified by the department's electronic patient list (for age criterion) and by direct observation (for alertness and looking out of the cubicle). Suitable patients will be assigned the next sequential study intervention determined a priori by computerised random number generation. Allocation will be will be concealed with the use of sealed opaque envelopes. Only the intervention administrator will know the patients allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised random number generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We anticipate 1% of patients will request assistance in the Control Arm. We expect that a clinically significant difference would be 5% in either of the other Arms. To demonstrate this we need at least 332 patients in each arm (equal number of patients in each group, alpha 0.05, power 0.8, 2 sided). Total number of patients = 3 x 332 = 996. This will be rounded up to 1000.
The proportion of requests for assistance in each group will be compared using the Chi square test.
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Patients no longer call out (see above)
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Date of first participant enrolment
Anticipated
1/03/2017
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Actual
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Date of last participant enrolment
Anticipated
31/05/2017
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Actual
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Date of last data collection
Anticipated
31/05/2017
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
15230
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
295500
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Hospital
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Name [1]
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Austin Hospital
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Address [1]
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Studley Road, Heidelberg, Victoria, 3084
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Austin Hospital
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Address
Studley Rd., Heidelberg, Victoria 3084
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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na
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Address [1]
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na
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Country [1]
294323
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Ethics approval
Ethics application status
Not required
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Summary
Brief summary
There is considerable anecdotal evidence that smiling at a patient while walking past their cubicle increases the number of requests for assistance. This is perceived as a nuisance by some staff who believe they are busy enough and that the assistance should be provided by the patient's attending nurse. Given this perception, some staff deliberately do not look at or smile at a patient as they walk past. This trial will determine if smiling truly does increase requests.
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Trial website
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Trial related presentations / publications
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Public notes
Thé protocol for this project was reviewed by the Austin Health Office for Research. Details were also discussed with the Principal Investigator. It was noted that one of the three interventions (not looking, looking, smiling) will happen every time anybody walks past a patient's cubicle. Also, the interventions last only a few seconds, are associated with no risk to the patient and, as no patient data is collected, there are no confidentiality or privacy issues. Given these conditions, it was determined that review and approval by the institutions ethics committee was not required.
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Contacts
Principal investigator
Name
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Prof David Taylor
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Address
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Emergency Department, Austin Hospital, Studley Road, Heidelberg, Victoria, 3084
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Country
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Australia
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Phone
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+61 3 9496 4711
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof David Taylor
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Address
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Emergency Department, Austin Hospital, Studley Road, Heidelberg, Victoria, 3084
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Country
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Australia
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Phone
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+61 3 9496 4711
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof David Taylor
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Address
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Emergency Department, Austin Hospital, Studley Road, Heidelberg, Victoria, 3084
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Country
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Australia
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Phone
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+61 3 9496 4711
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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.
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