ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

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]

Difference in MET performance of non-technical skills after implementation of NTST as assessed by qualitative scoring on an observation tool

Timepoint [1]

1 year

Primary outcome [2]

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]

1 year

Secondary outcome [1]

Patient-centric: ICU length-of-stay. These data will recorded by active patient follow up and later review of case records.

Timepoint [1]

1 year

Secondary outcome [2]

Patient-centric: Mortality at ICU discharge. These data will recorded by active patient follow up and later review of case records.

Timepoint [2]

1 year

Secondary outcome [3]

Patient-centric: Hospital length-of-stay. These data will recorded by active patient follow up and later review of case records.

Timepoint [3]

1 year

Secondary outcome [4]

Patient-centric: Mortality at ICU discharge. These data will recorded by active patient follow up and later review of case records.

Timepoint [4]

1 year

Secondary outcome [5]

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]

1 year

Secondary outcome [6]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Lyell McEwin Hospital - Elizabeth Vale

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Lyell McEwin Hospital

Address [1]

Haydown Road
Elizabeth Vale
SA 5112

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Safety and Quality Unit

Address [1]

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Human Research Ethics Committee (TQEH/LMH/MH)

Ethics committee address [1]

The Queen Elizabeth Hospital
Woodville Road
Woodville South
SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/01/2012

Approval date [1]

18/05/2012

Ethics approval number [1]

2012069

Summary

Brief summary

The concept of non-technical skills training (NTST) arose in the aviation industry after observation that a number of avoidable incidents were caused by human error rather than mechanical failure. In medical training, clinical knowledge and skills are emphasised with little attention given to “human factors”. These encompass such aspects as leadership, team-working, communication and decision-making. Thus far, study in this area has been restricted to simulations. Our project aims to evaluate the impact of implementation of training in non-technical skills for our Medical Emergency Team (MET) service on team performance and patient outcomes.
This will be a multi-partite quality improvement project run at the Lyell McEwin Hospital, a tertiary metropolitan hospital in Adelaide. We plan to perform a retrospective audit of existing MET service data to establish baseline data. Then a period of prospective study will occur before and after delivery of NTST to members of the MET service. Team attendances will be independently observed for demonstration of non-technical skills and patients will be tracked during their hospital admission. A pilot observation will also be conducted to validate the observational assessment tool and measure inter-rater reliability between the investigators.
The primary outcomes will be 1) MET performance of non-technical skills as graded by a specifically developed qualitative assessment tool and 2) incidence of efferent limb failure as defined by a) requirement for a second MET attendance within 24 hours for the same calling criterion, b) unplanned admission to the Intensive Care Unit (ICU) within 24 hours of MET attendance, c) unexpected cardiac arrest and/or death within 24 hours of MET attendance. Secondary outcomes will include hospital and ICU length-of-stay, and vital status at hospital discharge. These will be used as a comparator between all periods of the project.
NTST will be delivered to MET members by the investigators in collaboration with a group of active instructors from QANTAS and the Royal Australian Air Force Reserves. Oversight will be provided by the hospital Safety and Quality Unit. The baseline audit will include 2000 patients and the observational stage of the study is anticipated to enrol 600 patients, equally divided between the before- and after-NTST periods.
We aim to demonstrate that training in non-technical skills improves MET service performance leading to a reduction in incidence of efferent limb failure. The anticipation is that this will then extrapolate to reductions in length-of-stay and mortality.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Richard Chalwin

Address

Lyell McEwin Hospital
Elizabeth Vale
SA 5112

Country

Australia

Phone

+61 8 8182 9000

Fax

richard.chalwin@health.sa.gov.au

Contact person for public queries

Name

Dr Richard Chalwin

Address

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112

Country

Australia

Phone

+61882820890

Fax

+61882820889

richard.chalwin@health.sa.gov.au

Contact person for scientific queries

Name

Dr Richard Chalwin

Address

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112

Country

Australia

Phone

+61882820890

Fax

+61882820889

richard.chalwin@health.sa.gov.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

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