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Trial registered on ANZCTR


Registration number
ACTRN12616000040460
Ethics application status
Not required
Date submitted
7/01/2016
Date registered
19/01/2016
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Concise Regular Assessment and Feedback for Teaching and learning (CRAFT): a pilot study to evaluate the effect of a deliberate teaching tool on the educational environment of vocational trainees in anaesthesiology
Scientific title
Concise Regular Assessment and Feedback for Teaching and learning (CRAFT): a pilot study to evaluate the effect of a deliberate teaching tool on the educational environment of vocational trainees in anaesthesiology
Secondary ID [1] 287696 0
None
Universal Trial Number (UTN)
U1111-1175-6804
Trial acronym
CRAFT pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Educational environment 296530 0
Condition category
Condition code
Anaesthesiology 296793 296793 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Concise Regular Assessment and Feedback for Teaching and learning (CRAFT) model

The CRAFT model has 3 phases:
i. Prebrief - A brief encounter at the start of the list to determine the trainee’s previous experience relevant to the list and mutually agreed learning goals for the session, led by
the trainee and guided by the supervising clinician.
ii. Teaching - Teaching during the list, guided by the mutually agreed learning objectives
iii. Debrief - Takes place at the end of a list, and is organised as follows: Reaction (allows trainee to express their initial emotional reaction), Analysis (framing of actions and use of the advocacy-inquiry approach), Summary (distill lessons from debrief and provide suggestions for future learning).

This deliberate teaching tool is to be used for all in-theatre teaching encounters during normal working hours (Monday-Friday, 0700-1800) where both the supervisor and trainee are study participants, during a 4-week study period. The supervisor (specialist anaesthetist) leads the teaching encounter but may be prompted by the trainee. Material for pre-reading will be provided to the specialists prior to the 4-week intervention period. This will consist of a background summary and instruction and tips on how to use the intervention, with an emphasis on providing effective feedback using the advocacy-inquiry model. A brief description of the intervention will be provided to trainees. The Site Investigator will contact trainees at the end of each week to determine compliance with using the tool, and follow-up with specialists and trainees as required.

Intervention code [1] 293542 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296957 0
Educational environment, assessed by survey of trainees designed specifically for this study (modified Anaesthesia Trainee Educational Environment Measure or mATEEM).
Timepoint [1] 296957 0
Survey completed at end of 4 week intervention period.
Primary outcome [2] 296958 0
Feasibility of study design with regards to quantitative (mATEEM) and qualitative (trainee focus group) measures, assessed based on results of both measures and feedback from Site Investigators.
Timepoint [2] 296958 0
mATEEM and trainee focus group completed at end of 4 week intervention period.
Primary outcome [3] 296959 0
Levels of outcome variability, to calculate sample size for quantitative aspect of main study.
Timepoint [3] 296959 0
At end of 4 week intervention period
Secondary outcome [1] 319767 0
Proportion of specialists and trainees in departments consenting to participate in study
Timepoint [1] 319767 0
At end of recruitment period, just prior to 4 week intervention period
Secondary outcome [2] 319768 0
Compliance rate of CRAFT model use during teaching encounters, assessed using information from trainees obtained by Site Investigator
Timepoint [2] 319768 0
At end of each week of 4 week intervention period

Eligibility
Key inclusion criteria
Delphi study phase: Experts identified through stated process. Expert = specialist anaesthetist registered in New Zealand or Australia with a formal medical education qualification.

Institution: Any hospital department of anaesthesia that is accredited for vocational training
with English as the main language of instruction, with consent from the Clinical Director and Supervisor of Training.

Specialists: Any specialist anaesthetist employed in a participating institution
who has not opted out of the study.

Trainees: Any trainee/resident/medical officer employed in a participating institution who
has not opted out of the study, with at least 8 weeks of clinical anaesthesia experience in that
department. Separate consent is obtained for trainee focus groups.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All institutions/participants: Those who have declined to consent.

Institutions: <30% of specialists or <50% of trainees consenting to participate.

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)
None.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is an interventional study with pre- and post-intervention measurement of the educational environment using a survey tool (mATEEM) and qualitative analysis using focus groups..
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Delphi phase (development and validation of survey): An item is deemed to be relevant to anaesthesia teaching encounters in the operating theatre if a mean of 5.0 or above is obtained and consensus is achieved (i.e. SD equal to or less than 1.0).

Statistician input to estimate the levels of outcome variability to determine samples sizes for main study, including power for any sub-analysis.

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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 7499 0
New Zealand
State/province [1] 7499 0

Funding & Sponsors
Funding source category [1] 292634 0
Hospital
Name [1] 292634 0
Department of Anaesthesia and Perioperative Medicine, North Shore Hospital, Waitemata District Health Board
Address [1] 292634 0
North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0622
Country [1] 292634 0
New Zealand
Primary sponsor type
Hospital
Name
Department of Anaesthesia & Perioperative Medicine, North Shore Hospital
Address
North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 291351 0
None
Name [1] 291351 0
None
Address [1] 291351 0
None
Country [1] 291351 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
The purpose of this study is to determine if the CRAFT tool, a tool developed to promote deliberate teaching in the operating theatre, can improve the educational environment of junior doctors training in anaesthesia.

The educational environment will be assessed using a specific survey tool developed for this purpose, the modified Anaesthesia Theatre Educational Environment Measure (mATEEM). In addition, qualitative aspects of the CRAFT tool application will measure assessed using focus groups.

This pilot study aims to:
1.) Develop and validate the mATEEM survey items
2) Determine the feasibility of the quantitative and qualitative aspects of the study
3) Determine participation rates of specialists and trainees in each department, and subsequent compliance rates of utilising the CRAFT tool
4) Estimate the levels of outcome variability to determine samples sizes for a future definitive study
Trial website
Trial related presentations / publications
Public notes
Institutional locality approval has been obtained from Awhina Research and Knowledge, Waitemata District Health Board (Approval ID: RM13266), who have determined that formal ethics approval is not necessary.

Contacts
Principal investigator
Name 61066 0
Dr Navdeep Sidhu
Address 61066 0
Department of Anaesthesia and Perioperative Medicine
North Shore Hospital
Private Bag 93-503
Takapuna
Auckland 0740
Country 61066 0
New Zealand
Phone 61066 0
+64 9 4868900
Fax 61066 0
+64 9 4423237
Email 61066 0
nav.sidhu@waitematadhb.govt.nz
Contact person for public queries
Name 61067 0
Dr Navdeep Sidhu
Address 61067 0
Department of Anaesthesia and Perioperative Medicine
North Shore Hospital
Private Bag 93-503
Takapuna
Auckland 0740
Country 61067 0
New Zealand
Phone 61067 0
+64 9 4868900
Fax 61067 0
+64 9 4423237
Email 61067 0
nav.sidhu@waitematadhb.govt.nz
Contact person for scientific queries
Name 61068 0
Dr Navdeep Sidhu
Address 61068 0
Department of Anaesthesia and Perioperative Medicine
North Shore Hospital
Private Bag 93-503
Takapuna
Auckland 0740
Country 61068 0
New Zealand
Phone 61068 0
+64 9 4868900
Fax 61068 0
+64 9 4423237
Email 61068 0
nav.sidhu@waitematadhb.govt.nz

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