Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001173482
Ethics application status
Approved
Date submitted
9/07/2016
Date registered
26/08/2016
Date last updated
28/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Independent Measures of Prognosis, Life-sustaining Care and InTerventions: Evaluating bias among health-workers in decision making in the Intensive Care Unit (ICU)
Scientific title
Independent Measures of Prognosis, Life-sustaining Care and InTerventions: Evaluating bias among health-workers in decision making in ICU
Secondary ID [1] 289645 0
nil known
Universal Trial Number (UTN)
Trial acronym
IMPLICIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bias in Decision Making 299441 0
Condition category
Condition code
Public Health 299422 299422 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants (ICU staff nurses, doctors, physios) are recruited at handover and assigned to one of two questionnaires. These present ICU clinical scenarios with hypothetical patients. Between the 2 questionnaires the clinical information is identical but the hypothetical patients differ in terms of social factors: Age, race, employment, drug use, body weight. Participants are asked to assess the scenario in terms of risk and then give their opinion on aggressive or limited therapy on a 10pt likert scale. The participants will be recruited at morning handover in ICU allowing for a "fatigued" (post night shift) and "non-fatigued" (pre day shift) population. Data will be collected on number of night shifts worked in the previous 7 days. The questionnaire takes roughly 10 mins to complete
Intervention code [1] 295262 0
Behaviour
Comparator / control treatment
It is a parallel group randomised study. Neither of the questionnaires are the control, both contain "positive" and "negative" social features.
We will compare the fatigued group to the non-fatigued group.
Control group
Active

Outcomes
Primary outcome [1] 298890 0
Differences in 10 point scores for perceived risk and agreement with proposed management plans between group A and group B, utilising the study-specific questionnaire.
This is a composite primary outcome.
The outcome is assessed using the study-specific questionnaire.
Timepoint [1] 298890 0
Outcome assessed at completion of questionnaire (data entry)
Secondary outcome [1] 325552 0
Differences in 10-point Likert scores between fatigued and non-fatigued groups utilising the study-specific questionnaire
Fatigue assessed by number of night shifts completed in last 7 days and immediacy of night shifts (i.e. have they just finished prior to completion of questionnaire?)
Timepoint [1] 325552 0
Completion of questionnaire

Eligibility
Key inclusion criteria
Current employee of health service, working in royal perth ICU as a doctor, nurse or physiotherapist.
Provides consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of fluency in written english

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 select from numbered sealed envelopes. Participants and investigators blinded to allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by online software (randomizer.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/05/2016
Date of last participant enrolment
Anticipated
17/08/2016
Actual
29/09/2016
Date of last data collection
Anticipated
17/08/2016
Actual
29/09/2016
Sample size
Target
140
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6146 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 294026 0
Hospital
Name [1] 294026 0
Royal Perth Hospital
Country [1] 294026 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Royal Perth Hospital
Wellington St
Perth
WA
6000
Country
Australia
Secondary sponsor category [1] 292848 0
None
Name [1] 292848 0
none
Address [1] 292848 0
none
Country [1] 292848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295436 0
Royal Perth Human Research Ethics Committee
Ethics committee address [1] 295436 0
Royal Perth Hospital,
Wellington St
Perth
Western Australia
6000
Ethics committee country [1] 295436 0
Australia
Date submitted for ethics approval [1] 295436 0
18/11/2015
Approval date [1] 295436 0
08/01/2016
Ethics approval number [1] 295436 0
15-174

Summary
Brief summary
This is a study of decision making and bias, as it relates to care in the intensive care unit. Participants are ICU staff, they will be recruited at handover after a night shift to give a fatigued group (end of night shift) and a non-fatigued group (start of day shift).
Participants will be allocated to one of two questionnaires (A&B) which are identical in terms of the hypothetical clinical scenarios, but differ in terms of the social status of the hypothetical patient. For example, a case might describe a patient who has been involved in an MVA with severe injuries necessitating ICU support, but in Questionnaire A the patient would be a policeman chasing a violent criminal and in B the patient IS the violent criminal.
Participants will be asked to rate the "risk" of the scenario on a 10 point likert scale, then rate their degree of agreement with an aggressive treatment strategy and a limited treatment strategy
We hypothesize that participants risk assessment and treatment strategies will significantly differ between the groups. We also hypothesize that these differences will be exaggerated when participants are fatigued.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67314 0
Dr Andrew Chapman
Address 67314 0
c/o RPH ICU, Royal Perth Hospital, Wellington St, Perth, WA, AUSTRALIA. 6000
Country 67314 0
Australia
Phone 67314 0
+61 8 92248721
Fax 67314 0
Email 67314 0
[email protected]
Contact person for public queries
Name 67315 0
Dr Andy Chapman
Address 67315 0
C/O RPH ICU
Royal Perth Hospital
Wellington St
Perth
WA
6000
Country 67315 0
Australia
Phone 67315 0
+61 8 92248721
Fax 67315 0
Email 67315 0
[email protected]
Contact person for scientific queries
Name 67316 0
Dr Andy Chapman
Address 67316 0
c/o RPH ICU, Royal Perth Hospital, Wellington St, Perth, WA, AUSTRALIA. 6000
Country 67316 0
Australia
Phone 67316 0
+61 8 92248721
Fax 67316 0
Email 67316 0
[email protected]

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.