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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
Scientific title
A randomised controlled trial to determine if either looking or smiling at an Emergency Department patient increases patient requests for assistance
Secondary ID [1] 291059 0
nil
Universal Trial Number (UTN)
Trial acronym
The SMIRK Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patient requests for assistance 301855 0
Condition category
Condition code
Public Health 301534 301534 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 297046 0
Behaviour
Comparator / control treatment
The control intervention (study arm) is Arm 1 - simply walking past the cubicle and neither looking nor smiling at the patient
Control group
Active

Outcomes
Primary outcome [1] 300937 0
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.
Timepoint [1] 300937 0
While administering the intervention. That is, while walking past the patient's cubicle
Secondary outcome [1] 331244 0
The nature of the patient's request for assistance. For example, assistance to go to the toilet
Timepoint [1] 331244 0
Within a few seconds of administering the intervention and responding to the patient's request.
Secondary outcome [2] 331245 0
Confounding variables associated with requests for assistance e.g. age/gender of patient, age/gender/ethnicity of the researcher administering the intervention
Timepoint [2] 331245 0
Immediately following the intervention

Eligibility
Key inclusion criteria
Emergency department patients, aged 18 years of more, who are alert and looking out of their cubicle
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Family or friends in attendance with the patient

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Patients no longer call out (see above)
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
31/05/2017
Actual
Date of last data collection
Anticipated
31/05/2017
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7425 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 15230 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 295500 0
Hospital
Name [1] 295500 0
Austin Hospital
Country [1] 295500 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Studley Rd., Heidelberg, Victoria 3084
Country
Australia
Secondary sponsor category [1] 294323 0
None
Name [1] 294323 0
na
Address [1] 294323 0
na
Country [1] 294323 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72150 0
Prof David Taylor
Address 72150 0
Emergency Department, Austin Hospital, Studley Road, Heidelberg, Victoria, 3084
Country 72150 0
Australia
Phone 72150 0
+61 3 9496 4711
Fax 72150 0
Email 72150 0
David.Taylor@austin.org.au
Contact person for public queries
Name 72151 0
David Taylor
Address 72151 0
Emergency Department, Austin Hospital, Studley Road, Heidelberg, Victoria, 3084
Country 72151 0
Australia
Phone 72151 0
+61 3 9496 4711
Fax 72151 0
Email 72151 0
David.Taylor@austin.org.au
Contact person for scientific queries
Name 72152 0
David Taylor
Address 72152 0
Emergency Department, Austin Hospital, Studley Road, Heidelberg, Victoria, 3084
Country 72152 0
Australia
Phone 72152 0
+61 3 9496 4711
Fax 72152 0
Email 72152 0
David.Taylor@austin.org.au

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.