Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000280808
Ethics application status
Approved
Date submitted
6/03/2012
Date registered
9/03/2012
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Non-technical Skills Training on Performance and Effectiveness of a Medical Emergency Team
Scientific title
Impact on a Medical Emergency Team of Non-Technical Skills Training in a before-and-after trial assessing performance and effectiveness
Secondary ID [1] 280085 0
NCT01551160
Universal Trial Number (UTN)
U1111-1128-9288
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-technical skills training for members of a hospital Medical Emergency Team 285996 0
Condition category
Condition code
Public Health 286188 286188 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non-technical skills training will be provided for members of a hospital Medical Emergency Team (MET) currently drawn from a pool of approximately 80 clinicians. This will take the form of a half-day group session to be conducted annually which will include lectures and simulations.
The training will be delivered by experienced clinicians under the supervision of accredited Royal Australian Air Force Reserve Crew Resource Management trainers.
This training will occur after the Medical Emergency Team has been observed during actual patient attendances. Their performance of non-technical skills will be quantatively assessed with a (yet to be validated) observational tool. A similar period of observation will occur after the training session has been delivered. The trial is only planned to observe performance before and after delivery of the first training session at this stage. A second period of after-observation may be conducted depending on funding availability. Training sessions will continue annually for at least 3 years after completion of the trial as part of a planned hospital quality improvement initiative.
600 patients attended during both observational periods will be followed up for hospital outcome per the secondary outcomes.
Baseline MET activity and patient outcomes will be assessed by audit of 2000 historical MET service records.
Intervention code [1] 284410 0
Other interventions
Comparator / control treatment
There will be no control treatment. Data will be recorded on prospectively observed performance of non-technical skills and patient outcomes in a before-and-after format. Otherwise all aspects of patient care and MET operation will remain the same. Therefore the MET will act as its own control with performance (and patient outcomes) during the before period being compared in analysis versus performance (and patient outcomes) during the after period.
A baseline audit will be conducted on all historical MET records between July 2009 and June 2014
Control group
Historical

Outcomes
Primary outcome [1] 286652 0
Difference in MET performance of non-technical skills after implementation of NTST as assessed by qualitative scoring on an observation tool
Timepoint [1] 286652 0
1 year
Primary outcome [2] 286653 0
Difference in incidence of efferent limb failure after implementation of NTST by follow-up of patients attended by the MET service and later review of records.
Timepoint [2] 286653 0
1 year
Secondary outcome [1] 296384 0
Patient-centric: ICU length-of-stay. These data will recorded by active patient follow up and later review of case records.
Timepoint [1] 296384 0
1 year
Secondary outcome [2] 296385 0
Patient-centric: Mortality at ICU discharge. These data will recorded by active patient follow up and later review of case records.
Timepoint [2] 296385 0
1 year
Secondary outcome [3] 296423 0
Patient-centric: Hospital length-of-stay. These data will recorded by active patient follow up and later review of case records.
Timepoint [3] 296423 0
1 year
Secondary outcome [4] 296424 0
Patient-centric: Mortality at ICU discharge. These data will recorded by active patient follow up and later review of case records.
Timepoint [4] 296424 0
1 year
Secondary outcome [5] 296425 0
MET service based: MET dose (i.e. number of MET calls per 1000 hospital in-patient admissions. These data will be obtained from MET service database records.
Timepoint [5] 296425 0
1 year
Secondary outcome [6] 296426 0
MET service based: Incidence of unplanned ICU admission, cardiac arrest of death per 1000 hospital in-patient admissions. These data will be obtained from MET service database records.
Timepoint [6] 296426 0
1 year

Eligibility
Key inclusion criteria
Patients or persons subject to LMH MET service review.
All MET members (currently numbering approximately 80 total eligible clinicians, with ad-hoc involvement per working patterns to provide 5 members per MET activation) will all be eligible for inclusion as the aim of the study is to assess the performance and function of the team (as an entity), rather than any individual. The members are not currently aware of the nature of the trial to facilitate(limited) blinding; they will be aware of observation occurring but not the nature of the data being recorded. Departmental heads and hospital executive have approved conduct of the observation.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients in the ICU, Emergency Department or Operating Theatre suite
Cancellation of the MET response prior to, or on arrival at, the location of activation
Patients < 16 years of age
MET attendances involving members of the investigating team acting in a clinical role will not be observed due to awareness of the study purpose and inevitable confounding

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)
All active members of the Medical Emergency Team (MET) will be provided with non-technical skills training. Their performance of non-technical skills at MET attendances will be observed in a before-and-after fashion. Patients will be followed up for hospital outcomes only (see secondary outcomes).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
The MET service will maintain the same composition, structure and operating policy during all study periods.
From the patient perspective, this will be a non-interventional trial and care will not be directly affected by the conduct of the trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2013
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4453 0
Lyell McEwin Hospital - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 284840 0
Hospital
Name [1] 284840 0
Lyell McEwin Hospital
Country [1] 284840 0
Australia
Primary sponsor type
Individual
Name
Dr Richard Chalwin
Address
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country
Australia
Secondary sponsor category [1] 283718 0
None
Name [1] 283718 0
Address [1] 283718 0
Country [1] 283718 0
Other collaborator category [1] 260603 0
Hospital
Name [1] 260603 0
Safety and Quality Unit
Address [1] 260603 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country [1] 260603 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286829 0
The Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 286829 0
Ethics committee country [1] 286829 0
Australia
Date submitted for ethics approval [1] 286829 0
01/01/2012
Approval date [1] 286829 0
18/05/2012
Ethics approval number [1] 286829 0
2012069

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

Contacts
Principal investigator
Name 33875 0
Dr Richard Chalwin
Address 33875 0
Lyell McEwin Hospital
Elizabeth Vale
SA 5112
Country 33875 0
Australia
Phone 33875 0
+61 8 8182 9000
Fax 33875 0
Email 33875 0
[email protected]
Contact person for public queries
Name 17122 0
Dr Richard Chalwin
Address 17122 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 17122 0
Australia
Phone 17122 0
+61882820890
Fax 17122 0
+61882820889
Email 17122 0
[email protected]
Contact person for scientific queries
Name 8050 0
Dr Richard Chalwin
Address 8050 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 8050 0
Australia
Phone 8050 0
+61882820890
Fax 8050 0
+61882820889
Email 8050 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.